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Gilead’s BIC/LEN HIV Tablet Matches Biktarvy in Phase 3 Switch Trial

Gilead plans regulatory filings based on ARTISTRY data following noninferiority of its BIC/LEN tablet.

Overview

  • Topline ARTISTRY-2 results show switching virologically suppressed adults from Biktarvy to once‑daily BIC/LEN maintained viral suppression at Week 48, meeting the primary noninferiority endpoint.
  • The primary measure was the proportion of participants with HIV-1 RNA at or above 50 copies per milliliter at Week 48 in a randomized, double‑blind study.
  • Participants were assigned in a 2:1 ratio to switch to BIC/LEN or remain on Biktarvy, supporting evaluation of a single‑tablet maintenance option.
  • Investigators reported the regimen was generally well tolerated with no new or significant safety concerns identified in the trial.
  • Gilead will combine ARTISTRY-2 with prior ARTISTRY-1 data for presentations at a scientific congress and for regulatory submissions, and the fixed‑dose BIC/LEN remains investigational.