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

Abstract

BACKGROUND:

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:

Between July 2019 and March 2020, 1880 HCV-infected patients with compensated liver disease who received SOF/VEL 400/100 mg once daily for 12 weeks 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.

RESULTS:

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.

CONCLUSIONS:

SOF/VEL for 12 weeks is efficacious and well-tolerated by chronic HCV-infected patients with compensated liver disease in Taiwan.

• Authors: Chen-Hua Liu, Po-Yueh Chen, Jyh-Jou Chen, Ching-Chu Lo, Wei-Wen Su, Kuo-Chih Tseng, Chun-Jen Liu, Chia-Sheng Huang, Ke-Jhang Huang, Sheng-Shun Yang, Cheng-Yuan Peng, Ming-Chang Tsai, Wei-Yu Kao, Chi-Yang Chang, Yu-Lueng Shih, Yu-Jen Fang, Chi-Yi Chen, Pei-Lun Lee, Jow-Jyh Huang, Pei-Yuan Su, Chi-Wei Tseng, Chien-Ching Hung, Chung-Hsin Chang, Yi-Jie Huang, Hsueh-Chou Lai, Chun-Chao Chang, Fu-Jen Lee, Tsai-Yuan Hsieh, Jia-Horng Kao
• Journal: Hepatology international (Hepatol Int) Vol. 15 Issue 2 Pg. 338-349 (Apr 2021) ISSN: 1936-0541 [Electronic] United States
• PMID: 33677787 (Publication Type: Journal Article)

Chemical References

• Antiviral Agents
• Carbamates
• Heterocyclic Compounds, 4 or More Rings
• velpatasvir
• Sofosbuvir

Topics

• Antiviral Agents (therapeutic use)
• Carbamates (therapeutic use)
• Genotype
• Hepacivirus (genetics)
• Hepatitis C, Chronic (complications, drug therapy)
• Heterocyclic Compounds, 4 or More Rings (therapeutic use)
• Humans
• Sofosbuvir (therapeutic use)
• Sustained Virologic Response
• Taiwan (epidemiology)