Real-world efficacy and safety of universal 8-week glecaprevir/pibrentasvir in patients with chronic hepatitis C with early chronic kidney disease or pre-end-stage renal disease: Insights from a nationwide hepatisis C virus registry in Taiwan.
Journal
The Kaohsiung journal of medical sciences
Journal Volume
41
Journal Issue
2
Start Page
Article number e12929
ISSN
2410-8650
Date Issued
2025-02
Author(s)
Wang, Szu-Jen
Huang, Chung-Feng
Chang, Te-Sheng
Lo, Ching-Chu
Hung, Chao-Hung
Huang, Chien-Wei
Chong, Lee-Won
Cheng, Pin-Nan
Yeh, Ming-Lun
Peng, Cheng-Yuan
Cheng, Chien-Yu
Huang, Jee-Fu
Bair, Ming-Jong
Lin, Chih-Lang
Yang, Chi-Chieh
Kuo, Hsing-Tao
Hsieh, Tsai-Yuan
Lee, Tzong-Hsi
Lee, Pei-Lun
Wu, Wen-Chih
Lin, Chih-Lin
Su, Wei-Wen
Yang, Sheng-Shun
Wang, Chia-Chi
Hu, Jui-Ting
Mo, Lein-Ray
Chen, Chun-Ting
Huang, Yi-Hsiang
Chang, Chun-Chao
Huang, Chia-Sheng
Chen, Guei-Ying
Kao, Chien-Neng
Tai, Chi-Ming
Lee, Mei-Hsuan
Tsai, Pei-Chien
Dai, Chia-Yen
Lin, Han-Chieh
Chuang, Wang-Long
Tseng, Kuo-Chih
Chen, Chi-Yi
Wang, Shu-Chi
Yu, Ming-Lung
Abstract
An 8-week regimen of glecaprevir/pibrentasvir is recommended for treatment-naïve patients with chronic hepatitis C (CHC). In alignment with the Taiwanese government's objective to eliminate hepatitis C by 2025, this study aimed to provide real-world evidence on the use of this regimen in treatment-naïve patients with chronic kidney disease (CKD) by using data from the Taiwan Association for the Study of the Liver HCV Registry (TACR). CKD was defined by an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m or higher with proteinuria persisting for over 3 months. Patients were categorized as having early CKD (eGFR ≥45 mL/min/1.73 m) or pre-end-stage renal disease (pre-ESRD) (eGFR <45 mL/min/1.73 m). Among 1072 patients who received at least one dose of the regimen, 1054 had available data for assessing sustained virologic response at 12 weeks posttreatment (SVR12). The overall SVR12 rate was 99.6%, with rates of 99.7% for pre-ESRD patients and 99.6% for early CKD patients. Subgroup analysis showed 100% efficacy for genotype 3 and dyslipidemia, 99.5% for diabetes, 99.4% for cardiovascular disease, 96.9% for a history of cerebral vascular accident, and 95.5% for patients with a history of drug injection or HIV co-infection. Adverse events were reported in 16.8% of patients, with 0.8% experiencing serious events, and only two cases were treatment-related. Renal function significantly improved, with overall eGFR increasing from 39.2 to 41.9 mL/min/1.73 m. Early CKD patients showed an eGFR rise from 53.5 to 57.1, while pre-ESRD patients improved from 27.1 to 29.2 at SVR12. The study concluded that the 8-week regimen is highly effective, well-tolerated, and associated with significant renal function improvement in treatment-naïve CHC patients with both early CKD and pre-ESRD.
Subjects
chronic hepatitis C (CHC)
chronic kidney disease (CKD)
direct‐acting antivirals (DAA)
end‐stage renal disease (ESRD)
real‐world
SDGs
Type
journal article