Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Academic Article uri icon

Overview

abstract

  • UNLABELLED: 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 at 12 weeks posttreatment (SVR12) across all major HCV genotypes (GTs). 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 posttransplant. Patients without cirrhosis who were HCV treatment-naive (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 transplant 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 prespecified 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 have received a liver or kidney transplant. (ClinicalTrials.gov NCT02692703.) (Hepatology 2018; 00:000-000).

authors

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

publication date

  • July 25, 2018

Research

keywords

  • Benzimidazoles
  • Hepatitis C, Chronic
  • Kidney Transplantation
  • Liver Transplantation
  • Quinoxalines
  • Sulfonamides

Identity

PubMed Central ID

  • PMC6220874

Scopus Document Identifier

  • 85054321603

Digital Object Identifier (DOI)

  • 10.1002/hep.30046

PubMed ID

  • 29672891

Additional Document Info

volume

  • 68

issue

  • 4