The U.S. plans to launch a program to train health care workers in Mozambique in an effort to strengthen the country's health system and fight HIV/AIDS and malaria, Mozambican Health Minister Ivo Garrido announced Wednesday after a meeting with HHS Secretary Mike Leavitt and Mozambican President Armando Guebuza, AIM/AllAfrica reports (AIM/AllAfrica, 8/22). Leavitt and several U.S. officials are on a 10-day tour of four African countries to highlight programs funded by the President's Emergency Plan for AIDS Relief and the President's Malaria Initiative. Their first stop was South Africa, and they also plan to visit Rwanda and Tanzania (Kaiser Daily HIV/AIDS Report, 8/17).
Guebuza and Leavitt at the meeting discussed Mozambique's health infrastructure and ways to strengthen collaboration on health issues between the two countries. Garrido did not disclose further details on the training program but said priority will be given to health professionals working in rural areas in Mozambique. "We believe that we can do a lot more in this area, being the reason our discussions gravitated around issues such as training of human recourses," Garrido said.
Mozambique has a total of about 800 doctors, and there is about one doctor for every 24,000 residents, according to Garrido. This ratio is "frankly bad, when we consider that on average the developed countries have one doctor for less than 1,000 inhabitants," he said. Leavitt expressed his support for the country's efforts to fight HIV/AIDS and malaria, emphasizing that discussions held with Mozambican authorities will help both countries work together more closely. Current estimates show that Mozambique has an HIV/AIDS prevalence of 16.2%, and malaria is responsible for more than 40% of outpatient visits and 30% of deaths among people admitted to hospitals in the country (AIM/AllAfrica, 8/22).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
среда, 21 сентября 2011 г.
US Health Savings Accounts Attract Younger, Higher-Income FEHBP Members, Report Finds
Federal Employees Health Benefits Program members enrolled in high-deductible health plans associated with health savings accounts on average are younger than those enrolled in traditional plans and more likely to have annual incomes of $75,000 or more, according to a Government Accountability Office report released on Thursday, CQ HealthBeat reports. According to the report, which examined data for the first year in which HSAs became available in FEHBP, the average age of members who enrolled in high-deductible plans associated with HSAs was 46, compared with 59 for all members. In addition, the report finds that, when retirees are excluded, the average ages of FEHBP members who enrolled in high-deductible plans associated with HSAs was 44, compared with 47 for all members. However, according to the report, a new health plan unrelated to HSAs that recently became available in FEHBP also attracted a higher rate of younger members. The report states, "Thus it is not clear whether younger individuals were uniquely attracted to high deductible health plans, or if younger enrollees are typical of recently introduced health plans in general." The report finds that 43% of FEHBP members who enrolled in high-deductible plans associated with HSAs had annual incomes of $75,000 or more, compared with 23% of all members. According to the report, the results indicate that high-deductible plans associated with HSAs "uniquely attract higher-income individuals with the means to pay higher deductibles and the desire to accrue tax-free savings." The report also finds:
Cost-sharing for preventive care for FEHBP members enrolled in high-deductible plans associated with HSAs was "the same or less than (for) traditional plan enrollees and always covered certain preventive care services before the deductible was met," although the same services "were not always covered before the deductible by their traditional plan counterparts";
Traditional health plans were much more likely than high-deductible plans associated with HSAs to cover prescription drugs before the deductible was met; and
Monthly premiums for high-deductible health plans associated with HSAs averaged $91 for individuals and $208 for families, compared with $99 and $243, respectively, for traditional plans.
According to the report, more data is required to determine whether FEHBP members who enrolled in high-deductible plans associated with HSAs were healthier than all members. Rep. Pete Stark (D-Calif.) said the report "verifies" that high-deductible plans associated with HSAs "are designed for healthy, wealthy people," adding, "Despite this reality, President Bush is pushing them on low-income workers -- not to provide them with better health insurance, but to meet his long-term goal of dismantling employer-provided health care" (Reichard, CQ HealthBeat, 2/2).
The report is available online. Note: You must have Adobe Acrobat Reader to view the report.
Cost-sharing for preventive care for FEHBP members enrolled in high-deductible plans associated with HSAs was "the same or less than (for) traditional plan enrollees and always covered certain preventive care services before the deductible was met," although the same services "were not always covered before the deductible by their traditional plan counterparts";
Traditional health plans were much more likely than high-deductible plans associated with HSAs to cover prescription drugs before the deductible was met; and
Monthly premiums for high-deductible health plans associated with HSAs averaged $91 for individuals and $208 for families, compared with $99 and $243, respectively, for traditional plans.
According to the report, more data is required to determine whether FEHBP members who enrolled in high-deductible plans associated with HSAs were healthier than all members. Rep. Pete Stark (D-Calif.) said the report "verifies" that high-deductible plans associated with HSAs "are designed for healthy, wealthy people," adding, "Despite this reality, President Bush is pushing them on low-income workers -- not to provide them with better health insurance, but to meet his long-term goal of dismantling employer-provided health care" (Reichard, CQ HealthBeat, 2/2).
The report is available online. Note: You must have Adobe Acrobat Reader to view the report.
Benefits for Employers
In related news, the Wall Street Journal on Friday examined how HSAs "are generating savings on payroll taxes for companies that adopt them, and they could hasten a shift of health care costs from companies to employees." According to the Journal, HSAs might "be poised to become the 401(k)s of health care: a low-cost substitute for a once standard workplace-provided benefit." Employers receive tax benefits from HSAs, regardless of whether they "contribute a cent" to the accounts, and "the more of their own pay employees set aside each year, the bigger their employers' tax breaks" because of reduced payroll taxes, the Journal reports. According to Rebecca Miller, a tax specialist with McGladrey & Pullen, at a minimum payroll tax savings from HSAs "basically pay the administrative costs" of the accounts. Princeton University economist Uwe Reinhardt added that the payroll tax savings could provide employers with "an incentive to encourage contributions" to HSAs by employees. However, James Klein, president of the American Benefits Council, said, "In the scheme of what health care costs are, I doubt that would be a compelling reason to move to that kind of plan design" (Francis/Schultz, Wall Street Journal, 2/3).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
WHO EURO Region Ministerial Forum On TB Must Reach Out Beyond Borders Of Europe
The WHO EURO region's Ministerial Forum on tuberculosis on October 22, 2007, in Berlin, must take account of the threat of TB both outside as well as inside Europe if it is to be tackled adequately. These are the conclusions of authors of a Comment published in this week's edition of The Lancet.
The Comment is authored by Dr Bruce Currey, Professor Quazi Quamruzzaman, and Professor Mahmuder Rahman, Dhaka Community Hospital, Dhaka, Bangladesh. They say that in a 21st century that is becoming more and more global, to reduce the incidence of tuberculosis within Europe, European ministers must act together and act now, not simply to control, but also to eradicate poverty and tuberculosis in the source communities of Europe's migrant workers and major trade partners outside Europe. The Ministerial Forum must confront the raging red bull of tuberculosis infections outside Europe.
It goes on to say that the Berlin forum paper emphasises the 66 000 deaths from tuberculosis inside Europe in 2005, but overlooks the 1•6 million deaths outside Europe. It adds that radical reduction of the incidence of tuberculosis both inside and outside Europe requires prevention of the progression to new active cases as well as management of active cases. Eradication is possible, but not with drugs alone.
Further, it adds: "Trade and trade embargoes affect the incidence of tuberculosis. The Centres for Disease Control and Prevention has shown how radical intervention in the Hmong refugee centres of Thailand can reduce the incidence of tuberculosis and multidrug-resistant tuberculosis in the Hmong in Frenso, California."
The Comment authors propose a six-pronged approach to tackling the tuberculosis threat, including incorporating populations outside Europe, and the Forum accepting responsibility for actions such as arms trading and oil prices which increase inequality and tuberculosis incidence worldwide. The last of the six parts of the authors' suggested action calls on the Forum to get behind the UK Prime Minister's address to the UN in July 2007, to "act now" to tackle global poverty and "eradicate" the scourge of diseases such as tuberculosis, and his commitment that there are resources available to eradicate the disease.
The Comment concludes: "If the Berlin Ministerial Forum wishes to act now to eradicate tuberculosis, it must reach out far beyond the borders of Europe."
The Lancet
The Comment is authored by Dr Bruce Currey, Professor Quazi Quamruzzaman, and Professor Mahmuder Rahman, Dhaka Community Hospital, Dhaka, Bangladesh. They say that in a 21st century that is becoming more and more global, to reduce the incidence of tuberculosis within Europe, European ministers must act together and act now, not simply to control, but also to eradicate poverty and tuberculosis in the source communities of Europe's migrant workers and major trade partners outside Europe. The Ministerial Forum must confront the raging red bull of tuberculosis infections outside Europe.
It goes on to say that the Berlin forum paper emphasises the 66 000 deaths from tuberculosis inside Europe in 2005, but overlooks the 1•6 million deaths outside Europe. It adds that radical reduction of the incidence of tuberculosis both inside and outside Europe requires prevention of the progression to new active cases as well as management of active cases. Eradication is possible, but not with drugs alone.
Further, it adds: "Trade and trade embargoes affect the incidence of tuberculosis. The Centres for Disease Control and Prevention has shown how radical intervention in the Hmong refugee centres of Thailand can reduce the incidence of tuberculosis and multidrug-resistant tuberculosis in the Hmong in Frenso, California."
The Comment authors propose a six-pronged approach to tackling the tuberculosis threat, including incorporating populations outside Europe, and the Forum accepting responsibility for actions such as arms trading and oil prices which increase inequality and tuberculosis incidence worldwide. The last of the six parts of the authors' suggested action calls on the Forum to get behind the UK Prime Minister's address to the UN in July 2007, to "act now" to tackle global poverty and "eradicate" the scourge of diseases such as tuberculosis, and his commitment that there are resources available to eradicate the disease.
The Comment concludes: "If the Berlin Ministerial Forum wishes to act now to eradicate tuberculosis, it must reach out far beyond the borders of Europe."
The Lancet
Uterine Infection In Pregnant Women Linked With Asthma In Preterm Infants, Study Finds
A study published Tuesday in the Archives of Pediatric and Adolescent Medicine suggests that preterm infants born to women who had a uterine inflammation known as chorioamnionitis face an increased likelihood of developing asthma by age eight, USA Today reports (Rubin, USA Today, 2/2). Chorioamnionitis, a bacterial infection, affects roughly 8% of pregnancies and, by some estimates, is linked with more than 50% of preterm birth -- those before 37 weeks' gestation. Symptoms of the infection include a fever higher than 100.4 degrees, high maternal or fetal heart rate, uterine tenderness, foul-smelling amniotic fluid and elevated white blood-cell counts (Maugh, Los Angeles Times, 2/2). However, the condition can be difficult to diagnose because the symptoms are not definitive and might not occur in some women who have the infection, according to lead author Darios Getahun, a scientist at Kaiser Permanente Southern California's Department of Research and Evaluation (USA Today, 2/2).
Getahun's team reviewed electronic health records for 397,852 births in Southern California from 1991 to 2007 (Allen, Reuters, 2/1). Black children whose mothers gave birth before 37 weeks and had chorioamnionits were 50% more likely to develop asthma by age eight. The likelihood was more pronounced for Hispanic and white babies, who were 70% and 66% more likely to develop asthma, respectively. The increases persisted after researchers accounted for other asthma risk factors. The study found no link between higher asthma rates and chorioamnionitis in full-term births or preterm births among Asians or Pacific Islanders. Getahun's team is now trying to identify a marker in the woman's blood that could verify if symptoms are caused by chorioamnionitis (USA Today, 2/2).
Reprinted with kind permission from nationalpartnership. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.
© 2010 The Advisory Board Company. All rights reserved.
Upward Trend In Frequency And Cost Of Infections In US Hospitals
A new review of inpatient data from US hospitals shows that the number of infections caused by a common bacterium increased by over 7 percent each year from 1998 to 2003. The attendant economic burden to hospitals increased by nearly 12 percent annually. The research is published in the November 1 issue of Clinical Infectious Diseases, now available online.
Staphylococcus aureus (also known as staph) is a significant cause of a wide range of infectious diseases in humans, ranging from minor skin infections to life-threatening diseases such as pneumonia and meningitis. In 1998, US hospitals reported a little more than a quarter-million staph infections and slightly over 7 percent of those patients died. By the final year of this study, 2003, hospitals reported nearly 390,000 infections, representing 1 percent of that year's inpatient stays.
The authors suggest one possible reason for the increase in infections is the documented increase of a particularly dangerous type of antibiotic-resistant staph infection known as MRSA (methicillin-resistant Staphylococcus aureus). A more benign possibility is that doctors and hospitals have improved their infection detection and reporting practices.
The good news is that the staph-related in-hospital mortality rate dropped by almost 5 percent each year. The decrease in the in-hospital mortality risk may be due to the introduction of more stringent infection control programs or due to appropriate early treatment of MRSA infections with an effective antibiotic, the authors write.
Hospital expenditures associated with staph infections are substantial, increasing from $8.7 billion in 1998 to $14.5 billion in 2003. This economic burden incorporates such factors as extended length of hospitalization and additional surgery, medications, lab tests, and radiologic studies. Lead author Gary Noskin, MD, of Northwestern Memorial Hospital in Chicago, hypothesized that the reason the economic burden increased at a faster pace than the number of infections is because hospital costs are increasing more quickly.
The authors used data from the Agency for Healthcare Research and Quality's Nationwide Inpatient Sample database, which contains data from approximately 7 million hospital stays annually.
Unfortunately, the authors were not able to determine the contribution of MRSA infections to costs or outcomes because hospitals generally use the same codes for MRSA and regular staph infections. "We do suggest that coding standards should be changed to more accurately reflect the difference between these two bacteria so we can better understand the impact of MRSA," said Dr. Noskin.
###
Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of areas of infectious disease, and is one of the most highly regarded journals in this specialty. It is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Virginia, IDSA is a professional society representing more than 8,000 physicians and scientists who specialize in infectious diseases. For more information, visit idsociety/.
Source: Steve Baragona
Infectious Diseases Society of America
Staphylococcus aureus (also known as staph) is a significant cause of a wide range of infectious diseases in humans, ranging from minor skin infections to life-threatening diseases such as pneumonia and meningitis. In 1998, US hospitals reported a little more than a quarter-million staph infections and slightly over 7 percent of those patients died. By the final year of this study, 2003, hospitals reported nearly 390,000 infections, representing 1 percent of that year's inpatient stays.
The authors suggest one possible reason for the increase in infections is the documented increase of a particularly dangerous type of antibiotic-resistant staph infection known as MRSA (methicillin-resistant Staphylococcus aureus). A more benign possibility is that doctors and hospitals have improved their infection detection and reporting practices.
The good news is that the staph-related in-hospital mortality rate dropped by almost 5 percent each year. The decrease in the in-hospital mortality risk may be due to the introduction of more stringent infection control programs or due to appropriate early treatment of MRSA infections with an effective antibiotic, the authors write.
Hospital expenditures associated with staph infections are substantial, increasing from $8.7 billion in 1998 to $14.5 billion in 2003. This economic burden incorporates such factors as extended length of hospitalization and additional surgery, medications, lab tests, and radiologic studies. Lead author Gary Noskin, MD, of Northwestern Memorial Hospital in Chicago, hypothesized that the reason the economic burden increased at a faster pace than the number of infections is because hospital costs are increasing more quickly.
The authors used data from the Agency for Healthcare Research and Quality's Nationwide Inpatient Sample database, which contains data from approximately 7 million hospital stays annually.
Unfortunately, the authors were not able to determine the contribution of MRSA infections to costs or outcomes because hospitals generally use the same codes for MRSA and regular staph infections. "We do suggest that coding standards should be changed to more accurately reflect the difference between these two bacteria so we can better understand the impact of MRSA," said Dr. Noskin.
###
Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of areas of infectious disease, and is one of the most highly regarded journals in this specialty. It is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Virginia, IDSA is a professional society representing more than 8,000 physicians and scientists who specialize in infectious diseases. For more information, visit idsociety/.
Source: Steve Baragona
Infectious Diseases Society of America
Understanding how bacteria communicate may help scientists prevent disease
Rahul Kulkarni, assistant professor of physics at Virginia Tech, has been awarded a Ralph E. Powe Junior Faculty
Enhancement Award from Oak Ridge Associated Universities to continue his research on quorum sensing in bacteria. He is
modeling the sequence of events that initiate activity, such as virulence, by a bacteria colony once it has reached a
critical size.
The Powe award provides seed money of $5,000 to faculty members who are in the first two years of their tenure track as an
investment in promising achievements in an important area. The institution matches the award.
Much like a legislative body, some bacteria need a quorum, the presence of a critical number of individuals, before they can
engage in particular activities. Typically these are activities that are only productive when carried out in unison by a
community of bacteria.
The example often given is bioluminescence. Scientists noticed that once a population or colony of particular bacteria
reached a certain size, the colony began to emit light. "Now many people realize that other important activities also depend
upon a quorum, such as biofilm formation, releasing toxins, or becoming a virulent invader," said Rahul Kulkarni. While
Kulkarni works with Vibrio cholerae as a model bacteria, quorum sensing appears to be a universal process in bacteria. So
what he learns about the communication process known as quorum sensing could one day help scientists prevent a broad range of
diseases caused by bacteria that are human pathogens.
How do bacteria know how many are present? Each bacterium releases a small molecule, called an autoinducer. Each bacterium
also has receptors - proteins on its cell surface -- to sense autoinducers. As the amount of autoinducer reaches a critical
level, the bacteria know they have a quorum because a change is initiated in the receptor protein, which then causes a series
of further changes within each bacterium.
Kulkarni is looking at the network of genes involved in this process. Working with a group at Princeton University and at
Virginia Tech, "we are trying to understand how changes in the environment are integrated and result in changes in behavior,"
he said.
What was not known until recently is a crucial missing link in the network in each bacterium that results in the ability to
change behavior. Just before he came to Virginia Tech in August 2004, Kulkarni and his collaborators at Princeton solved the
mystery. Using bioinformatics and modeling, Kulkarni drafted theoretical predictions for the missing regulatory element,
which were confirmed experimentally by his colleagues at Princeton.
"We showed that the crucial missing element was a group of genes called small RNAs. ("The small RNA chaperone Hfq and
multiple small RNAs control quorum sensing in Vibrio harveyi and Vibrio cholerae," by D.H. Lenz, K.C. Mok, B.N. Lilley, R.V.
Kulkarni, N.S. Wingreen, and B.L. Bassler, published in Cell, July 9, 2004). "As it turns out, quorum sensing is a hot topic
in biology, and small RNAs is another hot topic. The convergence of these topics is exciting, and it has resulted in several
additional questions," Kulkarni said.
He will address these questions in his Powe-funded research. "We are asking, what are the environmental signals, apart from
quorum sensing, that are integrated by the small RNAs to initiate changes in behavior. An example might be the amount of
nutrients in the environment. Another question is why are there multiple RNAs? The sensing and communication circuit
functions even if some of the RNAs are removed - in fact, even if there is only one small RNA. Modeling the circuit will be
crucial in understanding how it functions and integrates signals from multiple inputs," Kulkarni said.
A third question is how the circuit regulates important biological processes, such as biofilm formation and virulence.
"Biofilms make bacteria resistant to antibiotics, so preventing the formation of biofilms or short-circuiting bacteria's
ability to become virulent by disturbing their communication network so they remain harmless, is an alternative strategy to
controlling disease," he said.
Kulkarni will continue his collaboration with the Princeton University group on V. cholerae and will collaborate with
Virginia Tech Biology Professor Ann Stevens, whose group is working on V. fischeri, the bacteria that causes luminescence and
whose genome has recently been sequenced ("Complete genome sequence of Vibrio fischeri: A symbiotic bacterium with pathogenic
congeners," by E. G. Ruby, M. Urbanowski, J. Campbell, A. Dunn, M. Faini, R. Gunsalus, P. Lostroh, C. Lupp, J. McCann, D.
Millikan, A. Schaefer, E. Stabb, A. Stevens, K. Visick, C. Whistler, and E. P. Greenberg, published Feb. 22, 2005 in the
Proceedings of the National Academy of Science.).
Kulkarni received his Master of Science degree in physics from the Indian Institute of Technology in Kanpur and his Ph.D. in
physics from Ohio State University. He was a postdoctoral researcher at the University of California, Davis, and a
postdoctoral research scientist at the NEC Laboratories America Inc. in Princeton, N.J.
Contact: Susan Trulove
STrulovevt.edu
540-231-5646
Virginia Tech
vtnews.vt.edu
Enhancement Award from Oak Ridge Associated Universities to continue his research on quorum sensing in bacteria. He is
modeling the sequence of events that initiate activity, such as virulence, by a bacteria colony once it has reached a
critical size.
The Powe award provides seed money of $5,000 to faculty members who are in the first two years of their tenure track as an
investment in promising achievements in an important area. The institution matches the award.
Much like a legislative body, some bacteria need a quorum, the presence of a critical number of individuals, before they can
engage in particular activities. Typically these are activities that are only productive when carried out in unison by a
community of bacteria.
The example often given is bioluminescence. Scientists noticed that once a population or colony of particular bacteria
reached a certain size, the colony began to emit light. "Now many people realize that other important activities also depend
upon a quorum, such as biofilm formation, releasing toxins, or becoming a virulent invader," said Rahul Kulkarni. While
Kulkarni works with Vibrio cholerae as a model bacteria, quorum sensing appears to be a universal process in bacteria. So
what he learns about the communication process known as quorum sensing could one day help scientists prevent a broad range of
diseases caused by bacteria that are human pathogens.
How do bacteria know how many are present? Each bacterium releases a small molecule, called an autoinducer. Each bacterium
also has receptors - proteins on its cell surface -- to sense autoinducers. As the amount of autoinducer reaches a critical
level, the bacteria know they have a quorum because a change is initiated in the receptor protein, which then causes a series
of further changes within each bacterium.
Kulkarni is looking at the network of genes involved in this process. Working with a group at Princeton University and at
Virginia Tech, "we are trying to understand how changes in the environment are integrated and result in changes in behavior,"
he said.
What was not known until recently is a crucial missing link in the network in each bacterium that results in the ability to
change behavior. Just before he came to Virginia Tech in August 2004, Kulkarni and his collaborators at Princeton solved the
mystery. Using bioinformatics and modeling, Kulkarni drafted theoretical predictions for the missing regulatory element,
which were confirmed experimentally by his colleagues at Princeton.
"We showed that the crucial missing element was a group of genes called small RNAs. ("The small RNA chaperone Hfq and
multiple small RNAs control quorum sensing in Vibrio harveyi and Vibrio cholerae," by D.H. Lenz, K.C. Mok, B.N. Lilley, R.V.
Kulkarni, N.S. Wingreen, and B.L. Bassler, published in Cell, July 9, 2004). "As it turns out, quorum sensing is a hot topic
in biology, and small RNAs is another hot topic. The convergence of these topics is exciting, and it has resulted in several
additional questions," Kulkarni said.
He will address these questions in his Powe-funded research. "We are asking, what are the environmental signals, apart from
quorum sensing, that are integrated by the small RNAs to initiate changes in behavior. An example might be the amount of
nutrients in the environment. Another question is why are there multiple RNAs? The sensing and communication circuit
functions even if some of the RNAs are removed - in fact, even if there is only one small RNA. Modeling the circuit will be
crucial in understanding how it functions and integrates signals from multiple inputs," Kulkarni said.
A third question is how the circuit regulates important biological processes, such as biofilm formation and virulence.
"Biofilms make bacteria resistant to antibiotics, so preventing the formation of biofilms or short-circuiting bacteria's
ability to become virulent by disturbing their communication network so they remain harmless, is an alternative strategy to
controlling disease," he said.
Kulkarni will continue his collaboration with the Princeton University group on V. cholerae and will collaborate with
Virginia Tech Biology Professor Ann Stevens, whose group is working on V. fischeri, the bacteria that causes luminescence and
whose genome has recently been sequenced ("Complete genome sequence of Vibrio fischeri: A symbiotic bacterium with pathogenic
congeners," by E. G. Ruby, M. Urbanowski, J. Campbell, A. Dunn, M. Faini, R. Gunsalus, P. Lostroh, C. Lupp, J. McCann, D.
Millikan, A. Schaefer, E. Stabb, A. Stevens, K. Visick, C. Whistler, and E. P. Greenberg, published Feb. 22, 2005 in the
Proceedings of the National Academy of Science.).
Kulkarni received his Master of Science degree in physics from the Indian Institute of Technology in Kanpur and his Ph.D. in
physics from Ohio State University. He was a postdoctoral researcher at the University of California, Davis, and a
postdoctoral research scientist at the NEC Laboratories America Inc. in Princeton, N.J.
Contact: Susan Trulove
STrulovevt.edu
540-231-5646
Virginia Tech
vtnews.vt.edu
The rapid "feminization" of the AIDS pandemic must be confronted
A Johns Hopkins physician and scientist who has spent a quarter-century leading major efforts to combat HIV and AIDS
worldwide has issued an urgent call for global strategies and resources to confront the rapid "feminization" of the AIDS
pandemic.
In an article appearing in the journal Science online June 10, Thomas C. Quinn, M.D., professor of infectious diseases at
Hopkins and a senior investigator at the National Institute of Allergy and Infectious Disease, reports that women have in the
last 20 years moved from those least affected by HIV to those in whom the disease is spreading fastest. "There has been a
shift in the AIDS pandemic, and the victims are different now," says Quinn, senior author of the Science article.
"Women make up nearly half of the 40 million people worldwide currently infected with HIV, the virus that causes AIDS, and in
some developing countries, women represent the vast majority of those living with HIV/AIDS," Quinn writes, whereas, at the
start of the pandemic in the early 1980s, men accounted for almost 90 percent of cases in developed countries. In the United
States from 1999 to 2003, the yearly increase in AIDS cases rose by 15 percent, but only by 1 percent in men.
"HIV/AIDS first targeted gay men and hemophiliacs in the early 1980s, then subsequently spread most quickly among intravenous
drug users and heterosexuals," he adds. "Now, it is having the most profound impact on women."
Internationally, Quinn and his team have led clinical trials of the first effective treatments that prevent HIV from
replicating, helped establish laboratory and treatment facilities in the Democratic Republic of the Congo, India and Uganda,
and counseled other governments across Africa and Asia about control efforts.
In the new article, he argues that women deserve a separate strategy because of the increasing and disproportionate numbers
becoming infected, and the social consequences of so many young mothers dying and leaving behind children who may also be
infected as well as orphaned. He also points out that medical research suggests hormonal and developmental factors place
young women at greater risk than men for contracting the virus when exposed to it.
In sub-Saharan Africa, 60 percent of people living with HIV are female, Quinn says, and in South Africa, Zambia and Zimbabwe,
young women ages 15 to 24 are three to six times more likely to be infected than men. Women make up half the adult population
living with the virus in the Caribbean and one-third of those in Latin America.
The reasons for the rise in female cases differ among countries, with 97 percent of female HIV infections in the United
States due to heterosexual transmission (81 percent) and intravenous drug use (16 percent). In the developing world,
heterosexual transmission is responsible for nearly all of the infections among women, and mother-to-child transmission
during childbirth further contributes to the spread of the disease. Women are particularly vulnerable to such cultural
factors as their relative lack of power in sexual relationships, widespread poverty, policies that deny women an education
and tolerance of violence against women.
Excessive biological vulnerability to HIV among young women, although not fully understood, is believed to be due to an
immature genital whose mucosal lining is easier for the virus to penetrate; to hormonal factors, such as the use of birth
control pills; and to a high incidence of sexually transmitted diseases, which inflame the female genital area and provide
additional target cells for the virus to infect.
According to Quinn, "societal changes will help over the long run, but immediate and faster action requires coordinated
efforts to focus on women, develop effective microbicides that women can use themselves and a gender-specific vaccine program
that takes into account the different immune responses between women and men."
Also needed, he says, are cultural programs for reshaping gender roles, such as educating more women about safe-sex
practices, use of condoms, lessons on negotiating safe sex, and awareness campaigns about where to seek testing and
treatment.
"Women are different when it comes to HIV infection," says Quinn. "If medical progress is to continue on how best to prevent
and treat the disease, then developing specific strategies that empower women will be key to its success."
For more information or to schedule an interview with Quinn, please contact David March at 410-955-1534, or dmarch1jhmi.edu.
Johns Hopkins Medical Institutions
hopkinsmedicine
worldwide has issued an urgent call for global strategies and resources to confront the rapid "feminization" of the AIDS
pandemic.
In an article appearing in the journal Science online June 10, Thomas C. Quinn, M.D., professor of infectious diseases at
Hopkins and a senior investigator at the National Institute of Allergy and Infectious Disease, reports that women have in the
last 20 years moved from those least affected by HIV to those in whom the disease is spreading fastest. "There has been a
shift in the AIDS pandemic, and the victims are different now," says Quinn, senior author of the Science article.
"Women make up nearly half of the 40 million people worldwide currently infected with HIV, the virus that causes AIDS, and in
some developing countries, women represent the vast majority of those living with HIV/AIDS," Quinn writes, whereas, at the
start of the pandemic in the early 1980s, men accounted for almost 90 percent of cases in developed countries. In the United
States from 1999 to 2003, the yearly increase in AIDS cases rose by 15 percent, but only by 1 percent in men.
"HIV/AIDS first targeted gay men and hemophiliacs in the early 1980s, then subsequently spread most quickly among intravenous
drug users and heterosexuals," he adds. "Now, it is having the most profound impact on women."
Internationally, Quinn and his team have led clinical trials of the first effective treatments that prevent HIV from
replicating, helped establish laboratory and treatment facilities in the Democratic Republic of the Congo, India and Uganda,
and counseled other governments across Africa and Asia about control efforts.
In the new article, he argues that women deserve a separate strategy because of the increasing and disproportionate numbers
becoming infected, and the social consequences of so many young mothers dying and leaving behind children who may also be
infected as well as orphaned. He also points out that medical research suggests hormonal and developmental factors place
young women at greater risk than men for contracting the virus when exposed to it.
In sub-Saharan Africa, 60 percent of people living with HIV are female, Quinn says, and in South Africa, Zambia and Zimbabwe,
young women ages 15 to 24 are three to six times more likely to be infected than men. Women make up half the adult population
living with the virus in the Caribbean and one-third of those in Latin America.
The reasons for the rise in female cases differ among countries, with 97 percent of female HIV infections in the United
States due to heterosexual transmission (81 percent) and intravenous drug use (16 percent). In the developing world,
heterosexual transmission is responsible for nearly all of the infections among women, and mother-to-child transmission
during childbirth further contributes to the spread of the disease. Women are particularly vulnerable to such cultural
factors as their relative lack of power in sexual relationships, widespread poverty, policies that deny women an education
and tolerance of violence against women.
Excessive biological vulnerability to HIV among young women, although not fully understood, is believed to be due to an
immature genital whose mucosal lining is easier for the virus to penetrate; to hormonal factors, such as the use of birth
control pills; and to a high incidence of sexually transmitted diseases, which inflame the female genital area and provide
additional target cells for the virus to infect.
According to Quinn, "societal changes will help over the long run, but immediate and faster action requires coordinated
efforts to focus on women, develop effective microbicides that women can use themselves and a gender-specific vaccine program
that takes into account the different immune responses between women and men."
Also needed, he says, are cultural programs for reshaping gender roles, such as educating more women about safe-sex
practices, use of condoms, lessons on negotiating safe sex, and awareness campaigns about where to seek testing and
treatment.
"Women are different when it comes to HIV infection," says Quinn. "If medical progress is to continue on how best to prevent
and treat the disease, then developing specific strategies that empower women will be key to its success."
For more information or to schedule an interview with Quinn, please contact David March at 410-955-1534, or dmarch1jhmi.edu.
Johns Hopkins Medical Institutions
hopkinsmedicine
Updated HIV Treatment Guidelines Now Include Three GSK HIV Medications For Initial Antiretroviral Treatment Regimens
Updated treatment guidelines issued
today by the International AIDS Society-USA (IAS-USA) now include three
GlaxoSmithKline HIV medications as part of their recommendations for
initial antiretroviral therapy. These guidelines were presented today at
the International AIDS Conference (IAC) in Toronto, Canada.
In the guidelines, EPZICOM(TM) (abacavir sulfate and lamivudine) and
COMBIVIR(R) (lamivudine and zidovudine) are both recommended nucleoside
reverse transcriptase inhibitors, and LEXIVA(R) (fosamprenavir calcium)
boosted with ritonavir is now listed among the recommended options for
protease inhibitor-based regimens in the initial treatment of adults with
HIV infection.
Additional information in the guidelines recommends the use of EPZICOM
as an initial NRTI backbone. "Abacavir in combination with lamivudine, has
comparable antiretroviral activity with the other dual NRTI components
listed in the guidelines." The guidelines also support the use of COMBIVIR
as a first-line therapy based on the "extensive clinical trial data set and
phase 4 experience supporting use."
The IAS-USA commissions expert panels to issue recommendations and
guidelines to provide standard approaches to patient care. The updated
guidelines published in the current issue of Journal of the American
Medical Association (JAMA) stated that, "[t]he choice of initial drug
centers on acceptability; predicted tolerance; pill burden; comorbid
conditions; short- term, mid-term and long-term adverse event profiles."
The updated guidelines reflect the international perspectives of the
panelists and are designed to serve as a tool for clinicians in countries
where resources are sufficient to provide relatively unrestricted choices
of drugs.
"We are pleased to see that the guidelines committee has recognized
COMBIVIR, EPZICOM, and LEXIVA as important treatment options for patients
with HIV," said Mark Shaefer, Director, Clinical Development, HIV
Infectious Disease Medicine Development Center at GSK.
IMPORTANT INDICATION AND SAFETY INFORMATION
FOR COMBIVIR, EPZICOM, AND LEXIVA
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to
others.
COMBIVIR
COMBIVIR is a combination tablet containing Epivir(R) (lamivudine, 3TC)
and Retrovir(R) (zidovudine, AZT).
INDICATIO COMBIVIR is indicated in combination with other antiretroviral agents for the treatment of HIV infection.
IMPORTANT SAFETY INFORMATION
All HIV drugs have side effects. The most commonly reported side
effects by patients who take COMBIVIR are: headache (35%), upset stomach
(33%), fatigue (27%), and nasal signs and symptoms (20%). Patients should
see their doctor regularly because serious side effects can occur, such as
muscle damage and a decrease in red and white blood cells. A buildup of
lactic acid in the blood and an enlarged liver, including fatal cases, have
been seen.
Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of COMBIVIR).
Patients should discuss any change in treatment with your doctor. Patients
who have both HBV and HIV and stop treatment with COMBIVIR should be
closely monitored by a doctor for at least several months.
Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus who are taking
anti-HIV medicines and are also being treated for hepatitis C with
interferon with or without ribavirin. If you are taking COMBIVIR as well as
interferon with or without ribavirin and you experience side effects, be
sure to tell your doctor.
When you start taking HIV medicines, your immune system may get
stronger and could begin to fight infections that have been hidden in your
body, such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
Changes in body fat may occur in some patients taking antiretroviral
therapy. These changes may include an increased amount of fat in the upper
back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat
from the legs, arms, and face may also occur. The cause and long-term
health effects of these conditions are not known at this time.
For complete prescribing information about COMBIVIR, visit
us.gsk/products/assets/us_combivir.pdf.
EPZICOM INDICATION
- EPZICOM, in combination with other antiretroviral agents, is indicated
for the treatment of HIV infection in adults.
- EPZICOM is one of 3 medicines containing abacavir. Before starting
EPZICOM, your healthcare professional will review your medical
history in order to avoid the use of abacavir if you have
experienced an allergic reaction to abacavir in the past.
- In one study, more patients had a severe hypersensitivity reaction
in the abacavir once-daily group than in the abacavir twice-daily
group.
- EPZICOM should not be used as part of a triple nucleoside regimen.
IMPORTANT SAFETY INFORMATION
EPZICOM contains abacavir, which is also contained in ZIAGEN(R)
(abacavir sulfate) and TRIZIVIR(R) (abacavir sulfate, lamivudine, and
zidovudine). Patients taking EPZICOM may have a serious allergic reaction
(hypersensitivity reaction) that can cause death.
If you get a symptom from 2 or more of the following groups while
taking EPZICOM, stop taking EPZICOM and call your doctor right away:
1. Fever
2. Rash
3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
4. Generally ill feeling, extreme tiredness, or achiness
5. Shortness of breath, cough, or sore throat.
Carefully read the Warning Card that your pharmacist gives you and
carry it with you at all times.
- If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM
or any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If
you take EPZICOM or any other abacavir-containing medicine again after
you have had an allergic reaction, WITHIN HOURS you may get life-
threatening symptoms that may include very low blood pressure or death.
- If you stop EPZICOM for any other reason, even for a few days, and you
are not allergic to EPZICOM, talk with your healthcare professional
before taking it again. Taking EPZICOM again can cause a serious or
life-threatening reaction, even if you never had an allergic reaction
before. If your healthcare professional tells you that you can take
EPZICOM again, start taking it when you are around medical help or
people who can call a doctor if you need one.
- A buildup of lactic acid in the blood and an enlarged liver, including
fatal cases, have been reported.
- Do not take EPZICOM if your liver does not function normally.
- Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of
EPZICOM). Discuss any change in treatment with your doctor. If you have
both HBV and HIV and stop treatment with EPZICOM, you should be closely
monitored by your doctor for at least several months.
- Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus who are taking
anti-HIV medicines and are also being treated for hepatitis C with
interferon with or without ribavirin. If you are taking EPZICOM as well
as interferon with or without ribavirin and you experience side effects,
be sure to tell your doctor.
- When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
- Changes in body fat may occur in some patients taking antiretroviral
therapy. The cause and long-term health effects of these conditions are
not known at this time.
- The most common side effects seen with the drugs in EPZICOM dosed once-
daily were allergic reaction, trouble sleeping, depression, headache,
tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain,
abnormal dreams, and anxiety. Most of the side effects do not cause
people to stop taking EPZICOM.
For full prescribing information please visit treathiv
LEXIVA
LEXIVA is a protease inhibitor that was co-discovered by
GlaxoSmithKline and Vertex Pharmaceuticals Incorporated.
INDICATION
- LEXIVA is indicated in combination with other antiretroviral agents for
the treatment of HIV infection in adults.
- The PI-experienced patient study was not large enough to reach a
definitive conclusion that LEXIVA/ritonavir and lopinavir/ritonavir
are clinically equivalent.
- Once-daily administration of LEXIVA/ritonavir is not recommended for
PI-experienced patients. LEXIVA does not cure HIV or prevent passing
HIV to others.
IMPORTANT SAFETY INFORMATION
- You should not take LEXIVA if you have had an allergic reaction to
LEXIVA or AGENERASE(R) (amprenavir).
- High blood sugar, diabetes or worsening of diabetes, and bleeding in
hemophiliacs have occurred in some patients taking protease inhibitors.
- When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
- Changes in body fat may occur in some patients taking antiretroviral
therapy. The cause and long-term health effects of these conditions are
not known at this time.
- Skin rashes can occur in patients taking LEXIVA. Rarely, rashes were
severe or life threatening.
- Opportunistic infections can develop when you have HIV and your immune
system is weak. It is very important that you see your healthcare
provider regularly while you are taking LEXIVA to discuss any side
effects or concerns.
- Most common side effects in clinical studies were diarrhea, headache,
nausea, rash, and vomiting. In most cases, these side effects did not
cause people to stop taking their medicine.
Drug Interactions
- LEXIVA should not be taken with: AGENERASE(R) (amprenavir), Halcion(R)
(triazolam), ergot medications (Cafergot(R), Migranal(R), D.H.E. 45(R),
and others), Propulsid(R) (cisapride), Versed(R) (midazolam), Orap(R)
(pimozide), Zocor(R) (simvastatin), Mevacor(R) (lovastatin), Rifadin(R)
(rifampin), Rescriptor(R) (delavirdine mesylate), or St. John's wort
(Hypericum perforatum). If you are taking Norvir(R) (ritonavir), you
should not take Tambocor(R) (flecainide), or Rythmol(R) (propafenone
hydrochloride).
- Serious and/or life-threatening events could occur between LEXIVA and
other medications, including Cordarone(R) (amiodarone), lidocaine
(intravenous only), Elavil(R) (amitriptyline HCl) and Tofranil(R)
(imipramine pamoate), tricyclic antidepressants, and Quinaglute(R)
(quinidine).
- Women who use birth control pills should choose a different kind of
contraception. LEXIVA can affect the safety and effectiveness of birth
control pills.
- Patients taking Viagra(R) (sildenafil citrate) or LEVITRA(R) (vardenafil
HCl) with LEXIVA may be at an increased risk of side effects.
- This list of drug interactions is not complete. Be sure to tell your
healthcare provider about all medicines you are taking or plan to take,
including over-the-counter drugs, vitamins, and herbals.
Resistance
- Missing or skipping doses of your medicine may make it easier for the
virus to mutate and multiply. Your medicines may not work as well
against a mutated virus and you may become cross-resistant to other HIV
medicines. It's important to take your medicine exactly as prescribed.
For full prescribing information please go to LEXIVA.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. The company is engaged in basic research programs
designed to investigate new targets to treat HIV.
GSK's Bridges to Access program can help provide qualified individuals
with access to GSK's antiretroviral medications, as well as help identify
insurance or other support for medications. Patients may be eligible for
this program if they are not eligible for prescription drug benefits
through any other private or public insurer, payer or program. In 2004,
GlaxoSmithKline donated more than $372.5 million worth of prescription
drugs to 475,000 patients. For more information, visit bridgestoaccess.gsk or call 1- 866-PATIENT.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex
co-discovered the HIV protease inhibitor, LEXIVA, with GlaxoSmithKline.
Vertex's press releases are available at vrtx.
GlaxoSmithKline
vrtx
View drug information on Combivir; Lexiva; Trizivir.
today by the International AIDS Society-USA (IAS-USA) now include three
GlaxoSmithKline HIV medications as part of their recommendations for
initial antiretroviral therapy. These guidelines were presented today at
the International AIDS Conference (IAC) in Toronto, Canada.
In the guidelines, EPZICOM(TM) (abacavir sulfate and lamivudine) and
COMBIVIR(R) (lamivudine and zidovudine) are both recommended nucleoside
reverse transcriptase inhibitors, and LEXIVA(R) (fosamprenavir calcium)
boosted with ritonavir is now listed among the recommended options for
protease inhibitor-based regimens in the initial treatment of adults with
HIV infection.
Additional information in the guidelines recommends the use of EPZICOM
as an initial NRTI backbone. "Abacavir in combination with lamivudine, has
comparable antiretroviral activity with the other dual NRTI components
listed in the guidelines." The guidelines also support the use of COMBIVIR
as a first-line therapy based on the "extensive clinical trial data set and
phase 4 experience supporting use."
The IAS-USA commissions expert panels to issue recommendations and
guidelines to provide standard approaches to patient care. The updated
guidelines published in the current issue of Journal of the American
Medical Association (JAMA) stated that, "[t]he choice of initial drug
centers on acceptability; predicted tolerance; pill burden; comorbid
conditions; short- term, mid-term and long-term adverse event profiles."
The updated guidelines reflect the international perspectives of the
panelists and are designed to serve as a tool for clinicians in countries
where resources are sufficient to provide relatively unrestricted choices
of drugs.
"We are pleased to see that the guidelines committee has recognized
COMBIVIR, EPZICOM, and LEXIVA as important treatment options for patients
with HIV," said Mark Shaefer, Director, Clinical Development, HIV
Infectious Disease Medicine Development Center at GSK.
IMPORTANT INDICATION AND SAFETY INFORMATION
FOR COMBIVIR, EPZICOM, AND LEXIVA
HIV medicines do not cure HIV infection/AIDS or prevent passing HIV to
others.
COMBIVIR
COMBIVIR is a combination tablet containing Epivir(R) (lamivudine, 3TC)
and Retrovir(R) (zidovudine, AZT).
INDICATIO COMBIVIR is indicated in combination with other antiretroviral agents for the treatment of HIV infection.
IMPORTANT SAFETY INFORMATION
All HIV drugs have side effects. The most commonly reported side
effects by patients who take COMBIVIR are: headache (35%), upset stomach
(33%), fatigue (27%), and nasal signs and symptoms (20%). Patients should
see their doctor regularly because serious side effects can occur, such as
muscle damage and a decrease in red and white blood cells. A buildup of
lactic acid in the blood and an enlarged liver, including fatal cases, have
been seen.
Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of COMBIVIR).
Patients should discuss any change in treatment with your doctor. Patients
who have both HBV and HIV and stop treatment with COMBIVIR should be
closely monitored by a doctor for at least several months.
Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus who are taking
anti-HIV medicines and are also being treated for hepatitis C with
interferon with or without ribavirin. If you are taking COMBIVIR as well as
interferon with or without ribavirin and you experience side effects, be
sure to tell your doctor.
When you start taking HIV medicines, your immune system may get
stronger and could begin to fight infections that have been hidden in your
body, such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
Changes in body fat may occur in some patients taking antiretroviral
therapy. These changes may include an increased amount of fat in the upper
back and neck ("buffalo hump"), breast, and around the trunk. Loss of fat
from the legs, arms, and face may also occur. The cause and long-term
health effects of these conditions are not known at this time.
For complete prescribing information about COMBIVIR, visit
us.gsk/products/assets/us_combivir.pdf.
EPZICOM INDICATION
- EPZICOM, in combination with other antiretroviral agents, is indicated
for the treatment of HIV infection in adults.
- EPZICOM is one of 3 medicines containing abacavir. Before starting
EPZICOM, your healthcare professional will review your medical
history in order to avoid the use of abacavir if you have
experienced an allergic reaction to abacavir in the past.
- In one study, more patients had a severe hypersensitivity reaction
in the abacavir once-daily group than in the abacavir twice-daily
group.
- EPZICOM should not be used as part of a triple nucleoside regimen.
IMPORTANT SAFETY INFORMATION
EPZICOM contains abacavir, which is also contained in ZIAGEN(R)
(abacavir sulfate) and TRIZIVIR(R) (abacavir sulfate, lamivudine, and
zidovudine). Patients taking EPZICOM may have a serious allergic reaction
(hypersensitivity reaction) that can cause death.
If you get a symptom from 2 or more of the following groups while
taking EPZICOM, stop taking EPZICOM and call your doctor right away:
1. Fever
2. Rash
3. Nausea, vomiting, diarrhea, or abdominal (stomach area) pain
4. Generally ill feeling, extreme tiredness, or achiness
5. Shortness of breath, cough, or sore throat.
Carefully read the Warning Card that your pharmacist gives you and
carry it with you at all times.
- If you stop EPZICOM because of an allergic reaction, NEVER take EPZICOM
or any other abacavir-containing medicine (ZIAGEN, TRIZIVIR) again. If
you take EPZICOM or any other abacavir-containing medicine again after
you have had an allergic reaction, WITHIN HOURS you may get life-
threatening symptoms that may include very low blood pressure or death.
- If you stop EPZICOM for any other reason, even for a few days, and you
are not allergic to EPZICOM, talk with your healthcare professional
before taking it again. Taking EPZICOM again can cause a serious or
life-threatening reaction, even if you never had an allergic reaction
before. If your healthcare professional tells you that you can take
EPZICOM again, start taking it when you are around medical help or
people who can call a doctor if you need one.
- A buildup of lactic acid in the blood and an enlarged liver, including
fatal cases, have been reported.
- Do not take EPZICOM if your liver does not function normally.
- Some patients infected with both hepatitis B virus (HBV) and HIV have
worsening of hepatitis after stopping lamivudine (a component of
EPZICOM). Discuss any change in treatment with your doctor. If you have
both HBV and HIV and stop treatment with EPZICOM, you should be closely
monitored by your doctor for at least several months.
- Worsening of liver disease (sometimes resulting in death) has occurred
in patients infected with both HIV and hepatitis C virus who are taking
anti-HIV medicines and are also being treated for hepatitis C with
interferon with or without ribavirin. If you are taking EPZICOM as well
as interferon with or without ribavirin and you experience side effects,
be sure to tell your doctor.
- When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
- Changes in body fat may occur in some patients taking antiretroviral
therapy. The cause and long-term health effects of these conditions are
not known at this time.
- The most common side effects seen with the drugs in EPZICOM dosed once-
daily were allergic reaction, trouble sleeping, depression, headache,
tiredness, dizziness, nausea, diarrhea, rash, fever, stomach pain,
abnormal dreams, and anxiety. Most of the side effects do not cause
people to stop taking EPZICOM.
For full prescribing information please visit treathiv
LEXIVA
LEXIVA is a protease inhibitor that was co-discovered by
GlaxoSmithKline and Vertex Pharmaceuticals Incorporated.
INDICATION
- LEXIVA is indicated in combination with other antiretroviral agents for
the treatment of HIV infection in adults.
- The PI-experienced patient study was not large enough to reach a
definitive conclusion that LEXIVA/ritonavir and lopinavir/ritonavir
are clinically equivalent.
- Once-daily administration of LEXIVA/ritonavir is not recommended for
PI-experienced patients. LEXIVA does not cure HIV or prevent passing
HIV to others.
IMPORTANT SAFETY INFORMATION
- You should not take LEXIVA if you have had an allergic reaction to
LEXIVA or AGENERASE(R) (amprenavir).
- High blood sugar, diabetes or worsening of diabetes, and bleeding in
hemophiliacs have occurred in some patients taking protease inhibitors.
- When you start taking HIV medicines, your immune system may get stronger
and could begin to fight infections that have been hidden in your body,
such as pneumonia, herpes virus, or tuberculosis. If you have new
symptoms after starting your HIV medicines, be sure to tell your doctor.
- Changes in body fat may occur in some patients taking antiretroviral
therapy. The cause and long-term health effects of these conditions are
not known at this time.
- Skin rashes can occur in patients taking LEXIVA. Rarely, rashes were
severe or life threatening.
- Opportunistic infections can develop when you have HIV and your immune
system is weak. It is very important that you see your healthcare
provider regularly while you are taking LEXIVA to discuss any side
effects or concerns.
- Most common side effects in clinical studies were diarrhea, headache,
nausea, rash, and vomiting. In most cases, these side effects did not
cause people to stop taking their medicine.
Drug Interactions
- LEXIVA should not be taken with: AGENERASE(R) (amprenavir), Halcion(R)
(triazolam), ergot medications (Cafergot(R), Migranal(R), D.H.E. 45(R),
and others), Propulsid(R) (cisapride), Versed(R) (midazolam), Orap(R)
(pimozide), Zocor(R) (simvastatin), Mevacor(R) (lovastatin), Rifadin(R)
(rifampin), Rescriptor(R) (delavirdine mesylate), or St. John's wort
(Hypericum perforatum). If you are taking Norvir(R) (ritonavir), you
should not take Tambocor(R) (flecainide), or Rythmol(R) (propafenone
hydrochloride).
- Serious and/or life-threatening events could occur between LEXIVA and
other medications, including Cordarone(R) (amiodarone), lidocaine
(intravenous only), Elavil(R) (amitriptyline HCl) and Tofranil(R)
(imipramine pamoate), tricyclic antidepressants, and Quinaglute(R)
(quinidine).
- Women who use birth control pills should choose a different kind of
contraception. LEXIVA can affect the safety and effectiveness of birth
control pills.
- Patients taking Viagra(R) (sildenafil citrate) or LEVITRA(R) (vardenafil
HCl) with LEXIVA may be at an increased risk of side effects.
- This list of drug interactions is not complete. Be sure to tell your
healthcare provider about all medicines you are taking or plan to take,
including over-the-counter drugs, vitamins, and herbals.
Resistance
- Missing or skipping doses of your medicine may make it easier for the
virus to mutate and multiply. Your medicines may not work as well
against a mutated virus and you may become cross-resistant to other HIV
medicines. It's important to take your medicine exactly as prescribed.
For full prescribing information please go to LEXIVA.
About GlaxoSmithKline
GlaxoSmithKline is one of the world's leading research-based
pharmaceutical and healthcare companies and an industry leader in HIV
research and therapies. The company is engaged in basic research programs
designed to investigate new targets to treat HIV.
GSK's Bridges to Access program can help provide qualified individuals
with access to GSK's antiretroviral medications, as well as help identify
insurance or other support for medications. Patients may be eligible for
this program if they are not eligible for prescription drug benefits
through any other private or public insurer, payer or program. In 2004,
GlaxoSmithKline donated more than $372.5 million worth of prescription
drugs to 475,000 patients. For more information, visit bridgestoaccess.gsk or call 1- 866-PATIENT.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex
co-discovered the HIV protease inhibitor, LEXIVA, with GlaxoSmithKline.
Vertex's press releases are available at vrtx.
GlaxoSmithKline
vrtx
View drug information on Combivir; Lexiva; Trizivir.
When HIV And Liver Disease Co-Exist
Since successful antiretroviral therapies have made HIV a treatable condition, more HIV patients who are also infected with hepatitis B or C are experiencing the progression of their liver disease. In the face of this novel challenge, experts in the field convened to share information and opinions on the management of such patients. The conference discussions are summarized in June issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD) The article is also available online at Wiley Interscience (interscience.wiley/journal/hepatology).
Because of shared modes of transmission, HIV and viral hepatitis infections often coexist. Since therapies have made HIV a manageable condition, hepatologists are seeing more infected patients with complex liver issues. To address questions about care for these co-infected patients, an international forum was convened in Jackson Hole, Wyoming in September 2006. The meeting brought together laboratory and clinical researchers, drug developers and government representatives to discuss the state of the field, research needs, and collaborative possibilities. The conference topics are summarized by Kenneth Sherman, MD, PhD, of the University of Cincinnati and colleagues in the current issue of Hepatology.
An estimated 3 to 4 million people are infected with both HIV and hepatitis B (HBV) while 4 to 5 million people have HIV and chronic hepatitis C (HCV). "The natural history of coinfection, particularly for HCV/HIV in the era of highly active antiretroviral therapies is still a matter of debate, and is important as it influences intervention strategies," the authors report. However, recent studies have shown increasing rates of liver disease and related death among those with HIV.
Conference attendees discussed immune responses to hepatic disease in patients with HIV as well as how the viruses interact to result in liver injury. They also considered how treatment options, including antiretroviral agents, might affect the liver.
In treating HIV/HCV co-infected patients, studies have shown that pegylated interferon with ribavirin is better than interferon-only regimens. For patients with HIV/HBV, combination therapy is routine, though viral mutation and drug resistance remain troubling issues. A key topic of conversation was the development of new agents for treating viral hepatitis in patients with HIV. Challenges include the risk of hepatic injury and low patient tolerance which limits compliance. All agreed that new agents should be tried.
Until recently, liver transplantation was not an option for patients with HIV; however, it is now a possibility. "It is imperative not to wait until the patient is moribund," the authors report, adding that successful outcomes depend on the collaboration of surgeons, hepatologists, infectious disease specialists and pharmacologists.
"In summary, a number of areas were identified as needing further research," they conclude. "A close cooperation between clinicians and researchers is required to ensure high quality translational research."
###
Article: "HIV and Liver Disease Forum: Conference Proceedings," Sherman, Kenneth; Peters, Marion; Koziel, Margaret. Hepatology; June 2007; (DOI: 10.1002/hep.21722).
Contact: Amy Molnar
John Wiley & Sons, Inc.
Because of shared modes of transmission, HIV and viral hepatitis infections often coexist. Since therapies have made HIV a manageable condition, hepatologists are seeing more infected patients with complex liver issues. To address questions about care for these co-infected patients, an international forum was convened in Jackson Hole, Wyoming in September 2006. The meeting brought together laboratory and clinical researchers, drug developers and government representatives to discuss the state of the field, research needs, and collaborative possibilities. The conference topics are summarized by Kenneth Sherman, MD, PhD, of the University of Cincinnati and colleagues in the current issue of Hepatology.
An estimated 3 to 4 million people are infected with both HIV and hepatitis B (HBV) while 4 to 5 million people have HIV and chronic hepatitis C (HCV). "The natural history of coinfection, particularly for HCV/HIV in the era of highly active antiretroviral therapies is still a matter of debate, and is important as it influences intervention strategies," the authors report. However, recent studies have shown increasing rates of liver disease and related death among those with HIV.
Conference attendees discussed immune responses to hepatic disease in patients with HIV as well as how the viruses interact to result in liver injury. They also considered how treatment options, including antiretroviral agents, might affect the liver.
In treating HIV/HCV co-infected patients, studies have shown that pegylated interferon with ribavirin is better than interferon-only regimens. For patients with HIV/HBV, combination therapy is routine, though viral mutation and drug resistance remain troubling issues. A key topic of conversation was the development of new agents for treating viral hepatitis in patients with HIV. Challenges include the risk of hepatic injury and low patient tolerance which limits compliance. All agreed that new agents should be tried.
Until recently, liver transplantation was not an option for patients with HIV; however, it is now a possibility. "It is imperative not to wait until the patient is moribund," the authors report, adding that successful outcomes depend on the collaboration of surgeons, hepatologists, infectious disease specialists and pharmacologists.
"In summary, a number of areas were identified as needing further research," they conclude. "A close cooperation between clinicians and researchers is required to ensure high quality translational research."
###
Article: "HIV and Liver Disease Forum: Conference Proceedings," Sherman, Kenneth; Peters, Marion; Koziel, Margaret. Hepatology; June 2007; (DOI: 10.1002/hep.21722).
Contact: Amy Molnar
John Wiley & Sons, Inc.
System To Pinpoint Airline Passengers Who Contaminate Cabins
Researchers developing a system that uses mathematical models and sensors to locate passengers releasing hazardous materials or pathogens inside airline cabins have shown that the technique can track a substance to an area the size of a single seat.
The technique might enable officials to identify passengers responsible for the unintentional release of germs, such as contagious viruses, or the intentional release of pathogens or chemical agents in a terrorist attack, said Qingyan (pronounced Chin-Yan) Chen, a professor of mechanical engineering at Purdue University.
"The goal is to be able to track the source if a person released a biological agent, such as anthrax, or inadvertently released a pathogen such as pandemic flu by sneezing, for example," he said.
The research is supported by the Air Transportation Center of Excellence for Airline Cabin Environment Research, established by the Federal Aviation Administration. The work aims to improve air quality and safety inside airline cabins.
The inadvertent release of infectious pathogens inside an aircraft is especially dangerous during lengthy international flights, said Chen, who is a principal director of the center. The effort involves an interdisciplinary team of Purdue researchers from chemical and mechanical engineering, physics and chemistry.
The center's Purdue-related research focuses on developing mathematical models for software that will be needed to operate such a tracking system and learning how to precisely place several sensors to accurately trace hazardous airborne materials back to the source.
Research findings are detailed in a paper being published in June in Indoor Air - International Journal of Indoor Environment and Health. The paper was Chen and mechanical engineering doctoral student Tengfei Zhang.
The technique, called "inverse simulation," analyzes how a material disperses throughout the cabin and then runs the dispersion in reverse to find its origin. Sensors track the airflow pattern and collect data related to factors such as temperature, velocity and concentration of gases and particles in the air.
"This is difficult to do, in part because an airline cabin is a pretty large area," Chen said. "The procedure now requires several days of computing time to complete the track, meaning the method could be used only after a contamination occurs."
Chen has recreated a commercial airliner's passenger compartment, complete with rows of seating, at Purdue's Ray W. Herrick Laboratories. Data from experiments in the lab are used to validate results from the computational models. The lab is equipped with three sensors and recreates the exhalation and body heat of passengers and an airliner's "linear diffuser" environmental control system, which supplies fresh and recirculated air for passengers. Boxy devices located on several seats reproduce body heat, and each has a tube that expels a gas to simulate passengers exhaling. Recreating body heat is important because it affects airflow inside airliners, Chen said.
Future work will concentrate on speeding the computation time, with a goal of one day creating a system that alerts pilots in real time and pinpoints a contaminant's source.
"We need to find a way to enhance the computing speed, and we have a strategy to do that," Chen said.
The method is most accurate when three sensors are used to track a material. Using three sensors, the Purdue researchers showed that the method could track a substance to within about two feet of its origin in an airline cabin.
"We would be able to tell you the general area of the origin, and from that you could figure out which passenger seats were in this area," said Chen, whose research is based at Herrick Laboratories.
The same principle could be applied to systems designed for other environments, such as office buildings, he said.
The Air Transportation Center of Excellence for Airline Cabin Environment Research includes Auburn University, Harvard University, Boise State University, Kansas State University, the University of California at Berkeley, and the University of Medicine and Dentistry of New Jersey. Auburn is the center's lead administrative university, while Purdue and Harvard are co-technical leaders.
Research through the center aims to:
* Understand and mitigate environmental health issues on airplanes, including contamination of cabin air with engine oil or hydraulic fluid.
* Study how cabin pressure affects passengers, especially those with cardiopulmonary conditions, as well as flight attendants and pilots who work in the environment daily.
* See how elevated ozone levels at higher altitudes affect the cabin environment.
* Look at the basic science of how contaminants travel through the cabin.
* Learn which sensors best detect certain materials in cabin air.
* Discover the best strategies to decontaminate an airplane.
Purdue's team is concentrating on tracking and decontaminating airborne agents.
The research is funded primarily by the Federal Aviation Administration. The center is sponsored by the FAA's Office of Aerospace Medicine.
www.purdue.edu
The technique might enable officials to identify passengers responsible for the unintentional release of germs, such as contagious viruses, or the intentional release of pathogens or chemical agents in a terrorist attack, said Qingyan (pronounced Chin-Yan) Chen, a professor of mechanical engineering at Purdue University.
"The goal is to be able to track the source if a person released a biological agent, such as anthrax, or inadvertently released a pathogen such as pandemic flu by sneezing, for example," he said.
The research is supported by the Air Transportation Center of Excellence for Airline Cabin Environment Research, established by the Federal Aviation Administration. The work aims to improve air quality and safety inside airline cabins.
The inadvertent release of infectious pathogens inside an aircraft is especially dangerous during lengthy international flights, said Chen, who is a principal director of the center. The effort involves an interdisciplinary team of Purdue researchers from chemical and mechanical engineering, physics and chemistry.
The center's Purdue-related research focuses on developing mathematical models for software that will be needed to operate such a tracking system and learning how to precisely place several sensors to accurately trace hazardous airborne materials back to the source.
Research findings are detailed in a paper being published in June in Indoor Air - International Journal of Indoor Environment and Health. The paper was Chen and mechanical engineering doctoral student Tengfei Zhang.
The technique, called "inverse simulation," analyzes how a material disperses throughout the cabin and then runs the dispersion in reverse to find its origin. Sensors track the airflow pattern and collect data related to factors such as temperature, velocity and concentration of gases and particles in the air.
"This is difficult to do, in part because an airline cabin is a pretty large area," Chen said. "The procedure now requires several days of computing time to complete the track, meaning the method could be used only after a contamination occurs."
Chen has recreated a commercial airliner's passenger compartment, complete with rows of seating, at Purdue's Ray W. Herrick Laboratories. Data from experiments in the lab are used to validate results from the computational models. The lab is equipped with three sensors and recreates the exhalation and body heat of passengers and an airliner's "linear diffuser" environmental control system, which supplies fresh and recirculated air for passengers. Boxy devices located on several seats reproduce body heat, and each has a tube that expels a gas to simulate passengers exhaling. Recreating body heat is important because it affects airflow inside airliners, Chen said.
Future work will concentrate on speeding the computation time, with a goal of one day creating a system that alerts pilots in real time and pinpoints a contaminant's source.
"We need to find a way to enhance the computing speed, and we have a strategy to do that," Chen said.
The method is most accurate when three sensors are used to track a material. Using three sensors, the Purdue researchers showed that the method could track a substance to within about two feet of its origin in an airline cabin.
"We would be able to tell you the general area of the origin, and from that you could figure out which passenger seats were in this area," said Chen, whose research is based at Herrick Laboratories.
The same principle could be applied to systems designed for other environments, such as office buildings, he said.
The Air Transportation Center of Excellence for Airline Cabin Environment Research includes Auburn University, Harvard University, Boise State University, Kansas State University, the University of California at Berkeley, and the University of Medicine and Dentistry of New Jersey. Auburn is the center's lead administrative university, while Purdue and Harvard are co-technical leaders.
Research through the center aims to:
* Understand and mitigate environmental health issues on airplanes, including contamination of cabin air with engine oil or hydraulic fluid.
* Study how cabin pressure affects passengers, especially those with cardiopulmonary conditions, as well as flight attendants and pilots who work in the environment daily.
* See how elevated ozone levels at higher altitudes affect the cabin environment.
* Look at the basic science of how contaminants travel through the cabin.
* Learn which sensors best detect certain materials in cabin air.
* Discover the best strategies to decontaminate an airplane.
Purdue's team is concentrating on tracking and decontaminating airborne agents.
The research is funded primarily by the Federal Aviation Administration. The center is sponsored by the FAA's Office of Aerospace Medicine.
www.purdue.edu
UNAIDS Encouraged By Decision By Libya's High Judicial Council To Revoke Death Penalty For Health Care Professionals
The Joint United Nations Programme on HIV/AIDS (UNAIDS)
welcomes the ruling by the High Judicial Council of Libya to revoke the death sentence
previously imposed on six healthcare workers by the Supreme Court. The Council
announced recently that it would commute the death sentence for the medical
professionals to life imprisonment.
The six health care workers (five Bulgarian nurses and one Palestinian doctor), imprisoned
since 1999, had been accused of deliberately infecting 426 children with HIV whilst working
at a hospital in Benghazi, Libya.
Although welcoming the revocation of the death sentence, UNAIDS is concerned that certain
scientific evidence appears to not have been taken into consideration during the
proceedings which, could have led to their acquittal. In this regard, UNAIDS expresses the
hope that this decision will open the way for a speedy and just resolution of this matter.
Since the proceedings began, the Palestinian Doctor has been granted Bulgarian citizenship
and the Bulgarian government is expected to enter into further discussions with Libya on the
transfer of the six to Bulgaria.
Since 1999, 56 of the children found to be infected with the virus have died. UNAIDS
expresses its deep concern and empathy for the children affected and for their families, and
welcomes the news that an agreement has reportedly been reached to ensure that they
have future treatment, care and support.
UNAIDS will continue to support the Government of Libya for a comprehensive response to
HIV; to prevent HIV transmission; provide for treatment, care and support for those living
with HIV; and protect the rights of those affected by HIV.
UNAIDS is an innovative joint venture of the United Nations, bringing together the efforts and
resources of the UNAIDS Secretariat and ten UN system organizations in the AIDS response. The
Secretariat headquarters is in Geneva, Switzerland-with staff on the ground in more than 80
countries. Coherent action on AIDS by the UN system is coordinated in countries through UN theme
groups, and joint programmes on AIDS. UNAIDS' Cosponsors include UNHCR, UNICEF, WFP,
UNDP, UNFPA, UNODC, ILO, UNESCO, WHO and the World Bank.
unaids
welcomes the ruling by the High Judicial Council of Libya to revoke the death sentence
previously imposed on six healthcare workers by the Supreme Court. The Council
announced recently that it would commute the death sentence for the medical
professionals to life imprisonment.
The six health care workers (five Bulgarian nurses and one Palestinian doctor), imprisoned
since 1999, had been accused of deliberately infecting 426 children with HIV whilst working
at a hospital in Benghazi, Libya.
Although welcoming the revocation of the death sentence, UNAIDS is concerned that certain
scientific evidence appears to not have been taken into consideration during the
proceedings which, could have led to their acquittal. In this regard, UNAIDS expresses the
hope that this decision will open the way for a speedy and just resolution of this matter.
Since the proceedings began, the Palestinian Doctor has been granted Bulgarian citizenship
and the Bulgarian government is expected to enter into further discussions with Libya on the
transfer of the six to Bulgaria.
Since 1999, 56 of the children found to be infected with the virus have died. UNAIDS
expresses its deep concern and empathy for the children affected and for their families, and
welcomes the news that an agreement has reportedly been reached to ensure that they
have future treatment, care and support.
UNAIDS will continue to support the Government of Libya for a comprehensive response to
HIV; to prevent HIV transmission; provide for treatment, care and support for those living
with HIV; and protect the rights of those affected by HIV.
UNAIDS is an innovative joint venture of the United Nations, bringing together the efforts and
resources of the UNAIDS Secretariat and ten UN system organizations in the AIDS response. The
Secretariat headquarters is in Geneva, Switzerland-with staff on the ground in more than 80
countries. Coherent action on AIDS by the UN system is coordinated in countries through UN theme
groups, and joint programmes on AIDS. UNAIDS' Cosponsors include UNHCR, UNICEF, WFP,
UNDP, UNFPA, UNODC, ILO, UNESCO, WHO and the World Bank.
unaids
Washington Post Examines HIV/AIDS Outreach Efforts Aimed At African Immigrants
The Washington Post on Tuesday examined HIV/AIDS outreach efforts aimed at African immigrants in the U.S. According to the Post, some health researchers say that the "message" that HIV/AIDS also affects Africans in the U.S. is "growing in importance as they become increasingly concerned that the AIDS epidemic ravaging sub-Saharan Africa is following migrants from that continent to America."
Local studies conducted across the U.S. have found "greatly disproportionate" HIV/AIDS rates among Africans, and health care providers in the Washington, D.C., area are recording similar trends, the Post reports. However, many providers are encountering a similar problem in that because many health departments do not ask patients where they were born, most HIV-positive African immigrants are categorized in surveys as "black" or "African-American."
"Quite frankly, many providers don't distinguish between Africans and African-Americans," Garth Graham, deputy assistant secretary for minority health at HHS, said. He added, "It doesn't take into account the different cultural backgrounds and perceptions of wellness and disease that these individuals have ... that's one of the glaring challenges that we're facing."
Other health care providers say that the issue is compounded by stigma, language barriers and fears over deportation. Some immigrants are not familiar with the concept of preventive medicine and do not realize that an early HIV diagnosis can improve survival changes, according to providers. "You have to be sick to go to the doctor in Africa," Ashenafi Waktola, a district-area physician who was born in Ethiopia, said, adding, "That is disastrous with AIDS."
According to the Post, there are no "precise" national data about HIV/AIDS among African immigrants. However, studies conducted in places such as Minnesota and the Seattle area, which have relatively large African immigrant populations, have found much higher HIV/AIDS rates among Africans. Studies in Canada and Europe have found similar results, the Post reports. In the district area, information on country of origin "varies so much by jurisdiction and is so spotty that it provides only a blurry snapshot," according to the Post. However, a recent district Health Department survey conducted among groups that provide HIV/AIDS services to impoverished populations in the region found that 10% of those clients were born in Africa.
In addition, of the 31,256 AIDS cases reported in Maryland through September 2007, African immigrants accounted for 716, or 2.3%, of the cases -- slightly higher than their percentage of the population, which is about 2%. In Montgomery County, Md., 392, or 15%, of all reported AIDS cases were among Africans, who account for about 4% of the population. According to officials with Maryland's AIDS Administration, they are unsure how to explain the disparity between the Montgomery County and statewide data because reporting about country of origin by health providers is "often inconsistent or incomplete," William Honablew, an administration spokesperson, said. Other officials said that it is possible that health providers in Montgomery more routinely offer HIV tests to immigrants and record country of origin data more reliably. According to Honablew, the large majority of AIDS cases among African immigrants in Maryland have been recorded in Montgomery and Prince George's counties, and the AIDS Administration is planning an HIV program targeting African communities in those counties.
In Virginia, country of origin was recorded in 26% of the 1,062 new HIV cases reported in 2006, according to the state Department of Health. African immigrants, who account for less than 1% of the population in the area, accounted for 5% of all 1,062 newly recorded cases. According to the Post, African immigrants "almost certainly would account for a higher share if national origin were consistently recorded." According to a study conducted by a Seattle-King County epidemiologist, African immigrants in 2003 and 2004 accounted for at least 13% of the 639 new HIV infections in nine Northern Virginia counties.
Many health care providers and researchers said they believe that most HIV-positive immigrants contracted the virus in their homelands in part because the virus is diagnosed in the later stages in many cases. Because few educational materials aimed at African immigrants are available, outreach workers sometimes use materials written for U.S.-born blacks that have little cultural relevance for Africans, the Post reports. In addition, stigma often presents a large obstacle. Because African immigrant communities are "segmented and tight-knit," providers say that African immigrants "fear they would know a doctor or interpreter from the same community and that word of their condition would spread," according to the Post (Brulliard, Washington Post, 9/2).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Local studies conducted across the U.S. have found "greatly disproportionate" HIV/AIDS rates among Africans, and health care providers in the Washington, D.C., area are recording similar trends, the Post reports. However, many providers are encountering a similar problem in that because many health departments do not ask patients where they were born, most HIV-positive African immigrants are categorized in surveys as "black" or "African-American."
"Quite frankly, many providers don't distinguish between Africans and African-Americans," Garth Graham, deputy assistant secretary for minority health at HHS, said. He added, "It doesn't take into account the different cultural backgrounds and perceptions of wellness and disease that these individuals have ... that's one of the glaring challenges that we're facing."
Other health care providers say that the issue is compounded by stigma, language barriers and fears over deportation. Some immigrants are not familiar with the concept of preventive medicine and do not realize that an early HIV diagnosis can improve survival changes, according to providers. "You have to be sick to go to the doctor in Africa," Ashenafi Waktola, a district-area physician who was born in Ethiopia, said, adding, "That is disastrous with AIDS."
According to the Post, there are no "precise" national data about HIV/AIDS among African immigrants. However, studies conducted in places such as Minnesota and the Seattle area, which have relatively large African immigrant populations, have found much higher HIV/AIDS rates among Africans. Studies in Canada and Europe have found similar results, the Post reports. In the district area, information on country of origin "varies so much by jurisdiction and is so spotty that it provides only a blurry snapshot," according to the Post. However, a recent district Health Department survey conducted among groups that provide HIV/AIDS services to impoverished populations in the region found that 10% of those clients were born in Africa.
In addition, of the 31,256 AIDS cases reported in Maryland through September 2007, African immigrants accounted for 716, or 2.3%, of the cases -- slightly higher than their percentage of the population, which is about 2%. In Montgomery County, Md., 392, or 15%, of all reported AIDS cases were among Africans, who account for about 4% of the population. According to officials with Maryland's AIDS Administration, they are unsure how to explain the disparity between the Montgomery County and statewide data because reporting about country of origin by health providers is "often inconsistent or incomplete," William Honablew, an administration spokesperson, said. Other officials said that it is possible that health providers in Montgomery more routinely offer HIV tests to immigrants and record country of origin data more reliably. According to Honablew, the large majority of AIDS cases among African immigrants in Maryland have been recorded in Montgomery and Prince George's counties, and the AIDS Administration is planning an HIV program targeting African communities in those counties.
In Virginia, country of origin was recorded in 26% of the 1,062 new HIV cases reported in 2006, according to the state Department of Health. African immigrants, who account for less than 1% of the population in the area, accounted for 5% of all 1,062 newly recorded cases. According to the Post, African immigrants "almost certainly would account for a higher share if national origin were consistently recorded." According to a study conducted by a Seattle-King County epidemiologist, African immigrants in 2003 and 2004 accounted for at least 13% of the 639 new HIV infections in nine Northern Virginia counties.
Many health care providers and researchers said they believe that most HIV-positive immigrants contracted the virus in their homelands in part because the virus is diagnosed in the later stages in many cases. Because few educational materials aimed at African immigrants are available, outreach workers sometimes use materials written for U.S.-born blacks that have little cultural relevance for Africans, the Post reports. In addition, stigma often presents a large obstacle. Because African immigrant communities are "segmented and tight-knit," providers say that African immigrants "fear they would know a doctor or interpreter from the same community and that word of their condition would spread," according to the Post (Brulliard, Washington Post, 9/2).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
U.N. Launches Programs In Three Indian Prisons To Prevent Spread Of HIV Among Inmates
The United Nation's Office on Drugs and Crime has launched programs in three Indian prisons that aim to prevent the spread of HIV among inmates, the Press Trust of India reports. According to Jaidev Sarangi, a prison expert with UNODC, the United Nations in collaboration with state governments and civil societies has launched programs in Tihar jail in New Delhi, Arthur Road jail in Mumbai and Amritsar Central jail in Punjab.
There are 14,126 inmates in Tihar, 2,000 in Arthur Road and 2,000 in Amritsar, the Press Trust of India reports. According to a study conducted by India's Ministry of Social Justice and Empowerment and UNODC, about 10% of the inmate population in Tihar was found to be using drugs. Sunil Kumar Gupta, a law officer at the prison, said that there are 38 inmates at the prison who are HIV-positive.
"The basic purpose is to address the twin problems of drugs and HIV in prisons," Sarangi said. He added, "So, our strategy is to prepare the inmates to face the challenges of drug abuse and HIV in jails and also after their release." According to Sarangi, the programs will provide prison staff and inmates with HIV/AIDS education by engaging them in workshops. "We try to increase their knowledge and awareness about drugs and HIV in priso[n] settings," he said, adding that the "next step is the enhancement of life skills to enable prisoners to cope with day-to-day challenges in an out of prisons."
According to Sarangi, similar programs have been launched in prisons in Sri Lanka and Nepal. R. Gunashekar, project officer for UNODC, said that the "next step is to [establish similar programs] in one jail in each state and Union Territories in the country" (Press Trust of India, 7/10).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
There are 14,126 inmates in Tihar, 2,000 in Arthur Road and 2,000 in Amritsar, the Press Trust of India reports. According to a study conducted by India's Ministry of Social Justice and Empowerment and UNODC, about 10% of the inmate population in Tihar was found to be using drugs. Sunil Kumar Gupta, a law officer at the prison, said that there are 38 inmates at the prison who are HIV-positive.
"The basic purpose is to address the twin problems of drugs and HIV in prisons," Sarangi said. He added, "So, our strategy is to prepare the inmates to face the challenges of drug abuse and HIV in jails and also after their release." According to Sarangi, the programs will provide prison staff and inmates with HIV/AIDS education by engaging them in workshops. "We try to increase their knowledge and awareness about drugs and HIV in priso[n] settings," he said, adding that the "next step is the enhancement of life skills to enable prisoners to cope with day-to-day challenges in an out of prisons."
According to Sarangi, similar programs have been launched in prisons in Sri Lanka and Nepal. R. Gunashekar, project officer for UNODC, said that the "next step is to [establish similar programs] in one jail in each state and Union Territories in the country" (Press Trust of India, 7/10).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Wall Street Journal Examines Reason Abbott Increased Price Of Antiretroviral Norvir
Previously undisclosed documents and e-mails reviewed by the Wall Street Journal indicate that executives at Abbott Laboratories attempted to "diminish the attraction" of the company's antiretroviral drug Norvir by increasing the price of the drug, the Journal reports. Norvir is used in combination therapies that include drugs manufactured by pharmaceutical companies other than Abbott, according to the Journal. According to the documents and e-mails, Abbott in the fall of 2003 "grew worried about new competition to" its antiretroviral Kaletra, and the company's executives began discussing ways to decrease the popularity of Norvir with the "goal of forcing" HIV-positive people "to drop the rival drugs and turn to Kaletra," the Journal reports (Carreyou, Wall Street Journal, 1/3). In December 2003, Abbott quadrupled the per-patient wholesale price of Norvir, which is known generically as ritonavir. Norvir is used primarily as a booster for other protease inhibitors, such as Bristol-Myers Squibb's Reyataz and Merck's Crixivan (Kaiser Daily HIV/AIDS Report, 8/5/04). Abbott exempted Medicaid, Medicare and state AIDS Drug Assistance Programs from the price increase, and the company announced that it would expand its patient assistance program. Institutions, such as state prisons, were not exempt from the price increase. The cost of Norvir increased from $51.30 for 30 100mg capsules to $257.10 for 30 100mg capsules, or by $5,000 more annually, which made Kaletra -- costing $7,000 annually -- the less expensive option for HIV-positive people residing in the U.S., according to the Journal. The increase "created a huge price discrepancy" between Kaletra and rival drugs, according to David Wohl, an associate professor at the University of North Carolina who also works with HIV-positive prison inmates. Abbott has said that it did not increase the price of Norvir to promote Kaletra and that the increase did not affect other drug companies. According to Abbott, the price increase was intended to better show Norvir's medical value, the Journal reports.
Reaction, Legal Actions
According to the Journal, the price increase "triggered an uproar" among some HIV/AIDS advocates and physicians. After a May 2004 hearing to consider authorization of a cheaper generic version of Norvir before its patent expired, NIH stated that it did not have the authority to determine if a drug's price was too high and ruled against a generic. The public "outcry faded" over time and "[p]rivate health insurers took a bigger blow but had little leverage, because they could hardly deny patients a lifesaving drug," according to the Journal. However, Abbott settled a lawsuit over Norvir's pricing filed by the AIDS Healthcare Foundation and agreed to support programs at the foundation, the Journal reports. Illinois Attorney General Lisa Madigan (D) has been investigating Norvir's price increase for three years and has said that it might violate the state's consumer fraud law. In addition, a lawsuit filed in U.S. district court in Oakland, Calif., by two HIV-positive people and the Service Employees International Union's Health and Welfare Fund is scheduled to go to trial in early 2008, the Journal reports (Wall Street Journal, 1/3).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
View drug information on Crixivan; Kaletra Capsules and Oral Solution; Norvir.
Why Are The Elderly So Vulnerable To Pneumonia?
A study featured on the cover of the March 15 Journal of Immunology is providing insight into why the elderly are so vulnerable to pneumonia and other bacterial infections.
The study has been published online in advance of print.
Compared with younger adults, the elderly are at higher risk of becoming seriously ill or dying from pneumonia. Moreover, vaccines against the disease are less effective in the elderly.
To help understand why, Loyola researchers examined two types of immune system cells, macrophages and B cells, located in specialized areas in the spleens of mice. (Macrophages gobble up bacteria, while B cells produce antibodies that fight bacteria.)
Macrophages and B cells appeared to be just as effective in old mice as they were in younger mice. But there were fewer of them.
"If we knew how to replenish these cells, we might be able to lower the risk of bacterial infections in the elderly," said senior author Pamela Witte, a professor in the Department of Microbiology and Immunology at Loyola University Chicago Stritch School of Medicine. "This is an unexplored area in aging."
The finding also could provide clues to developing vaccines against pneumococcal pneumonia that would be more effective in the elderly, said first author Shirin Birjandi, who is completing her PhD at Loyola.
For example, Birjandi said, current vaccines instruct B cells to make antibodies against bacteria that cause pneumonia. But if humans are like mice, the elderly will have fewer B cells. So it might make more sense to develop vaccines that instead target other immune system cells, Birjandi said.
In their study, Loyola researchers examined B cells and macrophages that form microscopic rings in the spleen called marginal zones. These marginal zones form protective rings, preventing bacteria from passing through.
Photographs taken by the researchers show that in the spleens of young mice, macrophages form distinct rings in the marginal zones. (One of these photos appears on the cover of the Journal of Immunology.) In old mice, however, the photographs show that marginal zone rings are dramatically disrupted. (In humans, the equivalent ages of the old mice would be between 70 and 80.)
Researchers wrote that understanding changes such as these "is important for developing more efficient therapies for preventing diseases, such as bacterial pneumonia, that have shown to be highly detrimental in the elderly."
Other co-authors of the study are Jill Ippolito and Anand Ramadorai.
The research was supported by grants from the National Institutes of Health.
Source:
Loyola University Health System
The study has been published online in advance of print.
Compared with younger adults, the elderly are at higher risk of becoming seriously ill or dying from pneumonia. Moreover, vaccines against the disease are less effective in the elderly.
To help understand why, Loyola researchers examined two types of immune system cells, macrophages and B cells, located in specialized areas in the spleens of mice. (Macrophages gobble up bacteria, while B cells produce antibodies that fight bacteria.)
Macrophages and B cells appeared to be just as effective in old mice as they were in younger mice. But there were fewer of them.
"If we knew how to replenish these cells, we might be able to lower the risk of bacterial infections in the elderly," said senior author Pamela Witte, a professor in the Department of Microbiology and Immunology at Loyola University Chicago Stritch School of Medicine. "This is an unexplored area in aging."
The finding also could provide clues to developing vaccines against pneumococcal pneumonia that would be more effective in the elderly, said first author Shirin Birjandi, who is completing her PhD at Loyola.
For example, Birjandi said, current vaccines instruct B cells to make antibodies against bacteria that cause pneumonia. But if humans are like mice, the elderly will have fewer B cells. So it might make more sense to develop vaccines that instead target other immune system cells, Birjandi said.
In their study, Loyola researchers examined B cells and macrophages that form microscopic rings in the spleen called marginal zones. These marginal zones form protective rings, preventing bacteria from passing through.
Photographs taken by the researchers show that in the spleens of young mice, macrophages form distinct rings in the marginal zones. (One of these photos appears on the cover of the Journal of Immunology.) In old mice, however, the photographs show that marginal zone rings are dramatically disrupted. (In humans, the equivalent ages of the old mice would be between 70 and 80.)
Researchers wrote that understanding changes such as these "is important for developing more efficient therapies for preventing diseases, such as bacterial pneumonia, that have shown to be highly detrimental in the elderly."
Other co-authors of the study are Jill Ippolito and Anand Ramadorai.
The research was supported by grants from the National Institutes of Health.
Source:
Loyola University Health System
United Therapeutics Announces Pulmonary Hypertension Opinion Leaders' Guidance On Intravenous Therapies
United
Therapeutics Corporation (Nasdaq: UTHR) today announced new guidance from
pulmonary arterial hypertension opinion leaders relating to intravenous
therapies. The new guidance was issued by the Scientific Leadership
Committee (SLC) of the Pulmonary Hypertension Association in response to
the release of a slide presentation prepared by CDC researchers entitled
"Bloodstream infections among patients treated with intravenous
epoprostenol and intravenous treprostinil for pulmonary arterial
hypertension, United States 2004 - 2006". The slides accompanied a
presentation to the SLC on February 23, 2007, and may be published as a
report in the CDC's Morbidity and Mortality Weekly Report. The new guidance
from pulmonary hypertension opinion leaders is for physicians to be mindful
of the range of possible gram negative and gram positive infectious
organisms in patients with long-term central catheters and initiate
appropriately broad spectrum antibiotics in patients with suspected
bloodstream infections until culture results and antibiotic sensitivity are
known.
"We welcome the new guidance from pulmonary hypertension opinion
leaders," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and
Chief Executive Officer. "We believe that if a patient is predisposed to
sepsis, then subcutaneous Remodulin, which has never been associated with
septicemia, is the safest catheter-based treatment option; other patients
have a very small chance of developing sepsis. For a disease in which mean
survival is counted in single digit years, everyone wants to go the extra
mile to provide patients needing prostacyclin therapy with the most options
-- this is why we developed the micro-pump, ice-free and rapid-switch
characteristics of intravenous Remodulin."
Scientific Leadership Committee Guidance
The Pulmonary Hypertension Association Scientific Leadership Committee
(SLC) is composed of more than 20 leaders in the field of pulmonary
hypertension. The members of the SLC are clinicians, research scientists,
and nurses who come from medical centers recognized for performing
outstanding research and providing excellent care for patients with
pulmonary hypertension. The mission of the SLC is to provide medical and
scientific leadership and guidance for the mission of the Pulmonary
Hypertension Association by proactively facilitating the development of new
knowledge about pulmonary hypertension, actively disseminating knowledge
about pulmonary hypertension to medical and public audiences, and
advocating and raising awareness about pulmonary hypertension.
Following the CDC researcher's presentation, the SLC posted the
following guidance statement on the Pulmonary Hypertension Association
website, phassociation:
"The SLC notes the observation that patients on long-term intravenous
therapy are susceptible to bloodstream infections caused by a broad range
of organisms. The Centers for Disease Control and Prevention (CDC) report
suggests a hypothesis that different patient profiles may be subject to
higher risk of various types of infections. The SLC considers the CDC
document to be a hypothesis generating report which does not permit
definitive or specific conclusions at this time. Therefore, the SLC
supports the following:
1. Further appropriately designed studies are required to determine the validity of the hypothesis raised by the current document.
2. Pending rigorous studies, physicians should be mindful of the range of possible gram negative and gram positive infectious organisms in patients with long-term central catheters and initiate appropriately broad spectrum antibiotics in patients with suspected bloodstream infections until culture results and antibiotic sensitivity are known.
3. Choice of specific parenteral prostacyclin agents, as well as all pulmonary vascular targeted therapy should continue to be based on a global assessment of efficacy, risk, expense and feasibility of each agent in each individual patient's clinical context."
United Therapeutics' Response
"We will work closely with the Pulmonary Hypertension Association and
prescribers to improve patient care. We are confident that central line
filters and heightened emphasis on sterility best practices will go a long
way to address the issues raised in the CDC presentation," said Roger
Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.
"As with any therapy for a life-threatening condition, prescribers will
balance the risk/benefit profile of IV Remodulin against their patients'
needs in light of the experiences they have had with the drug."
United Therapeutics plans to take the following actions in response to
the Scientific Leadership Committee guidance:
-- United Therapeutics will commence a multi-center, multi-national,
multi-year and multi-agent prospective study to scientifically test the
hypothesis of whether there are differences in the risk of sepsis and
sepsis sub-types among parenterally-delivered prostacyclin mimetics and
analogs. The company anticipates this study to enroll several hundred
patients and is expected to commence later this year. "We are excited
about taking the lead in testing some of the hypotheses suggested by
the CDC's observations," said David Zaccardelli, PharmD, United
Therapeutics' Senior Vice President for Pharmaceutical Development. "No
doubt there is much new information to be learned from prospective
study of a large number of patients receiving chronic intravenous
therapy for pulmonary hypertension."
-- United Therapeutics also plans to coordinate a working group with the
Pulmonary Hypertension Association and physicians and nurses, along
with its network of specialty distributors and home health care
providers, to develop unified best practice recommendations related to
the chronic administration of IV prostanoids via central venous
catheters.
-- United Therapeutics will revise Remodulin package labeling to more
fully describe the known infection risk and appropriate technique that
should be practiced when preparing and administering intravenous
treprostinil.
About Remodulin
Remodulin(R) is indicated as a continuous subcutaneous infusion or IV
infusion (for those not able to tolerate a subcutaneous infusion) for the
treatment of PAH in patients with NYHA Class II-IV symptoms to diminish
symptoms associated with exercise.
Remodulin is indicated to diminish the rate of clinical deterioration
in patients requiring transition from Flolan(R); the risks and benefits of
each drug should be carefully considered prior to transition.
Important Safety Information:
Remodulin is contraindicated in patients with hypersensitivity to
Remodulin, its ingredients, or similar drugs. Remodulin is a potent
vasodilator. It lowers blood pressure, which may be further lowered by
other drugs that also reduce blood pressure. Remodulin inhibits platelet
aggregation and therefore, may increase the risk of bleeding, particularly
in patients on anticoagulants. Abrupt withdrawal or sudden large reductions
in dosage of Remodulin may result in worsening of PAH symptoms and should
be avoided. Caution should be used in patients with hepatic or renal
problems. The most common side effects of Remodulin included those related
to the method of infusion. For subcutaneous infusion, infusion site pain
and infusion site reaction (redness and swelling) occurred in the majority
of patients. These symptoms were often severe and could lead to treatment
with narcotics or discontinuation of Remodulin. For IV infusion, line
infections, sepsis, arm swelling, tingling sensations, bruising, and pain
were most common. General side effects (>5% more than placebo) were
diarrhea, jaw pain, vasodilation, and edema.
About United Therapeutics
United Therapeutics is a biotechnology company focused on the
development and commercialization of unique products for patients with
chronic and life- threatening cardiovascular, cancer and infectious
diseases.
Forward-Looking Statements
In addition to historical information, this press release contains
forward-looking statements about the publication of a report in the CDC's
Morbidity and Mortality Weekly Report, United Therapeutics' plans to
commence a study of sepsis in parenterally-delivered prostanoids, and the
design of such study and its enrollment commencement date, United
Therapeutics' plans to coordinate a working group to develop unified best
practice recommendations for IV prostanoids, its plans to revise Remodulin
package labeling, and expectations with respect to the impact of central
line filters and best practices on the issues raised in the presentation
that are based on United Therapeutics' current beliefs and expectations as
to future outcomes. These expectations are subject to risks and
uncertainties such as those described in United Therapeutics' periodic
reports filed with the Securities and Exchange Commission which may cause
actual results to differ materially from anticipated results. Consequently,
such forward-looking statements are qualified by the cautionary statements,
cautionary language and risk factors set forth in United Therapeutics'
periodic reports and documents filed with the Securities and Exchange
Commission, including the company's most recent Form 10-K and Form 10-Q.
United Therapeutics is providing this information as of February 26, 2007
and undertakes no obligation to publicly update or revise the information
contained in this press release whether as a result of new information,
future events or any other reason.
United Therapeutics Corporation
unither
View drug information on Remodulin.
Therapeutics Corporation (Nasdaq: UTHR) today announced new guidance from
pulmonary arterial hypertension opinion leaders relating to intravenous
therapies. The new guidance was issued by the Scientific Leadership
Committee (SLC) of the Pulmonary Hypertension Association in response to
the release of a slide presentation prepared by CDC researchers entitled
"Bloodstream infections among patients treated with intravenous
epoprostenol and intravenous treprostinil for pulmonary arterial
hypertension, United States 2004 - 2006". The slides accompanied a
presentation to the SLC on February 23, 2007, and may be published as a
report in the CDC's Morbidity and Mortality Weekly Report. The new guidance
from pulmonary hypertension opinion leaders is for physicians to be mindful
of the range of possible gram negative and gram positive infectious
organisms in patients with long-term central catheters and initiate
appropriately broad spectrum antibiotics in patients with suspected
bloodstream infections until culture results and antibiotic sensitivity are
known.
"We welcome the new guidance from pulmonary hypertension opinion
leaders," said Martine Rothblatt, Ph.D., United Therapeutics' Chairman and
Chief Executive Officer. "We believe that if a patient is predisposed to
sepsis, then subcutaneous Remodulin, which has never been associated with
septicemia, is the safest catheter-based treatment option; other patients
have a very small chance of developing sepsis. For a disease in which mean
survival is counted in single digit years, everyone wants to go the extra
mile to provide patients needing prostacyclin therapy with the most options
-- this is why we developed the micro-pump, ice-free and rapid-switch
characteristics of intravenous Remodulin."
Scientific Leadership Committee Guidance
The Pulmonary Hypertension Association Scientific Leadership Committee
(SLC) is composed of more than 20 leaders in the field of pulmonary
hypertension. The members of the SLC are clinicians, research scientists,
and nurses who come from medical centers recognized for performing
outstanding research and providing excellent care for patients with
pulmonary hypertension. The mission of the SLC is to provide medical and
scientific leadership and guidance for the mission of the Pulmonary
Hypertension Association by proactively facilitating the development of new
knowledge about pulmonary hypertension, actively disseminating knowledge
about pulmonary hypertension to medical and public audiences, and
advocating and raising awareness about pulmonary hypertension.
Following the CDC researcher's presentation, the SLC posted the
following guidance statement on the Pulmonary Hypertension Association
website, phassociation:
"The SLC notes the observation that patients on long-term intravenous
therapy are susceptible to bloodstream infections caused by a broad range
of organisms. The Centers for Disease Control and Prevention (CDC) report
suggests a hypothesis that different patient profiles may be subject to
higher risk of various types of infections. The SLC considers the CDC
document to be a hypothesis generating report which does not permit
definitive or specific conclusions at this time. Therefore, the SLC
supports the following:
1. Further appropriately designed studies are required to determine the validity of the hypothesis raised by the current document.
2. Pending rigorous studies, physicians should be mindful of the range of possible gram negative and gram positive infectious organisms in patients with long-term central catheters and initiate appropriately broad spectrum antibiotics in patients with suspected bloodstream infections until culture results and antibiotic sensitivity are known.
3. Choice of specific parenteral prostacyclin agents, as well as all pulmonary vascular targeted therapy should continue to be based on a global assessment of efficacy, risk, expense and feasibility of each agent in each individual patient's clinical context."
United Therapeutics' Response
"We will work closely with the Pulmonary Hypertension Association and
prescribers to improve patient care. We are confident that central line
filters and heightened emphasis on sterility best practices will go a long
way to address the issues raised in the CDC presentation," said Roger
Jeffs, Ph.D., United Therapeutics' President and Chief Operating Officer.
"As with any therapy for a life-threatening condition, prescribers will
balance the risk/benefit profile of IV Remodulin against their patients'
needs in light of the experiences they have had with the drug."
United Therapeutics plans to take the following actions in response to
the Scientific Leadership Committee guidance:
-- United Therapeutics will commence a multi-center, multi-national,
multi-year and multi-agent prospective study to scientifically test the
hypothesis of whether there are differences in the risk of sepsis and
sepsis sub-types among parenterally-delivered prostacyclin mimetics and
analogs. The company anticipates this study to enroll several hundred
patients and is expected to commence later this year. "We are excited
about taking the lead in testing some of the hypotheses suggested by
the CDC's observations," said David Zaccardelli, PharmD, United
Therapeutics' Senior Vice President for Pharmaceutical Development. "No
doubt there is much new information to be learned from prospective
study of a large number of patients receiving chronic intravenous
therapy for pulmonary hypertension."
-- United Therapeutics also plans to coordinate a working group with the
Pulmonary Hypertension Association and physicians and nurses, along
with its network of specialty distributors and home health care
providers, to develop unified best practice recommendations related to
the chronic administration of IV prostanoids via central venous
catheters.
-- United Therapeutics will revise Remodulin package labeling to more
fully describe the known infection risk and appropriate technique that
should be practiced when preparing and administering intravenous
treprostinil.
About Remodulin
Remodulin(R) is indicated as a continuous subcutaneous infusion or IV
infusion (for those not able to tolerate a subcutaneous infusion) for the
treatment of PAH in patients with NYHA Class II-IV symptoms to diminish
symptoms associated with exercise.
Remodulin is indicated to diminish the rate of clinical deterioration
in patients requiring transition from Flolan(R); the risks and benefits of
each drug should be carefully considered prior to transition.
Important Safety Information:
Remodulin is contraindicated in patients with hypersensitivity to
Remodulin, its ingredients, or similar drugs. Remodulin is a potent
vasodilator. It lowers blood pressure, which may be further lowered by
other drugs that also reduce blood pressure. Remodulin inhibits platelet
aggregation and therefore, may increase the risk of bleeding, particularly
in patients on anticoagulants. Abrupt withdrawal or sudden large reductions
in dosage of Remodulin may result in worsening of PAH symptoms and should
be avoided. Caution should be used in patients with hepatic or renal
problems. The most common side effects of Remodulin included those related
to the method of infusion. For subcutaneous infusion, infusion site pain
and infusion site reaction (redness and swelling) occurred in the majority
of patients. These symptoms were often severe and could lead to treatment
with narcotics or discontinuation of Remodulin. For IV infusion, line
infections, sepsis, arm swelling, tingling sensations, bruising, and pain
were most common. General side effects (>5% more than placebo) were
diarrhea, jaw pain, vasodilation, and edema.
About United Therapeutics
United Therapeutics is a biotechnology company focused on the
development and commercialization of unique products for patients with
chronic and life- threatening cardiovascular, cancer and infectious
diseases.
Forward-Looking Statements
In addition to historical information, this press release contains
forward-looking statements about the publication of a report in the CDC's
Morbidity and Mortality Weekly Report, United Therapeutics' plans to
commence a study of sepsis in parenterally-delivered prostanoids, and the
design of such study and its enrollment commencement date, United
Therapeutics' plans to coordinate a working group to develop unified best
practice recommendations for IV prostanoids, its plans to revise Remodulin
package labeling, and expectations with respect to the impact of central
line filters and best practices on the issues raised in the presentation
that are based on United Therapeutics' current beliefs and expectations as
to future outcomes. These expectations are subject to risks and
uncertainties such as those described in United Therapeutics' periodic
reports filed with the Securities and Exchange Commission which may cause
actual results to differ materially from anticipated results. Consequently,
such forward-looking statements are qualified by the cautionary statements,
cautionary language and risk factors set forth in United Therapeutics'
periodic reports and documents filed with the Securities and Exchange
Commission, including the company's most recent Form 10-K and Form 10-Q.
United Therapeutics is providing this information as of February 26, 2007
and undertakes no obligation to publicly update or revise the information
contained in this press release whether as a result of new information,
future events or any other reason.
United Therapeutics Corporation
unither
View drug information on Remodulin.
The Use of Topical Ointments for the Treatment of Osteoarthritis Questioned
Topical ointments used to treat the symptoms of osteoarthritis the major cause of disability in older people do not work for more than a few weeks say researchers according to a recent study. According to researchers, the current guidelines in Europe and the United States recommend the use of topical treatments containing non-steroidal anti-inflammatory drugs to relieve osteoarthritis pain.
Researchers explain many people with osteoarthritis use topical treatments because they cannot tolerate oral NSAIDs. These drugs often cause stomach upset, and many people who start taking them stop.The current study analyzed results from 13 previous studies comparing topical NSAID treatments to sham treatments or treatment with NSAIDs taken by mouth. Results showed the topical treatments were better at relieving pain than the sham treatments, but only for about two weeks.
The most effective treatment, even in the first week, was taking an NSAID by mouth. As expected, the studies showed oral NSAIDs were more likely to cause gastrointestinal problems and more people quit taking them. However, the topical treatments had problems as well, causing more itching, burning and rashes.
Thus researchers conclude saying that more studies have to be done in this regard to support the long term use of topical NSAIDs in osteoarthritis.
Researchers explain many people with osteoarthritis use topical treatments because they cannot tolerate oral NSAIDs. These drugs often cause stomach upset, and many people who start taking them stop.The current study analyzed results from 13 previous studies comparing topical NSAID treatments to sham treatments or treatment with NSAIDs taken by mouth. Results showed the topical treatments were better at relieving pain than the sham treatments, but only for about two weeks.
The most effective treatment, even in the first week, was taking an NSAID by mouth. As expected, the studies showed oral NSAIDs were more likely to cause gastrointestinal problems and more people quit taking them. However, the topical treatments had problems as well, causing more itching, burning and rashes.
Thus researchers conclude saying that more studies have to be done in this regard to support the long term use of topical NSAIDs in osteoarthritis.
Study Finds Respiratory Symptoms More Reliable Indicator Of H1N1, Not Fever Alone
New research shows that individuals with mild H1N1 infection may go undetected using standard diagnostic criteria, according to a study in the August issue of the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology, (APIC). The study concludes that coughing or other respiratory symptoms are more accurate in determining influenza infection than presence of a fever.
Currently, public health officials rely on body temperature (detecting fever) to screen individuals for potential infection with H1N1. For example, during a pandemic, standard screening at airports relies on body temperature scanners to detect the presence of fever. However, the study's authors found that coughing, not fever, is a more reliable indicator of infection because nearly half of the individuals with mild infection may not have fever.
A team led by Sang Won Park, MD, professor at the Seoul National University, investigated confirmed cases of H1N1 who were hospitalized and quarantined during the early stages of the pandemic in 2009. The study's results showed only 45.5 percent of the case subjects had fever. Individuals with mild infection and no fever have the potential to evade detection at airports or medical triage units, thus continuing the chain of infection.
"Our study found that fever is not reliable for case definition, even though it has been regarded as a key factor in determining influenza infection," said Dr. Park. "We are aware of other studies that show fever present in as few as 31 percent of confirmed cases of influenza. We found that the most sensitive indicator was cough."
Dr. Park adds that that "screening should take any kind of respiratory manifestation into account."
About AJIC: American Journal Of Infection Control
AJIC: American Journal of Infection Control covers key topics and issues in infection control and epidemiology. Infection preventionists, including physicians, nurses, and epidemiologists, rely on AJIC for peer-reviewed articles covering clinical topics as well as original research. As the official publication of the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), AJIC is the foremost resource on infection control, epidemiology, infectious diseases, quality management, occupational health, and disease prevention. AJIC also publishes infection control guidelines from APIC and the CDC. Published by Elsevier, AJIC is included in MEDLINE and CINAHL.
Notes
"Mild form of 2009 H1N1 influenza infection detected by active surveillance: Implications for infection Control" appears in the American Journal of Infection Control, Volume 38, Issue 6 (August 2010) published by Elsevier.
Authors:
Ina Jeong, MD, Division of Pulmonary and Critical Care Medicine, Department
of Internal Medicine and Lung Institute, Seoul National University
Chang-hoon Lee, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Deog Kyeom Kim, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Hee Soon Chung, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Sang Won Park, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Source:
APIC
Currently, public health officials rely on body temperature (detecting fever) to screen individuals for potential infection with H1N1. For example, during a pandemic, standard screening at airports relies on body temperature scanners to detect the presence of fever. However, the study's authors found that coughing, not fever, is a more reliable indicator of infection because nearly half of the individuals with mild infection may not have fever.
A team led by Sang Won Park, MD, professor at the Seoul National University, investigated confirmed cases of H1N1 who were hospitalized and quarantined during the early stages of the pandemic in 2009. The study's results showed only 45.5 percent of the case subjects had fever. Individuals with mild infection and no fever have the potential to evade detection at airports or medical triage units, thus continuing the chain of infection.
"Our study found that fever is not reliable for case definition, even though it has been regarded as a key factor in determining influenza infection," said Dr. Park. "We are aware of other studies that show fever present in as few as 31 percent of confirmed cases of influenza. We found that the most sensitive indicator was cough."
Dr. Park adds that that "screening should take any kind of respiratory manifestation into account."
About AJIC: American Journal Of Infection Control
AJIC: American Journal of Infection Control covers key topics and issues in infection control and epidemiology. Infection preventionists, including physicians, nurses, and epidemiologists, rely on AJIC for peer-reviewed articles covering clinical topics as well as original research. As the official publication of the Association for Professionals in Infection Control and Epidemiology, Inc. (APIC), AJIC is the foremost resource on infection control, epidemiology, infectious diseases, quality management, occupational health, and disease prevention. AJIC also publishes infection control guidelines from APIC and the CDC. Published by Elsevier, AJIC is included in MEDLINE and CINAHL.
Notes
"Mild form of 2009 H1N1 influenza infection detected by active surveillance: Implications for infection Control" appears in the American Journal of Infection Control, Volume 38, Issue 6 (August 2010) published by Elsevier.
Authors:
Ina Jeong, MD, Division of Pulmonary and Critical Care Medicine, Department
of Internal Medicine and Lung Institute, Seoul National University
Chang-hoon Lee, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Deog Kyeom Kim, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Hee Soon Chung, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Sang Won Park, MD, Department of Internal Medicine, Seoul National University College of Medicine, Boramae Medical Center, Seoul, Republic of Korea.
Source:
APIC
U.K. To Provide About $12B To Improve Health Services In Developing Countries, Fight HIV/AIDS, Official Says
United Kingdom International Development Secretary Douglas Alexander on Monday announced that the government will provide six billion British pounds, or $11.8 billion, over seven years to improve health services and systems in developing countries to fight HIV/AIDS, AFP/Google reports (AFP/Google, 6/2).
According to Alexander, the seven-year strategy aims to ensure universal access to HIV prevention, treatment, care and support. The Achieving Universal Access strategy will commit the United Kingdom to increasing coverage of services for injection drug users, meeting the needs of AIDS orphans and children affected by the disease, and working with other groups to reduce the cost of antiretroviral treatment, the Press Association reports. The strategy also will commit the country to preventing mother-to-child HIV transmission and increasing the availability of family planning services, including male and female condoms. The United Kingdom will spend more than 200 million pounds, or about $394 million, over the next three years to support social protection programs and will increase funding for research and development of HIV/AIDS vaccines and microbicides by 50%.
Under the plan, the U.K. Department for International Development also will provide about $100 million pounds, or $197 million, over the next six years to improve Nigeria's national response to HIV. About $30 million pounds, or $60 million, of that funding will be specifically allocated to provide no-cost condoms to Nigeria (Press Association, 6/2).
According to Alexander, the seven-year strategy aims to ensure universal access to HIV prevention, treatment, care and support. The Achieving Universal Access strategy will commit the United Kingdom to increasing coverage of services for injection drug users, meeting the needs of AIDS orphans and children affected by the disease, and working with other groups to reduce the cost of antiretroviral treatment, the Press Association reports. The strategy also will commit the country to preventing mother-to-child HIV transmission and increasing the availability of family planning services, including male and female condoms. The United Kingdom will spend more than 200 million pounds, or about $394 million, over the next three years to support social protection programs and will increase funding for research and development of HIV/AIDS vaccines and microbicides by 50%.
Under the plan, the U.K. Department for International Development also will provide about $100 million pounds, or $197 million, over the next six years to improve Nigeria's national response to HIV. About $30 million pounds, or $60 million, of that funding will be specifically allocated to provide no-cost condoms to Nigeria (Press Association, 6/2).
Comments
Alexander in a written statement said the financial commitment "demonstrates [the United Kingdom's] determination to remain at the forefront of global efforts to achieve universal access." He added, "If we are to achieve universal access and to halt and reverse the spread of AIDS, the evidence demonstrates that we require a long-term approach, across a range of health systems and services" (AFP/Google, 6/2).
Shadow International Development Secretary Andrew Mitchell welcomed the announcement but called for more scrutiny. The "strategy paper is sensible and constructive," Mitchell said, adding, "But the government needs to be more self-critical about whether we are actually getting the results we expect, both on behalf of the people we are trying to help, and of British taxpayers." Mitchell noted that an annual assessment of the program's impact is needed rather than the planned independent review in three years. "We also need specific interim country-level targets so that leaders can be held to account on their promise to deliver universal access to HIV/AIDS prevention and treatment by 2010," he said.
Phil Bloomer, director of campaigns and policy at Oxfam, said, "The announcement of this much needed, long-term financial commitment to help strengthen health systems in the developing world is a very welcome one." He added, "But tackling the AIDS epidemic will require more than investment in health systems. It is also about factors such as education, awareness raising, counseling and the provision of security of food and income for all those who need it, whether" living with or affected by HIV/AIDS (Press Association, 6/2).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2008 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
US Congress Must Include Additional Money for Global Fund in Final Budget Bill, Editorial Says
Congress must approve final budget legislation that includes a Senate amendment that would authorize an additional $500 million for the... Global Fund To Fight AIDS, Tuberculosis and Malaria in order to "solidif[y] America's commitment to the battle against three deadly diseases plaguing the developing world," an Indianapolis Star editorial says (Indianapolis Star, 3/19). The Senate on Thursday approved 51-49 a fiscal year 2006 $2.6 trillion budget resolution (S Con Res 18), including an amendment that would provide a $500 million increase in funding for the Global Fund and bring the total FY 2006 amount for the fund to $800 million. President Bush in his FY 2006 budget request proposed $300 million go to the Global Fund. The House also must approve the funding increase for it to take effect (Kaiser Daily HIV/AIDS Report, 3/18). By approving the funding increase, the Senate "took an important step toward reducing the diseases' staggering death toll," the editorial says. The increase also could help to "leverage donations from other countries," according to the editorial. The Global Fund has "an impressive track record in fighting AIDS," and to deny the group additional funding "would be a setback in the battle against AIDS and other infectious diseases," the Star concludes (Indianapolis Star, 3/19).
"Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from kaisernetwork kaisernetwork. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork/dailyreports/hiv.. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Use Of Certain Antibiotics In Topical Cream Could Prevent HIV Transmission, Study Says
A class of antibiotics known as aminoglycosides could be used to make a topical cream that would trigger production of a protein in humans to prevent HIV transmission, according to a study published Tuesday in PLoS Biology, the Orlando Sentinel reports.
For the study, researchers led by Alexander Cole of the University of Central Florida used the antibiotics to trigger a dormant human gene to produce a protein called retrocyclins that resists HIV transmission. The researchers applied the antibiotics to vaginal tissues and cervical cells and found that it stimulated the tissues and cells to produce retrocyclins. Cole said there is a "good chance the aminoglycosides antibiotics will be used in a topical cream as a way to prevent the transmission of HIV from men to women." He noted that more research, including human trials, is necessary to determine the safety and efficacy of a potential cream.
Cole said the discovery that aminoglycosides can trigger cells to produce retrocyclins is a "promising find," adding that the researchers "will be moving forward with this -- full steam ahead." Phalguni Gupta, a scientist at the University of Pittsburgh who specializes in infectious diseases, said the research is "very hopeful," adding that the use of aminoglycosides in a cream or gel would be an "important part of the arsenal in the fight against" HIV/AIDS (Quintero, Orlando Sentinnel, 4/28).
The study is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
For the study, researchers led by Alexander Cole of the University of Central Florida used the antibiotics to trigger a dormant human gene to produce a protein called retrocyclins that resists HIV transmission. The researchers applied the antibiotics to vaginal tissues and cervical cells and found that it stimulated the tissues and cells to produce retrocyclins. Cole said there is a "good chance the aminoglycosides antibiotics will be used in a topical cream as a way to prevent the transmission of HIV from men to women." He noted that more research, including human trials, is necessary to determine the safety and efficacy of a potential cream.
Cole said the discovery that aminoglycosides can trigger cells to produce retrocyclins is a "promising find," adding that the researchers "will be moving forward with this -- full steam ahead." Phalguni Gupta, a scientist at the University of Pittsburgh who specializes in infectious diseases, said the research is "very hopeful," adding that the use of aminoglycosides in a cream or gel would be an "important part of the arsenal in the fight against" HIV/AIDS (Quintero, Orlando Sentinnel, 4/28).
The study is available online.
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The Severity Of Side Effects After Salmon Vaccination Depends On The Antigen Composition
During the course of his doctoral studies, Stephen Mutoloki examined tissue reactions of salmon to oil-based vaccines and elucidated the components that play a significant role in the development of these reactions.
Vaccines are used in aquaculture to avoid outbreaks of infection from bacteria and viruses. If given at the start of the sea-water phase, oil-based vaccines provide protection against bacterial infection for the entire life in the animal. However, oil-based vaccines produce local side-effects in the form of pigmentation and adhesions between internal organs, which in some cases are severe enough to reduce the carcase quality at slaughter. The underlying mechanisms of side-effect development are little known.
Stephen Mutoloki discovered that the reaction to the vaccine, and especially to the bacterial component of the vaccine, comes in several "waves". These waves consist of cells that migrate to the injection site, and in the van of these is the "rapid-response troop", the neutrophilic granulocytes. These are followed by the "clean-up team", the macrophages, and later still by the cells that provide the actual protection against disease later in life, the lymphocytes. This is the same sequence one finds in a natural infection and is the result of a collaboration between the processes of inflammation and of immunity. How aggressive the reaction within the tissue is, depends on how many granulocytes that are involved and how many clean-up cells arrive.
The main findings in Dr. Mutoloki's work show that the species has a lot to say for how effectively the "clean-up" progresses. The rainbow trout has in general more effective cleaning-up cells, while the Atlantic salmon does a poorer job with a correspondingly greater and longer-lasting tissue reaction. The clean-up phase is also affected by the vaccine's composition, that is, the more unrefined a vaccine, the more inflammatory cells that will accumulate and the greater the tissue reaction. The type of antigen in the vaccine is also significant. Moritella viscosa is, for example, more difficult to clean up after than Aeromonas salmonicida. And if the vaccinated fish uses more resources to clean up than to create immunity against future infections, the tissue relation may become too dominating and produce unwanted side-effects.
NORWEGIAN SCHOOL OF VETERINARY SCIENCE
UllevГҐlsveien 72
veths.no
Vaccines are used in aquaculture to avoid outbreaks of infection from bacteria and viruses. If given at the start of the sea-water phase, oil-based vaccines provide protection against bacterial infection for the entire life in the animal. However, oil-based vaccines produce local side-effects in the form of pigmentation and adhesions between internal organs, which in some cases are severe enough to reduce the carcase quality at slaughter. The underlying mechanisms of side-effect development are little known.
Stephen Mutoloki discovered that the reaction to the vaccine, and especially to the bacterial component of the vaccine, comes in several "waves". These waves consist of cells that migrate to the injection site, and in the van of these is the "rapid-response troop", the neutrophilic granulocytes. These are followed by the "clean-up team", the macrophages, and later still by the cells that provide the actual protection against disease later in life, the lymphocytes. This is the same sequence one finds in a natural infection and is the result of a collaboration between the processes of inflammation and of immunity. How aggressive the reaction within the tissue is, depends on how many granulocytes that are involved and how many clean-up cells arrive.
The main findings in Dr. Mutoloki's work show that the species has a lot to say for how effectively the "clean-up" progresses. The rainbow trout has in general more effective cleaning-up cells, while the Atlantic salmon does a poorer job with a correspondingly greater and longer-lasting tissue reaction. The clean-up phase is also affected by the vaccine's composition, that is, the more unrefined a vaccine, the more inflammatory cells that will accumulate and the greater the tissue reaction. The type of antigen in the vaccine is also significant. Moritella viscosa is, for example, more difficult to clean up after than Aeromonas salmonicida. And if the vaccinated fish uses more resources to clean up than to create immunity against future infections, the tissue relation may become too dominating and produce unwanted side-effects.
NORWEGIAN SCHOOL OF VETERINARY SCIENCE
UllevГҐlsveien 72
veths.no
Taiwan Harm Reduction Program For IDUs Praised At International Conference
Taiwan's harm reduction program for injection drug users -- which has reduced the number of new HIV cases among the group by about 50% over a three-year period -- recently received praise at the International Harm Reduction Association's 20th International Conference in Bangkok, Thailand, Inter Press Service reports. According to Inter Press Service, Taiwan's HIV incidence declined to 1,752 new cases in 2008, compared with more than 3,300 in 2005 -- nearly double the number recorded in 2004. Sheng Mou Hu, the country's health minister at the time, said the success in reducing the number of new HIV cases can be attributed to the approach that "harm reduction should be based on human rights." The program was launched in 2006 and includes elements like enhanced screening and monitoring of HIV-positive IDUs, a needle-exchange program and methadone replacement initiatives. As a result, IDUs in Taiwan are presented to the public as "patients" who required medical attention rather than criminals, Inter Press Service reports.
Ton Smits, executive director of the Asian Harm Reduction Network, said, "No other country in Asia can match Taiwan's achievement in launching and sustaining this harm reduction program." He said that in most Asian countries, policies relating to drug control "are in direct conflict with HIV-related policy, undermining harm reduction programs in the region." He also noted that 3% of IDUs in Southeast Asia have access to harm reduction services and that such programs are "facing a financial crisis," with a 90% resource gap in 2009. According to Gerry Stimson, executive director of IHRA, 2% to 3% of all available resources for HIV/AIDS is spent on harm reduction strategies. Stimson said, "If we are serious about reducing HIV infection amongst IDUs, then we are going to need between $2 billion and $3 billion this year and the next."
According to Inter Press Service, some encouraging signs have been seen in other Asian countries -- such as China, Malaysia, Thailand and Vietnam -- that are beginning programs similar to Taiwan's that treat IDUs through public health approaches rather than law enforcement measures. IDUs still are listed as one of the most vulnerable groups in the region, Inter Press Service reports. According to IHRA, there are close to 16 million IDUs in 158 countries worldwide. Information released at the conference said that some estimates place the number of HIV-positive IDUs at three million, while others place it at more than 6.6 million (Macan-Markar, Inter Press Service, 4/25).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Ton Smits, executive director of the Asian Harm Reduction Network, said, "No other country in Asia can match Taiwan's achievement in launching and sustaining this harm reduction program." He said that in most Asian countries, policies relating to drug control "are in direct conflict with HIV-related policy, undermining harm reduction programs in the region." He also noted that 3% of IDUs in Southeast Asia have access to harm reduction services and that such programs are "facing a financial crisis," with a 90% resource gap in 2009. According to Gerry Stimson, executive director of IHRA, 2% to 3% of all available resources for HIV/AIDS is spent on harm reduction strategies. Stimson said, "If we are serious about reducing HIV infection amongst IDUs, then we are going to need between $2 billion and $3 billion this year and the next."
According to Inter Press Service, some encouraging signs have been seen in other Asian countries -- such as China, Malaysia, Thailand and Vietnam -- that are beginning programs similar to Taiwan's that treat IDUs through public health approaches rather than law enforcement measures. IDUs still are listed as one of the most vulnerable groups in the region, Inter Press Service reports. According to IHRA, there are close to 16 million IDUs in 158 countries worldwide. Information released at the conference said that some estimates place the number of HIV-positive IDUs at three million, while others place it at more than 6.6 million (Macan-Markar, Inter Press Service, 4/25).
Reprinted with kind permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation.
© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Treatment Not 'Economical' Way To Fight Global HIV/AIDS; Prevention Would Save More Lives, Money, Opinion Piece Says
"It is humane to pay for AIDS drugs in Africa, but it isn't economical," and spending money on prevention would save more lives, economist Emily Oster writes in an opinion piece in the July 25 issue of... Forbes. By comparing the number of years of life saved by antiretroviral drugs with the number of years saved by other interventions, such as education, Oster shows that treatment is the most expensive way to fight the disease but is not the most effective. For example, if a regimen of generic antiretroviral drugs cost $1 per person per day, and one year of drug therapy saves one year of life, then each life-year costs $365, excluding the cost of delivering the drug to the patient, Oster says. However, using antibiotics to treat sexually transmitted diseases that produce open sores -- such as gonorrhea, syphilis and genital warts -- and therefore increase a person's risk of contracting HIV would cost just $3.65 per year of life saved, according to Oster. In addition, estimates from an aggressive education campaign in Uganda indicate that education would save lives at just $16 annually per year of life. "It may be that we have an objective other than maximizing the efficiency of dollars spent," Oster says, noting that providing hope to millions of Africans who are parents might "have value in and of itself." Oster continues, "But if we choose treatment, we must know what we are giving up. The tradeoffs are there whether we want to face them or not," concluding, "What economics can do is tell us -- in numbers, in black and white -- what we give up and what we gain" (Oster, Forbes, 7/25).
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
The Quest For An Effective HIV Vaccine Presents New Possibilities, Challenges
A vaccine that prevents HIV infection remains an important goal in the fight against AIDS, but the current top HIV vaccine candidates may not work in this way, say scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Rather, the first successful preventive HIV vaccines, if administered prior to HIV infection, may reduce HIV levels in the body, thereby delaying the progression to AIDS and the need to start antiretroviral drugs. These vaccines may also reduce the chance that a person infected with HIV would pass the virus on to other people, according to NIAID Director Anthony S. Fauci, M.D., and Margaret I. Johnston, Ph.D., director of NIAID's Vaccine Research Program in the Division of AIDS.
In a review article in the New England Journal of Medicine, Drs. Johnston and Fauci examine the daunting challenges posed by HIV, the evolution of HIV vaccine research, the role T cells may play in HIV vaccine effectiveness, and how the first successful HIV vaccine may fit into a comprehensive HIV/AIDS prevention effort.
Vaccines typically work by mimicking the effects of natural exposure to a specific microbe. Because of initial exposure, the immune system develops the ability to recognize the specific microbe and can protect the human body against it if it reappears. HIV, however, has thwarted scientists' efforts thus far to develop a classic preventive vaccine for the virus because of its ability to integrate into target cells and evade clearance by the immune system. The interaction between HIV and the immune system is complex, and how different HIV-specific immune responses help to control infection is only partially understood.
"The development of an HIV vaccine is a complex research challenge because the virus is unusually well-equipped to elude immune defenses," says Dr. Fauci. "Much progress has been made; however, we must continue research efforts to improve our understanding of HIV and how it evades the immune system, to design new vaccine candidates and to assess the most promising ones in clinical trials."
Dr. Johnston adds, "An important research challenge is to determine if these so-called T-cell vaccines that primarily induce a cellular immune response can have a beneficial effect by reducing viral levels and preserving critical cells needed to control infection. There will be a tremendous public health challenge as well, in an HIV vaccine that does not completely prevent the virus from establishing itself in the body."
Once HIV enters the body, it infects crucial CD4+ T cells, replicates, spreads throughout the body and establishes HIV reservoirs in lymphatic tissues. Within weeks of exposure, virus levels peak and then decline to levels that may remain low for months or years. It is believed that CD8+ T cells--so-called killer T-cells--are responsible for this reduction in HIV levels; however, their ability to continue to suppress the virus declines over time as the virus mutates and the immune system is progressively destroyed.
The infection of CD4+ T cells occurs very early in HIV disease, and virus persists indefinitely. Other viruses also replicate robustly but, unlike HIV, most do not establish a permanent reservoir of infected cells in the body. The window of opportunity to prevent long-term HIV infection may close permanently once a pool of latently infected cells is in place, Drs. Johnston and Fauci note. Neutralizing antibodies, which can attach to and eliminate free virus, only appear after HIV levels have declined substantially. Further, the effectiveness of these antibodies is stymied because of the rapid genetic changes that occur in HIV's outer envelope protein, which allow the virus to escape detection.
While early efforts to develop an HIV vaccine focused on the viral envelope, an improved understanding of how HIV causes disease has brought increased attention to the role that T cells could play in an HIV vaccine by spurring cellular immunity. Numerous animal and human studies have confirmed how important cellular immunity is in the early and later stages of HIV infection, even though the virus is never completely eliminated. Vaccines that induce strong cellular immune responses may have some benefits, say the authors. In non-human primate models of HIV infection, T-cell vaccines have reportedly decreased the total amount of virus produced during early infection, caused a reduction in virus levels following the acute stage of infection, or produced some combination of these effects. In many of these animals, disease progression was also delayed.
Based on the scientific evidence, several questions remain, say Drs. Johnston and Fauci: Can a vaccine that does not prevent HIV infection but reduces virus levels and preserves a segment of uninfected CD4+ T cells from destruction benefit the immunized individual" Might people immunized with T-cell vaccines before HIV exposure remain disease-free for a prolonged period once they are infected"
Additionally, T-cell vaccines may reduce secondary HIV transmission if they can help the immune system keep viral replication at a very low level for a long time. Studies have suggested that people with high levels of virus--namely those in the early and late stages of infection--are most likely to infect their sexual partners. A preventive vaccine given before exposure to HIV might stifle the initial burst of virus, better control virus levels and potentially reduce that person's ability to infect other people, Drs. Johnston and Fauci assert.
Vaccines of this type present several complications, however. T-cell-mediated control of HIV infection may not stave off disease forever. Additional human studies would be needed to determine if the vaccine also reduces the spread of HIV. Finally, an HIV vaccine that delays but does not completely prevent disease could not stand alone as a preventive measure; the public health community would need to include it as part of a broader HIV prevention program, so that recipients would minimize, or ideally, not engage in high-risk behaviors, according to the authors.
Currently, several vaccines that induce primarily T-cell responses are in or will soon enter expanded human clinical trials to determine if they impact HIV infection. Researchers also continue to give high priority to creating an HIV vaccine that induces broadly neutralizing antibodies, which might prevent the establishment of HIV infection. Although rare, such antibodies do exist, giving hope to scientists that a vaccine to induce such antibodies can be designed.
Drs. Johnston and Fauci conclude that a vaccine that prevents HIV infection by clearing the virus before cells become latently infected remains the goal. In addition, they believe that even a vaccine that does not prevent infection could prove beneficial if it prolongs the disease-free period and possibly even reduces virus transmission. If such a vaccine is shown to be successful and is eventually licensed, it would need to be delivered as part of a comprehensive, multifaceted HIV prevention program.
###
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit niaid.nih/.
Reference: MI Johnston and AS Fauci. An HIV vaccine--evolving concepts. The New England Journal of Medicine DOI: 10.1056/NEJMra066267 (2007).
Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases
In a review article in the New England Journal of Medicine, Drs. Johnston and Fauci examine the daunting challenges posed by HIV, the evolution of HIV vaccine research, the role T cells may play in HIV vaccine effectiveness, and how the first successful HIV vaccine may fit into a comprehensive HIV/AIDS prevention effort.
Vaccines typically work by mimicking the effects of natural exposure to a specific microbe. Because of initial exposure, the immune system develops the ability to recognize the specific microbe and can protect the human body against it if it reappears. HIV, however, has thwarted scientists' efforts thus far to develop a classic preventive vaccine for the virus because of its ability to integrate into target cells and evade clearance by the immune system. The interaction between HIV and the immune system is complex, and how different HIV-specific immune responses help to control infection is only partially understood.
"The development of an HIV vaccine is a complex research challenge because the virus is unusually well-equipped to elude immune defenses," says Dr. Fauci. "Much progress has been made; however, we must continue research efforts to improve our understanding of HIV and how it evades the immune system, to design new vaccine candidates and to assess the most promising ones in clinical trials."
Dr. Johnston adds, "An important research challenge is to determine if these so-called T-cell vaccines that primarily induce a cellular immune response can have a beneficial effect by reducing viral levels and preserving critical cells needed to control infection. There will be a tremendous public health challenge as well, in an HIV vaccine that does not completely prevent the virus from establishing itself in the body."
Once HIV enters the body, it infects crucial CD4+ T cells, replicates, spreads throughout the body and establishes HIV reservoirs in lymphatic tissues. Within weeks of exposure, virus levels peak and then decline to levels that may remain low for months or years. It is believed that CD8+ T cells--so-called killer T-cells--are responsible for this reduction in HIV levels; however, their ability to continue to suppress the virus declines over time as the virus mutates and the immune system is progressively destroyed.
The infection of CD4+ T cells occurs very early in HIV disease, and virus persists indefinitely. Other viruses also replicate robustly but, unlike HIV, most do not establish a permanent reservoir of infected cells in the body. The window of opportunity to prevent long-term HIV infection may close permanently once a pool of latently infected cells is in place, Drs. Johnston and Fauci note. Neutralizing antibodies, which can attach to and eliminate free virus, only appear after HIV levels have declined substantially. Further, the effectiveness of these antibodies is stymied because of the rapid genetic changes that occur in HIV's outer envelope protein, which allow the virus to escape detection.
While early efforts to develop an HIV vaccine focused on the viral envelope, an improved understanding of how HIV causes disease has brought increased attention to the role that T cells could play in an HIV vaccine by spurring cellular immunity. Numerous animal and human studies have confirmed how important cellular immunity is in the early and later stages of HIV infection, even though the virus is never completely eliminated. Vaccines that induce strong cellular immune responses may have some benefits, say the authors. In non-human primate models of HIV infection, T-cell vaccines have reportedly decreased the total amount of virus produced during early infection, caused a reduction in virus levels following the acute stage of infection, or produced some combination of these effects. In many of these animals, disease progression was also delayed.
Based on the scientific evidence, several questions remain, say Drs. Johnston and Fauci: Can a vaccine that does not prevent HIV infection but reduces virus levels and preserves a segment of uninfected CD4+ T cells from destruction benefit the immunized individual" Might people immunized with T-cell vaccines before HIV exposure remain disease-free for a prolonged period once they are infected"
Additionally, T-cell vaccines may reduce secondary HIV transmission if they can help the immune system keep viral replication at a very low level for a long time. Studies have suggested that people with high levels of virus--namely those in the early and late stages of infection--are most likely to infect their sexual partners. A preventive vaccine given before exposure to HIV might stifle the initial burst of virus, better control virus levels and potentially reduce that person's ability to infect other people, Drs. Johnston and Fauci assert.
Vaccines of this type present several complications, however. T-cell-mediated control of HIV infection may not stave off disease forever. Additional human studies would be needed to determine if the vaccine also reduces the spread of HIV. Finally, an HIV vaccine that delays but does not completely prevent disease could not stand alone as a preventive measure; the public health community would need to include it as part of a broader HIV prevention program, so that recipients would minimize, or ideally, not engage in high-risk behaviors, according to the authors.
Currently, several vaccines that induce primarily T-cell responses are in or will soon enter expanded human clinical trials to determine if they impact HIV infection. Researchers also continue to give high priority to creating an HIV vaccine that induces broadly neutralizing antibodies, which might prevent the establishment of HIV infection. Although rare, such antibodies do exist, giving hope to scientists that a vaccine to induce such antibodies can be designed.
Drs. Johnston and Fauci conclude that a vaccine that prevents HIV infection by clearing the virus before cells become latently infected remains the goal. In addition, they believe that even a vaccine that does not prevent infection could prove beneficial if it prolongs the disease-free period and possibly even reduces virus transmission. If such a vaccine is shown to be successful and is eventually licensed, it would need to be delivered as part of a comprehensive, multifaceted HIV prevention program.
###
NIAID is a component of the National Institutes of Health. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on basic immunology, transplantation and immune-related disorders, including autoimmune diseases, asthma and allergies.
The National Institutes of Health (NIH)--The Nation's Medical Research Agency--includes 27 Institutes and Centers and is a component of the U. S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit niaid.nih/.
Reference: MI Johnston and AS Fauci. An HIV vaccine--evolving concepts. The New England Journal of Medicine DOI: 10.1056/NEJMra066267 (2007).
Contact: Kathy Stover
NIH/National Institute of Allergy and Infectious Diseases
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