Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 US Veterans

BackgroundReal-world effectiveness data are needed to inform hepatitis C virus (HCV) treatment decisions. AimTo assess sustained virological response (SVR) of sofosbuvir (SOF)-based regimens in routine medical practice. MethodsObservational, intent-to-treat cohort analysis of genotype 1 and 2 HCV-infected veterans initiating SOF-based regimens with recommended treatment duration of 12weeks. ResultsFour 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). ConclusionsIn 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.