HCV without cirrhosis: GLE + PIB highly effective across all genotypes

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  • Once-daily glecaprevir + pibrentasvir (GLE+PIB) is highly effective for clearing all HCV genotypes (GTs) in patients without cirrhosis, whether treatment-naïve or previously treated with peginterferon/ribavirin (PR).

Why this matters

  • Both components—a pangenotypic NS3/4A protease inhibitor and an NS5A inhibitor—are investigational.
  • Coformulated GLE/PIB 300/120 mg is under review by the US Food and Drug Administration.

Study design

  • Phase 2 open-label multicenter, multinational, dose-ranging trials (SURVEYOR-1 and 2) of 449 adults with HCV GT1 (25%), GT2 (29%), GT3 (39%), and GT4-6 (8%).
  • Each study had a GLE+PIB dose-optimization part ± ribavirin, and a duration-optimization part.
  • Primary endpoint was sustained virologic response at 12 wk posttherapy (SVR12).
  • Funding: AbbVie.
  • ...