Efficacy and safety of direct-acting antiviral agent regimens in a real-world cohort of adult Chinese patients with chronic hepatitis C virus infection

ABSTRACT Background and aims To investigate the safety and efficacy of direct-acting antiviral (DAA) regimens in a cohort of Chinese patients with chronic hepatitis C virus (HCV) infection. Methods A total of 222 adult Chinese patients were enrolled and treated via DAA regimens in accordance with HCV management guidelines. Treatment responses were evaluated 4 weeks after treatment, at the end of treatment (EOT) and 12 weeks post-treatment. Virological responses, biochemical responses, model for end-stage liver disease (MELD) and Child-Pugh (CP) scores were recorded. Results A total of 218 patients (98.2%) achieved sustained virological response 12 weeks post-treatment and 4 patients relapsed. The combined number of rapid virological responses for all six regimens was 170/222 (76.6%), and 221/222 (99.6%) had achieved virological responses by the end of treatment. In decompensated cirrhosis patients the baseline mean CP score was 6.8 ± 1.3 and the mean MELD score was 10.1 ± 3.3. Compared with the mean CP score at baseline, the mean score is significantly lower at the end of treatment (5.7±1.3) and 12 weeks post-treatment (5.6±1.0). Estimated glomerular filtration rates did not differ significantly from baseline during the treatment or 12 weeks post-treatment. The incidence of adverse events in patients with chronic hepatitis C and compensated cirrhosis was 42/172 (24.4%), and in patients with decompensated cirrhosis it was 8/22 (36.4%). The most frequently reported adverse events were elevated indirect bilirubin, fatigue and rash. There were no cases of serious adverse events, death or treatment discontinuation because of adverse events. Conclusion DAA regimens were highly effective and well tolerated irrespective of HCV genotype, cirrhosis, liver or kidney transplantation, hepatocellular carcinoma, HCV/hepatitis B virus co-infection, or renal failure, as demonstrated by improved CP score in decompensated cirrhosis patients.