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On the heels of the phase II trial results (JW Gastroenterol Apr 12 2013), phase III trial results are now available on sofosbuvir-based regimens for the treatment of chronic hepatitis C virus (HCV) infection in treatment-naive patients. The primary endpoint of the two industry-funded, phase III trials was sustained virologic response at 12 weeks after end of treatment (SVR12).
In the single-group, open-label NEUTRINO trial, 327 patients with HCV genotypes 1 (89%), 4 (9%), 5 (<1%), and 6 (2%) received oral sofosbuvir (400 mg daily), peginterferon (180 µg weekly), and ribavirin (1000–1200 mg daily) for 12 weeks. Among the study group, 17% were black, 71% had IL28B genotype TT or TC, and 17% had cirrhosis. SVR12 was 89% for genotype 1 (92% for…