ATLAS-2M (152-week results)
Trial question
Is administration of cabotegravir plus rilpivirine 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 152
2.7
1
2.7 %
2.0 %
1.4 %
0.7 %
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 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 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 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.
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