title: Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans.
abstract: BACKGROUND
  Real-world effectiveness data are needed to inform hepatitis C virus (HCV) treatment decisions.
  
  
  OBJECTIVE
  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.
authors.affiliation: Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.|Department of Medicine, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: L I
authors.initials: LI
authors.lastname: Backus
authors.affiliation: Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: P S
authors.initials: PS
authors.lastname: Belperio
authors.affiliation: Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: T A
authors.initials: TA
authors.lastname: Shahoumian
authors.affiliation: Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: T P
authors.initials: TP
authors.lastname: Loomis
authors.affiliation: Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
authors.forename: L A
authors.initials: LA
authors.lastname: Mole
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D006526:Hepatitis C / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000008:administration & dosage; D008103:Liver Cirrhosis / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D012254:Ribavirin / Q000008:administration & dosage; D000069616:Simeprevir / Q000008:administration & dosage; D000069474:Sofosbuvir / Q000008:administration & dosage / Q000627:therapeutic use*; D014728:Veterans
chemical_list: D000998:Antiviral Agents; D012254:Ribavirin; D007372:Interferons; D000069616:Simeprevir; D000069474:Sofosbuvir