Objectives: Patients with chronic hepatitis C virus (HCV) and cirrhosis are in critical need of treatment that is both effective and tolerable. The combination of simeprevir (SMV), a protease inhibitor, and sofosbuvir (SOF), a polymerase inhibitor, without peginterferon and/or ribavirin (PEGINF/RBV) has been shown to achieve sustained virologic response (SVR) exceeding 90% in patients with HCV genotype 1 with prior nonresponse and/or cirrhosis. The present report describes the efficacy of SMV and SOF in patients with cirrhosis, prior or current hepatic decompensation, and other contraindications to PEGINF/RBV.
Methods: A total of 120 consecutive patients with cirrhosis and contraindications to PEGINF/RBV were treated with SMV and SOF for 12 weeks. The primary end point was SVR at 12 weeks after the completion of treatment.
Results: The mean age of the cohort was 60 years; 63% were male, 48% were Caucasian, 44% were African American, 69% were of genotype 1A, 49% were treatment naïve, 96% were interleukin-28B non-CC, 33% were of Child class B or C, and 25% had prior hepatic decompensation. The SVR by intention-to-treat was 81% with a relapse rate of 14%. The SVR by per-protocol analysis was 87% with a relapse rate of 13%. The only baseline factor associated with SVR by multifactor analysis was Child class. SVR in patients with Child class A, B, and C was 87, 77, and 67%, respectively. Eleven percent of the patients developed severe adverse events, which included sepsis (two), variceal bleeding (two), hepatocellular carcinoma (two), and hyperbilirubinemia (eight). One of the patients with sepsis died. Two patients developed relapse more than 12 weeks after stopping SMV and SOF.
Conclusions: The combination of SMV and SOF achieves high rates of SVR in patients with advanced cirrhosis but is lower with worsening Child class.