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