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news.Human Genome Sciences, a biotechnology company, has reported that the final results of two pivotal Phase III trials demonstrate that Albuferon met its primary endpoint of non-inferiority to peginterferon alfa-2a in the treatment of patients with chronic hepatitis C.
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The Phase III studies, known as Achieve 1 and Achieve 2/3, evaluated albinterferon alfa-2b versus peginterferon alfa-2a, in combination with ribavirin, for use in the treatment of interferon-naive patients with chronic hepatitis C. Achieve 1 was conducted in patients infected with genotype 1 virus, and Achieve 2/3 was conducted in patients with genotypes 2 and 3 virus. The two studies treated a combined total of 2255 treatment-naive patients.
Based on an intention-to-treat analysis, the data demonstrate that albinterferon alfa-2b met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a in both Achieve 1 and Achieve 2/3.
In Achieve 1, 48.2% (213/442) of patients in the 900mcg albinterferon alfa-2b treatment group achieved sustained virologic response (SVR), versus 51% (225/441) in the peginterferon alfa-2a treatment group. The primary analysis, which was adjusted for baseline stratification factors, showed a difference in sustained viral response (SVR) rates of -1.8% (95% CI -8.1%, 4.5%, p=0.0008 for non-inferiority).
In Achieve 2/3, 79.8% (249/312) of patients achieved SVR in the 900mcg albinterferon alfa-2b treatment group, versus 84.8% (263/310) in the peginterferon alfa-2a group (p=0.0086 for non-inferiority). The primary analysis, which was adjusted for baseline stratification factors, showed a difference in SVR rates of -4.8% (95% CI -10.7%, 1.1%, p=0.0086 for non-inferiority).
Albuferon (Albinterferon alfa-2b) is being developed by Human Genome Sciences (HGS) and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
David Stump, executive vice president of R&D at HGS, said: “The Phase III data show that Albuferon, with half the injections, achieved a rate of sustained virologic response comparable to Pegasys. We plan to file global marketing applications in fall 2009, following discussions with regulatory authorities – and we believe that Albuferon, assuming licensure, could become a leading treatment for chronic hepatitis C.”