Bictegravir 75 mg + lenacapavir 50 mg
Maintenance treatment of HIV-1 infection · Adults with HIV-1 who are virologically suppressed
GILD · Gilead Sciences
Regulatory designations
Full timeline
4 milestonesFDA decision expected
PDUFA action date for the once-daily bictegravir and lenacapavir single-tablet regimen NDA.
Gilead — NDA acceptance and August 27 action date↗FDA accepted the NDA with Priority Review
FDA accepted the application for adults with HIV who are virologically suppressed and assigned the August 27 action date.
Gilead — FDA Priority Review for BIC/LEN↗ARTISTRY-1 and ARTISTRY-2 Week 48 results presented
At CROI 2026, both Phase 3 studies showed that switching to BIC/LEN maintained virologic suppression with efficacy comparable to the control regimens and no significant new safety concerns.
Gilead — Phase 3 ARTISTRY-1 and ARTISTRY-2 results↗Phase 3 ARTISTRY-1 study started
The randomized switch study began evaluating once-daily bictegravir/lenacapavir in virologically suppressed adults receiving complex antiretroviral regimens.
ClinicalTrials.gov — ARTISTRY-1 study record (NCT05502341)↗Related News
No related news available.