MAGELLAN-2

MAGELLAN-2 Study: glecaprevir/pibrentasvir in liver or kidney transplanted patients

Reau N. EASL 2017, Abs. LBO-03

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
2
3
Treatment history
Naive
IFN-Experienced
Cirrhosis
No
Special population
Liver transplantation
Kidney transplantation

DOWNLOAD THIS SLIDE KIT

BROWSE SLIDES

Design

  • GLE/PIB: 100/40 mg 3 tablets QD
  • Patients enrolled in Australia, Canada, Italy, New Zealand, Puerto Rico, Spain, Taiwan, the United Kingdom and the United States

Objective

  • Primary endpoint: SVR12 ( HCV < 15 IU/mL)
  • Non-inferiority to historical 94% SVR 12 standard-of-care rate, achieved if > 86% (8% margin)

Baseline characteristics

SVR12, %

Adverse events and laboratory abnormalities, N (%)


* 2 related to study drugs : sinusitis (Day 2), abnormal hepatic function (post-treatment week 4)

  • One patient experienced mild liver transplant rejection, unrelated to study drugs

Summary

  • Glecaprevir/pibrentasvir for 12 weeks achieved a 99% SVR12 rate in patients with liver or kidney transplant and genotype 1-6
  • This rate was not inferior to historical standard of care
  • Treatment was well-tolerated