Gilead Sciences Announces Statistically Significant Data From Phase II/III
Study of PREVEON for the Treatment of Patients with HIV Infection
FOSTER CITY, CALIF. (April 6) BW HEALTHWIRE -April 6, 1998--Gilead Sciences, Inc.
(NASDAQ:GILD) announced today that its preliminary analysis of a Phase II/III study
indicates that treatment of HIV-infected patients with PREVEON(TM) (adefovir dipivoxil) in
combination with other antiretroviral therapies resulted in a statistically significant reduction
in HIV viral load when compared to placebo controls.
Data from this study, known as GS 408, have just been unblinded and only preliminary
results are available. The data demonstrate that treatment with PREVEON was associated
with a mean DAVG24 (time-weighted difference from baseline over 24 weeks) of -0.24 log10
compared with -0.04 log10 for placebo (p less than 0.0001). The mean absolute difference
in HIV RNA compared to baseline at the end of the 24 week controlled treatment period
was -0.39 log10 for the PREVEON group compared with -0.01 log10 in the placebo group.
Changes in CD4 cell counts were also observed. The mean DAVG24 for CD4 count was
+3.3 cells/mm3 in the PREVEON group compared with -4.7 cells/mm3 in the placebo
group (p = 0.11). The mean absolute change in CD4 count at the end of the 24 week
treatment period was +15.0 cells for the PREVEON group compared with -6.2 cells in the
placebo group.
Study drug discontinuation rates over the 24 week period were 17.6 percent in the
PREVEON group compared with 14 percent in the placebo group. Grade 3 or 4 adverse
events were reported in 13 percent of patients receiving PREVEON compared with 7.7
percent of placebo patients; events reported in more than 1 percent of active patients
included diarrhea (2.3 percent) and headache (1.4 percent).
Additional analyses of these data by Gilead Sciences and the independent study team are
ongoing and more complete results are anticipated to be presented at upcoming scientific
conferences this year. Study Design Summary
The GS 408 study was conducted at 34 medical centers in the United States and enrolled
a total of 442 patients infected with HIV who had HIV RNA greater than 2,500 copies/mL
and a CD4 cell count greater than or equal to 200 cells/mm3. The co-principal investigators
are Study Chair Dr. James Kahn of the University of California, San Francisco and Study
Statistician Dr. Stephen Lagakos of Harvard University.
In the study, patients were randomly assigned to receive treatment with either PREVEON
(120 mg once per day) or inactive placebo in addition to any approved anti-HIV treatment
regimen the patient was receiving at the time of enrollment, provided that the patient had
been on a stable regimen for at least eight weeks. In addition to PREVEON or placebo,
patients enrolled in the study received L-carnitine, a nutritional supplement.
The primary goal of the study was to determine if adding PREVEON to any background
antiretroviral treatment regimen would decrease viral load (HIV RNA) compared with the
addition of placebo. The median age of enrolled patients was 39 years. Ninety-three percent
of patients were male. Baseline mean CD4 count was 355 cells/mm3; baseline mean HIV
RNA level was 4.4 log10. Seven percent of patients were receiving monotherapy at the time
of enrollment, while 38 percent were receiving three or more antiretrovirals at baseline.
Background on PREVEON
PREVEON is an investigational, once-daily, orally administered, reverse transcriptase
inhibitor in late-stage clinical studies for the potential treatment of HIV. To date, more than
2,800 patients have been enrolled in clinical studies of PREVEON at one of two dose levels
(120 mg or 60 mg once per day), including more than 1,000 patients who have received
PREVEON through an expanded access program for patients with limited treatment
options. Additional studies are ongoing to examine further the safety and efficacy of
PREVEON in a variety of combination studies and patient populations, including studies in
patients not previously treated with anti-HIV therapies, patients not previously treated with a
protease inhibitor and patients who have failed treatment with triple combination or protease
containing regimens. During clinical testing, the most common side effects reported with
PREVEON have been dose-related gastrointestinal effects, including nausea and loss of
appetite. In addition, elevations in serum creatinine and liver transaminases have been
reported.
Gilead Sciences is an independent biopharmaceutical company that seeks to provide
accelerated treatment solutions for patients and the people who care for them. The
Company discovers, develops and commercializes proprietary therapeutics for important
viral diseases, including a currently marketed product, VISTIDE(R) (cidofovir injection), for
the treatment of CMV retinitis, a sight-threatening viral infection in patients with AIDS. In
addition, the Company is developing products to treat diseases caused by HIV, hepatitis B
virus and influenza virus. Gilead common stock is traded on The Nasdaq Stock Market
under the symbol GILD.
Note to Editors: PREVEON is a trademark and VISTIDE is a registered trademark of Gilead
Sciences, Inc.
To receive more information, please visit the Gilead Web site at www.gilead.com or call
Corporate Communications at 1-800-GILEAD-5 (1-800-445-3235). |
