Dataset from A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current INI- NNRTI-, or PI-based Antiretroviral Regimen in HIV-1-infected Adults Who Are Virologically Suppressed

The Antiretroviral Therapy as Long Acting Suppression (ATLAS) study is being conducted to
establish if human immunodeficiency virus type-1 (HIV-1) infected adult subjects with current
viral suppression on a regimen with 2 nucleoside reverse transcriptase inhibitors (NRTIs)
plus a third agent, remain suppressed upon switching to a two-drug intramuscular (IM)
long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). This is a Phase 3,
multi-phase, randomized, open label, active-controlled, multicenter, parallel-group,
non-inferiority study in HIV-1, antiretroviral therapy (ART)-adult subjects who are stably
suppressed on a current antiretroviral (ARV) regimen. This study is designed to demonstrate
the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg
regimen every 4 weeks (Q4W: monthly) compared with maintenance of current ARV regimen
containing 2 NRTIs plus an INI, NNRTI, or a PI. Eligible subjects will be randomized (1:1)
into the Maintenance Phase at Day 1 to either continue current ART or switch to initiate oral
therapy with CAB 30 mg + RPV 25 mg once daily for 4 Weeks followed by Q4 weekly (monthly) CAB
LA + RPV LA injections. Following the Maintenance phase at Week 52, subjects who were
randomized to continue their current ART regimen will be given an option to switch to CAB LA
+ RPV LA injections. Those subjects would transition to LA dosing, beginning with 4 weeks
oral CAB + RPV therapy at Week 52, and receive the first IM CAB LA + RPV LA injections at
Week 56.