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Abstract: TH-OR031

EXPEDITION-4: Efficacy and Safety of Glecaprevir/Pibrentasvir in Patients with Chronic Hepatitis C Genotype 1-6 Infection by Dialysis Status

Session Information

Category: Chronic Kidney Disease (Non-Dialysis)

  • 305 CKD: Clinical Trials and Tubulointerstitial Disorders

Authors

  • Kovesdy, Csaba P., University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Dumas, Emily, AbbVie, Chicago, Illinois, United States
  • Thompson, Alexander, St. Vincent''s Hospital Melbourne and the University of Melbourne, Fitzroy, New South Wales, Australia
  • Horsmans, Yves, Université Catholique De Louvain, Louvain-la-Neuve, Brussels, Belgium
  • Reynaert, Hendrik, University Hospital UZBrussel, Brussels, Belgium
  • Ghali, Peter, McGill University, Montreal, Quebec, Canada
  • Alric, Laurent, CHU Toulouse, Toulouse, France
  • Larrey, Dominique, Hôpital Saint Eloi CHRU Montpellier, Montpellier, France
  • Rizzardini, Giuliano, Ospedale Luigi Sacco, Milan, Italy
  • Park, Caroline, AbbVie, Chicago, Illinois, United States
  • Lei, Yang, AbbVie, Chicago, Illinois, United States
  • Pugatch, David, AbbVie, Chicago, Illinois, United States
  • Mensa, Federico, AbbVie, Chicago, Illinois, United States
  • Elkhashab, Magdy, Toronto Liver Centre, Toronto, Ontario, Canada
  • Sise, Meghan E., Massachusetts General Hospital, Boston, Massachusetts, United States
Background

Hepatitis C (HCV)-infected patients with late-stage kidney disease have limited treatment options. The ribavirin-free regimen of glecaprevir/pibrentasvir (coformulated as G/P; glecaprevir identified by AbbVie and Enanta) has a renal excretion <1% and has yielded sustained virologic response (SVR) >97% in clinical trials. Here we report efficacy and safety by dialysis status from a Phase 3 study of G/P in HCV genotype (GT) 1-6-infected patients.

Methods

HCV GT1-6 patients with an eGFR <30 mL/min/1.73 m2, without cirrhosis or with compensated cirrhosis, received G/P (300 mg/120 mg) once daily for 12 weeks. Outcomes were analyzed by predialysis (CKD stages 4-5) and dialysis status.

Results

The trial enrolled 104 patients (predialysis, 19; dialysis, 85): 76% were men, 58% treatment-naïve, 19% cirrhotic, and 52% GT1-infected. The overall SVR12 and SVR24 rates were 98% and 96%, respectively, without virologic failures. The rates of serious AEs were 26% (predialysis) and 24% (dialysis); none was considered G/P-related. In predialysis patients, mean ± SD change in creatinine clearance from baseline to Week 12 was -1.4 ± 3.6 mL/min (median: -1.0 mL/min).

Conclusion

G/P is an all-oral pangenotypic anti-HCV treatment with high efficacy and a favorable safety profile, regardless of patients’ dialysis status.

AbbVie sponsored the studies, contributed to their design, collection, analysis, and interpretation of the data, and participated in the writing, review, and approval of the abstract. All authors had access to relevant data. This abstract contains information on the investigational products glecaprevir (ABT-493) and pibrentasvir (ABT-530).

Medical writing support, was provided by Vojislav Pejovic of Medical Expressions, Chicago, IL, funded by AbbVie.

Funding

  • Commercial Support