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BROWSE SLIDES

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