Pharmaceutical Business review

Gilead hepatitis B drug reaches phase III objective

<p>The so-called Study 102 showed that Viread is non-inferior to the company&#0039;s once-daily antiviral drug Hepsera among patients with chronic hepatitis B virus (HBV) infection. The primary efficacy endpoint was the proportion of patients with a complete response at week 48. <br /><br />The company said that at 48 weeks, 70.8% of patients being treated with Viread had a complete response, compared to 48.8% of those being treated with Hepsera. The most commonly observed treatment-emergent adverse events of moderate intensity or higher included abdominal pain, back pain, headache and respiratory infections, Gilead added. <br /><br />Chronic hepatitis B remains a serious disease that impacts more than one million people in the US and an estimated 400 million people worldwide, said Franck Rousseau, MD, vice president of clinical research at Gilead. We believe Viread has the potential to be an important treatment option for patients with chronic hepatitis B.<br /><br />Full study results of the phase III trial of Viread, known generically as tenofovir disoproxil fumarate or tenofovir D, will be submitted for presentation at an upcoming scientific meeting.<br /><br />Study 102 is one of two phase III pivotal studies evaluating the efficacy, safety and tolerability of Viread for the treatment of chronic hepatitis B. The second study (Study 103), a 48-week trial among patients with hepatitis B &#0039;e&#0039; antigen-positive chronic hepatitis B, is expected to be complete later in 2007.</p>