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Aliment Pharmacol Ther. 2015 Sep;42(5):559-73. doi: 10.1111/apt.13300. Epub 2015 Jun 26.

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

Author information

1
Office of Public Health/Population Health Program, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.
2
Department of Medicine, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA, USA.

Abstract

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.

PMID:
26113432
DOI:
10.1111/apt.13300
[Indexed for MEDLINE]
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