OCT 29 2026
Gilead Sciences — bictegravir/lenacapavir $GILD
for HIV-1 infection (treatment)
Accepted APR 29 2026.
About
HIV-1 is a virus that attacks the body's immune system and, without treatment, can lead to life-threatening infections and cancers. The combination drug bictegravir/lenacapavir delivers two medicines that block the virus at different stages: bictegravir stops HIV from inserting its genetic material into human cells, while lenacapavir interferes with the virus's protective shell. Using two distinct mechanisms together may provide a durable way to control the virus and maintain a suppressed state.
Pivotal trial
The goal of this clinical study is to learn more about the effects of switching to the study drugs, bictegravir (BIC)/lenacapavir (LEN), fixed-dose combination (FDC) versus current therapy bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) FDC in people living with HIV-1 (PWH). The primary objective of this study is to learn how effective it is to switch to BIC/LEN FDC tablets versus continuing on B/F/TAF FDC tablets in virologically suppressed PWH.
Source: ClinicalTrials.gov
Also in development
Drug Watch — recent news on bictegravir/lenacapavir
- Bictegravir/Lenacapavir Single-Tablet HIV Regimen Under FDA Review - Infectious Disease Advisor
- TheBodyPro: Can two-drug therapy benefit older, HIV treatment-experienced patients? The promise of bictegravir/lenacapavir - European AIDS Treatment Group
- [CROI 2026] aidsmap: Bictegravir/lenacapavir combination pill could be an option for people taking complex regimens - European AIDS Treatment Group
- Bictegravir/lenacapavir combination pill could be an option for people taking complex regimens - Aidsmap
- Bictegravir/Lenacapavir Combo Pill Could Replace Complex HIV Treatment - POZ