Gilead Sciences and Merck said detailed results from the Phase 3 ISLEND-1 and ISLEND-2 trials will be presented at AIDS 2026, showing that an investigational once-weekly oral HIV regimen of islatravir and lenacapavir maintained virologic suppression in adults who switched from standard antiretroviral therapy. The companies said the findings support the potential of the single-tablet regimen to become the first once-weekly oral treatment option for people living with HIV who are already suppressed on stable therapy.
The trials evaluated islatravir 2 mg plus lenacapavir 300 mg in adults who switched from Biktarvy in ISLEND-1 or other daily standard-of-care oral regimens in ISLEND-2. At Week 48, the regimen was noninferior to comparator therapies in both studies, with no new safety concerns identified and a safety profile generally similar to the regimens studied in the trials.
In ISLEND-1, no participants who switched to islatravir/lenacapavir had HIV-1 RNA at or above 50 copies per mL at Week 48, compared with one participant who stayed on Biktarvy. In ISLEND-2, 0.3% of participants on the investigational regimen had HIV-1 RNA at or above 50 copies per mL, versus 1.3% among those who remained on standard care. Treatment-related adverse events were low in both studies, and CD4+ T-cell and lymphocyte counts remained stable through Week 48.
The companies said the data will support regulatory submissions. Investigators also reported higher treatment satisfaction and lower treatment burden among participants who switched to the once-weekly oral regimen.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!