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.
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