California, USA-based biopharmaceutical company Gilead Sciences says that a Phase III trial of its once-daily anti-HIV drug Viread (tenofovir disoproxil fumarate) indicates that the agent has potential in the treatment of hepatitis B infection. Data from the trial showed that the product was non-inferior to the company's own antiviral Hepsera (adefovir dipivoxil) in patients suffering HBeAg-negative/anti-HBe positive HBV infection.
The trial's primary efficacy endpoint, a complete response (< 400 copies of HBV DNA per ml) at week 48, was achieved by 70.8% of those in the Viread arm, versus 48.8% in the group treated with Hepsera. In addition, the incidence of treatment-emergent adverse events associated with the two drugs was comparable.
Gilead said that Viread, which was approved for the treatment of HIV in the USA in 2001 and Europe in 2002 (Marketletters passim), may be an important therapy option for HBV-infected patients. The firm added that it will present full data from the trial at an upcoming scientific meeting.
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