SURVEYOR 2 - Part 4

SURVEYOR-II Study - Part 4: glecaprevir/pibrentasvir for 8 weeks in genotype 2, 4, 5 or 6

Hassanein TI. AASLD 2016, Abs. LB-15

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
2
4
6
Treatment history
Naive
IFN-Experienced
SOF-experienced
Cirrhosis
No

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Design


* Fibroscan® < 12.5 kPa or FibroTest® = 0.48 + APRI < 1

Objective

  • SVR12 (HCV RNA < 25 IU/ml)
  • Non-inferiority of SVR12 for genotype 2 if lower margin of the 2-sided 95% CI > 89% (comparison to historical control of 95% SVR12 rate)

Baseline characteristics and SVR12

Adverse events and laboratory abnormalities, %


* Cholecystitis (Day 30 of treatment) in 1 patient, urosepsis (post-treatment Day 15) in 1 patient, both assessed as not related to study drug

Summary

  • 97% of genotype 2, 4, 5, or 6-infected patients without cirrhosis achieved SVR12 following 8 weeks of GLE/PIB
    • In DAA-naïve patients with genotype 2, 8-weeks of GLE/PIB yielded a SVR12 rate of 99%, that was non-inferior to the historical 95% SVR12 rate achieved with 12 weeks of SOF + RBV
    • There were no virologic failures in patients with genotype 4, 5 or 6 infection
    • SVR12 was not impacted by baseline HCV RNA, genotype/subtype, F0-F3 fibrosis stage, baseline polymorphisms, and prior treatment experience with IFN/PEG-IFN- or SOF-based regime ns SVR rates were similar to those following 12-weeks with GLE/PIB
  • In patients with genotype 2 infection, 42% (53/126) had NS5A RAS 31M at baseline ; 96% (51/53) of these patients achieved SVR12
    • The 2 relapses occurred in treatment-experienced patients with genotype 2a and baseline NS5A RAS L31M, with no treatment-emergent RAS at failure
  • GLE/PIB for 8 weeks was well-tolerated, with no discontinuations due to adverse event, no drug-related serious adverse event, and rare grade 3 or higher laboratory abnormalities