MAGELLAN-1 Study, part 1

MAGELLAN-I Study, Part 1 : Glecaprevir+ Pibrentasvir in genotype 1 with failure to DAA regimen - Phase II

Poordad F. Hepatology 2017 (Epub ahead of print)

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
1a
Treatment history
PI-experienced
NS5A experienced
SOF-experienced
Cirrhosis
No

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Design


* Low dose arm halted (based on dose-findings results across all genotypes)
** Randomisation stratified by genotype (1b or non-1b) and prior treatment (NS5A inhibitor-experienced, NS3/4A PI-experienced but NS5A inhibitor-naive, or other)

Objective

  • SVR12 (HCV RNA< 25 IU /ml), by ITT

Baseline characteristics

Prior regimen

  • PI-experienced , NS5A naïve, n = 25; NS5A-experienced, PI-naïve, n = 8
  • PI and NS5A-experienced, n = 17
  • SOF-experienced, n = 16

2 virologic failures in genotype 1a

SRV12 (ITTm) according to baseline RAVs

Adverse events and laboratory abnormalities, %

Summary

  • High SVR12 rates after 12 weeks of Glecaprevir + Pibrentasvir with only 2 virologic failures in 50 DAA-experienced genotype 1 patients without cirrhosis
    • Baseline NS3 and/or NS5A RAVs did not impact SVR12 (most patients (≥80%) had at least 1 baseline polymorphism in NS3 or NS5A)
    • RBV did not increase SVR12 rate
  • Good tolerability, with mild adverse events
  • No grade 3 or 4 laboratory abnormalities
  • No discontinuation due to adverse events