SURVEYOR-II Part 1

SURVEYOR-II study - Part 1: ABT-493 + ABT-530 ± RBV in genotypes 2 or 3 – Phase II

Kwo P. AASLD 2015, Abs. 248 ; Wyles D. AASLD 2015, Abs. 250

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

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Design

  • RBV (bid dosing): 1000 or 1200 mg/day according to body weight (< or = 75 kg)

Objective

  • SVR12 (HCV RNA < LLOQ)

Baseline characteristics (genotype 3)

Baseline characteristics (genotype 2)

SRV12


* At baseline: no NS3 RAV, A30K NS5A RAV ; A t relapse: NS3 RAVs (Y56H + Q168R) and NS5A RAVs (A30K + Y93H)

SRV12


* Lost to follow-up after treatment W2
At baseline: N3 RAV in 1 patient, NS5A RAVs in 39 (31M in 36/39) ; no virologic failure

Adverse events and laboratory abnormalities (genotype 3)


* Abdominal pain and sensation of heat

Adverse events and laboratory abnormalities (genotype 2)


* Atrial fibrillation (not related)

Summary

  • High SVR12 rates were achieved in HCV genotype 3-infected patients without cirrhosis after 12 weeks of once daily ABT-493 + ABT-530
    • All but one patient achieved SVR12 with ABT- 493 300 mg + ABT- 530 120 mg
  • SVR12 of 100% in genotype 2 with the different regimens tested (1/75 patients lost to follow-up, no failure in the 74 others)
    • All patients with baseline NS3 or NS5A RAVs achieved SVR12
  • Adverse events were mostly mild in severity
    • 1 discontinuation for adverse event
  • Selected doses for future studies: ABT-493 300 mg qd + ABT-530 120 mg qd