SURVEYOR-II Part 2

SURVEYOR-II study - Part 2: ABT-493 + ABT-530 in genotypes 2 or 3 – Phase II

Poordad F. EASL 2016, Abs. SAT-157, J Hepatol 2016; 64:S768, Muir AJ. EASL 2016, Abs. PS098, J Hepatol 2016; 64:S186, Kwo PY. EASL 2016, Abs. LB01, J Hepatol 2016; 64:S208

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

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Design


* Metavir > 3 or Ishak > 4, or Fibroscan = 14.6 kPa, or FibroTest = 0.75 + APRI > 2, and Child- Pugh = 6

Objective

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

Baseline characteristics, patients without cirrhosis

Baseline characteristics, patients with genotype 3 and cirrhosis

SRV12 (HCV RNA < 25 IU /ml)


*, ** : SVR12 = 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, %

Summary

  • High SVR rates were achieved in HCV genotype 2 and genotype 3-infected patients without cirrhosis after 8 weeks of ABT-493 + ABT-530
    • By ITTm, all patients achieved SVR12
    • No impact on efficacy of baseline NS3 and/or NS5A RAVs
  • 100% SVR12 with 12 weeks once-daily ABT-493 and ABT-530 in treatment-naïve genotype 3-infected patients with compensated cirrhosis regardless of RBV coadministration
  • Adverse events were mostly mild in severity