6/28/23, 12:47 AM ATLAS-2M (48-week results) Pathway Feedback Search Clinical Topics Home Studies ATLAS 2M 48-week results) ATLAS 2M 48-week results) Disease Human immunodeficiency virus i Trial question Is administration of cabotegravir plus rilpivirin 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/recv1VWngvkS2mxQ5 1/2 6/28/23, 12:47 AM ATLAS-2M (48-week results) Pathway Primary outcome HIV-1 RNA 50 copies/mL at week 48 2.0 % 2 1.5 % 1.0 % 1 Difference not exceeding nonferiority margin 0.5 % 0.0 % Every 8 weeks dosing Every 4 weeks dosing Difference not exceeding nonferiority margin in HIV-1 RNA 50 copies/mL at week 48 (2% vs. 1%; AD 0.8%, 95% CI -0.6 to 2.2) Secondary outcomes No significant difference in HIV-1 RNA < 50 copies/mL at week 48 (94% vs. 93%; AD 0.8%, 95% CI -2.1 to 3.7) No significant difference in the rate of test for homogeneity by stratum for plasma HIV-1 RNA 50 copies/mL at > 24 weeks (AD 0.8%, 95% CI -2.2 to 4.4) No significant difference in the rate of test for homogeneity by stratum for plasma HIV-1 RNA < 50 copies/mL at > 24 weeks (95% vs. 97%; ARD -1.6, 95% CI -7.4 to 3.7) 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 48. 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 (ATLAS-2M), 48-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet. 2021 Dec 19;396(10267):1994- 2005. Open reference URL https://web.pathway.md/studies/recv1VWngvkS2mxQ5 2/2