Background. It is urgent for patients with hepatitis C virus (HCV) infection to find a safe, effective, and interferon-free regimen\nto optimize therapy. A comprehensive analysis was performed to evaluate the efficacy and safety of the grazoprevir combined\nwith elbasvir, with or without ribavirin (RBV), in 777 treatment-naive and treatment-experienced patients with HCV genotype\n1 infection from 3 randomized controlled trials (RCTs). Method. We collected data from the following trials: C-WORTHY\n(NCT01717326), C-SALVAGE (NCT02105454), and C-EDGE (NCT02105467). All patients received grazoprevir plus elbasvir with\nor withoutRBVfor 12 or 18weeks.The sustained virological response (SVR) 12weeks after end of treatment was calculated for overall\nand subgroups. Results. 568 (73%) patients were treatment-naive. Overall, 95% (95% CI: 93ââ?¬â??96) patients achieved SVR12, 95%\n(95% CI: 92ââ?¬â??96) for treatment-naive and 96% (95% CI: 92ââ?¬â??98) for previously treated patients, respectively. Treatment duration and\ntreatment regimen did not have great difference in SVR12 rates. The most common AEs were fatigue (18%ââ?¬â??29%), headache (20%),\nnausea (8%ââ?¬â??14%), and asthenia (4%ââ?¬â??12%). One patient (<1%) receiving grazoprevir plus elbasvir alone and one (<1%) receiving\ngrazoprevir plus elbasvir plus RBV had treatment-related serious AEs. Conclusions.The result shows that 12-week grazoprevir plus\nelbasvir therapy is safe and effective for treatment-naive patients with HCV genotype 1.
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