Sofosbuvir/velpatasvir plus ribavirin for child-pugh b and child-pugh c hepatitis c virus-related cirrhosis

Chen Hua Liu, 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 FangPei 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

Research output: Contribution to journalArticlepeer-review

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. The safety 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. (Clin Mol Hepatol 2021;27:575-588).

Original languageEnglish
Pages (from-to)575-588
Number of pages14
JournalClinical and molecular hepatology
Volume27
Issue number4
DOIs
Publication statusPublished - Oct 2021

Keywords

  • Antiviral agents
  • Hepatitis, Chronic
  • Liver cirrhosis
  • Ribavirin
  • Sofosbuvir

ASJC Scopus subject areas

  • Hepatology
  • Molecular Biology

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