LONDON — A daily fixed-dose of simeprevir and sofosbuvir, with or without ribavirin, for 12 or 24 weeks led to a sustained virologic response in patients with hepatitis C virus infection, according to research from a COSMOS phase 2 trial presented at the International Liver Congress.
Researchers randomized and analyzed 87 hepatitis C virus-infected patients, who were either treatment-naive, null responders to pegylated interferon/ribavirin (PR) with advanced fibrosis (METAVIR F3-4) or genotype 1 (GT1) – infected. Fifty-four percent were null responders; 47% METAVIR F4; 79% IL28B genotype non-CC; and 78% GT1a (40% with Q80K). Each patient received 150 mg of simeprevir (SMV) and 400 mg of sofosbuvir (SOF), ± 1,000 to 1,200 mg ribavirin (RBV) per day for 12 or 24 weeks.
Sustained virological response (SVR12) rates were high in both sets of patients, 92.7% with fibrosis/cirrhosis and 96.3% with GT1a Q80K-positive polymorphism patients. Overall SVR12 was 94%. In the 12-week group, 93% of patients with and without RBV achieved SVR12. There were two relapses in patients being treated with RBV and one relapse in a non-RBV treated patient. Among 24-week patients, 100% of patients without treatment of RBV achieved SVR12 and 93% achieved SVR12 when treated with RBV (44/46). Eighty-four patients completed the trial, with three withdrawing, one due to an adverse event (AE). Four patients experienced serious AEs during treatment. The RBV did not improve SVR in either subgroup, according to researchers.
For more information:
Lawitz E. #O165: Simeprevir plus Sofosbuvir with/without Ribavirin in HCV Genotype 1 prior Null-Responder/Treatment Naive Patients (Cosmos Study): Primary Endpoint (SVR12) Results in Patients with Metavir F3-4 (Cohort 2). Presented at: The International Liver Congress 2014; April 9-13, London.
Disclosure: Relevant financial disclosures were not provided by researchers.