Sofosbuvir/velpatasvir for patients with chronic hepatitis C virus infection and compensated liver disease: real-world data in Taiwan.

Chen–Hua Liu ,Tsai‐Yuan Hsieh,Cheng Yuan Peng ,Chung Hsin Chang ,Pei Lun Lee ,Jyh Jou Chen ,Wei Su ,Chi Yi Chen ,Chia‐Hung Chang ,Chun Chao Chang ,Pei–Yuan Su ,Chun–Jen Liu ,Po Yueh Chen ,Chia Sheng Huang ,Chi Wei Tseng ,Max Tsai ,Hsueh Chou Lai ,Ke Huang ,Fu Jen Lee ,Yung-Fu Huang ,Kuo‐Chih Tseng ,Chien‐Ching Hung ,Yu Jen Fang ,Wei Yu Kao ,Jow Jyh Huang ,Ching Chu Lo ,Yu Lueng Shih ,Shih-Chieh Yang ,Jia Horng Kao

doi:10.1007/s12072-021-10158-x

Abstract

Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan. Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100mg once daily for 12weeks were included at 15 academic centers in Taiwan. The sustained virologic response at off-treatment week 12 (SVR12) was assessed for evaluable (EP) and per-protocol populations (PP). The tolerance was also reported. The SVR12 rates by EP and PP analyses were 95.6% [1798 of 1880 patients; 95% confidence interval (CI) 94.6-96.5%] and 99.3% (1798 of 1811 patients; 95% CI 98.8-99.6%), respectively. Among 82 patients who failed to achieve SVR12, 13 (15.9%) were attributed to virologic failures. The SVR12 rates were comparable regardless of baseline characteristics. A total of 1859 (98.9%) patients completed 12-week SOF/VEL treatment. Four (0.2%) patients discontinued treatment due to adverse events (AEs). All patients with serious AEs or deaths were judged not related to SOF/VEL. The AEs occurring in ≥ 10% included headache (16.8%), fatigue (16.2%), nausea (11.8%), and insomnia (11.1%). Nine (0.5%) and 2 (0.1%) patients had grade 3 total bilirubin and alanine aminotransferase elevations. SOF/VEL for 12weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan.

Highlights

Chronic hepatitis C virus (HCV) infection is the leading cause of cirrhosis, hepatocellular carcinoma (HCC), hepatic decompensation and liver transplantation
The sustained virologic response at off-treatment week 12 (SVR12) rates by evaluable population (EP) and PP analyses were 95.6% (1,798 of 1,880 patients; 95% confidence interval (CI): 94.6%-96.5%) and 99.3% (1,798 of 1,811 patients; 95% CI: 98.8%-99.6%), respectively
We reported common adverse event (AEs) with rates of ≥ 10% and the proportion of patients with ≥ grade 2 total bilirubin or ALT elevation according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Summary

Introduction

Chronic hepatitis C virus (HCV) infection is the leading cause of cirrhosis, hepatocellular carcinoma (HCC), hepatic decompensation and liver transplantation. The health-related outcomes are substantially improved following effective antiviral therapies for HCV [4]. DAAs with pangenotypic potency and fixed-dose combination (FDC) are recommended to be the first-line therapies because these regimens can simplify the care by obviating the needs for HCV genotype (GT) testing and intensive on-treatment monitoring [5,6,7]. The World Health Organization (WHO) recommends the pangenotypic DAAs for HCV in order to move toward the viral elimination by 2030. Data regarding the real-world effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) for East Asian patients with chronic hepatitis C virus (HCV) infection and compensated liver disease are limited. We evaluated the performance of SOF/VEL for 12 weeks for HCV-infected patients with compensated liver disease in a large real-world cohort in Taiwan

Methods

Results

Conclusion