Gilead announces ARTISTRY-1 trial meets primary endpoint

Gilead (GILD) announced topline results from the Phase 3 ARTISTRY-1 trial. The open-label trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from a multi-tablet regimen to an investigational single-tablet regimen of bictegravir 75 mg/lenacapavir 50 mg. BIC/LEN efficacy was found to be statistically non-inferior to multi-tablet regimens. Gilead plans to file the Phase 3 data from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress. In ARTISTRY-1, the once-daily single-tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to baseline multi-tablet antiretroviral therapy regimens. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels of 50 copies/mL at Week 48, defined by the FDA snapshot algorithm. In the trial, BIC/LEN was generally well tolerated, with no significant or new safety concerns identified. ARTISTRY-1 is a multicenter Phase 2/3 clinical trial comparing the investigational once-daily combination of bictegravir, a global guidelines-recommended integrase strand transfer inhibitor, and lenacapavir, a first-in-class capsid inhibitor, versus current therapy in people with HIV who are virologically suppressed on complex regimens. In Phase 3, participants were randomized 2:1 to receive a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg or continue their stable baseline complex regimen. The primary endpoint was the proportion of patients with HIV-1 RNA greater than or equal to50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints at week 48 included the proportion of participants with virologic suppression, change in baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events. Further evaluation of this investigational combination includes the double-blind, Phase 3 ARTISTRY-2 trial which is evaluating the safety and efficacy of switching from Biktarvy to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg in virologically suppressed people with HIV-1. A topline data readout for the primary endpoint is anticipated before the end of the year. Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not been established in combination.