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Effectiveness of sofosbuvir‐based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans
Author(s) -
Backus L. I.,
Belperio P. S.,
Shahoumian T. A.,
Loomis T. P.,
Mole L. A.
Publication year - 2015
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13300
Subject(s) - sofosbuvir , medicine , simeprevir , ribavirin , genotype , hepatitis c virus , odds ratio , gastroenterology , cohort , hepatitis c , pegylated interferon , virology , virus , biochemistry , chemistry , gene
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 .