Human Genome Sciences, a biopharmaceutical company, has announced that Albuferon met its primary endpoint of non-inferiority to peginterferon alfa-2a in Achieve 1, a Phase III clinical trial of Albuferon in combination with ribavirin in treatment-naive patients with genotype 1 chronic hepatitis C.
Based on an intention-to-treat analysis of the treatment group assigned to receive 900mcg Albuferon (albinterferon alfa-2b) every two weeks, the topline results demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a (Pegasys), with 48.2% (213/442) of patients achieving sustained virologic response (SVR) in the 900mcg albinterferon alfa-2b treatment group versus 51% (225/441) in the peginterferon alfa-2a treatment group, said Human Genome Sciences (HGS).
The primary analysis, which is adjusted for baseline stratification factors, showed a difference in SVR rates of -1.8% (95% CI -8.1%, 4.5%, p=0.0008 for non-inferiority), the company added.
In the randomized, multi-center, active-controlled non-inferiority Achieve 1 Phase III trial, 1,331 treatment-naive patients with genotype 1 chronic hepatitis C were initially assigned to one of three treatment groups, including two groups that received subcutaneously administered albinterferon alfa-2b once every two weeks at doses of 900mcg or 1,200mcg, and an active control group that received peginterferon alfa-2a once weekly at a dose of 180mcg – with all patients receiving daily oral ribavirin concomitantly.
Albinterferon alfa-2b is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
Thomas Watkins, president and CEO of HGS, said: These Phase III data show that, with half the injections, the efficacy of Albuferon was comparable to Pegasys. We look forward to the filing of global marketing applications in fall 2009, following discussions with regulatory authorities. Assuming licensure, we believe Albuferon could become a market-leading treatment for chronic hepatitis C.