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Combined Simeprevir and Sofosbuvir Is Promising for HCV Genotype 1 Infection

August 11, 2014

Combined Simeprevir and Sofosbuvir Is Promising for HCV Genotype 1 Infection

  1. Atif Zaman, MD, MPH

Sustained virologic response rates were >90% even in previous nonresponders and without the addition of ribavirin; phase III trial results are awaited.

  1. Atif Zaman, MD, MPH

Both simeprevir-based and sofosbuvir-based regimens are approved for the treatment of hepatitis C virus (HCV) infection. Since simeprevir, an NS3/4A protease inhibitor, and sofosbuvir, a nucleotide-analogue NS5B polymerase inhibitor, have different mechanisms of action, a combination of these two direct-acting antiviral agents (DAAs) may be an effective interferon-free regimen for the treatment of HCV genotype 1 infection.

In an industry-funded, randomized, open-label study, patients with HCV genotype 1 infection who were treatment-naive or previously failed treatment with peginterferon and ribavirin received sofosbuvir (400 mg daily) plus simeprevir (150 mg daily) with or without ribavirin (1000–1200 mg daily) for 12 or 24 weeks. Twice as many patients were randomized to the 24-week treatment groups as were randomized to the 12-week treatment groups. The primary endpoint was sustained virologic response 12 weeks after treatment completion (SVR12).

Of 167 patients who started treatment, 154 achieved SVR12 (92%). SVR12 rates were consistently >90% regardless of prior treatment experience, cirrhosis status, host IL28B genotype, HCV genotype (1a or 1b), receipt of ribavirin, or duration of treatment (12 or 24 weeks). No patients experienced virologic failure during treatment. Only 2% of patients discontinued treatment.

Comment

This small study demonstrates promising results of a combination of a simple DAA regimen that is safe and effective in the treatment of HCV genotype 1 infection without the addition of ribavirin and treatment duration of only 12 weeks. This non–FDA-approved regimen has been used with some success outside of the research setting. However, pending results of the phase III trial will determine whether this regimen is included among the next-generation, interferon-free regimens for the treatment of HCV infection.

  • Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose

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