吉利德和默沙东公布ISL/LEN每周一次口服HIV方案48周三期详细数据

Gilead Sciences, Inc. (GILD) and Merck (MRK), announced detailed results from the Phase 3 ISLEND-1 and ISLEND-2 trials evaluating the investigational once-weekly oral single-tablet regimen of Islatravir 2 mg/Lenacapavir 300 mg (ISL/LEN). The data, presented at the 26th International AIDS Conference, showed that ISL/LEN maintained high rates of virologic suppression at Week 48 in adults living with HIV, who switched from daily antiretroviral therapy.
Trial Results
In ISLEND-1, participants switching from BIKTARVY maintained virologic suppression, with no participants of ISL/LEN patients showing HIV-1 RNA = 50 copies/mL at Week 48 compared to 0.3% on BIKTARVY.
In ISLEND-2, patients switching from other standard daily regimens also maintained suppression, with 0.3% of ISL/LEN patients showing HIV-1 RNA = 50 copies/mL compared to 1.3% on standard of care.
Safety profiles were generally comparable across groups. In ISLEND-1, treatment-related adverse events occurred in 13.5% of ISL/LEN patients versus 13.2% on BIKTARVY, with nausea and headache each reported in 3%. Serious adverse events were reported in 5.3% of ISL/LEN patients versus 4.6% on BIKTARVY.
In ISLEND-2, treatment-related adverse events occurred in 18% of ISL/LEN patients versus less than 1% on standard of care, with headache (5%), nausea (3%), and diarrhea (3%) most common. Discontinuations due to adverse events were low (2% and 1.7%, respectively).
CD4+ T-cell counts and body weight remained stable across both trials.
Expert Commentary
"Once-daily, combination, single-tablet antiretroviral therapy is the cornerstone of HIV treatment today. However, the treatment landscape is evolving," said Jürgen Rockstroh, University Hospital Bonn. "The ISLEND-1 study results show the potential of ISL/LEN as the first once-weekly oral single-tablet treatment option."
Amy Colson, Research Director at Zinberg Clinic added: "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."
Mechanism of Action
Islatravir is Merck's next-generation nucleoside analog with multiple mechanisms of action including inhibition of HIV-1 reverse transcriptase translocation. Lenacapavir is Gilead's first-in-class capsid inhibitor that disrupts HIV-1 at multiple stages of its lifecycle. Together, their pharmacokinetic profiles enable once-weekly dosing.
Outlook
Results from ISLEND-1 and ISLEND-2 will form the basis of regulatory submissions. If approved ISL/LEN could become the first once-weekly oral HIV treatment option for adults with virologic suppression.
GILD has traded between $108.06 and $157.29 over the past year. The stock is currently trading at $130.73, down 1.86%.
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