Monday April 6, 7:31 am Eastern Time
Company Press Release
Gilead Sciences Announces Data From Clinical Study of PREVEON in
Combination With Other Anti-HIV Agents in Treatment-Naive Patients
Interim Analysis of Triple Combination Clinical Study GS 411 Presented At Scientific Conference
FOSTER CITY, Calif.--(BW HealthWire)--April 6, 1998-- Gilead Sciences, Inc. (Nasdaq:GILD - news) announced today
that a 20 week interim analysis of clinical study GS 411 suggests that once-daily treatment with PREVEON(TM) (adefovir
dipivoxil) in combination with other anti-HIV agents reduced HIV RNA and increased CD4 cell counts in amounts similar to
changes seen in a standard of care control group.
The study is a randomized, open label, controlled trial that enrolled treatment-naive HIV infected patients, who had not
previously received antiretroviral therapy. Patients assigned to one of four PREVEON containing regimens received
PREVEON (120 mg once per day), a protease inhibitor (indinavir) and one or two of the following reverse transcriptase
inhibitors: zidovudine (ZDV), lamivudine (3TC) or stavudine (d4T). Patients in the control group received treatment with a
standard of care triple combination regimen of ZDV, 3TC and indinavir.
These data were presented Sunday, April 5, at the 11th International Conference on Antiviral Research (ICAR) in San Diego,
California by James F. Rooney, M.D., Vice President, Clinical Affairs at Gilead Sciences.
Triple Regimens Containing PREVEON Reduce Viral Load 2.1 to 2.5 log10
This interim analysis included data from the first 85 patients and examined safety and efficacy endpoints after 4, 8, 12 and 20
weeks of treatment. At 20 weeks, approximately 80 percent of patients treated with one of four PREVEON containing
regimens achieved undetectable levels of HIV RNA (less than or equal to 400 copies/mL) and had a median decrease in HIV
RNA of 2.1 to 2.5 log10. This was similar to results in the control group, in which 80 percent of patients had undetectable HIV
RNA levels with a median decrease of 2.15 log10. Patients treated with triple drug regimens containing PREVEON had a
median increase from baseline of 92 CD4 cells/mm3 compared to a median increase of 66 CD4 cells/mm3 in the triple drug
control group.
Grade 3 or 4 laboratory abnormalities in the study included increases in liver transaminase elevations reported in 8% of patients
treated with regimens containing PREVEON and 5% in the control group. Elevations in CK (creatine kinase), a marker of
muscle metabolism, were reported in 3% of patients treated with PREVEON containing regimens and 5% in the control group.
To date, a total of 160 patients have been enrolled in this study, which is ongoing at 18 clinical trial sites throughout the United
States. To be eligible for this study, patients must have a CD4 count greater than or equal to 100 cells/mm3, an HIV RNA level
greater than or equal to 5,000 copies/mL and must not have received prior treatment with anti-HIV agents.
Ongoing Clinical Program
To date, approximately 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. 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.
In addition to study GS 411 in treatment-naive patients, the clinical studies of PREVEON include a combination study in
treatment-experienced patients (GS 408), a study in patients not previously treated with a protease inhibitor (GS 417) and a
study in patients who have failed treatment with triple combination or protease inhibitor-containing regimens (National Institutes
of Health-sponsored studies ACTG 359 and ACTG 372). Two studies also are ongoing in patients with advanced HIV
disease who have received prior treatment, one in the United States (CPCRA) and another in Europe and Australia
(ADHOC). For information about Gilead's ongoing clinical trials or expanded access, contact Gilead's Medical Information
Department at 1-800-GILEAD-5.
Gilead Sciences is an independent biopharmaceutical company that seeks to provide accelerated 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 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 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).
Contact:
Gilead Sciences, Inc.
Lana Lauher, 650/573-4858 (Investors)
or
Laurie Hurley, 650/573-4894 (Media)
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