May 07, 2002
Gilead Announces Preliminary 48-Week Study Results Showing Viread Comparable to Stavudine in Treatment-Naive HIV Patients
"This trial provides compelling evidence that Viread can be used as the cornerstone of a patient's first antiretroviral regimen," said John C. Martin, PhD, President and Chief Executive Officer of Gilead. "These data demonstrate that as a part of combination therapy for 48 weeks Viread can provide efficacy and safety comparable to stavudine, one of the most commonly prescribed nucleoside reverse transcriptase inhibitors."
The primary efficacy endpoint of the study is the proportion of patients in each arm achieving HIV RNA suppression below 400 copies/mL at week 48. Additional efficacy endpoints include the proportion of patients in each study arm who achieve viral suppression below 50 copies/mL at week 48, as well as increases in CD4 cell count. Data also were analyzed to determine `responders', defined as the proportion of patients in each arm who achieved and maintained confirmed HIV RNA less than 400 copies/mL, and who have not discontinued from the study or added another antiretroviral drug through 48 weeks. Gilead anticipates submitting these 48-week interim data for presentation at a scientific conference later this year and to regulatory authorities for potential inclusion in the U.S. and European product labels.
In the interim analysis of the ITT population, in which missing data are counted as failures, an identical 87 percent of patients in the Viread arm (n=299) and the stavudine arm (n=301) achieved suppression of HIV RNA below 400 copies/mL at 48 weeks of treatment (95% CI: -6%, +5%). When missing data are excluded, 95 percent of patients receiving Viread compared to 96 percent of patients receiving stavudine had reductions in HIV RNA to below 400 copies/mL (95% CI: -4%, +2%). Using the `responder' analysis, 80 percent of patients receiving Viread compared to 82 percent of patients in the stavudine group had reductions in HIV RNA to below 400 copies/mL (95% CI: -9%, +3%).
The proportion of patients achieving HIV RNA suppression below 50 copies/mL was also evaluated in the study. The missing-equals-failure analysis demonstrates that 82 percent of patients in the Viread arm compared to 81 percent of patients in the stavudine arm achieved this result (95% CI: -6%, +6%). When missing data are excluded, 90 percent of patients in the Viread arm compared to 89 percent in the stavudine arm had reductions in HIV RNA to below 50 copies/mL (95% CI: -4%, +5%).
Additionally, patients in both treatment groups experienced significant increases in CD4 cell count. At 48 weeks, combination treatment including Viread was associated with a mean increase from baseline of 169 cells/mm3 and treatment including stavudine was associated with a mean increase from baseline of 167 cells/mm3.
In each treatment group, therapy was generally well tolerated and the study discontinuation rate was nine percent. The incidence of grade 3/4 adverse events in the Viread-containing study arm was 19 percent compared to 17 percent in the stavudine-containing study arm. The incidence of grade 3/4 laboratory abnormalities in the Viread arm was 28 percent compared to 31 percent in the stavudine arm.
In the United States, Viread is indicated for use 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.
Viread is approved in Europe for use in combination with other antiretroviral agents for the treatment of HIV infection in patients who are experiencing early virological failure.
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.
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. Such risks and uncertainties include the risk that these 48 week data will not be observed through longer treatment periods and uncertainty regarding inclusion of these data in the Viread product label. 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 December 31, 2001 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.
For complete prescribing information, please visit www.viread.com.
Viread is a trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's web site at www.gilead.com or call the Gilead Corporate Communications Department at 1-800-GILEAD-5 or 1-650-574-3000.
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