SURVEYOR-II Part 2

SURVEYOR-II study - Part 2: glecaprevir + pibrentasvir in genotypes 2 or 3 – Phase II

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

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
2
3
Treatment history
Naive
IFN-Experienced
Cirrhosis
Yes
No

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Design

Objective

  • SVR12 (HCV RNA < 25 IU /ml), by ITT

Baseline characteristics

SVR12 (HCV RNA < 25 IU /ml), ITT


*, ** : SVR 12 = 100% by ITTm , excluding non virologic failure
* 1 patient was lost to follow-up after W6 with undetectable RNA at that visit
** 1 patient withdrew consent at W6 with undetectable RNA at that visit

Resistance analysis (population sequencing with 15% threshold)

  • Baseline RAVs
    • 58% of genotype 2 : NS3 only in 13% , NS5A only in 38%, NS3 + NS5A in 6%
    • 46% of genotype 3 without cirrhosis, 38% of genotype 3 with cirrhosis
  • No impact on SVR12

Adverse events and laboratory abnormalities , 8 weeks of GLE + PIB, %

Summary

  • Very high SVR rates were achieved in HCV after 8 weeks of GLE 300 mg + PIB 120 mg qd
    • In genotype 2 naïve or experienced and genotype 3 naïve patients without cirrhosis
    • By ITTm, all patients achieved SVR12
    • No impact on efficacy of baseline NS3 and/or NS5A RASs
  • 92% SVR12 with 12 weeks once-daily GLE 120 mg + PIB 120 mg in treatment-experienced genotype 3-infected patients without cirrhosis
  • Adverse events were mostly mild in severity