BioCentury
ARTICLE | Clinical News

Gilead, J&J present data for simeprevir/sofosbuvir combo

November 5, 2013 2:03 AM UTC

Gilead Sciences Inc. (NASDAQ:GILD) and Johnson & Johnson (NYSE:JNJ) presented additional data on Monday at the American Association for the Study of Liver Diseases meeting from the Phase IIa COSMOS trial, which is evaluating once-daily oral simeprevir ( TMC435) in combination with once-daily oral sofosbuvir ( GS-7977) from Gilead with or without ribavirin for 12 or 24 weeks to treat HCV genotype 1 infection. According to the partners, the results show that 12 weeks of treatment with the combination may confer similar clinical benefit as 24 weeks of treatment and that there is no benefit from adding ribavirin to simeprevir and sofosbuvir. In 2011, Gilead's Pharmasset Inc. unit partnered with J&J to evaluate a combination of the companies' HCV candidates in a Phase II trial.

In 80 prior null responders to peginterferon and ribavirin with mild to moderate liver fibrosis, simeprevir plus sofosbuvir without ribavirin for 12 weeks led to a sustained virologic response (SVR) 12 weeks after end of treatment in 93% of patients compared to 96% for simeprevir plus sofosbuvir with ribavirin for 12 weeks, 79% for simeprevir plus sofosbuvir with ribavirin for 24 weeks and 93% for simeprevir plus sofosbuvir without ribavirin for 24 weeks. Gilead and J&J also presented SVR4 data for a cohort of 41 evaluable treatment-naïve patients or previous null responders with advanced liver fibrosis. Medivir AB (SSE:MVIR B) previously reported interim data from both cohorts of the trial. J&J has ex-Nordic rights to develop and commercialize simeprevir from Medivir. ...