An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan.
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Yu Ming-Lung, Tai Chi-Ming, Mo Lein-Ray, Kuo Hsing-Tao, Huang Chung-Feng, Tseng Kuo-Chih, Lo Ching-Chu, Bair Ming-Jong, Wang Szu-Jen, Huang Jee-Fu, Yeh Ming-Lun, Chen Chun-Ting, Tsai Ming-Chang, Huang Chien-Wei, Lee Pei-Lun, Yang Tzeng-Hue, Huang Yi-Hsiang, Chong Lee-Won, Chen Chien-Lin, Yang Chi-Chieh, Hung Chao-Hung, Yang Sheng-Shun, Cheng Pin-Nan, Hsieh Tsai-Yuan, Hu Jui-Ting, Wu Wen-Chih, Cheng Chien-Yu, Chen Guei-Ying, Zhou Guo-Xiong, Tsai Wei-Lun, Kao Chien-Neng, Lin Chih-Lang, Wang Chia-Chi, Lin Ta-Ya, Lin Chih-Lin, Su Wei-Wen, Lee Tzong-Hsi, Chang Te-Sheng, Liu Chun-Jen, Dai Chia-Yen, Chen Chi-Yi, Kao Jia-Horng, Lin Han-Chieh, Chuang Wan-Long, Peng Cheng-Yuan
Аннотация
METHODS: 7,677 HCV-infected patients from Taiwan Hepatitis C Registry (TACR) who received at least one dose of sofosbuvir/velpatasvir or glecaprevir/pibrentasvir, and fulfilled the EASL/AASLD-IDSA criteria for simplified treatment were analyzed. Multivariate analysis was conducted on patient characteristics and safety data.
RESULTS: Overall, 92.8% (7,128/7,677) of patients achieved sustained virological response and only 1.9% (146/7,677) experienced Grades 2-4 laboratory abnormalities in key liver function parameters (alanine aminotransferase, aspartate aminotransferase, and total bilirubin), with only 18 patients (0.23%) experiencing Grades 3-4 abnormalities. Age > 70 years old, presence of hepatocellular carcinoma, total bilirubin > 1.2 mg/dL, estimated glomerular filtration rate < 60 mL/min/1.73 m2, and Fibrosis-4 > 3.25 were associated with higher risks of Grades 2-4 abnormalities. Patients with any of these had an odds of 4.53 times than that of those without in developing Grades 2-4 abnormalities (p < 0.01).
CONCLUSIONS: Real-world data from Taiwan confirmed that simplified HCV treatment for eligible patients with pan-genotypic regimens is effective and well tolerated. The TACR algorithm, developed based on this study's results, can further identify patients who can be safely managed by non-specialist care.