The FDA approved Gilead Sciences (NASDAQ: GILD) Bixlenvo (bictegravir 75 mg / lenacapavir 50 mg, a once-daily single-tablet HIV regimen) on Thursday August 27, 2026 for adults with HIV-1 who are virologically suppressed on a stable antiretroviral regimen for at least 6 months and have no history of treatment failure or known resistance to bictegravir or lenacapavir. Approval was based on the Phase 3 ARTISTRY-1 and ARTISTRY-2 trials presented at CROI 2026, both of which met non-inferiority for virologic suppression at Week 48 with a tolerable safety profile. Lenacapavir is Gilead's first-in-class HIV-1 capsid inhibitor (already approved as long-acting subcutaneous Sunlenca), and Bixlenvo is the first oral single-tablet regimen anchored on capsid inhibition. Dosing requires a two-day initiation period with Sunlenca before switching to Bixlenvo alone. The approval extends the single-tablet regimen category to an estimated 5%+ of U.S. HIV-suppressed adults on complex multi-pill regimens who could not previously use one-tablet options.
Gilead Sciences (NASDAQ: GILD) and Merck (NYSE: MRK) presented detailed Phase 3 ISLEND-1 and ISLEND-2 Week 48 data during the late-breaking session at AIDS 2026 Wednesday July 29, 2026 in Rio de Janeiro. The investigational once-weekly oral single-tablet regimen of islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) demonstrated non-inferior efficacy versus daily standard-of-care antiretroviral therapy in virologically-suppressed adults living with HIV who switched from daily Biktarvy (ISLEND-1) or other daily oral regimens (ISLEND-2). Primary endpoint results: 0% of ISLEND-1 participants on once-weekly ISL/LEN had HIV-1 RNA at 50 copies/mL or higher at Week 48 compared to 0.3% remaining on daily Biktarvy; in the open-label ISLEND-2 trial, 0.3% of participants on ISL/LEN had HIV-1 RNA at 50 copies/mL or higher versus 1.3% on daily standard-of-care regimens. Safety profile was generally similar to comparator regimens with no new safety signals identified. The Week 48 data will support planned regulatory submissions for the first once-weekly oral HIV treatment regimen. Lenacapavir is Gilead's first-in-class HIV capsid inhibitor; islatravir is Merck's nucleoside reverse transcriptase translocation inhibitor (NRTTI).
The 26th International AIDS Conference (AIDS 2026) opens Sunday July 26, 2026 in Rio de Janeiro, Brazil and runs through Friday July 31. Two peptide-adjacent HIV modality readouts anchor the industry program. Gilead Sciences (NASDAQ: GILD) will present twice-yearly lenacapavir (first-in-class HIV capsid inhibitor) long-term open-label extension data from the Phase 3 PURPOSE 1 trial, where zero new HIV infections occurred among participants receiving lenacapavir across more than 7,178 person-years of follow-up at Week 52, and from PURPOSE 2, where one HIV infection occurred among participants continuing lenacapavir across 5,295 person-years of follow-up. Separately, Gilead and Merck's once-weekly oral single-tablet islatravir 2 mg / lenacapavir 300 mg (ISL/LEN) Phase 3 ISLEND-1 and ISLEND-2 detailed data is scheduled for the late-breaking session on Wednesday July 29. Topline released July 21 showed 0% of ISLEND-1 once-weekly ISL/LEN participants had HIV-1 RNA at 50 copies/mL or higher at Week 48 (versus 0.3% remaining on daily Biktarvy). Merck plans separate presentations across its daily, weekly, and monthly HIV treatment and prevention pipeline including alimatravir (MK-8527), the investigational once-monthly oral HIV prevention pill licensed Friday July 24 to Aspen Pharmacare and six other generic manufacturers for 129 low- and middle-income countries.