Gilead's BIC/LEN single-tablet regimen showed non-inferiority to existing therapies in maintaining virologic suppression in ARTISTRY-1 and ARTISTRY-2 Phase 3 trials at 48 weeks, presented at CROI 2026.25
Merck's DOR/ISL daily pill demonstrated non-inferiority to Gilead's Biktarvy with 91.8% vs 90.6% viral suppression at 48 weeks in Phase 3 trials, also at CROI 2026; FDA review target is April 28, 2026.27
Gilead plans regulatory submission for BIC/LEN based on ARTISTRY data, with potential market launch in late 2026.25
These developments clear paths for new daily oral HIV treatments, reinforcing Gilead's HIV franchise dominance while Merck seeks market entry.2
Sources:
2. https://www.biospace.com/drug-development/gilead-merck-clear-path-to-market-for-daily-hiv-pills-with-new-late-stage-data
5. https://www.gilead.com/news/news-details/2026/gileads-single-tablet-regimen-of-bictegravir-and-lenacapavir-maintained-virological-suppression-in-people-with-hiv-who-switched-antiretroviral-therapy
7. https://www.merck.com/news/merck-announces-late-breaking-data-from-three-phase-3-trials-evaluating-doravirine-islatravir-dor-isl-an-investigational-once-daily-two-drug-regimen-for-the-treatment-of-adults-living-with-hiv-1/