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

Ming Lung Yu, Chi‐Ming ‐M 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 YangChao Hung Hung, Sheng‐Shun ‐S 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 ‐L 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*

*Corresponding author for this work

Research output: Contribution to journalJournal Article peer-review

Abstract

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 m 2, 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.

Original languageEnglish
Pages (from-to)461-475
Number of pages15
JournalHepatology International
Volume18
Issue number2
DOIs
StatePublished - 04 2024
Externally publishedYes

Bibliographical note

© 2024. The Author(s).

Keywords

  • American Association for the Study of Liver Diseases and the Infectious Diseases Society of America
  • Direct-acting antivirals
  • European Association for the Study of the Liver
  • Laboratory abnormalities
  • Liver function
  • Safety
  • Simplified treatment
  • Taiwan hepatitis C registry
  • glecaprevir/pibrentasvir
  • sofosbuvir/velpatasvir
  • Benzimidazoles
  • Humans
  • Bilirubin
  • Quinoxalines/therapeutic use
  • Heterocyclic Compounds, 4 or More Rings
  • Lactams, Macrocyclic
  • Liver Neoplasms/drug therapy
  • Hepatitis C, Chronic/complications
  • Proline/analogs & derivatives
  • Leucine/analogs & derivatives
  • Hepacivirus/genetics
  • Cyclopropanes
  • Genotype
  • Antiviral Agents
  • Benzopyrans
  • Taiwan/epidemiology
  • Aminoisobutyric Acids
  • Hepatitis C/drug therapy
  • Sulfonamides
  • Sofosbuvir/therapeutic use
  • Carbamates
  • Aged

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