Gilead submits applications to market Viread

Viread has already been approved in the US and EU for the treatment of HIV as part of combination antiretroviral therapy.

The submissions contain data from two Phase III pivotal clinical trials, studies 102 and 103, in patients chronically infected with the hepatitis B virus (HBV). These studies evaluate the efficacy, safety and tolerability of Viread compared to Gilead’s hepatitis B treatment Hepsera (adefovir dipivoxil).

Eugene Schiff, chief of the division of hepatology and director of the center for liver diseases at the University of Miami School of Medicine, said: “New treatments are critically important in the fight against chronic hepatitis B, a potentially life-threatening infection that impacts millions of people worldwide. We’ve made great progress in our ability to diagnose and treat the disease, but a significant unmet medical need remains and ongoing efforts in research and development are essential.”