SURVEYOR-I Part 1

SURVEYOR-I Study - Part 1: glecaprevir + pibrentasvir in genotype 1 – Phase II

Kwo PY. J Hepatol 2017; 67 :263-71

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
Treatment history
Naive
IFN-Experienced
Cirrhosis
No

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Design

Objective

  • SVR12, (HCV RNA < LLOQ)

Baseline characteristics

SRV12, ITT (%)

All patients (58%) with baseline NS3 and/or NS5A RAVs achieved SVR12

1 relapse on GLE + PIB 40 mg: white male, 55 years, genotype 1a, IL28B CC, F0-F1, treatment-naïve, no RAVs at baseline, emergent NS5A RAVs at relapse (Q30K + H58D)

  • 100% (29/29) treatment-experienced patients achieved SVR12
  • 98% (49/50) treatment-naïve patients achieved SVR12

Adverse events and laboratory abnormalities

Summary

  • High SVR rates were achieved in HCV genotype 1-infected patients without cirrhosis after 12 weeks of GLE + PIB
    • All but one patient achieved SVR12
    • 1 relapse in a patient treated with the lowest PIB 40 mg dose
  • Adverse events were mostly mild in severity
  • Selected doses for future studies: GLE 300 mg qd + PIB 120 mg qd