An investigational once-weekly oral regimen combining islatravir and lenacapavir was noninferior to continued daily antiretroviral therapy in adults with virologically suppressed HIV, according to a press release from Gilead Sciences and Merck. Findings from the phase 3 ISLEND-1 and ISLEND-2 trials will be presented at the 26th International AIDS Conference. According to the companies, the data will support regulatory submissions.
Both trials evaluated a once-weekly single-tablet regimen containing islatravir 2 mg and lenacapavir 300 mg in adults with virologically suppressed HIV receiving stable oral antiretroviral therapy. ISLEND-1 compared patients who switched from bictegravir/emtricitabine/tenofovir alafenamide with those who continued their existing treatment. ISLEND-2 followed a similar design but included patients taking other daily oral standard-of-care regimens.
In the randomized, double-blind ISLEND-1 trial, the once-weekly regimen met the primary endpoint of noninferiority for maintaining virologic suppression at week 48. None of the patients who switched to islatravir/lenacapavir had HIV-1 RNA levels of at least 50 copies/mL, compared with one patient who remained on bictegravir/emtricitabine/tenofovir alafenamide. Treatment-related adverse events were reported in 13.5% of patients receiving islatravir/lenacapavir and 13.2% of those in the comparator group. Nausea and headache were the most common treatment-related adverse events. Serious adverse events occurred at similar frequencies in both groups, and few patients discontinued treatment because of adverse events. Researchers reported little change in CD4-positive T-cell counts, lymphocyte counts, or body weight through week 48.
In the randomized, open-label ISLEND-2 trial, the investigational regimen also met the primary endpoint of noninferiority. HIV-1 RNA levels of at least 50 copies/mL were reported in 0.3% of patients receiving islatravir/lenacapavir compared with 1.3% of patients who continued daily standard-of-care therapy. Treatment-related adverse events occurred in 18% of patients receiving the investigational regimen and in fewer than 1% of those receiving standard-of-care therapy. Headache, nausea, and diarrhea were the most frequently reported treatment-related adverse events. As in ISLEND-1, researchers reported little change in CD4-positive T-cell counts, lymphocyte counts, or body weight during the 48-week follow-up period.
According to the press release, participants who received the once-weekly regimen also reported greater treatment satisfaction and lower treatment burden than those who continued daily oral therapy.
The islatravir/lenacapavir combination remains investigational and has not been approved for clinical use.
Source: Merck
