An algorithm for simplified hepatitis C virus treatment with non-specialist care based on nation-wide data from Taiwan

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2024年1月21日

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

摘要

Background

Both European Association for the Study of the Liver (EASL) and American Association for the Study of Liver Diseases and the Infectious Diseases Society of America (AASLD-IDSA) guidelines recommend simplified hepatitis C virus (HCV) treatment with pan-genotypic sofosbuvir/velpatasvir or glecaprevir/pibrentasvir for eligible patients. This observational study used real-world data to assess these regimens’ safety in eligible patients and develop an algorithm to identify patients suitable for simplified treatment by non-specialists.

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.

Graphical Abstract