Gilead and Merck today (Tuesday, July 21) announced new results from the Phase 3 ISLEND-1(NCT06630286) andISLEND-2(NCT06630299) trials evaluating the treatment responses of people living with HIV with virological suppression who switched from BIKTARVY® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) or a standard of care oral daily antiretroviral regimen to an investigational once-weekly single-tablet regimenof islatravir 2 mg/lenacapavir 300 mg (ISL/LEN), according to a press release from the two pharmaceutical companies.
“This novel combination has the potential to be the first approved long-acting oral treatment for adults with supressed HIV taken once weekly,” the press release noted.
The press release pointed to key findings from the studies showing that ISL/LEN maintained virological suppression in adults with HIV who switched antiretroviral therapy.
With ISLEND-1, Week 48 results showed that the once-weekly single tablet regimen of ISL/LEN was “statistically noninferior” to a standard of care treatment with BIKTARVY in maintaining virologic suppression; no participants who switched to ISL/LEN had HIV-1 RNA greater than 50 copies/mL (as determined by the US FDA-defined snapshot algorithm), compared to 0.3 percent of participants who remained on BIKTARVY.
(as per the National Institutes of Health, to be “statistically noninferior” means that a new treatment or intervention is proven to be no worse than an existing standard of care by more than a clinically acceptable, predefined amount.”)
At 48 weeks in the ISLEND-2 study, ISL/LEN was found to be statistically non-inferior to standard of care treatment with daily therapies; 0.3 percent of participants receiving ISL/LEN had HIV-1 RNA greater than 50 copies/mL (as determined by the US FDA-defined snapshot algorithm) compared to 1.3 percent who remained on baseline medication.
According to the press release, a majority of participants who switched to once-weekly oral ISL/LEN were more satisfied with the regimen compared with taking daily standard of care antiretroviral regimens and found once-weekly ISL/LEN was less of a burden compared with taking daily standard of care antiretroviral regimens, based on HIV Patient Perspective of Regimen Change outcomes reporting.
Results of the trials were announced at a virtual press conference today and will also be presented as “late-breaking abstracts” during oral sessions on Wednesday, July 29, at the 26th annual International AIDS Conference happening inRio de Janeiro.
Gilead and Merck plan to file the data as part of its upcoming regulatory submissions, according to today’s press release, and, if approved, ISL/LEN would “expand treatment options for people living with HIV, becoming the first approved long-acting oral therapy that allows for less frequent dosing for adults with virological suppression.”