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Efficacy and safety of glecaprevir/pibrentasvir in renally impaired patients with chronic HCV infection

 Eric Lawitz  ;  Robert Flisiak  ;  Manal Abunimeh  ;  Meghan E Sise  ;  Jun Y Park  ;  Marwan Kaskas  ;  Annette Bruchfeld  ;  Marcus-Alexander Wörns  ;  Andrea Aglitti  ;  Philippe J Zamor  ;  Zhenyi Xue  ;  Gretja Schnell  ;  Yash J Jalundhwala  ;  Ariel Porcalla  ;  Federico J Mensa  ;  Marcello Persico 
 LIVER INTERNATIONAL, Vol.40(5) : 1032-1041, 2020-05 
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chronic kidney disease ; cirrhosis ; direct-acting antiviral ; hepatitis C virus ; pangenotypic
Background and aims: Chronic hepatitis C virus (HCV) infection increases the risk of incident chronic kidney disease (CKD) and progression to end-stage renal disease (ESRD). Previously available direct-acting antiviral regimens are not approved for patients with advanced CKD across all HCV genotypes. Methods: EXPEDITION-5 is a phase 3 study to evaluate efficacy and safety of the fixed-dose combination of glecaprevir and pibrentasvir (G/P) for chronic HCV infection (genotype 1 through 6) in adults without cirrhosis or with compensated cirrhosis and with stage 3b, 4 or 5 CKD. Patients received approved duration of G/P according to HCV genotype, cirrhosis status and prior HCV treatment experience. The primary efficacy endpoint was percentage of patients with sustained virologic response at 12 weeks post-treatment (SVR12). Results: Among the 101 patients enrolled in the study, 24% had predialysis CKD and 76% were on dialysis. Eighty-four patients were treated with G/P for 8 weeks, 13 patients for 12 weeks and four patients for 16 weeks. Fifty-five per cent of patients had genotype 1, 27% had genotype 2, 15% had genotype 3 and 4% had genotype 4, and none had genotype 5 or 6 infection. The SVR12 rate was 97% (98/101, 95% confidence interval, 91.6-99.0). No patients experienced virologic failure. Adverse events (AEs) reported in at least 5% of the patients were pruritus, bronchitis, hypertension and generalized pruritus. Serious AEs were reported in 12% of patients; none related to study drug. Conclusions: G/P treatment yielded high SVR12 rates irrespective of the presence of stage 3b, 4 or 5 CKD. No safety signals were detected. CLINICALTRIALS. Gov identifier: This Phase 3 clinical trial was funded by AbbVie and registered with clinicaltrials.gov as NCT03069365 (EXPEDITION-5).
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
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