Abstract
Background & Aims
We
investigated the real-world effectiveness of sofosbuvir,
ledipasvir/sofosbuvir, and paritaprevir/ritonavir/ombitasvir and
dasabuvir (PrOD) in treatment of different subgroups of patients
infected with hepatitis C virus (HCV) genotypes 1, 2, 3, or 4.
Methods
We
performed a retrospective analysis of data from 17,487 patients with
HCV infection (13,974 with HCV genotype 1; 2131 with genotype 2; 1237
with genotype 3; and 135 with genotype 4) who began treatment with
sofosbuvir (n=2986), ledipasvir/sofosbuvir (n=11,327), or PrOD (n=3174),
with or without ribavirin, from January 1, 2014 through June 20, 2015
in the Veterans Affairs healthcare system. Data through April 15, 2016
were analyzed to assess completion of treatments and sustained virologic
response 12 weeks after treatment (SVR12). The mean age of patients was
61±7 years, 97% were male, 52% were non-Hispanic white, 29% were
non-Hispanic black, 32% had a diagnosis of cirrhosis (9.9% with
decompensated cirrhosis), 36% had a FIB-4 score >3.25 (indicator of
cirrhosis), and 29% had received prior treatment.
Results
An
SVR12 was achieved by 92.8% (95% CI, 92.3%–93.2%) of subjects with HCV
genotype 1 infection (no significant difference between
ledipasvir/sofosbuvir and PrOD regimens), 86.2% (95% CI, 84.6%–87.7%) of
those with genotype 2 infection (treated with sofosbuvir and
ribavirin), 74.8% (95% CI, 72.2%–77.3%) of those with genotype 3
infection (77.9% in patients given ledipasvir/sofosbuvir plus ribavirin,
87.0% in patients given sofosbuvir and pegylated-interferon plus
ribavirin, and 70.6% of patients given sofosbuvir), and 89.6% (95% CI
82.8%–93.9%) of those with genotype 4 infection. Among patients with
cirrhosis, 90.6% of patients with HCV genotype 1, 77.3% with HCV
genotype 2, 65.7% with HCV genotype 3, and 83.9% with HCV genotype 4
achieved an SVR12. Among previously treated patients, 92.6% with
genotype 1, 80.2% with genotype 2, 69.2% with genotype 3, and 93.5% with
genotype 4 achieved an SVR12. Among treatment-experienced patients,
92.8% with genotype 1, 88.0% with genotype 2, 77.5% with genotype 3, and
88.3% with genotype 4 achieved an SVR12. Eight-week regimens of
ledipasvir/sofosbuvir produced an SVR12 in 94.3% of eligible patients
with HCV genotype 1 infection; this regimen was underused.
Conclusions
High
proportions of patients with HCV infections genotypes 1–4 (ranging from
75%–93%) in the VA national healthcare system achieved SVR12,
approaching the results reported in clinical trials—especially patients
with genotype 1 infection. An 8 week regimen of ledipasvir/sofosbuvir is
effective for eligible patients with HCV genotype 1 infection and could
produce cost savings. There is substantial room for improvement in SVRs
among persons with cirrhosis and genotype 2 or 3 infections.
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