Sofosbuvir/Velpatasvir for Hepatitis C Virus Infection: Real-World Effectiveness and Safety from a Nationwide Registry in Taiwan

doi:10.1007/s40121-021-00576-7

中山醫學大學機構典藏 CSMUIR > 中山醫學大學研究成果 > 期刊論文 > Item 310902500/23385

Please use this identifier to cite or link to this item: https://ir.csmu.edu.tw:8080/ir/handle/310902500/23385

Title:	Sofosbuvir/Velpatasvir for Hepatitis C Virus Infection: Real-World Effectiveness and Safety from a Nationwide Registry in Taiwan
Authors:	Cheng, PN;Mo, LR;Chen, CT;Chen, CY;Huang, CF;Kuo, HT;Lo, CC;Tseng, KC;Huang, YH;Tai, CM;Peng, CY;Bair, MJ;Chen, CH;Yeh, ML;Lin, CL;Lin, CY;Lee, PL;Chong, LW;Hung, CH;Chang, T;Huang, JF;Yang, CC;Hu, JT;Lin, CW;Wang, CC;Su, WW;Hsieh, TY;Lin, CL;Tsai, WL;Lee, TH;Chen, GY;Wang, SJ;Chang, CC;Yang, SS;Wu, WC;Huang, CS;Chou, KH;Kao, CN;Tsai, PC;Liu, CH;Lee, MH;Cheng, CY;Tsai, MC;Liu, CJ;Dai, CY;Lin, HC;Kao, JH;Chuang, WL;Yu, ML
Keywords:	Hepatitis C;Sofosbuvir;Velpatasvir;Direct-acting antivirals;Real-world;Taiwan
Date:	2021
Issue Date:	2022-08-05T09:36:25Z (UTC)
Publisher:	SPRINGER LONDON LTD
ISSN:	2193-8229
Abstract:	Introduction Pangenotypic direct-acting antivirals are expected to cure hepatitis C virus (HCV) in more than 95% of treated patients. However, data on the effectiveness and safety of sofosbuvir/velpatasvir (SOF/VEL) in Taiwan are limited. This study aims to characterize the patient population in the nationwide Taiwan Association for the Study of the Liver (TASL) HCV Registry and evaluate treatment outcome in Taiwanese patients receiving SOF/VEL. Methods This study was a retrospective-prospective, observational, multicenter, real-world analysis. Adults with chronic hepatitis C were treated with SOF/VEL 400/100 mg +/- ribavirin for 12 weeks. The primary outcome was sustained virologic response 12 weeks after end of therapy (SVR12). Factors associated with not achieving SVR12 were evaluated using logistic regression and covariate analysis. Safety was also assessed. Results In total, 3480 patients were included: 86.8% genotype 1/2, 2.8% genotype 3, 0.1% genotype 4/5, 9.6% genotype 6; unclassified, 0.8%; 12.2% compensated cirrhosis; 3.3% decompensated cirrhosis; and 15.8% chronic kidney disease. Overall SVR12 rate was 99.4% (genotype 1, 99.5%; genotype 2, 99.4%; genotype 3, 96.9%; genotype 4, 100%; genotype 6, 99.7%). SVR12 rates among patients with compensated cirrhosis, decompensated cirrhosis, and chronic kidney disease stages 4-5 were 99.5%, 100%, and 100%, respectively. There were 21 patients (0.6%) who did not achieve SVR12. Factors associated with failure were treatment adherence below 60%, high viral load, and genotype 3 (p < 0.001, p = 0.028, and p = 0.001, respectively). Adverse events occurred in 10% of patients; 0.6% were serious and one was related to treatment. Treatment discontinuation occurred in 0.3% of patients; none were treatment related. The estimated glomerular filtration rate remained stable throughout treatment and follow-up, regardless of baseline values and cirrhosis status. Conclusion SOF/VEL was highly effective and well tolerated in Taiwanese patients, irrespective of viral genotype, liver disease severity, and comorbidities.
URI:	http://dx.doi.org/10.1007/s40121-021-00576-7 https://www.webofscience.com/wos/woscc/full-record/WOS:000736401400001 https://ir.csmu.edu.tw:8080/handle/310902500/23385
Relation:	INFECTIOUS DISEASES AND THERAPY ,2022,v11,issue 1, P485-500
Appears in Collections:	[中山醫學大學研究成果] 期刊論文

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