FDAnews
www.fdanews.com/articles/89934-hgs-begins-trial-of-treatment-for-chronic-hepatitis-c

HGS BEGINS TRIAL OF TREATMENT FOR CHRONIC HEPATITIS C

December 20, 2006

Human Genome Sciences (HGS) has initiated dosing in ACHIEVE 1, one of two pivotal Phase III clinical trials of Albuferon (albinterferon alpha 2b) in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement.

The combination of pegylated interferon alpha and ribavirin is the current standard of care and produces cures in approximately 50 percent of all genotype 1 hepatitis C patients completing therapy. However, a substantial additional percentage of patients never receive therapy for a variety of reasons. Side effects, many of which are associated with injections of interferon alpha, continue to be a significant treatment-limiting issue, according to HGS. Albuferon requires half as many injections, and clinical results to date suggest the potential for less impairment of health-related quality of life, with efficacy and safety at least comparable to pegylated interferon.

The Albuferon Phase III clinical development program includes two randomized, open-label, active-controlled, multicenter, noninferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus peginterferon alfa-2a (PEGASYS) in combination with ribavirin.

The company has initiated dosing in the first Phase III trial, ACHIEVE 1, which will randomize a minimum of 1,278 patients into three treatment groups, including two groups that will receive subcutaneously administered Albuferon once every two weeks and an active control group that will receive PEGASYS once every week at a dose of 180 micrograms. All patients will receive oral ribavirin concomitantly. The total duration of therapy will be 48 weeks, with 24 weeks of follow-up. The primary efficacy endpoint is sustained virologic response, defined as undetectable hepatitis C RNA at week 72. It is expected that the second Phase III trial, ACHIEVE 2/3, will be initiated in the first half of 2007.