Twelve-week ribavirin-free direct-acting antivirals for treatment-experienced Chinese with HCV genotype 1b infection including cirrhotic patients.

Abstract

Treatment-experienced chronic hepatitis C (CHC) genotype (GT) 1b represents a major medical burden in China. We evaluate the efficacy, safety and cost-effectiveness of ribavirin (RBV)-free pan-oral direct-acting antivirals (DAAs) in treatment-experienced Chinese with GT1b CHC, including patients with cirrhosis. One hundred forty treatment-experienced GT1b CHC Chinese with and without cirrhosis were included in this study. Ninety-four patients were treated with either daclatasvir (DCV, 60mg)-sofosbuvir (SOF, 400mg) (group 1, n=46) or ledipasvir (LDV, 90mg)-SOF (400mg) (group 2, n=48) for 12weeks. Forty-six patients treated with pegylated interferon and RBV therapy for 72weeks were enrolled as the control group (group 3). Patients were followed at 4-weekly intervals till 24weeks after the end of treatment. All patients in group 1 (46/46, 100%) and 2 (48/48, 100%) had achieved sustained virologic response at 24weeks after the end of treatment (SVR 24), which was significantly higher than that of group 3 (13/46, 28.3%) (p<0.001). The SVR 24 rates of cirrhotic patients in group 1 (27/27, 100%) and 2 (27/27, 100%) were also significantly higher than that of group 3 (3/25, 12%) (p<0.001). Twelveweeks of RBV-free LDV-SOF and DCV-SOF was either cost-saving or cost-effective. Adverse events were significantly lower in group 1 and 2 compared with group 3 (p<0.001). Compared with standard therapies, 12weeks of RBV-free DAA therapies is highly effective, well tolerated and cost-effective in treatment-experienced Chinese with GT1b CHC including patients with cirrhosis.