Long-acting cabotegravir + rilpivirine for HIV-1 treatment: ATLAS week 96 results.

BACKGROUND ATLAS (NCT02951052), a Phase 3, multicenter, open-label study, demonstrated that switching to injectable cabotegravir (CAB) + rilpivirine (RPV) long-acting (LA) dosed every 4 weeks was noninferior at Week (W) 48 to continuing three-drug daily oral antiretroviral therapy (CAR). Results from the W96 analysis are presented. METHODS AND DESIGN Participants completing W52 of ATLAS were given the option to withdraw, transition to ATLAS-2 M (NCT03299049), or enter an Extension Phase (EP) to continue LA therapy (LA arm) or switch from CAR to LA therapy (Switch arm). Endpoints assessed at W96 included proportion of participants with plasma HIV-1 RNA <50 copies/mL, incidence of confirmed virologic failure (CVF; two consecutive HIV-1 RNA ≥200 copies/mL), safety and tolerability, pharmacokinetics, and patient-reported outcomes. RESULTS Most participants completing the Maintenance Phase transitioned to ATLAS-2 M (88%, n = 502/572). Overall, 52 participants were included in the W96 analysis of ATLAS; of these, 100% (n = 23/23) and 97% (n = 28/29) in the LA and Switch arms had plasma HIV-1 RNA <50 copies/mL at W96, respectively. One participant had plasma HIV-1 RNA ≥50 copies/mL in the Switch arm (173 copies/mL). No participants met the CVF criterion during the EP. No new safety signals were identified. All Switch arm participants surveyed preferred LA therapy to their previous daily oral regimen (100%, n = 27/27). CONCLUSIONS In this subgroup of ATLAS, 98% (n = 51/52) of participants at the EP W96 analysis maintained virologic suppression with LA therapy. Safety, efficacy, and participant preference results support the therapeutic potential of CAB+RPV LA treatment for virologically suppressed people living with HIV-1.