• Ching-Chu Lo, Chung-Feng Huang, Pin-Nan Cheng, Kuo-Chih Tseng, Chi-Yi Chen, Hsing-Tao Kuo, 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, Chun-Ting Chen, 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, Lein-Ray Mo, Sheng-Shun Yang, Wen-Chih Wu, Chia-Sheng Huang, Chou-Kwok Hsiung, Chien-Neng Kao, Pei-Chien Tsai, Chen-Hua Liu, Mei-Hsuan Lee, Chun-Jen Liu, Chia-Yen Dai, Wan-Long Chuang, Han-Chieh Lin, Jia-Horng Kao, Ming-Lung Yu, and TACR investigators.
• Division of Gastroenterology, Department of Internal Medicine, St. Martin De Porres Hospital, Chiayi, Taiwan; Chung-Jen Junior College of Nursing, Health Sciences and Management, Chiayi, Taiwan.
• J Formos Med Assoc. 2022 Aug 1; 121 (8): 1567-1578.

Background/PurposeThe Taiwan Association for the Study of the Liver (TASL) HCV Registry (TACR) is a nationwide registry of chronic hepatitis C patients in Taiwan. This study evaluated antiviral effectiveness of ledipasvir (LDV)/sofosbuvir (SOF) in patients in the TACR.MethodsPatients enrolled in TACR from 2017-2020 treated with LDV/SOF were eligible. The primary outcome was the proportion of patients with sustained virologic response 12 weeks after end of treatment (SVR12).Results5644 LDV/SOF ± ribavirin-treated patients were included (mean age: 61.4 years; 54.4% female). Dominant viral genotypes were GT1 (50.8%) and GT2 (39.3%). 1529 (27.1%) patients had liver cirrhosis, including 201 (3.6%) with liver decompensation; 686 (12.2%) had chronic kidney disease. SVR12 was achieved in 98.6% of the overall population and in 98.2% and 98.7% of patients with and without cirrhosis, respectively. SVR12 rates in patients with compensated cirrhosis treated with LDV/SOF without RBV were >98%, regardless of prior treatment experience. SVR12 was 98.6%, 98.4%, 100%, 100%, and 98.7% among those with GT1, GT2, GT4, GT5, and GT6 infections, respectively. Although patient numbers were relatively small, SVR12 rates of 100% were reported in patients infected with HCV GT2, GT5, and GT6 with decompensated cirrhosis and 98% in patients with severely compromised renal function. LDV/SOF adherence ≤60% (P < 0.001) was the most important factor associated with treatment failure. Incidence of adverse events was 15.8%, with fatigue being the most common.ConclusionLDV/SOF is effective and well tolerated in routine clinical practice in Taiwan. Cure rates were high across patient populations.Copyright © 2022 Formosan Medical Association. Published by Elsevier B.V. All rights reserved.

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