Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection and severe renal impairment.

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.

• Authors: Chen-Hua Liu, Sheng-Shun Yang, Cheng-Yuan Peng, Woan-Tyy Lin, Chun-Jen Liu, Tung-Hung Su, Tai-Chung Tseng, Pei-Jer Chen, Ding-Shinn Chen, Jia-Horng Kao
• Journal: Journal of viral hepatitis (J Viral Hepat) Vol. 27 Issue 6 Pg. 568-575 (06 2020) ISSN: 1365-2893 [Electronic] England
• PMID: 31981264 (Publication Type: Journal Article)
• Copyright: © 2020 John Wiley & Sons Ltd.

Chemical References

• Aminoisobutyric Acids
• Antiviral Agents
• Benzimidazoles
• Cyclopropanes
• Lactams, Macrocyclic
• Pyrrolidines
• Quinoxalines
• Sulfonamides
• pibrentasvir
• Proline
• Leucine
• glecaprevir

Topics

• Aminoisobutyric Acids (therapeutic use)
• Antiviral Agents (therapeutic use)
• Benzimidazoles (therapeutic use)
• Cyclopropanes (therapeutic use)
• Genotype
• Hepacivirus
• Hepatitis C, Chronic (drug therapy)
• Humans
• Lactams, Macrocyclic (therapeutic use)
• Leucine (analogs & derivatives, therapeutic use)
• Proline (analogs & derivatives, therapeutic use)
• Pyrrolidines (therapeutic use)
• Quinoxalines (therapeutic use)
• Renal Insufficiency, Chronic (complications)
• Retrospective Studies
• Sulfonamides (therapeutic use)
• Sustained Virologic Response
• Taiwan