Gilead publishes more Viread data in NEJM
US biopharmaceutical firm Gilead has published further data from two Phase III pivotal trials of its once-daily Viread (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B virus infection versus the company's own Hepsera (adefovir dipivoxil), in he New England Journal of Medicine.
Studies 102 and 103 were multi-center, randomized, double-blind Phase III trials evaluating the efficacy, safety, and tolerability of Viread (300mg once daily) compared to Hepsera (10mg once daily) in patients with compensated liver disease and HBeAg-negative (presumed pre-core mutant) chronic hepatitis B and HBeAg-positive hepatitis B, respectively.
At week 48, significantly-more patients receiving Viread achieved the primary endpoint compared to Hepsera-treated subjects (71% vs 49% of people in Study 102, p<0.001; and 67% vs 12% in Study 103, p<0.001). The drug was approved in the USA in August.
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