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

Cheng, Pin-Nan; Mo, Lein-Ray; Chen, Chun-Ting; Chen, Chi-Yi; Huang, Chung-Feng; Kuo, Hsing-Tao; Lo, Ching-Chu; Tseng, Kuo-Chih; Huang, Yi-Hsiang; Tai, Chi-Ming; Peng, Cheng-Yuan; Bair, Ming-Jong; Chen, Chien-Hung; Yeh, Ming-Lun; Lin, Chih-Lang; Lin, Chun-Yen; Lee, Pei-Lun; Chong, Lee-Won; Hung, Chao-Hung; Chang, Te Sheng; Huang, Jee-Fu; Yang, Chi-Chieh; Hu, Jui-Ting; Lin, Chih-Wen; Wang, Chia-Chi; Su, Wei-Wen; Hsieh, Tsai-Yuan; Lin, Chih-Lin; Tsai, Wei-Lun; Lee, Tzong-Hsi; Chen, Guei-Ying; Wang, Szu-Jen; Chang, Chun-Chao; Yang, Sheng-Shun; Wu, Wen-Chih; Huang, Chia-Sheng; Chou, Kwok-Hsiung; Kao, Chien-Neng; Tsai, Pei-Chien; Liu, Chen-Hua; Lee, Mei-Hsuan; Cheng, Chien-Yu; Tsai, Ming-Chang; Liu, Chun-Jen; Dai, Chia-Yen; Lin, Han-Chieh; Kao, Jia-Horng; Chuang, Wan-Long; Yu, Ming-Lung

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

Cheng, Pin-Nan; Mo, Lein-Ray; Chen, Chun-Ting; Chen, Chi-Yi; Huang, Chung-Feng; Kuo, Hsing-Tao; Lo, Ching-Chu; Tseng, Kuo-Chih; Huang, Yi-Hsiang; Tai, Chi-Ming; Peng, Cheng-Yuan; Bair, Ming-Jong; Chen, Chien-Hung; Yeh, Ming-Lun; Lin, Chih-Lang; Lin, Chun-Yen; Lee, Pei-Lun; Chong, Lee-Won; Hung, Chao-Hung; Chang, Te Sheng; Huang, Jee-Fu; Yang, Chi-Chieh; Hu, Jui-Ting; Lin, Chih-Wen; Wang, Chia-Chi; Su, Wei-Wen; Hsieh, Tsai-Yuan; Lin, Chih-Lin; Tsai, Wei-Lun; Lee, Tzong-Hsi; Chen, Guei-Ying; Wang, Szu-Jen; Chang, Chun-Chao; Yang, Sheng-Shun; Wu, Wen-Chih; Huang, Chia-Sheng; Chou, Kwok-Hsiung; Kao, Chien-Neng; Tsai, Pei-Chien; Liu, Chen-Hua; Lee, Mei-Hsuan; Cheng, Chien-Yu; Tsai, Ming-Chang; Liu, Chun-Jen; Dai, Chia-Yen; Lin, Han-Chieh; Kao, Jia-Horng; Chuang, Wan-Long; Yu, Ming-Lung.

Afiliação

Cheng PN; Division of Gastroenterology and Hepatology, Department of Internal Medicine, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Mo LR; Division of Gastroenterology, Tainan Municipal Hospital, Tainan, Taiwan.
Chen CT; Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital Penghu Branch, National Defense Medical Center, Taipei, Taiwan.
Chen CY; Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
Huang CF; Division of Gastroenterology and Hepatology, Department of Medicine, Ditmanson Medical Foundation Chiayi Christian Hospital, Chiayi, Taiwan.
Kuo HT; Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Lo CC; School of Medicine and Hepatitis Research Center, College of Medicine, and Center for Cancer Research and Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
Tseng KC; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Yongkang District, Tainan, Taiwan.
Huang YH; Division of Gastroenterology, Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan.
Tai CM; Department of Internal Medicine, Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
Peng CY; School of Medicine, Tzuchi University, Hualien, Taiwan.
Bair MJ; Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
Chen CH; Institute of Clinical Medicine, School of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan.
Yeh ML; Department of Internal Medicine, E-Da Hospital, Kaohsiung, Taiwan.
Lin CL; School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan.
Lin CY; Center for Digestive Medicine, Department of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Lee PL; School of Medicine, China Medical University, Taichung, Taiwan.
Chong LW; Division of Gastroenterology, Department of Internal Medicine, Taitung Mackay Memorial Hospital, Taitung, Taiwan.
Hung CH; Mackay Medical College, New Taipei City, Taiwan.
Chang TS; Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan City, Taiwan.
Huang JF; School of Medicine and Hepatitis Research Center, College of Medicine, and Center for Cancer Research and Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
Yang CC; Department of Internal Medicine, Kaohsiung Municipal Siaogang Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Hu JT; Department of Gastroenterology and Hepatology, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.
Lin CW; Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Linkou Branch, Taiwan.
Wang CC; Graduate Institute of Biomedical Science, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Su WW; Liouying Division of Gastroenterology and Hepatology, Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan.
Hsieh TY; Division of Hepatology and Gastroenterology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
Lin CL; School of Medicine, Fu-Jen Catholic University, New Taipei City, Taiwan.
Tsai WL; Division of Hepato-Gastroenterology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Taoyuan City, Taiwan.
Lee TH; Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Chen GY; Division of Hepatogastroenterology, Department of Internal Medicine, ChiaYi Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Wang SJ; School of Medicine and Hepatitis Research Center, College of Medicine, and Center for Cancer Research and Center for Liquid Biopsy and Cohort Research, Kaohsiung Medical University, Kaohsiung, Taiwan.
Chang CC; Department of Internal Medicine, Kaohsiung Municipal Ta-Tung Hospital, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Yang SS; Department of Gastroenterology, Division of Internal Medicine, Show Chwan Memorial Hospital, Changhua, Taiwan.
Wu WC; Liver Center, Cathay General Hospital, Taipei, Taiwan.
Huang CS; Division of Gastroenterology and Hepatology, E-Da Dachang Hospital, and School of Medicine, College of Medicine, I-Shou University, Kaohsiung, Taiwan.
Chou KH; Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation and School of Medicine, Tzu Chi University, Hualien, Taiwan.
Kao CN; Department of Gastroenterology and Hepatology, Changhua Christian Hospital, Changhua, Taiwan.
Tsai PC; Division of Gastroenterology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
Liu CH; Department of Gastroenterology, Taipei City Hospital, Renai Branch, Taipei, Taiwan.
Lee MH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan.
Cheng CY; Division of Gastroenterology and Hepatology, Far Eastern Memorial Hospital, New Taipei, Taiwan.
Tsai MC; Penghu Hospital, Ministry of Health and Welfare, Penghu, Taiwan.
Liu CJ; Division of Gastroenterology, Department of Internal Medicine, Yuan's General Hospital, Kaohsiung, Taiwan.
Dai CY; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
Lin HC; Division of Gastroenterology and Hepatology, Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
Kao JH; Division of Gastroenterology and Hepatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan.
Chuang WL; Hepatobiliary Division, Department of Internal Medicine and Hepatitis Center, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
Yu ML; Yang-Ming Hospital, Taipei, Taiwan.

Infect Dis Ther ; 11(1): 485-500, 2022 Feb.

Article em En | MEDLINE | ID: mdl-34967920

ABSTRACT

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.