February 25, 2002
Gilead Sciences' Viread Suppresses HIV Viral Load Through 48 Weeks in Phase III Clinical Trial
- Additional Long-Term Safety Data Presented at 9th Conference on Retroviruses and Opportunistic Infections -
The data are scheduled for presentation (#413-W) at the 9th Conference on Retroviruses and Opportunistic Infections in Seattle by Kathleen Squires, MD, Associate Professor of Medicine, Keck School of Medicine, University of Southern California.
"These results clearly demonstrate that Viread can produce a durable antiviral response in patients who have developed resistance to available drugs, offering new hope for successful long-term treatment," said Dr. Squires. "Viral resistance is one of the most serious challenges facing long-term HIV treatment today, and Viread's favorable resistance profile, combined with its proven efficacy and safety profile, represent a major step forward."
About Study 907
Upon entry into the study, patients were randomized (2:1) to receive Viread or placebo in addition to their existing antiretroviral therapy. After 24 weeks of blinded, placebo-controlled dosing, all patients were switched to receive open-label Viread for the remainder of the 48-week study period. The 24-week results met the study's primary efficacy endpoint of reduction in viral load. At 48 weeks, study results demonstrated that patients who received Viread 300 mg in addition to their existing antiretroviral regimen (n=368) achieved a significant mean HIV RNA reduction (DAVG48) of 0.57 log(10) copies/mL, similar to that observed at week 24. In addition, 48-week results revealed that 41 percent of patients achieved a reduction in HIV RNA to less than 400 copies/mL, also consistent with 24 week data. The mean average increase in CD4 cells was 13 cells/mm(3). The safety profile of Viread was similar to that observed during the 24 week placebo-controlled portion of the trial, during which the safety of Viread was similar to placebo.
Study 907 Virology Analysis
Data from the Viread Expanded Access Program in the United States and France will be described in a poster presentation (#415-W) by Steven Follansbee, MD, Kaiser Permanente Medical Center, San Francisco, CA. Safety and efficacy analyses up to 30 weeks were available from 1,360 U.S. patients and up to 16 weeks in 813 French patients. Data from these highly treatment-experienced patients were consistent with safety and efficacy results from controlled clinical trials of Viread.
New Prodrug of Tenofovir
"The breadth of data presented at the Retrovirus conference underscore Gilead's commitment to the fight against HIV," said John C. Martin, Ph.D., President and CEO, Gilead Sciences. "Long-term data from our Phase III clinical trial confirm the potency, safety and resistance profile of Viread observed in earlier clinical trials, and will help physicians as they evaluate the best treatment options for their patients."
In the United States, Viread is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in a controlled study of Viread of 24 weeks duration and in a controlled, dose ranging study of Viread of 48 weeks duration. Both studies were conducted in treatment-experienced adults with evidence of HIV-1 viral replication despite ongoing antiretroviral therapy. Studies in antiretroviral-naive patients are ongoing; consequently, the risk-benefit ratio for this population has yet to be determined.
HIV Resistance Profile
The most common adverse events in patients receiving Viread were mild to moderate gastrointestinal events, such as nausea, diarrhea, vomiting and flatulence. Laboratory abnormalities observed in clinical studies occurred with similar frequency in the Viread and placebo-treated groups. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.
Ongoing Clinical Studies
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements, including the risk that the safety and efficacy data observed in the studies described in this press release may not continue to be observed in broader patient groups or through longer periods of treatment. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in the Gilead Annual Report on Form 10-K for the year ended Dec. 31, 2000 and in Gilead's Quarterly Reports on Form 10-Q, all of which are on file with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update any such forward-looking statements.
Viread is a trademark of Gilead Sciences, Inc.
Note: In "log(10)" the 10 is subscript; in cells/mm(3), the 3 is superscript.
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