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 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

doi:10.3350/CMH.2021.0155

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 journal › Article › peer-review

10 Citations (Scopus)

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 language	English
Pages (from-to)	575-588
Number of pages	14
Journal	Clinical and molecular hepatology
Volume	27
Issue number	4
DOIs	https://doi.org/10.3350/CMH.2021.0155
Publication status	Published - Oct 2021

Keywords

Antiviral agents
Hepatitis, Chronic
Liver cirrhosis
Ribavirin
Sofosbuvir

ASJC Scopus subject areas

Hepatology
Molecular Biology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.3350/CMH.2021.0155

Cite this

Liu, C. H., Chen, C. Y., Su, W. W., Liu, C. J., Lo, C. C., Huang, K. J., Chen, J. J., Tseng, K. C., Chang, C. Y., Peng, C. Y., Shih, Y. L., Huang, C. S., Kao, W. Y., Yang, S. S., Tsai, M. C., Wu, J. H., Chen, P. Y., Su, P. Y., Hwang, J. J., ... Kao, J. H. (2021). Sofosbuvir/velpatasvir plus ribavirin for child-pugh b and child-pugh c hepatitis c virus-related cirrhosis. Clinical and molecular hepatology, 27(4), 575-588. https://doi.org/10.3350/CMH.2021.0155

Liu, CH, Chen, CY, Su, WW, Liu, CJ, Lo, CC, Huang, KJ, Chen, JJ, Tseng, KC, Chang, CY, Peng, CY, Shih, YL, Huang, CS, Kao, WY, Yang, SS, Tsai, MC, Wu, JH, Chen, PY, Su, PY, Hwang, JJ, Fang, YJ, Lee, PL, Tseng, CW, Lee, FJ, Lai, HC, Hsieh, TY, Chang, CC, Chang, CH, Huang, YJ & Kao, JH 2021, 'Sofosbuvir/velpatasvir plus ribavirin for child-pugh b and child-pugh c hepatitis c virus-related cirrhosis', Clinical and molecular hepatology, vol. 27, no. 4, pp. 575-588. https://doi.org/10.3350/CMH.2021.0155

@article{fb70b23b862b4e4c9a29cbb8e1aef5ab,

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

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).",

keywords = "Antiviral agents, Hepatitis, Chronic, Liver cirrhosis, Ribavirin, Sofosbuvir",

author = "Liu, {Chen Hua} and Chen, {Chi Yi} and Su, {Wei Wen} and Liu, {Chun Jen} and Lo, {Ching Chu} and Huang, {Ke Jhang} and Chen, {Jyh Jou} and Tseng, {Kuo Chih} and Chang, {Chi Yang} and Peng, {Cheng Yuan} and Shih, {Yu Lueng} and Huang, {Chia Sheng} and Kao, {Wei Yu} and Yang, {Sheng Shun} and Tsai, {Ming Chang} and Wu, {Jo Hsuan} and Chen, {Po Yueh} and Su, {Pei Yuan} and Hwang, {Jow Jyh} and Fang, {Yu Jen} and Lee, {Pei Lun} and Tseng, {Chi Wei} and Lee, {Fu Jen} and Lai, {Hsueh Chou} and Hsieh, {Tsai Yuan} and Chang, {Chun Chao} and Chang, {Chung Hsin} and Huang, {Yi Jie} and Kao, {Jia Horng}",

note = "Funding Information: This study was supported by Ministry of Science and Technology, Taiwan (107-2314-B-002-038-MY2). Funding Information: Chen-Hua Liu: advisory board for Abbvie, Gilead Sciences, Merck Sharp & Dohme; speaker{\textquoteright}s bureau for Abbott, Abbvie, Gil-ead Sciences, Merck Sharp & Dohme; research grant from Ab-bvie, Gilead Science, Merck Sharp & Dohme. Sheng-Shun Yang: advisory board for Abbvie, Roche, Ipsen; speaker{\textquoteright}s bureau for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. Jia-Horng Kao: advisory board for Abbott, Ab-bvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker{\textquoteright}s bureau for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche. All the other authors declare no competing interests. Publisher Copyright: {\textcopyright} 2021 by Korean Association for the Study of the Liver.",

year = "2021",

month = oct,

doi = "10.3350/CMH.2021.0155",

language = "English",

volume = "27",

pages = "575--588",

journal = "Clinical and molecular hepatology",

issn = "2287-2728",

publisher = "Korean Association for the Study of the Liver",

number = "4",

}

TY - JOUR

T1 - Sofosbuvir/velpatasvir plus ribavirin for child-pugh b and child-pugh c hepatitis c virus-related cirrhosis

AU - Liu, Chen Hua

AU - Chen, Chi Yi

AU - Su, Wei Wen

AU - Liu, Chun Jen

AU - Lo, Ching Chu

AU - Huang, Ke Jhang

AU - Chen, Jyh Jou

AU - Tseng, Kuo Chih

AU - Chang, Chi Yang

AU - Peng, Cheng Yuan

AU - Shih, Yu Lueng

AU - Huang, Chia Sheng

AU - Kao, Wei Yu

AU - Yang, Sheng Shun

AU - Tsai, Ming Chang

AU - Wu, Jo Hsuan

AU - Chen, Po Yueh

AU - Su, Pei Yuan

AU - Hwang, Jow Jyh

AU - Fang, Yu Jen

AU - Lee, Pei Lun

AU - Tseng, Chi Wei

AU - Lee, Fu Jen

AU - Lai, Hsueh Chou

AU - Hsieh, Tsai Yuan

AU - Chang, Chun Chao

AU - Chang, Chung Hsin

AU - Huang, Yi Jie

AU - Kao, Jia Horng

N1 - Funding Information: This study was supported by Ministry of Science and Technology, Taiwan (107-2314-B-002-038-MY2). Funding Information: Chen-Hua Liu: advisory board for Abbvie, Gilead Sciences, Merck Sharp & Dohme; speaker’s bureau for Abbott, Abbvie, Gil-ead Sciences, Merck Sharp & Dohme; research grant from Ab-bvie, Gilead Science, Merck Sharp & Dohme. Sheng-Shun Yang: advisory board for Abbvie, Roche, Ipsen; speaker’s bureau for Abbvie, Bristol-Myers Squibb, Gilead Sciences, Ipsen, Merck Sharp & Dohme. Jia-Horng Kao: advisory board for Abbott, Ab-bvie, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche; speaker’s bureau for Abbott, Abbvie, Bayer, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis, Roche. All the other authors declare no competing interests. Publisher Copyright: © 2021 by Korean Association for the Study of the Liver.

PY - 2021/10

Y1 - 2021/10

N2 - 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).

AB - 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).

KW - Antiviral agents

KW - Hepatitis, Chronic

KW - Liver cirrhosis

KW - Ribavirin

KW - Sofosbuvir

UR - http://www.scopus.com/inward/record.url?scp=85119956552&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85119956552&partnerID=8YFLogxK

U2 - 10.3350/CMH.2021.0155

DO - 10.3350/CMH.2021.0155

M3 - Article

C2 - 34255961

AN - SCOPUS:85119956552

SN - 2287-2728

VL - 27

SP - 575

EP - 588

JO - Clinical and molecular hepatology

JF - Clinical and molecular hepatology

IS - 4

ER -

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

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this