EXPEDITION-2

EXPEDITION-2 Study: glecaprevir/pibrentasvir in patients with HIV co-infection

Rockstroh J. EASL 2017, Abs. LB-522

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
2
3
4
Treatment history
Naive
IFN-Experienced
Cirrhosis
Yes
No
Special population
HIV co-infection

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Design

  • GLE/PIB: 100/40 mg 3 tablets QD

Objective

  • SVR12 (HCV RNA< 15 IU /ml)

Baseline characteristics and SVR12

One patient with Genotype 3a infection and cirrhosis had on-treatment virologic failure

  • At treatment W8
  • NS3 RASs
    • no polymorphisms at baseline
    • Y56H at failure
  • NS5A RASs
    • A30V at baseline
    • S24F + M28K at failure

HIV RNA suppression

  • No virologic breakthrough

Adverse events and laboratory abnormalities, %


* Cerebrovascular accident and hemorrhage, unrelated to treatment ; treatment discontinuation on D23

Summary

  • GLE/PIB (300 mg/120 mg QD) achieved a SVR of 98% in HCV infected patients with HIV infection,
    • After 8 weeks of therapy if no cirrhosis (SVR12 of 99.3%)
    • After 12 weeks of therapy if cirrhosis
  • SVR12 was not impacted by baseline HCV viral load or other baseline factors
  • GLE/PIB was well tolerated with a favorable safety profile in patients with or without cirrhosis
    • No drug-related serious adverse event
    • No grade = 3 laboratory abnormalities in ALT or AST