Roche's Phase IIa study of R1626, an investigational therapy for chronic hepatitis C virus (HCV) infection, has shown a significant end-of-treatment response rate when given in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). R1626 also shows a high barrier to the development of resistance.
After four weeks of treatment with this triple combination, followed by 44 weeks of Pegasys and Copegus, levels of HCV were undetectable in 84% of patients infected with genotype 1 virus. This was higher than patients treated with Pegasys and Copegus alone for the entire 48-week treatment period (65%).
R1626, discovered and developed by Roche, belongs to a class of antivirals called polymerase inhibitors, which are being studied with the current standard hepatitis C combination therapy with pegylated interferon and ribavirin.
The Phase IIa multicenter trial enrolled 104 patients with genotype 1 HCV, who had not previously received treatment. The primary endpoint was to evaluate the four-week efficacy and safety of combining R1626 with Pegasys alone or with Pegasys plus Copegus, in comparison to a current HCV standard of care, pegylated interferon plus ribavirin.
A Phase IIb study with R1626 was initiated in November 2007 to determine the optimal dose of R1626 in combination with Pegasys and Copegus. This Phase IIb trial, called POLI 1, is now fully enrolled with approximately 500 patients with genotype 1 hepatitis C.
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