PSI-7977: Additional Phase IIb data

Data from 8 evaluable patients in a cohort of 10 null responders with HCV genotype 1 infection in the U.S. Phase IIb ELECTRON trial showed that 6 patients experienced viral relapse within 4 weeks of completing 12 weeks of treatment with once-daily 400 mg GS-7977 plus ribavirin. Gilead said the other 2 null responders have not relapsed but only have been followed for 2 weeks post-treatment. Earlier this month, Gilead disclosed in its 4Q11 earnings call that all evaluable patients with HCV genotype 1 infection receiving GS-7977 plus ribavirin for 12 weeks from both the null responder and treatment-naïve cohorts in the ELECTRON trial achieved a rapid virologic response (RVR) at week 4 of treatment. The number of evaluable patients was not disclosed (see BioCentury, Feb. 6).

SVR4 data for null responders with HCV genotype 1 infection will be presented at the Retroviruses and Opportunistic Infections meeting in Seattle in March. SVR4 data from treatment-naïve patients with HCV genotype 1 infection who are receiving GS-7977 plus ribavirin for 12 weeks in the Phase IIb QUANTUM trial are expected this quarter, while SVR4 data from treatment-naïve patients with HCV genotype 1 infection in ELECTRON are expected in 2Q12. Gilead gained GS-7977 through its acquisition of Pharmasset Inc. last month (see BioCentury, Jan. 23). ...