Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis
- Author:
Chen-Hua LIU
1
;
Chi-Yi CHEN
;
Wei-Wen SU
;
Chun-Jen LIU
;
Ching-Chu LO
;
Ke-Jhang HUANG
;
Jyh-Jou CHEN
;
Kuo-Chih TSENG
;
Chi-Yang CHANG
;
Cheng-Yuan PENG
;
Yu-Lueng SHIH
;
Chia-Sheng HUANG
;
Wei-Yu KAO
;
Sheng-Shun YANG
;
Ming-Chang TSAI
;
Jo-Hsuan WU
;
Po-Yueh CHEN
;
Pei-Yuan SU
;
Jow-Jyh HWANG
;
Yu-Jen FANG
;
Pei-Lun LEE
;
Chi-Wei TSENG
;
Fu-Jen LEE
;
Hsueh-Chou LAI
;
Tsai-Yuan HSIEH
;
Chun-Chao CHANG
;
Chung-Hsin CHANG
;
Yi-Jie HUANG
;
Jia-Horng KAO
Author Information
- Publication Type:Original Article
- From:Clinical and Molecular Hepatology 2021;27(4):575-588
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background/Aims:Real-world studies assessing the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) plus ribavirin (RBV) for Child-Pugh B/C hepatitis C virus (HCV)-related cirrhosis are limited.
Methods:We included 107 patients with Child-Pugh B/C HCV-related cirrhosis receiving SOF/VEL plus RBV for 12 weeks in Taiwan. The sustained virologic response rates at off-treatment week 12 (SVR12) for the evaluable population (EP), modified EP, and per-protocol population (PP) were assessed. Thesafety profiles were reported.
Results:The SVR12 rates in the EP, modified EP and PP were 89.7% (95% confidence interval [CI], 82.5–94.2%), 94.1% (95% CI, 87.8–97.3%), and 100% (95% CI, 96.2–100%). Number of patients who failed to achieve SVR12 were attributed to virologic failures. The SVR12 rates were comparable regardless of patient characteristics. One patient discontinued treatment because of adverse events (AEs). Twenty-four patients had serious AEs and six died, but none were related to SOF/VEL or RBV. Among the 96 patients achieving SVR12, 84.4% and 64.6% had improved Child-Pugh and model for endstage liver disease (MELD) scores. Multivariate analysis revealed that a baseline MELD score ≥15 was associated with an improved MELD score of ≥3 (odds ratio, 4.13; 95% CI, 1.16–14.71; P=0.02). Patients with chronic kidney disease (CKD) stage 1 had more significant estimated glomerular filtration rate declines than patients with CKD stage 2 (-0.42 mL/min/1.73 m2/month; P=0.01) or stage 3 (-0.56 mL/min/1.73 m2/month; P<0.001).
Conclusions:SOF/VEL plus RBV for 12 weeks is efficacious and well-tolerated for Child-Pugh B/C HCV-related cirrhosis.
