– Novel Investigational Combination Pairs Merck's Islatravir, a Next-Generation Nucleoside Analog with Distinct Mechanisms of Action, Including Reverse Transcriptase Translocation Inhibition, with Gilead's Lenacapavir, a First-in-Class Capsid Inhibitor that Disrupts HIV at Multiple Stages of its Lifecycle –

– Islatravir/Lenacapavir has the Potential to be the First Approved Long-Acting Oral HIV Treatment Taken Once-Weekly –

Gilead Sciences, Inc. (NASDAQ:GILD) and Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced that the primary efficacy endpoint at Week 48 was met in both the Phase 3 ISLEND-1 and ISLEND-2 trials with the investigational oral once-weekly single-tablet HIV treatment regimen of islatravir/lenacapavir. The ISLEND trials are evaluating the efficacy and safety of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) in people with HIV who are virologically suppressed and switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally comparable to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Gilead and Merck plan to file the Phase 3 data from the ISLEND trials with regulatory authorities globally and submit the detailed findings for presentation at a future scientific congress.

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