MAGELLAN-1 Study, Part 2

MAGELLAN-I Study, Part 2 : Glecaprevir, pibrentasvir, genotype 1, genotype 4, NS3-experienced, NS5A-experienced, cirrhosis, no cirrhosis

Poordad F, Hepatology 2017, Nov 20 (Epub) & Pilot-Matias T, EASL 2017, Abs. SAT-204

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
4
Treatment history
PI (NS3)-experienced
NS5A experienced
Cirrhosis
Yes
No

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Design

  • GLE/PIB: 100/40 mg 3 tablets QD

Objective

  • SVR12 (HCV RNA< 25 IU /ml), with 2-sides 95% CI, by ITT

Baseline characteristics

SVR12 according to prior DAA class use, % (95% CI)

SVR12 by NS3 and NS5A RASs at baseline, % (95% CI)

  • 13 patients with baseline Y93H/N NS5A RASs : 13/13 achieved SVR12

9 virologic failures : 4 relapses (R) and 5 virologic breakthroughs (B)

Adverse events and laboratory abnormalities, %

Summary

  • In patients with prior PI failure and NS5A inhibitor-naïve, SVR12 of 100% after 12 or 16 weeks of glecaprevir / pibrentasvir
  • In patients with prior failure to both PI and NS5A inhibitor, lower SVR12 were achieved
  • In patients with with prior failure to NS5A inhibitor, SVR12 was 94% with 16 weeks of GLE/PIB, with no relapse
  • Good tolerability, with no treatment-related serious adverse event –
  • No grade 3 or 4 laboratory abnormalities
  • No discontinuation due to adverse events