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news.Gilead Sciences has announced positive findings from two Phase III pivotal clinical trials, studies 102 and 103, which evaluate the safety and efficacy of once-daily Viread among adult patients with chronic hepatitis B virus infection.
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Studies 102 and 103 compare Viread to Gilead’s Hepsera (adefovir dipivoxil) among patients with HBeAg-negative (presumed pre-core mutant) chronic hepatitis B and patients with HBeAg-positive hepatitis B, respectively.
Results from both studies show that patients with chronic hepatitis B who received Viread for 48 weeks experienced superior efficacy results compared to those who received Hepsera, as shown by the significantly higher percentage of Viread patients in each trial achieving the primary efficacy endpoint. Viread was well-tolerated by patients in both studies, according to 48-week data.
Study 102 is a multi-center, randomized, double-blind phase III clinical trial evaluating the efficacy, safety and tolerability of Viread compared to Hepsera among patients with HBeAg-negative presumed pre-core mutant chronic hepatitis B. Patients in the Viread arm experienced a comparable treatment response regardless of treatment history. Among treatment-experienced patients, 93% of Viread patients achieved a reduction in HBV DNA levels to below 400 copies/mL.
Study 103 is a multi-center, randomized, double-blind phase III clinical trial that evaluates the efficacy, safety and tolerability of Viread compared to Hepsera among treatment-naive patients with HBeAg-positive chronic hepatitis B. At 48 weeks, 67% of patients in the Viread arm had a complete response compared to 12% in the Hepsera arm (p<0.001). In addition, 76% of Viread patients compared to 13% of Hepsera patients achieved a reduction in HBV DNA levels to below 400 copies/mL (p<0.001). Normal ALT was observed in 69% of Viread patients compared to 54% of patients treated with Hepsera (p=0.018). The data from Studies 102 and 103 form the basis of Gilead's recent filings of marketing applications for Viread for the treatment of chronic HBV in the US and European Union, which were announced on October 11, 2007. Viread is currently indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and is the most-prescribed molecule in HIV combination therapy in the US.