SURVEYOR-II – Part 2 in cirrhosis

SURVEYOR-II study – Part 2 in cirrhosis: Glecaprevir + Pibrentasvir in genotypes 1 or 3

Gane E. Gastroenterology 2016;151:651-9

Anti-HCV
Glecaprevir (ABT-493)
Pibrentasvir (ABT-530)
Genotype
1
3
Treatment history
Naive
Cirrhosis
Yes

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Design


* Metavir > 3 or Ishak > 4 or Fibroscan = 14.6 kPa or FibroTest = 0.75 + APRI > 2
** Randomisation stratified by treatment history (naive or PEG-IFN + RBV experienced)
*** Treatment extended to 16 weeks in 4 PEG-IFN + RBV experienced patients

Objective

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

Baseline characteristics

SVR12 (HCV RNA < 25 IU/ml), % (95% CI)

Relapses

Resistance analysis (population sequencing with 15% threshold)

  • SVR12 was achieved in 100% of patients without baseline substitutions and efficacy remained high in the presence of baseline substitutions
  • All 11 genotype 3-infected patients with baseline NS5A substitutions, including 4 patients with additional NS3 substitutions, achieved SVR12

Adverse events and laboratory abnormalities, %

Summary

  • In this phase 2 study, the once-daily combination of Glecaprevir and Pibrentasvir for 12 weeks is sufficient to achieve high rates of SVR12 in patients with genotype 1 or genotype 3 infection and compensated cirrhosis
  • Adverse events were mostly mild in severity
  • Potential for a pangenotypic therapy without RBV co-administration