Clin Mol Hepatol.
2021 Oct;27(4):575-588. 10.3350/cmh.2021.0155.
Sofosbuvir/velpatasvir plus ribavirin for Child-Pugh B and Child-Pugh C hepatitis C virus-related cirrhosis
- Liu CH1,2,3
- Chen CY4
- Su WW5
- Liu CJ1,2
- Lo CC6
- Huang KJ7
- Chen JJ8
- Tseng KC9,10
- Chang CY11
- Peng CY12,13
- Shih YL14
- Huang CS15
- Kao WY16,17,18
- Yang SS19,20,21
- Tsai MC22
- Wu JH23
- Chen PY4
- Su PY5
- Hwang JJ6
- Fang YJ3
- Lee PL8
- Tseng CW9,10
- Lee FJ11
- Lai HC12,13
- Hsieh TY14
- Chang CC16,17,18
- Chang CH19
- Huang YJ19
- Kao JH
1,2,24,25
- Affiliations
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- 1Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan
- 2Hepatitis Research Center, National Taiwan University Hospital, Taipei, Taiwan
- 3Department of Internal Medicine, National Taiwan University Hospital, Yun-Lin Branch, Yunlin, Taiwan
- 4Division of Gastroenterology and Hepatology, Department of Internal Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan
- 5Division of Gastroenterology, Department of Internal Medicine, Changhua Christian Hospital, Changhua, Taiwan
- 6Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan
- 7Division of Gastroenterology and Hepatology, Department of Internal Medicine, China Medical University Beigang Hospital, Yunlin, Taiwan
- 8Division of Gastroenterology and Hepatology, Chi-Mei Medical Center, Liouying, Taiwan
- 9Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan
- 10School of Medicine, Tzuchi University, Hualien, Taiwan
- 11Division of Gastroenterology and Hepatology, Department of Internal Medicine, Fu Jen Catholic University Hospital, Taipei, Taiwan
- 12Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan
- 13School of Medicine, China Medical University, Taichung, Taiwan
- 14Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
- 15Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yang Ming Hospital, Chiayi, Taiwan
- 16Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan
- 17School of Medicine, Taipei Medical University College of Medicine, Taipei, Taiwan
- 18Graduate Institute of Clinical Medicine, Taipei Medical University College of Medicine, Taipei, Taiwan
- 19Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan
- 20School of Medicine, Chung Shan Medical University, Taichung, Taiwan
- 21Institute of Biomedical Sciences, National Chung Hsing University, Taichung, Taiwan
- 22Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chung Shan Medical University Hospital, Taichung, Taiwan
- 23Hamilton Glaucoma Center, Shiley Eye Institute and Viterbi Family Department of Ophthalmology, University of California, San Diego, CA, USA
- 24Graduate Institute of Clinical Medicine, National Taiwan University College of Medicine, Taipei, Taiwan
- 25Department of Medical Research, National Taiwan University Hospital, Taipei, Taiwan
- KMID: 2520841
- DOI: http://doi.org/10.3350/cmh.2021.0155
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.
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