SURVEYOR 2 - Part 3

SURVEYOR-II study – Part 3: glecaprevir/pibrentasvir ± RBV in genotype 3 with treatment experience and/or cirrhosis

Wyles D. AASLD 2016, Abs. 113

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
3
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
Yes
No

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Design

  • GLE/PIB: 100/40 mg 3 tablets QD

Objective

  • SVR12 (HCV RNA < 25 IU/ml)

Baseline characteristics

SVR12

Virologic failures


* RAVs detected by next-generation sequencing at 15% threshold :
? NS3 : 36, 43, 54, 55, 56, 80, 155, 156, 166, and 168
? NS5A : 24, 28, 29, 30, 31, 32, 58, 92, and 93

Adverse events and laboratory abnormalities


* Umbilical hernia, colon cancer, pleural effusion, squamous cell carcinoma of the skin, schizophrenia, angina pectoris

Summary

  • High efficacy with GLE/PIB in patients with HCV genotype 3 infection with compensated cirrhosis and/or prior treatment experience
    • SVR12 rates of 98% and 96% in treatment-naïve and treatment-experienced patients with cirrhosis following 12 and 16 weeks of the QD combination, respectively
    • SVR12 rate of 96% in treatment-experienced patients without cirrhosis following 16 weeks of treatment, or 91% after 12 weeks
  • GLE/PIB was well tolerated
    • with mostly mild adverse events
    • no drug related-related serious adverse event
    • few occurrences of grade 3 or higher laboratory abnormalities
    • and no study drug discontinuation