In:
Hepatology International, Springer Science and Business Media LLC, Vol. 18, No. 2 ( 2024-04), p. 461-475
Abstract:
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. Graphical Abstract
Type of Medium:
Online Resource
ISSN:
1936-0533
,
1936-0541
DOI:
10.1007/s12072-023-10609-7
Language:
English
Publisher:
Springer Science and Business Media LLC
Publication Date:
2024
detail.hit.zdb_id:
2393254-5
detail.hit.zdb_id:
2270316-0
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