Effectiveness of sofosbuvir‐based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans

Summary Background Real‐world effectiveness data are needed to inform hepatitis C virus ( HCV ) treatment decisions. Aim To assess sustained virological response ( SVR ) of sofosbuvir ( SOF )‐based regimens in routine medical practice. Methods Observational, intent‐to‐treat cohort analysis of genotype 1 and 2 HCV ‐infected veterans initiating SOF ‐based regimens with recommended treatment duration of 12 weeks. Results Four thousand and twenty‐six veterans with genotype 1 ( N  = 3203) and genotype 2 ( N  = 823) comprise the cohort. SVR rates for genotype 1 were 66.8% for SOF  + peginterferon + ribavirin ( RBV ), 75.3% for SOF  + simeprevir ( SIM ), 74.1% for SOF  +  SIM  +  RBV and for genotype 2 were 79.0% for SOF  +  RBV . Genotype 1 patients were less likely to achieve SVR with BMI ≥30 ( OR 0.64, 95% CI 0.49–0.84, P  < 0.001), a history of decompensated liver disease ( OR 0.51, 95% CI 0.36–0.71, P  < 0.001), treatment experience ( OR 0.58, 95% CI 0.48–0.71, P  < 0.001), APRI >2 ( OR 0.44, 95% CI 0.36–0.55, P  < 0.001) and with SOF  +  PEG  +  RBV compared with SOF  +  SIM ( OR 0.50, 95% CI 0.40–0.62, P  < 0.001). Age, sex, race/ethnicity, diabetes and genotype subtype did not predict SVR . Odds of achieving SVR with SOF  +  SIM  +  RBV did not differ compared with SOF  +  SIM ( OR 1.03, 95% CI 0.75–1.44, P  = 0.86). Genotype 2 patients were less likely to achieve SVR with prior treatment experience ( OR 0.55, 95% CI 0.35–0.88, P  = 0.009) and APRI >2 ( OR 0.39, 95% CI 0.25–0.62, P  < 0.001). Conclusions In this real‐world cohort, SVR rates were lower than in clinical trials. Genotype 1 and 2 HCV ‐infected patients with advanced liver disease by APRI >2 or FIB ‐4 > 3.25 were significantly less likely to achieve SVR . For genotype 1, a SOF  +  SIM  ±  RBV regimen was associated with a higher likelihood of SVR .