Kidney Week

Abstract: SA-PO496

MAGELLAN-2: Glecaprevir/Pibrentasvir for 12 Weeks in Renal Transplant Patients With Chronic Hepatitis C Virus Genotypes 1–6

Session Information

• Transplantation: Balancing Rejection and Infection
  November 04, 2017 | Location: Hall H, Morial Convention Center
  Abstract Time: 10:00 AM - 10:00 AM

Category: Transplantation

• 1702 Transplantation: Clinical and Translational

Authors

• Reau, Nancy, Rush University Medical Center, Chicago, Illinois, United States

Nancy Reau,

• Kwo, Paul, Stanford University School of Medicine, Stanford, California, United States

Paul Kwo,

• Rhee, Susan, AbbVie Inc., North Chicago, Illinois, United States

Susan Rhee,

• Prieto, Martin, Hospital Universitario y Politécnico La Fe and CIBERehd, Valencia, Spain

Martin Prieto,

• Gane, Edward, University of Auckland, Auckland, New Zealand

Edward Gane,

• Mantry, Parvez, The Liver Institute at Methodist Dallas, Dallas, Texas, United States

Parvez Mantry,

• Gulati, Abhishek, AbbVie Inc., North Chicago, Illinois, United States

Abhishek Gulati,

• Krishnan, Preethi, AbbVie Inc., North Chicago, Illinois, United States

Preethi Krishnan,

• Dumas, Emily, AbbVie Inc., North Chicago, Illinois, United States

Emily Dumas,

• Shulman, Nancy, AbbVie Inc., North Chicago, Illinois, United States

Nancy Shulman,

• Forns, Xavier, Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, Barcelona, Spain

Xavier Forns,

Background

Chronic HCV infection is associated with poor long-term patient and allograft survival following renal transplant. Treatment is challenging and limited data exist on the use of IFN-free direct-acting antiviral (DAA) therapies in these patients. This study evaluated the safety and efficacy of glecaprevir/pibrentasvir (G/P) in renal transplant patients with chronic HCV infection.

Methods

MAGELLAN-2 was a Phase 3, single-arm, open-label trial. Renal transplant patients infected with chronic HCV genotypes (GT) 1–6, who were treatment-naïve or -experienced (IFN- or SOF-based) and non-cirrhotic, received 12 weeks of G/P 300/120 mg once daily. Safety data and the percentage of patients achieving sustained virologic response (HCV RNA <LLOQ) at post-treatment Week 12 (SVR12) were assessed.

Results

Overall, 20 patients were enrolled: the majority were male (55%), white (55%), and treatment-naïve (80%); 30% had HCV GT1a, 55% had GT1b, 10% had GT3, and 5% had GT4 infection; 90% had F0–F1 and 10% had F3 fibrosis. Most patients had a baseline eGFR <60 mL/min/1.73 m² (55%), and baseline immunosuppressants (IS) were cyclosporine (20%), tacrolimus (55%), or other (25%); adjustments in IS dosing were minor. SVR12 was 100%. AEs were mostly mild; fatigue, nausea, and upper respiratory tract infection were most common (20% each). One patient had decreased creatinine clearance (<30 mL/min) during treatment 2 days after the last G/P dose, which was not related to the DAA. There were no DAA-related serious AEs and no graft rejections.

Conclusion

G/P for 12 weeks is highly efficacious for renal transplant patients infected with chronic HCV GT1–6, with a 100% SVR12 rate. G/P was well tolerated, with no discontinuations.

Funding

• Commercial Support –