6/28/23, 12:47 AM ATLAS-2M (152-week results) Pathway Feedback Search Clinical Topics Home Studies ATLAS 2M 152-week results) ATLAS 2M 152-week results) Disease Human immunodeficiency virus i Trial question Is administration of cabotegravir plus rilpivirine every 8 weeks noninferior to administration every 4 weeks in adults with human immunodeficiency virus-1 infection? Study design Multi-center Open label RCT Population Characteristics of study participants 27.0% female N = 1045 73.0% male 1045 patients (280 female, 765 male) Inclusion criteria: adults living with human immunodeficiency virus-1 infection Key exclusion criteria: pregnancy; moderate to severe hepatic impairment; preexisting physical or mental condition; high risk for seizures Interventions N=522 every 8 weeks dosing (cabotegravir 600 mg plus rilpivirine 900 mg administered IM every 8 weeks) N=523 every 4 weeks dosing (cabotegravir 400 mg plus rilpivirine 600 mg administered IM every 4 weeks) https://web.pathway.md/studies/recSY1Zb52a8MNkU2 1/2 6/28/23, 12:47 AM ATLAS-2M (152-week results) Pathway Primary outcome HIV-1 RNA 50 copies/mL at week 152 2.7 % 2.7 2.0 % 1.4 % 1 Difference not exceeding nonferiority margin 0.7 % 0.0 % Every 8 weeks dosing Every 4 weeks dosing Difference not exceeding nonferiority margin in HIV-1 RNA 50 copies/mL at week 152 (2.7% vs. 1%; AD 1.7%, 95% CI 0.1 to 3.3) Secondary outcomes No significant difference in HIV-1 RNA < 50 copies/mL at week 152 (87.4% vs. 85.9%; AD 1.5%, 95% CI -2.6 to 5.6) No significant difference in the rate of test for homogeneity by strata for HIV-1 RNA < 50 copies/mL at > 24 weeks (91.3% vs. 89.1%; AD -2.2%, 95% CI -5.6 to 10) Safety outcomes No significant difference in adverse events. Conclusion In adults living with human immunodeficiency virus-1 infection, every 8 weeks dosing was noninferior to every 4 weeks dosing with respect to a HIV-1 RNA 50 copies/mL at week 152. Reference Edgar T Overton, Gary Richmond, Giuliano Rizzardini et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection: 152-week results from ATLAS-2M, a randomized, open-label, Phase 3b, noninferiority study. Clin Infect Dis. 2023 Jan 20;ciad020. Open reference URL https://web.pathway.md/studies/recSY1Zb52a8MNkU2 2/2