Prelim Data Suggest Patients Receiving Combinations Containing
Combivir May Be More Likely to Have Undetectable Virus Than
Those Receiving 3TC+ATZ Separately
PR Newswire - February 03, 1998 13:04
/ADVANCE FOR RELEASE TODAY AT 5:30 P.M., EST TODAY/
/ADVANCE/CHICAGO, Feb. 3 /PRNewswire/ -- Preliminary data from a study
reported today suggest that patients receiving Combivir(R)
(lamivudine/zidovudine) and a protease inhibitor were more likely to have
undetectable levels of virus (less than 400 copies/mL) after 16 weeks of
treatment than patients receiving Epivir(R) (lamivudine; 3TC) and Retrovir(R)
(zidovudine; AZT) dosed separately with a protease inhibitor (96% vs. 72%;
p=.038). In addition, there were trends toward lower HIV RNA levels and
higher CD4 cell counts in the arm receiving Combivir.
Combivir tablets, which contain half the daily doses of Epivir+Retrovir
and can be dosed with one pill in the morning and one at night, represent the
first major step toward simplifying highly effective HIV combination drug
regimens which, for some people, are difficult to take. Combivir was released
for use by the Food and Drug Administration last fall and was developed in
hopes that its simplified, alternative dosing option would encourage adherence
to multiple drug regimens containing Epivir and Retrovir.
"While these are early results, the data would at least suggest that the
simpler dosing of Combivir may have contributed to better therapy adherence
which may help explain the increased likelihood of having undetectable viral
loads in that arm of the study," said Joseph P. Eron, M.D., associate
professor of medicine at the University of North Carolina, Chapel Hill, School
of Medicine.
In this open-label study, 240 patients receiving Epivir+Retrovir and a
protease inhibitor have been randomized to continue receiving their protease
inhibitor with either Combivir (150 mg lamivudine/300 mg zidovudine) twice
daily, or separate dosing of Epivir (150 mg) and Retrovir (300 mg) twice
daily. At entry, patients were stable on a regimen of a protease inhibitor,
150 mg Epivir twice daily and 600 mg Retrovir daily in divided doses, with
viral loads of less than 10,000 copies/mL and CD4 cell counts greater than
300 cells/mm3.
Data presented today involve 25 patients in the Combivir arm and
24 patients in the Epivir+Retrovir arm who have completed the 16-week study
period. At the outset of the study, 72 percent of these 25 patients who began
the Combivir arm had undetectable levels of virus and, after 16 weeks,
96 percent had undetectable viral loads. By contrast, 74 percent of these
24 patients who began the study in the Epivir+Retrovir arm had undetectable
viral loads at study entry and, after 16 weeks, 72 percent had undetectable
virus.
Patients in the study completed drug adherence diaries which are currently
being analyzed. Once those data are compiled, they will be used to evaluate
whether or not they may suggest a correlation between adherence to therapy and
the outcomes of the two study groups.
"While it is too early to draw any definitive conclusions, we are
encouraged by the suggestions that Combivir may ultimately be shown to have
greater clinical effectiveness than Epivir and Retrovir dosed separately,"
said Neil Graham, M.D., principal clinical research physician for HIV at Glaxo
Wellcome Inc.
There were no differences in side effects or tolerability between the
Combivir arm and the Epivir+Retrovir arm. The most commonly reported side
effects associated with treatment with these two drugs continue to be
headache, nausea, malaise and fatigue, runny nose and nasal congestion,
diarrhea, low white blood cells and anemia. In addition, Epivir as well as
Retrovir and other nucleoside analogues have been associated with rare but
potentially life-threatening lactic acidosis and hepatomegaly.
The study was presented today at a major AIDS meeting being held in
Chicago.
Glaxo Wellcome (NYSE: GLX), the pharmaceutical industry leader in HIV
research, manufactures and markets Combivir, as well as the individual
formulations of both Epivir and Retrovir. Glaxo Wellcome is also developing
the investigational anti-HIV medications abacavir (formerly 1592) and
amprenavir (formerly 141W94), which are both in phase III clinical trials.
The company also markets Mepron(R) (atovquone) as a treatment for mild to
moderate cases of pneumocystis carinii pneumonia. Epivir was discovered by
scientists at BioChem Pharma of Laval, Quebec, Canada, and was licensed to
Glaxo Wellcome in 1990.
SOURCE Glaxo Wellcome
/CONTACT: Doug Stokke, 919-483-2311, for Glaxo Wellcome/
(GLX)
------
Tonight, I spoke to a researcher at Boston's Beth Israel Deaconess Medical Center, where there are several HIV/AIDS trials in progress. None of these trials involve Combivir (as far as I know). But Beth Israel has inpatient and outpatient clinical HIV/AIDS patients, and according to the researcher, these patients have been requesting Combivir by name. Furthermore, many patients are very eager to switch from 3TC+AZT to Combivir, due to the easier administration of pills. Should Combivir be clinically proven to be more effective than the individual combination of drugs, it will become much more successful in the marketplace. This will certainly benefit BCHE.
In other news: Lehman Brothers reiterated its Outperform rating on BCHE last Friday. It expects that lamivudine will become a $4 billion drug for GLX. It will depend upon the licensing agreement how much it helps BCHE. BCHE currently receives about 13% of net sales of 3TC from GLX.
Todd |
