ATLAS-2M (48-week results)
Trial question
Is administration of cabotegravir plus rilpivirin every 8 weeks noninferior to administration every 4 weeks in adults with HIV-1 infection?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
27.0% female
73.0% male
N = 1045
1045 patients (280 female, 765 male)
Inclusion criteria: adult patients with HIV-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)
Primary outcome
Human immunodeficiency virus-1 RNA ≥ 50 copies/mL at week 48
2
1
2.0 %
1.5 %
1.0 %
0.5 %
0.0 %
Every 8 weeks dosing
Every 4 weeks dosing
Difference not exceeding
nonferiority margin ✓
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 (1% vs. 0%; 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 adult patients with HIV-1 infection, every 8 weeks dosing was noninferior to every 4 weeks dosing with respect to 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