Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection
Research output: Contribution to journal › Article
Colleges, School and Institutes
- 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.
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.
|Early online date||25 Jul 2018|
|Publication status||E-pub ahead of print - 25 Jul 2018|
- Journal Article, Glecaprevir, Pibrentasvir