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The U.S. Food and Drug Administration approved Viread for marketing in October 2001 and the European Commission granted approval in February 2002. Summary results from Study 903 were announced in a press release in May 2002.
"Data from this large study in treatment-naive patients demonstrate Viread is associated with potent anti-HIV activity and is well-tolerated," said Dr. Staszewski, a lead investigator for the study. "Importantly, analyses of measurements of laboratory markers reveal that patients in the stavudine arm of the study experienced significant increases in triglyceride and cholesterol levels compared to those in the Viread arm through 48 weeks. These are important data for clinicians to consider as they design an antiretroviral regimen for the long-term management of their patients."
"The data from this study support the use of Viread as part of a patient's first-line regimen, and should give physicians increased confidence in their ability to strategically construct effective, tolerable regimens that do not include a thymidine analogue drug such as AZT or d4T -- perhaps the next standard that we will see emerge in the treatment of HIV infection," Dr. Staszewski continued.
Study Design
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.
Study Results
In the 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 following 48 weeks of treatment (95 percent confidence interval (CI): -6 percent, +5 percent). 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 percent CI: -4 percent, +2 percent).
The proportion of patients achieving HIV RNA suppression below 50 copies/mL also was evaluated in the study. In the missing equals failure analysis, 82 percent of patients in the Viread arm compared to 81 percent of patients in the stavudine arm achieved this result (95 percent CI: -6 percent, +6 percent). 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 percent CI: -4 percent, +5 percent).
Additionally, the mean reduction in HIV RNA for both treatment groups was 3.09 log10 copies/mL. At 48 weeks, combination treatment including Viread was associated with a mean increase from baseline in CD4 cells of 169 cells/mm3 and treatment including stavudine was associated with a mean increase from baseline of 167 cells/mm3.
Evaluation of Safety Parameters
Of the laboratory markers evaluated, a statistically significant difference was seen between the two treatment arms in changes in triglycerides and cholesterol levels. Patients receiving Viread (n=242) had no mean change from baseline in triglycerides, compared to an increase of 74 mg/dL for patients in the stavudine arm (n=253; p less than 0.001). Increases in cholesterol levels for patients receiving Viread and stavudine were 25 mg/dL and 53 mg/dL, respectively (p less than 0.001). In addition, the incidence of mitochondrial-associated toxicities in the Viread-containing arm was three percent, compared to eleven percent in the stavudine-containing arm.
"The results of this study, along with data discussed in the additional abstracts to be presented this week, continue to suggest that Viread may provide a potent and safe therapeutic option for HIV patients across the spectrum of treatment stages," commented John C. Martin, Ph.D., President and Chief Executive Officer, Gilead Sciences. "We are particularly interested in the data that suggest a lower incidence of lipid abnormalities for patients treated with Viread, as compared to stavudine. We will continue to monitor both study groups for an additional two years in a blinded fashion to best evaluate how these data impact patients and the long-term success of their therapy."
About Viread
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.
Safety 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.
About HIV/AIDS
About Gilead Sciences
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.
CONTACT: Gilead Sciences, Inc.
Susan Hubbard, 650/522-5715 (Investors)
Amy Flood, 44-7715-809-567 (Media)
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