Kidney Week

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

• Clinical Trials in CKD Tubulointerstitium
  November 02, 2017 | Location: Room 392, Morial Convention Center
  Abstract Time: 04:30 PM - 04:42 PM

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

Csaba P. Kovesdy,

• Dumas, Emily, AbbVie, Chicago, Illinois, United States

Emily Dumas,

• Thompson, Alexander, St. Vincent''s Hospital Melbourne and the University of Melbourne, Fitzroy, New South Wales, Australia

Alexander Thompson,

• Horsmans, Yves, Université Catholique De Louvain, Louvain-la-Neuve, Brussels, Belgium

Yves Horsmans,

• Reynaert, Hendrik, University Hospital UZBrussel, Brussels, Belgium

Hendrik Reynaert,

• Ghali, Peter, McGill University, Montreal, Quebec, Canada

Peter Ghali,

• Alric, Laurent, CHU Toulouse, Toulouse, France

Laurent Alric,

• Larrey, Dominique, Hôpital Saint Eloi CHRU Montpellier, Montpellier, France

Dominique Larrey,

• Rizzardini, Giuliano, Ospedale Luigi Sacco, Milan, Italy

Giuliano Rizzardini,

• Park, Caroline, AbbVie, Chicago, Illinois, United States

Caroline Park,

• Lei, Yang, AbbVie, Chicago, Illinois, United States

Yang Lei,

• Pugatch, David, AbbVie, Chicago, Illinois, United States

David Pugatch,

• Mensa, Federico, AbbVie, Chicago, Illinois, United States

Federico Mensa,

• Elkhashab, Magdy, Toronto Liver Centre, Toronto, Ontario, Canada

Magdy Elkhashab,

• Sise, Meghan E., Massachusetts General Hospital, Boston, Massachusetts, United States

Meghan E. Sise, MD, MS

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 –