ATLAS (cabotegravir and rilpivirine)
Trial question
Is the combination of long-acting cabotegravir and rilpivirine non-inferior to standard oral ART for the maintenance of HIV-1 infection suppression?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
33.0% female
67.0% male
N = 618
618 patients (203 female, 413 male)
Inclusion criteria: patients who had had plasma HIV-1 RNA levels < 50 copies/mL for at least 6 months while taking standard oral ART
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 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
1.6 %
1.2 %
0.8 %
0.4 %
0.0 %
Long-acting therapy
Oral therapy
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in HIV-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 HIV-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 HIV-1 RNA levels < 50 copies/mL for at least 6 months while taking standard oral ART, long-acting therapy was noninferior to oral therapy with respect to HIV-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.
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