MEXICO CITY, Aug. 7 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE:
GSK) today announced that 96-week data from the HEAT study show that
once-daily EPZICOM (abacavir + lamivudine) provides comparable efficacy to
once-daily Truvada(R) (tenofovir DF + emtricitabine) as a first-line option
for the treatment of HIV. The data were presented today at the 17th
International AIDS Conference in Mexico City, Mexico.
HEAT is the first large, prospective, long-term, head-to-head trial to
evaluate the safety and efficacy of EPZICOM and Truvada both combined with
a boosted protease inhibitor (Kaletra) administered once-daily in adults
who had no previous exposure to HIV medicines. The study involved 688 HIV
therapy-naive patients: 343 randomized to treatment with EPZICOM and 345
randomized to treatment with Truvada.
Results of the study found that through 96 weeks efficacy endpoints for
EPZICOM were comparable to Truvada, regardless of baseline viral load. At
96 weeks 60% of subjects receiving EPZICOM versus 58% of subjects receiving
Truvada achieved a viral load <50 c/mL. Patients receiving EPZICOM also
experienced similar median CD4+ cell increases to those patients receiving
Truvada, 250 vs. 247. Overall, both regimens were generally well-tolerated
with comparable safety profiles and few study discontinuations due to
adverse events (6% for both treatment arms). Virologic failure occurred in
14% of patients for both groups.
"The result of the HEAT trial further demonstrates that EPZICOM is an
effective first-line option for treatment-naive HIV patients with a
well-established safety profile," said John Pottage, M.D., Vice President
Global Clinical Development at GlaxoSmithKline. "This study provides the
first, head-to-head, completed study comparing these two HIV treatments and
demonstrates comparable results between the two."
Additionally, a review of two important inflammatory biomarkers, hs-CRP
and IL-6, in the HEAT data set showed that levels of both biomarkers
decreased from baseline at 48 weeks and 96 weeks. Further, there were no
significant differences between EPZICOM and Truvada at any time points.
Elevations of these markers have been associated with increased risk of
cardiovascular events but the degree of association is still being
evaluated.
HEAT Study Explained
HEAT is a head-to-head prospective, randomized, double-blind,
placebo-matched, multicenter study evaluating the safety and efficacy of
EPZICOM and Truvada. The study assigned 688 patients to receive either
EPZICOM QD (n=343) or Truvada QD (n=345) both in combination with QD
lopinavir/ritonavir. The primary efficacy endpoint was to determine the
proportion of subjects with a viral load of <50 c/mL at 48 weeks and the
primary safety endpoint was to evaluate safety and tolerability of both
regimens at 96 weeks.
Results demonstrate that EPZICOM was comparable to Truvada in virologic
and immunologic efficacy. At 48 weeks, 68% of subjects receiving EPZICOM
versus 67% of subjects receiving Truvada achieved a viral load <50c/mL. At
96 weeks 60% of subjects receiving EPZICOM versus 58% of subjects receiving
Truvada achieved a viral load <50c/mL. Of those patients who were able to
achieve a viral load <50c/mL (ITT, M=F), both EPZICOM and Truvada saw
similar success rates regardless of whether baseline viral load was
<100,000c/mL (63% vs. 58%) or greater than or equal to 100,000c/mL (56% vs.
58%). Median CD4+ increase was comparable in both arms at week 96 (250 vs.
247).
Adverse events were similar in both arms. Both treatment arms had 6% of
patients prematurely withdraw due to adverse events. In addition, 15% of
patients had drug-related Grade 3-4 adverse events in both treatment arms.
Patients receiving EPZICOM reported higher rates of suspected abacavir
hypersensitivity reaction compared with Truvada (4% vs. <1%). Prospective
HLA-B*5701 screening was not employed in this study. One percent of
patients receiving Truvada developed proximal renal tubule dysfunction (vs.
0% for EPZICOM). Overall, treatment-limiting adverse events were comparable
between the two arms.
Important Information about EPZICOM
EPZICOM, in combination with other antiretroviral agents, is indicated
for the treatment of HIV-1 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.
EPZICOM does not cure HIV infection/AIDS or prevent passing HIV to others.
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. 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.
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 additional important information about EPZICOM please visit
http://www.epzicom.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.
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.
Enquiries:
US Media enquiries: Marc Meachem (919) 483 2839
Mary Anne Rhyne (919) 483 2839
US Analyst/ Investor enquiries: Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
SOURCE GlaxoSmithKline
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Related links:
http://www.treatHIV.com
http://www.epzicom.com
CONTACT:
US Media, Marc Meachem, +1-919-483-2839, or
Mary Anne Rhyne, +1-919-483-2839, or US Analyst or Investors,
Frank Murdolo, +1-215-751-7002, or Tom Curry +1-215-751-5419, all
for GlaxoSmithKline
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