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Most of the large registration studies conducted to evaluate the safety and efficacy of direct-acting antiviral regimens for hepatitis C virus (HCV) infection have not included patients with advanced disease.
In an industry-supported, phase II, open-label study, investigators randomized 337 patients with HCV genotype 1 (99%) or 4 infection and advanced cirrhosis to receive 12 or 24 weeks of combination sofosbuvir-ledipasvir (400 mg/90 mg; currently FDA approved for HCV genotype 1 infection) plus ribavirin (1000–1200 mg) daily. Two groups of patients were enrolled: patients who had not undergone transplantation (59 patients with Child-Pugh class B cirrhosis and 49 with Child-Pugh class C cirrhosis) and patients who had undergone transplantati…