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Simeprevir/Sofosbuvir Combo Gets FDA Nod as All-Oral Treatment for Hepatitis C Infection

Virologic response achieved in 95% of patients after 12 weeks

The FDA has approved simeprevir (Olysio, Medivir/Janssen) in combination with sofosbuvir (Sovaldi, Gilead) as an all-oral, interferon- and ribavirin-free treatment option for genotype-1 chronic hepatitis C virus (HCV) infection in adults as part of a combination antiviral treatment regimen.

Data supporting the simeprevir and sofosbuvir combination regimen were provided by the COSMOS trial, an open-label, randomized, phase II study that investigated the efficacy and safety of 12 or 24 weeks of simeprevir (150 mg once daily) in combination with sofosbuvir (400 mg once daily), with or without ribavirin, in HCV genotype-1 chronically infected treatment-naïve and treatment-experienced adults with compensated liver disease.

The recommended treatment duration of simeprevir with sofosbuvir is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis.

In the COSMOS study, 95% of patients (20/21) with no liver fibrosis to near-cirrhotic liver disease (METAVIR F4) receiving 12 weeks of treatment with simeprevir and sofosbuvir achieved a sustained virologic response at 12 weeks after the end of therapy (SVR12).

Regardless of whether the patients were treatment-naïve or treatment-experienced, 86% (6/7) with METAVIR F4 (cirrhosis) receiving 12 weeks of simeprevir in combination with sofosbuvir achieved SVR12, whereas 100% of patients (10/10) with cirrhosis who were treated with the combination for 24 weeks achieved SVR12.

For all patients in the COSMOS trial (treatment-naïve and treatment-experienced, METAVIR F0–F4), 93% (26/28) achieved SVR12 after 12 weeks of treatment, and 97% (30/31) achieved SVR12 after 24 weeks.

The most common adverse events reported during 12 weeks of treatment with simeprevir in combination with sofosbuvir without ribavirin were fatigue (25%), headache (21%), nausea (21%), insomnia (14%), and pruritus (11%). Rash and photosensitivity were reported in 11% and 7% of patients, respectively. During 24 weeks of treatment, dizziness (16%) and diarrhea (16%) were also reported.

Simeprevir is an NS3/4A protease inhibitor approved by the FDA for the treatment of chronic HCV infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype-1–infected adults with compensated liver disease, including cirrhosis.

Source: Medivir; November 6, 2014.

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