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
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
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