학술논문
Sofosbuvir/Ledipasvir in the Treatment of Chronic Hepatitis C - A Subgroup Analysis from A Nationwide Real-World HCV Registry Program (TACR) in Taiwan
Document Type
Article
Author
Ming-Lung Yu; Chi-Yi Chen; Kuo-Chih Tseng; Ching-Chu Lo; Pin-Nan Cheng; Cheng-Yuan Peng; Ming-Jong Bair; Chih-Lang Lin; Chi-Ming Tai; Chi-Chieh Yang; Chih-Wen Lin; Chun-Yen Lin; Chia-Chi Wang; Wei-Wen Su; Lee-Won Chong; Pei-Lun Lee; Tsai-yuan Hsieh; Chih-Lin Lin; Chun-Chao Chang; Chun-Ting Chen; Chao-Hung Hung; Wei-Lun Tsai; Guei-Ying Chen; Szu-Jen Wang; Chia-Sheng Huang; Kwok-Hsiung Chou; Cheng-Hsin Chu; Chien-Hung Chen; Tzong-Hsi Lee; Lein-Ray Mo; Yi-Hsiang Huang; Yung-Fa Chen; Chen-Hua Liu; Sheng-Shun Yang; Jui-Ting Hu; Chi-Tan Hu; Hsing-Tao Kuo; Chun-Che Lin; Jian-Neng Gao; Shih-Jer Hsu; Jain-Yu Cheng; Pei-Chien Tsai; Mei-Hsuan Lee; Chung-Feng Huang; Chun-Jen Liu; Chia-Yen Dai; Rong-Nan Chien; Jia-Horng Kao
Source
춘·추계 학술대회(The Liver Week). Aug 13, 2020 2020(1):132
Subject
Language
Korean
Abstract
Aims: TASL HCV Registry (TACR) is a nationwide registry program organized and supervised by Taiwan Association for the Study of the Liver (TASL), which aims to setup the database and biobank of patients with chronic hepatitis C (CHC) in Taiwan. The present study aimed to evaluate the treatment outcome of sofosbuvir (SOF)/ledipasvir (LDV) in Taiwanese CHC patients in TACR. Methods: By May 2020, 19 tertiary hospitals, 23 community hospitals and one primary care clinic join the TACR program. The baseline characteristics, prior liver and non-liver related medical history, DAA regimens, laboratory results, treatment course and outcome were recorded. The primary objective was sustained virological response, defined as undetectable HCV RNA 3 months after end-of-treatment (SVR12). Results: A total of 4742 SOF/LDV+ ribavirin treated CHC patients with available SVR12 data from 39 sites were enrolled in the current analysis. The mean age was 61.3 years, and female accounted for 54.8% of the population. The dominant viral genotypes were GT1b (52.6%) and GT2 (35.6%). 1354 (28.6%) patients had liver cirrhosis, including 156 (3.3%) with liver decompensation, 552 (11.6%) had preexisting hepatocellular carcinoma (HCC) before DAAs treatment and 413 (8.7%) had hepatitis B virus dual infections. The overall SVR12 rate was 98.5%, with 98.5%, 98.2%, 99.7% and 98.6% in treatment- naïve non-cirrhotics, treatment-naïve cirrhotics, treatment- experienced non-cirrhotics and treatment-experienced cirrhotics patients, respectively. While patients were stratified by HCV genotype, the SVR12 was 98.5%, 98.4% and 98.5% among those with GT1, GT2 and GT6 infection, respectively. The strongest factor independent associated with treatment failure was DAA adherence < 60% (odds ratio [OR]/95% confidence intervals [CI]: 125.4/25.7-612.4, P<0.0001), followed by active HCC (OR/CI: 6.20/2.57-14.97, P<0.0001), HIV co-infection (OR/CI: 3.01/1.14-7.92, P=0.026), and male gender (OR/ CI: 1.85/1.09-3.13, P=0.023). The eGFR decreased significantly at the end of treatment (EOT) (89.3 ml/min/1.73㎡ vs. 93.2 ml/min/1.73㎡, P< 0.001) and remained stable 3 months after EOT (89.3 ml/min/1.73㎡). However, the decreased eGFR was observed only in patients whose baseline eGFR > 90 ml/ min/1.73㎡. Instead, patients with chronic kidney diseases whose pretreatment eGFR < 60 ml/min/1.73㎡ had improved eGFR after SOF/LDV. Conclusions: SOF/LDV is highly effective in treating CHC patients in real-world setting of Taiwan. The satisfactory result could be explicitly generalized to patients with different viral genotypes and liver disease severities.