Sofosbuvir/Velpatasvir for Hepatitis C Virus Infection: Real-World Effectiveness and Safety from a Nationwide Registry in Taiwan
Year: 2021
Type: article
Study design: Observational Study
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.
Source: Infectious Diseases and Therapy
Authors: Pin-Nan Cheng, Lein-Ray Mo, Chun-Ting Chen, Chi-Yi Chen, Chung-Feng Huang, Hsing-Tao Kuo, Ching-Chu Lo, Kuo-Chih Tseng, Yi-Hsiang Huang, Chi-Ming Tai, Cheng-Yuan Peng, Ming-Jong Bair, Chien-Hung Chen, Ming-Lun Yeh, Chih-Lang Lin, Chun-Yen Lin, Pei-Lun Lee, Lee-Won Chong, Chao-Hung Hung, Te Sheng Chang, Jee-Fu Huang, Chi-Chieh Yang, Jui-Ting Hu, Chih-Wen Lin, Chia-Chi Wang, Wei-Wen Su, Tsai-Yuan Hsieh, Chih-Lin Lin, Wei-Lun Tsai, Tzong-Hsi Lee, Guei-Ying Chen, Szu-Jen Wang, Chun-Chao Chang, Sheng-Shun Yang, Wen-Chih Wu, Chia-Sheng Huang, Kwok-Hsiung Chou, Chien-Neng Kao, Pei-Chien Tsai, Chen-Hua Liu, Mei-Hsuan Lee, Chien-Yu Cheng, Ming-Chang Tsai, Chun-Jen Liu, Chia-Yen Dai, Han-Chieh Lin, Jia-Horng Kao, Wan-Long Chuang, Ming-Lung Yu, TACR investigators
Institutions: National Cheng Kung University Hospital, National Cheng Kung University, Tainan Municipal Hospital, Tainan Hospital, Tri-Service General Hospital, Chang Gung University, Kaohsiung Chang Gung Memorial Hospital, Chia-Yi Christian Hospital, National Defense Medical Center, Kaohsiung Medical University, Kaohsiung Medical University Chung-Ho Memorial Hospital, Chi Mei Medical Center, St. Martin de Porres Hospital, Tzu Chi University, Dalin Tzu Chi Hospital, National Yang Ming Chiao Tung University, Taipei Veterans General Hospital, E-Da Hospital, I-Shou University, China Medical University, China Medical University Hospital, Mackay Memorial Hospital, Mackay Medical University, Chang Gung Memorial Hospital, Keelung Chang Gung Memorial Hospital, Linkou Chang Gung Memorial Hospital, Taipei City Hospital, Fu Jen Catholic University, Shin Kong WHS Memorial Hospital, Chiayi Chang Gung Memorial Hospital, Kaohsiung Municipal Ta-Tung Hospital, Chang Bing Show Chwan Memorial Hospital, Cathay General Hospital, Tzu Chi Foundation, Taipei Tzu Chi Hospital, Changhua Christian Hospital, Kaohsiung Veterans General Hospital, Far Eastern Memorial Hospital, Ministry of Health and Welfare, Yuan's General Hospital, Taipei Medical University Hospital, Taipei Medical University, Taichung Veterans General Hospital, National Taiwan University Hospital, National Taiwan University, Tao Yuan General Hospital, Chung Shan Medical University Hospital, Chung Shan Medical University
Language: English
Topic: Hepatitis C virus research
Subfield: Hepatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $6,000
OpenAlex ID: W4200219817