Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection

Research output: Contribution to journalArticle

Authors

  • Nancy Reau
  • Paul Y Kwo
  • Susan Rhee
  • Robert S Brown
  • Kosh Agarwal
  • Peter Angus
  • Edward Gane
  • Jia-Horng Kao
  • Parvez S Mantry
  • K Rajender Reddy
  • Tram T Tran
  • Yiran B Hu
  • Abhishek Gulati
  • Preethi Krishnan
  • Emily O Dumas
  • Ariel Porcalla
  • Nancy S Shulman
  • Wei Liu
  • Suvajit Samanta
  • Roger Trinh
  • Xavier Forns

Colleges, School and Institutes

External organisations

  • Division of Pulmonary and Critical Care Medicine, Rush University Medical Center, Chicago, IL, USA
  • Histocompatibility, Immunogenetics & Disease Profiling Laboratory; Department of Pathology; Stanford University School of Medicine; Palo Alto CA USA
  • AbbVie Inc., North Chicago, IL, USA.
  • Weill Cornell Medical College, Center for Liver Disease and Transplantation, New York, NY, USA.
  • Institute of Liver Studies, King's College Hospital NHS Foundation Trust, London, UK.
  • RMIT University, Melbourne, Australia
  • New Zealand Liver Transplant Unit, Auckland City Hospital, Auckland, New Zealand.
  • National Taiwan University Hospital, Taipei, Taiwan.
  • The Liver Institute at Methodist Dallas, Dallas, TX, USA.
  • Academy of Natural Sciences of Drexel University; Philadelphia Pennsylvania USA
  • Cedars-Sinai Medical Center, Los Angeles, CA, USA.
  • Liver Unit, Hospital Clinic, CIBEREHD, IDIBAPS, University of Barcelona, Barcelona, Spain.

Abstract

Well-tolerated, ribavirin-free, pangenotypic hepatitis C virus (HCV) treatments for transplant recipients remain a high priority. Once-daily glecaprevir/pibrentasvir demonstrates high rates of sustained virologic response for 12 weeks post-treatment (SVR12) across all major HCV genotypes (GT). This trial evaluated the safety and efficacy of glecaprevir/pibrentasvir for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. MAGELLAN-2 was a phase 3, open-label trial conducted in patients who were ≥3 months post-transplant. Patients without cirrhosis who were HCV treatment-naïve (GT1-6) or treatment-experienced (GT1, 2, 4-6; with interferon-based therapy with or without sofosbuvir, or sofosbuvir plus ribavirin) received glecaprevir/pibrentasvir (300/120 mg) once daily for 12 weeks. The primary endpoint compared the percentage of patients receiving glecaprevir/pibrentasvir with SVR12 to a historic SVR12 rate based on the standard of care. Safety of glecaprevir/pibrentasvir was assessed. In total, 80 liver and 20 kidney transplant patients participated in the trial. Most patients had no or minimal fibrosis (80% had fibrosis scores F0-F1) and were infected with HCV GT1 (57%) or GT3 (24%). The overall SVR12 was 98% (n/N=98/100; 95% confidence interval, 95.3%-100%), which exceeded the pre-specified historic standard of care SVR12 threshold of 94%. One patient experienced virologic failure. One patient discontinued because of an adverse event considered to be unrelated to treatment; this patient achieved SVR12. Adverse events were mostly mild in severity and laboratory abnormalities were infrequent.

CONCLUSION: Once-daily glecaprevir/pibrentasvir for 12 weeks is a well-tolerated and efficacious, ribavirin-free treatment for patients with chronic HCV GT1-6 infection who had received a liver or kidney transplant. ClinicalTrials.gov NCT02692703. This article is protected by copyright. All rights reserved.

Bibliographic note

Notification of acceptance received 16/03/2018

Details

Original languageEnglish
JournalHepatology
Early online date25 Jul 2018
Publication statusE-pub ahead of print - 25 Jul 2018

Keywords

  • Journal Article, Glecaprevir, Pibrentasvir