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Two Phase 3 trials (ISLEND-1, ISLEND-2) met the primary endpoint of non-inferiority at Week 48 for the once-weekly oral islatravir/lenacapavir regimen versus BIKTARVY or standard-of-care daily ART. The companies plan to file the data with global regulators and present detailed results at a future scientific congress.
Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment Gilead and Merck Announce Positive Topline Results From Two Phase 3 Studies Evaluating Islatravir/Lenacapavir, an Oral Once-Weekly HIV Treatment – 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 standa