The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
OCT 29 2026
UPCOMING · 148 DAYS TO PDUFA

Gilead Sciences bictegravir/lenacapavir $GILD

for HIV-1 infection (treatment)

NDA · Priority Review

Accepted APR 29 2026.

About

HIV-1 is a virus that attacks the immune system, weakening the body’s ability to fight infections and leading to chronic illness if untreated. Bictegravir/lenacapavir combines two drugs: bictegravir blocks a key enzyme HIV uses to replicate its genetic material, while lenacapavir disrupts the virus’s protective protein shell. Together, they may offer a simplified treatment option that targets HIV at multiple stages of its lifecycle, potentially helping patients maintain viral suppression with fewer doses.

Pivotal trial

ISLEND-1 Phase 3 active not recruiting NCT06630286

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening. The primary objective is to evaluate the efficacy of switching to oral weekly ISL/...

Source: ClinicalTrials.gov

Also in development