6/28/23, 12:47 AM ATLAS (cabotegravir and rilpivirine) Pathway Feedback Search Clinical Topics Home Studies ATLAS (cabotegravir and rilpivirine) ATLAS (cabotegravir and rilpivirine) Disease Human immunodeficiency virus i Trial question Is the combination of long-acting cabotegravir and rilpivirine non-inferior to standard oral antiretroviral therapy for the maintenance of human immunodeficiency virus type 1 infection suppression? Study design Multi-center Open label RCT Population Characteristics of study participants 33.0% female N = 618 67.0% male 618 patients (203 female, 413 male) Inclusion criteria: patients who had had plasma human immunodeficiency virus type 1 RNA levels < 50 copies/mL for at least 6 months while taking standard oral antiretroviral therapy Key exclusion criteria: evidence of active HBV infection, previous virologic failure, interruption of the current antiretroviral regimen within 6 months before screening, or any interruption exceeding 1 month in duration Interventions N=308 long-acting therapy (a 3 ml intramuscular injection of 600 mg cabotegravir and 900 mg rilpivirine, followed by a 2 ml injection of a dose of 400 mg and 600 mg every 4 weeks through https://web.pathway.md/studies/recNQqnNvVfn9ds2G 1/2 6/28/23, 12:47 AM ATLAS (cabotegravir and rilpivirine) Pathway week 52) N=308 oral therapy (continuation of the current antiretroviral regimen for 52 weeks) Primary outcome Human immunodeficiency virus type 1 RNA level 50 copies/ml at week 48 1.6 % 1.6 1.2 % 1 0.8 % Difference not exceeding nonferiority margin 0.4 % 0.0 % Long-acting therapy Oral therapy Difference not exceeding nonferiority margin in human immunodeficiency virus type 1 RNA level 50 copies/ml at week 48 (1.6% vs. 1%; AD 0.6%, 95% CI -1.2 to 2.5) Secondary outcomes No significant difference in human immunodeficiency virus type 1 RNA level < 50 copies/ml at week 48 (92.5% vs. 95.5%; ARD -3, 95% CI -6.7 to 0.7) Safety outcomes No significant difference in serious adverse events. Significant differences in at least one adverse event (95% vs. 71%), mild to moderate drug-related adverse events (29% vs. 3%). Conclusion In patients who had had plasma human immunodeficiency virus type 1 RNA levels < 50 copies/mL for at least 6 months while taking standard oral antiretroviral therapy, long-acting therapy was noninferior to oral therapy with respect to human immunodeficiency virus type 1 RNA level 50 copies/ml at week 48. Reference Susan Swindells, Jaime-Federico Andrade-Villanueva, Gary J Richmond et al. Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression. N Engl J Med. 2020 Mar 19;382(12):1112-1123. Open reference URL https://web.pathway.md/studies/recNQqnNvVfn9ds2G 2/2