MEXICO CITY, Aug. 6 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) (GSK) announced today that a review of data from over 14,600 patients
in 54 clinical studies showed no increased risk of myocardial infarction
associated with the anti-HIV medication abacavir. GSK conducted this review
upon learning that the analysis undertaken by the D:A:D cohort had found an
unexpected but potential association between highly active antiretroviral
therapy (HAART) regimens containing abacavir and an increased risk of heart
attack. GSK's review of its clinical trial database was presented today at
the International AIDS Conference in Mexico City.
The analysis was conducted from a GSK internal database including data
from 54 clinical trials. The review pooled data from 9,639 subjects on
abacavir-containing HAART and 5,044 subjects on non-abacavir HAART.
Overall, less than 30 heart attacks had been reported across the abacavir
and non-abacavir groups and no increased risk of heart attack associated
with abacavir was observed.
"GSK took the responsibility to examine the existing body of clinical
data available to us as soon as we learned the results of the D:A:D
cohort," said John Pottage, M.D., Vice President Global Clinical
Development at GlaxoSmithKline. "The D:A:D findings were certainly
unexpected and are inconsistent with what we have seen with our own data.
GSK believes at this time that the D:A:D data are inconclusive."
In the GSK analysis the frequency of coronary artery disorders for both
groups was very low and similar to the general population: 2.5 events per
1,000 people in the abacavir HAART and 4 events per 1,000 people in the
non-abacavir HAART. Further, the frequency of heart attacks was 1.1 per
1,000 people in the abacavir HAART and 1.4 per 1,000 people in the
non-abacavir HAART. GSK's review of clinical and pre-clinical data to date
did not reveal a plausible biologic mechanism for the results seen in the
D:A:D study.
Inflammatory biomarkers that may be associated with cardiac risk,
hs-CRP and IL-6, were evaluated from the HEAT trial, a large, randomized,
controlled study of Epzicom and Truvada. The levels of these important
biomarkers decreased from baseline at both 48 and 96 weeks for both
abacavir and tenofovir. Additionally, there were no significant differences
between the active comparitors in the study.
NRTIs currently constitute the cornerstone of combination
antiretroviral therapy with abacavir recognized as a key component and
recommended in treatment guidelines globally. GSK could not replicate the
findings of the D:A:D analysis. In totality, the available data from the
observational cohort and from clinical trials are inconclusive. It is clear
however, that HAART overwhelmingly provides substantial survival benefits
to HIV patients. As with all medications, physicians and patients must
weigh the risks of HIV disease against the overall benefits and risks of
the antiretroviral medicines available. As a precaution, the underlying
risk of coronary heart disorder should be considered when prescribing
antiretroviral therapies, including abacavir, and action taken to minimize
all modifiable risk factors (e.g., hypertension, hyperlipidemia, diabetes
mellitus, and smoking).
About Abacavir
Abacavir sulfate is a nucleoside reverse transcriptase inhibitor with a
proven safety and efficacy profile as part of an HIV treatment regimen.
Abacavir is a key component in Ziagen(R), Trizivir(R) and Epzicom(R). The
most significant treatment-limiting event known to occur with abacavir is a
hypersensitivity reaction, which occurs in approximately eight percent of
patients and emerges within the first six weeks of therapy.
Important Safety Information about ZIAGEN
ZIAGEN, in combination with other antiretroviral agents, is indicated
for the treatment of HIV-1 infection in adults.
ZIAGEN is one of 3 medicines containing abacavir. Before starting
ZIAGEN, 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.
ZIAGEN does not cure HIV infection/AIDS or prevent passing HIV to
others.
Important Safety Information
ZIAGEN(R) contains abacavir sulfate, which is also contained in EPZICOM
(abacavir sulfate and lamivudine) and TRIZIVIR(R) (abacavir sulfate,
lamivudine, and zidovudine). Patients taking ZIAGEN may have a serious
allergic reaction (hypersensitivity reaction) that can cause death. Your
risk of having this allergic reaction is much higher if you have a gene
variation called HLA*B5701 than if you do not. Your doctor can determine
with a blood test if you have this gene variation.
If you get a symptom from 2 or more of the following groups while
taking ZIAGEN, stop taking ZIAGEN 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 ZIAGEN because of an allergic reaction, NEVER take ZIAGEN
or any other abacavir-containing medicine (EPZICOM, TRIZIVIR) again. If you
take ZIAGEN 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 ZIAGEN for any other reason, even for a few days, and you
are not allergic to ZIAGEN, talk with your healthcare professional before
taking it again. Taking ZIAGEN 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 ZIAGEN
again, start taking it when you are around medical help or people who can
call a doctor if you need one.
A build up of lactic acid in the blood and an enlarged liver, including
fatal cases, have been reported.
Do not take ZIAGEN if your liver does not function normally.
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 ZIAGEN 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.
Some HIV medicines including ZIAGEN may increase your risk of heart
attack. If you have heart problems, smoke, or suffer from diseases that
increase your risk of heart disease such as high blood pressure, high
cholesterol, or diabetes, tell your doctor.
The most common side effects of ZIAGEN include nausea, vomiting,
tiredness, headache, diarrhea, trouble sleeping, fever and chills, and loss
of appetite. Most of these side effects did not cause people to stop taking
ZIAGEN.
For additional important information about ZIAGEN please visit
http://www.treathiv.com.
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. For full information on
GSK's HIV medications, please visit http://www.treatHIV.com.
Enquiries:
US Media enquiries: Marc Meachem 1 (919) 483 2839
US Analyst/Investor enquiries: Frank Murdolo 1 (215) 751 7002
European Analyst/Investor enquiries: David Mawdsley +44 (020) 8047 5564
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995, GSK cautions investors that any
forward-looking statements or projections made by GSK, including those made
in this announcement, are subject to risks and uncertainties that may cause
actual results to differ materially from those projected. Factors that may
affect GSK's operations are described under 'Risk Factors' in the 'Business
Review' in the company's Annual Report on Form 20-F for 2007.
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SOURCE GlaxoSmithKline
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Related links:
http://www.treathiv.com
CONTACT:
US Media enquiries, Marc Meachem,
+1-919-483-2839, US Analyst - Investor enquiries, Frank Murdolo,
+1-215-751-7002, or European Analyst - Investor enquiries, David
Mawdsley, +44-(020)-8047-5564, all of GlaxoSmithKline
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