Phase III trials of Sovriad (Janssen R&D) show benefits in Hep C

In a pooled analysis of the Phase III QUEST-1 and QUEST-2 studies, 80 percent of treatment-naive Hepatitis C patients treated with Sovriad (simeprevir), from Janssen R&D, in combination with pegylated interferon and ribavirin achieved the primary endpoint of sustained virologic response 12 weeks after the end of treatment (SVR12) compared to 50 percent of patients treated with placebo plus pegylated interferon and ribavirin.

The pooled analysis found that 61 percent of patients with the IL28B TT genotype, 60 percent of patients with a METAVIR score of F4 and 75 percent of patients with genotype 1a HCV treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 21 percent, 34 percent and 47 percent of patients taking placebo plus pegylated interferon and ribavirin, respectively. Eight percent and 10 percent of patients treated with simeprevir combined treatment experienced on-treatment failure and relapse, respectively, compared to 33 percent and 15 percent of patients taking placebo treatment.

Additionally, in the pivotal Phase III PROMISE study, 79 percent of treatment-experienced Hepatitis C patients treated with simeprevir in combination who previously experienced a relapse after prior treatment with pegylated interferon-based therapy achieved the primary endpoint of SVR12 compared to 37 percent of patients treated with placebo plus combination. Data were presented at the Annual Meeting of the American Association for the Study of Liver Diseases.