Once-weekly oral islatravir/lenacapavir meets 48-week primary endpoint in phase 3 studies

9 June 2026. Related: Early access, Antiretrovirals.

Simon Collins, HIV i-Base

On 8 June 2026, Gilead Sciences and Merck/MSD released top-line results of the phase 3 ISLEND-1 and ISLEND-2 studies using an experimental once-weekly oral formulation of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN).

The press statement only noted that the primary endpoints of non-inferiority at week 48 had been met for both studies, compared to either daily Biktarvy or standard of care ART, respectively.

More detailed results will be presented at future meetings.

No unexpected side effects were reported.

Although the press release notes that results will be filed with global regulatory authorities, these are not specified.

Some agencies might require longer follow-up out to 96 weeks.

Reference

Gilead and Merck/MSD Press Release. Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly. (8 June 2026).
https://www.gilead.com/news/news-details/2026/gilead-and-merck-announce-positive-topline-results-from-two-phase-3-studies-evaluating-islatravirlenacapavir-an-oral-once-weekly-hiv-treatment