Abstract
Effective
antiviral therapy is essential for achieving sustained virological
response (SVR) in hepatitis C virus (HCV)-infected patients. The phase 2
COSMOS study reported high SVR rates in treatment-naïve and prior
null-responder HCV genotype (GT)1-infected patients receiving
simeprevir+sofosbuvir±ribavirin for 12/24 weeks. OPTIMIST-1
(NCT02114177) was a multicenter, randomized, open-label study assessing
the efficacy and safety of 12 and 8 weeks of simeprevir+sofosbuvir in
HCV GT1-infected treatment-naïve and -experienced patients without
cirrhosis. Patients were randomly assigned (1:1; stratified by HCV
GT/subtype and presence/absence of NS3 Q80K polymorphism [GT1b, GT1a
with Q80K, GT1a without Q80K]), prior HCV treatment history, and IL28B
GT [CC, non-CC]) to simeprevir 150 mg once daily (QD)+sofosbuvir 400 mg
QD for 12 or 8 weeks. Primary efficacy endpoint: SVR rate 12 weeks
after end of treatment (SVR12). Superiority in SVR12 was assessed for
simeprevir+sofosbuvir at 12 and 8 weeks versus a composite historical
control SVR rate. 310 patients were enrolled, randomized, and received
treatment (n=155 in each arm). SVR12 with simeprevir+sofosbuvir for 12
weeks (97% [150/155; 95% CI 94-100%]) was superior to the historical
control (87%). SVR12 with simeprevir+sofosbuvir for 8 weeks (83%
[128/155; 95% CI 76-89%]) was not superior to the historical control
(83%). The most frequent adverse events (AEs) were nausea, headache, and
fatigue (12-week arm: 15% [23/155]), 14% [22/155], and 12% [19/155];
8-week arm: 9% [14/155], 17% [26/155], and 15% [23/155], respectively).
No patients discontinued treatment due to an AE. One (1%; 12-week arm)
and three (2%; 8-week arm) patients experienced a serious AE (all
unrelated to study treatment). Conclusion:
Simeprevir+sofosbuvir for 12 weeks is highly effective in the treatment
of HCV GT1-infected, non-cirrhotic patients, including those with Q80K.
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