Initial results suggest efficacy of simeprevir/sofosbuvir in prior null-responders with HCV

Medivir AB recently announced interim results from a phase IIa study of a regimen of simeprevir and sofosbuvir in patients with hepatitis C who had been non-responsive to prior interferon-based therapy.

The results were collected from the first cohort of the COSMOS study, an open-label trial in which 80 patients with HCV genotype 1 and mild-to-moderate fibrosis who received 150 mg NS3/4A protease inhibitor simeprevir (TMC435, Medivir AB, Janssen R&D Ireland) and 400 mg nucleotide analog polymerase inhibitor sofosbuvir (GS-7977, Gilead Sciences) daily for 12 or 24 weeks, with or without ribavirin. According to a press release, all evaluable participants in all four groups upon treatment completion and at 4 and 12 weeks after cessation had undetectable levels of HCV RNA, with no serious adverse events reported.

A second cohort of patients, which will include treatment-naïve and null-responders with HCV genotype 1 and more advanced fibrosis, will receive similar doses and treatment durations in subsequent analysis. The company will also present study data at the Conference on Retroviruses and Opportunistic Infections in Atlanta, Ga. later this week.

Medivir AB recently announced interim results from a phase IIa study of a regimen of simeprevir and sofosbuvir in patients with hepatitis C who had been non-responsive to prior interferon-based therapy.

The results were collected from the first cohort of the COSMOS study, an open-label trial in which 80 patients with HCV genotype 1 and mild-to-moderate fibrosis who received 150 mg NS3/4A protease inhibitor simeprevir (TMC435, Medivir AB, Janssen R&D Ireland) and 400 mg nucleotide analog polymerase inhibitor sofosbuvir (GS-7977, Gilead Sciences) daily for 12 or 24 weeks, with or without ribavirin. According to a press release, all evaluable participants in all four groups upon treatment completion and at 4 and 12 weeks after cessation had undetectable levels of HCV RNA, with no serious adverse events reported.

A second cohort of patients, which will include treatment-naïve and null-responders with HCV genotype 1 and more advanced fibrosis, will receive similar doses and treatment durations in subsequent analysis. The company will also present study data at the Conference on Retroviruses and Opportunistic Infections in Atlanta, Ga. later this week.