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The FDA should soon approve the interferon-based regimen of sofosbuvir plus peginterferon and ribavirin for the treatment of hepatitis C virus (HCV) genotype 1 infection. Response rates of 90% have been achieved with only 12 weeks of therapy in treatment-naive patients without cirrhosis. The next step in the evolution of therapies for HCV genotype 1 infection is the development of interferon-free regimens.
In this phase II, open-label, randomized trial, investigators evaluated sofosbuvir (a nucleotide polymerase inhibitor; 400 mg) plus ledipasvir (an HCV NS5A inhibitor; 90 mg) in a single combination tablet taken daily with or without ribavirin (1000–1200 mg daily). In one cohort, 60 treatment-naive patients without cirrhosis were randomized…