Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection and severe renal impairment
Journal
Journal of Viral Hepatitis
Journal Volume
27
Journal Issue
6
Pages
568-575
Date Issued
2020
Author(s)
Yang S.-S.
Peng C.-Y.
Lin W.-T.
Abstract
Data are limited regarding the real-world effectiveness and safety of glecaprevir/pibrentasvir (GLE/PIB) in patients with chronic hepatitis C virus (HCV) infection and severe renal impairment (RI). We aimed to evaluate the performance of GLE/PIB in patients with chronic kidney disease (CKD) stage 4 or 5 in Taiwan. 108 chronic HCV patients with CKD stage 4 (n?=?32) or 5 (n?=?76) receiving GLE/PIB for 8-12?weeks were retrospectively recruited at 4 academic centres in Taiwan. The effectiveness was determined by sustained virologic response at off-therapy week 12 (SVR12) for evaluable (EP) and per-protocol populations (PP). The safety profiles were also assessed. By EP and PP analyses, the SVR12 rate was 99.1% (107 of 108 patients; 95% confidence interval (CI): 94.9%-99.8%) and 100% (107 of 107 patients; 95% CI: 96.5%-100%). The SVR12 rates were 100% (95% CI: 89.3%-100%) and 98.7% (95% CI: 92.9%-99.8%) in patients with CKD stage 4 and 5, respectively. One patient, who declined off-therapy follow-up after permanently discontinuing GLE/PIB at on-treatment week 9 due to scheduled cardiac surgery, had nonvirologic failure. Sixteen (14.8%) patients had serious adverse events (AEs), which were judged not related to GLE/PIB. The three most common AEs were pruritus (19.4%), fatigue (15.7%) and nausea (13.9%). None had ?3-fold upper limit of normal for total bilirubin and alanine aminotransferase levels. None of the 9 patients with hepatitis B virus (HBV) coinfection developed HBV-associated hepatitis. In conclusion, GLE/PIB for 8-12?weeks is effective and well-tolerated in HCV patients with severe RI. ? 2020 John Wiley & Sons Ltd
SDGs
Other Subjects
alanine aminotransferase; bilirubin; glecaprevir plus pibrentasvir; peginterferon; ribavirin; sofosbuvir; 2 amino 2 methylpropionic acid; antivirus agent; benzimidazole derivative; cyclopropane derivative; glecaprevir; leucine; macrocyclic lactam; pibrentasvir; proline; pyrrolidine derivative; quinoxaline derivative; sulfonamide; adult; aged; Article; chronic hepatitis C; chronic kidney failure; confidence interval; disease severity; drug efficacy; drug response; drug safety; drug tolerability; fatigue; female; follow up; headache; heart surgery; human; insomnia; major clinical study; male; mixed infection; nausea; priority journal; pruritus; retrospective study; Taiwan; very elderly; chronic kidney failure; complication; genotype; Hepacivirus; sustained virologic response; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Cyclopropanes; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Lactams, Macrocyclic; Leucine; Proline; Pyrrolidines; Quinoxalines; Renal Insufficiency, Chronic; Retrospective Studies; Sulfonamides; Sustained Virologic Response; Taiwan
Publisher
Blackwell Publishing Ltd
Type
journal article