Rush University Medical Center, Chicago, IL, USA.
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.
University of Melbourne, 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.
Queen Elizabeth Hospital and NIHR Liver Biomedical Research Unit, Birmingham, UK.
University of Pennsylvania, Philadelphia, PA, 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.
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.