Strong Ph III data for Gilead's Viread

US drugmaker Gilead Sciences presented strong data from two pivotal Phase III trials evaluating the safety and efficacy of once-daily Viread (tenofovir) among adult patients with chronic hepatitis B, at the annual meeting of the European Association for the Study of the Liver, in Milan, Italy.

Studies 102 and 103 evaluated treatment with Viread among chronic hepatitis B patients (HBeAg-negative and HBeAg-positive, respectively). Subjects in both trials were originally randomized to receive Viread or another Gilead HBV therapy, Hepsera (adefovir dipivoxol). After 48 weeks, all eligible patients were offered Viread monotherapy. In these studies, virologic response is defined as HBV DNA below 400 copies/mL. After 72 weeks of treatment, the vast majority of patients originally randomized to receive Viread maintained virologic response (Study 102: 91%; Study 103: 79%). All Hepsera-treated subjects who achieved virologic response at week 48 maintained suppression after switching to Viread. Among those who did not have a response at week 48, most had suppression after switching to Viread (Study 102: 94%; Study 103: 78%). Viread demonstrated potency in terms of achieving a complete response to HBV treatment, defined as loss of hepatitis B antigen (Study 103: 5% at 64 weeks), the firm added.

Viread is currently indicated in combination with other antiretroviral agents for HIV infection in adults and was approved as a treatment for chronic hepatitis B in adults by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) on April 28.