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Investigational Once-Weekly Oral HIV Treatment Regimen of Islatravir and Lenacapavir Maintained Virological Suppression in Adults With HIV Who Switched Antiretroviral Therapy
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- High Rates of Virologic Suppression Sustained at Week 48 Across ISL/LEN Treatment Groups in Both Phase 3 ISLEND Trials -
- ISL/LEN has the Potential to be the First Once-Weekly Oral HIV Treatment -
FOSTER CITY, Calif. & RAHWAY, N.J.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the detailed outcomes from the Phase 3 ISLEND-1 and ISLEND-2 trials will be presented for the first time at the 26th International AIDS Conference (AIDS 2026). The primary endpoint results at Week 48 showed that the investigational once-weekly oral single-tablet HIV treatment regimen of islatravir 2 mg/lenacapavir 300 mg (ISL/LEN) was effective in adults living with HIV who were virologically suppressed and switched from global guideline-recommended BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) (ISLEND-1) or other standard of care oral daily antiretroviral regimens (ISLEND-2). The safety profile of ISL/LEN was generally similar to the comparator regimens studied in the ISLEND trials, and no new safety concerns were identified. Results of both trials will be presented during late-breaking sessions at AIDS 2026 on Wednesday, July 29 and featured in the AIDS 2026 press program on Tuesday, July 21. These data will form the basis of regulatory submissions.
The ISLEND-1 ( NCT06630286) and ISLEND-2 (NCT06630299) trials evaluated the safety and efficacy of the once-weekly single tablet regimen of ISL/LEN. The data provide strong evidence for the potential of ISL/LEN to be the first and only once-weekly oral HIV treatment option for adults with virologic suppression on a stable antiretroviral regimen. The investigational combination pairs Merck's islatravir, a next-generation nucleoside analog with multiple mechanisms of action including HIV-1 reverse transcriptase translocation inhibition, with Gilead's lenacapavir, a first-in-class capsid inhibitor that disrupts HIV-1 at multiple stages of its lifecycle. The potency and pharmacokinetic profiles of islatravir and lenacapavir enable dosing as a complete once-weekly tablet for HIV treatment.
Results from ISLEND-1
Week 48 results showed that the once-weekly single tablet regimen of ISL/LEN was noninferior to BIKTARVY in maintaining virologic suppression; no (0%) participants who switched to ISL/LEN had HIV-1 RNA ≥ 50 copies/mL at Week 48 compared to 1 (0.3%) participant who remained on BIKTARVY (as determined by the US FDA-defined snapshot algorithm).
"Once-daily, combination, single-tablet antiretroviral therapy is the cornerstone of HIV treatment today. However, the treatment landscape is evolving," said Jürgen Rockstroh, Department of Medicine University Hospital Bonn, Germany. "Long-acting therapies provide an alternative to daily pills. The ISLEND-1 study results show the potential of ISL/LEN as the first once-weekly oral single-tablet treatment option."
In this blinded trial, treatment-related adverse events were reported in 13.5% of participants who switched to ISL/LEN and 13.2% of participants who remained on BIKTARVY and were generally comparable between groups. In both treatment groups, the most common treatment-related adverse events reported were nausea (3%) and headache (3%). A similar incidence of serious adverse events was reported in both treatment groups (5.3% ISL/LEN; 4.6% BIKTARVY). Discontinuations of ISL/LEN or BIKTARVY due to adverse events were low (2% and 1.7%, respectively). CD4+ T-cell and lymphocyte counts were stable in both treatment groups through Week 48 and no participant discontinued due to a decrease in CD4+ T-cell or lymphocyte count. There was no clinically meaningful difference in changes in body weight between the treatment groups at Week 48.
Results from ISLEND-2
At Week 48, ISL/LEN was found to be non-inferior to daily oral standard of care HIV treatments; 0.3% of participants receiving ISL/LEN had HIV-1 RNA ≥ 50 copies/mL compared to 1.3% who remained on standard of care antiretroviral regimens (as determined by the US FDA-defined snapshot algorithm).
"Single tablet regimens have transformed the outlook for millions of people living with HIV," said Amy Colson, Research Director at Community Resource Initiative and Medical Director of the Zinberg Clinic at Cambridge Health Alliance. "Having a treatment option with once weekly dosing can expand choice to help address individual needs and preferences. The 48-week findings provide the evidence for ISL/LEN as the potential first once-weekly oral treatment option to help support long-term treatment needs and be responsive to the preferences of people living with HIV."
In this open-label trial, treatment-related adverse events were reported in 18% of participants treated with ISL/LEN and <1% receiving standard of care antiretroviral regimens. In the ISL/LEN group, the most common treatment-related adverse events reported (≥2%) were headache (5%), nausea (3%) and diarrhea (3%). Discontinuations of study drug due to adverse events were low (1% and <1%, respectively). CD4+ T-cell counts and lymphocyte counts were stable in both treatment groups through Week 48 and no participant discontinued due to a decrease in CD4+ T-cell or lymphocyte counts. Through Week 48, body weight remained stable in both treatment groups.
Additionally, participants who switched to once-weekly oral ISL/LEN reported higher treatment satisfaction and lower treatment burden compared with taking standard of care daily HIV treatments based on HIV Patient Perspective of Regimen Change outcomes reporting.
Islatravir and lenacapavir in combination are investigational and not approved for use.
There is currently no cure for HIV or AIDS.
full press release
https://www.gilead.com/news/news-details/2026/gilead-to-present-new-hiv-research-at-aids-2026-across-prevention-treatment-and-cure
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