Gilead registers two Phase 3 trials of lenacapavir long-acting regimen with TAB and ZAB
Both studies compare a twice-yearly injectable HIV-1 regimen against existing standards of care and are now recruiting.
Gilead Sciences has two Phase 3 trials of its long-acting lenacapavir-based regimen listed as recruiting, each with a start date of July 14, 2026.
- A Phase 3 trial (NCT07683000) is evaluating the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.1 The study has an enrollment: 590 participants (estimated)1.
- A second Phase 3 trial (NCT07682961) is comparing the same LEN/TAB/ZAB regimen against an active comparator, with the goal to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.2 This trial also lists an enrollment: 590 participants (estimated)2, with the comparator arm receiving intramuscular (IM) CAB 600 mg + RPV 900 mg on Day 1, Week 4 and then every 8 weeks for up to 92 weeks.2
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.