Gilead Sciences Presents Pivotal Phase III Studies For Chronic Hepatitis B

Gilead Sciences has presented its three-year open label data from two pivotal phase III clinical trials, studies 102 and 103, evaluating the safety and efficacy of once-daily Viread (tenofovir disoproxil fumarate) among adult patients with chronic hepatitis B virus (HBV) infection.

The FDA approved Viread for chronic hepatitis B in adults in 2008 based on earlier (48-week) results from studies 102 and 103, and recently approved the inclusion of 96-week data in the product’s label.

The data showed that the majority of patients who received Viread for up to 144 weeks experienced sustained suppression of HBV DNA levels in the blood to below 400 copies/ml (87% in study 102 and 71% in Study 103). Along with this, cumulatively over 144 weeks, 8% of patients in study 103 (HBeAg-positive) experienced “s” antigen (HBsAg) loss, which can contribute to resolution of chronic hepatitis B infection. The company noticed no mutations associated with resistance to Viread developed in any patients up to 144 weeks of treatment.

Patrick Marcellin, principal investigator of study 102, said: “The development of resistance is a significant challenge for practitioners treating patients with chronic hepatitis B. The robust and comprehensive resistance surveillance in these studies provides important information for the medical community and shows that Viread offers a high barrier to resistance.”

Jenny Heathcote, principal investigator of study 103, said: “These data underscore the rationale for Viread’s position as a recommended first-line therapy for chronic hepatitis B infection. In particular, the loss of the hepatitis B ‘s’ antigen in 8% of patients, which is associated with resolution of HBV infection, is significant from a clinical perspective.”