Effectiveness of Sofosbuvir, Ledipasvir/Sofosbuvir, or
Paritaprevir/Ritonavir/Ombitasvir and Dasabuvir Regimens for Treatment of
Patients With Hepatitis C in the Veterans Affairs National Health Care System
#MMPMID27267053
Ioannou GN
; Beste LA
; Chang MF
; Green PK
; Lowy E
; Tsui JI
; Su F
; Berry K
Gastroenterology
2016[Sep]; 151
(3
): 457-471.e5
PMID27267053
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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 health care system. Data through April 15, 2016 were
analyzed to assess completion of treatments and sustained virologic response 12
weeks after treatment (SVR12). 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 Fibrosis-4
index score >3.25 (indicator of cirrhosis), and 29% had received prior antiviral
treatment. RESULTS: An SVR12 was achieved by 92.8% (95% confidence interval [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 plus
ribavirin), 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 SVR12.
Among treatment-naive patients, 92.8% with genotype 1; 88.0% with genotype 2;
77.5% with genotype 3; and 88.3% with genotype 4 achieved 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% to
93%) in the Veterans Affairs national health care system achieved SVR12,
approaching the results reported in clinical trials, especially in patients with
genotype 1 infection. An 8-week regimen of ledipasvir/sofosbuvir is effective for
eligible patients with HCV genotype 1 infection and could reduce costs. There is
substantial room for improvement in SVRs among persons with cirrhosis and
genotype 2 or 3 infections.
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