Abstract

Aims The aim is to evaluate the efficacy and safety of Sofosbuvir- (SOF-) based direct-acting antiviral agents (DAAs) treatment for patients with genotype (GT) 3/6 hepatitis C virus (HCV) infection. Methods Patients infected with GT 3/6 HCV and treated with SOF-based DAAs were enrolled in this prospective, open, single-center, and real-world study. Drugs included Sofosbuvir (SOF), Velpatasvir (VEL), Daclatasvir (DCV), and Ribavirin (RBV). The treatment regimens included SOF + RBV for 24 weeks, SOF + DCV ± RBV for 12/24 weeks, and SOF/VEL ± RBV for 12 weeks. Results A total of 54 patients were included. Age was 42.5 ± 10.4 years. Baseline HCV RNA was 6.29 ± 0.89log10 IU/mL. The numbers of GT 3a, 3b, and 6a patients were 10, 12, and 32, respectively. The numbers of chronic hepatitis, compensated cirrhosis, and decompensated cirrhosis patients were 39, 9, and 6, respectively. In patients with chronic hepatitis C and liver cirrhosis, sustained virological response 12 weeks after the end of treatment (SVR12) was 97.4% and 96.7%, respectively, and rapid virological response (RVR) was 75.0% and 57.1%, respectively. SVR12 of GT3a, GT3b, and GT6a was 100%, 83.3%, and 97%, respectively. ALT normality rate in chronic hepatitis group is higher than that in cirrhosis group at 4 weeks of treatment (89.7% versus 60.0%, p = 0.033) and at 12 weeks after EOT (94.9% versus 66.7%, p = 0.021). The overall incidence rate of adverse events was 44.4%, with fatigue being the most common (13.0%). Conclusion SOF-based DAAs regimen can achieve ideal SVR12 for Chinese patients with both GT3a and GT6a HCV infection. The tolerance and safety of SOF-based DAAs regimen are good.

Highlights

  • Introduction ere are71 million chronic hepatitis C (CHC) patients worldwide [1,2,3], and 350,000 people die of hepatitis C-related diseases every year

  • Direct-acting antiviral agents (DAAs) are the first choice for hepatitis C virus (HCV) by Chinese Medical Association [4], American Association for the Study of Liver Diseases [10], and European Association for the Study of the Liver [11]. e treatment regimens include multiple solutions based on Sofosbuvir (SOF)

  • Patients, who were infected with GT 3/6 HCV and treated with DAAs based on SOF in ird Affiliated Hospital of Sun Yat-sen University from December 1, 2017, to September 30, 2019, were enrolled in the study. is study complied with the Declaration of Helsinki and was approved by the ethics committee of the ird Affiliated Hospital of Sun Yat-sen University. e ethical approval number was [2018] 02-305-02

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Summary

Introduction

71 million chronic hepatitis C (CHC) patients worldwide [1,2,3], and 350,000 people die of hepatitis C-related diseases every year. Genotype 3 (GT3) and GT6 HCV infections are more common in southeast Asia and south China [5, 6]. People with these two genotypes are at higher risk of developing liver cancer [4, 7,8,9]. Compared with other genotypes of chronic HCV infection, patients with GT3-CHC have a faster progression in liver disease [7]. There is still lack of data on the efficacy and safety

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