ATLAS-2M efficacy: Every-2-month vs once-monthly CABENUVA
ATLAS-2M study design
ATLAS-2M was a large, phase 3b, open-label, noninferiority study1
Selected exclusion criteria1:
- Previous virologic failure
- Any known INSTI or NNRTI resistance (excluding K103N)
- HBV infection at screening
- Moderate to severe hepatic impairment
- Women who were pregnant or breastfeeding, or planned to become pregnant or breastfeed
- Acceptable ARV regimens (either initial or second ARV regimen) included 2 NRTIs plus an INSTI, NNRTI, or boosted PI (or ATV unboosted).2
- Patients transitioning from the ATLAS trial who were on oral antiretroviral therapy must have been on their current oral regimen for at least 52 weeks and had plasma HIV-1 RNA <50 copies/mL.2
- Newly enrolled patients were virologically suppressed for at least 6 months on 2 NRTIs + third agent, with suppression defined as plasma HIV-1 RNA <50 copies/mL.1
- Patients transitioning from ATLAS on once-monthly CABENUVA either completed at least 52 weeks in the comparative phase or switched from an oral regimen after Week 52 in the extension phase and had plasma HIV-1 RNA <50 copies/mL.1
- Oral lead-in regimen consisting of 30-mg cabotegravir and 25-mg rilpivirine given once daily for 4 weeks.
- Patients transitioning from the ATLAS trial with once-monthly exposure to CABENUVA received their first injections on Day 1.1
ATLAS-2M baseline characteristics
ATLAS-2M included a range of patients1
- At baseline, 7% of patients in the every-2-month arm and 5% of patients in the once-monthly arm had a CD4+ cell count <350
- 8 patients who were assigned male at birth identified as female at enrollment.1
ATLAS-2M: It starts with proven efficacy
Every-2-month CABENUVA was proven as effective as once-monthly CABENUVA1,3
ATLAS-2M: ITT-E FDA snapshot virologic outcomes through Week 152
- CVF was defined as 2 consecutive RNA levels ≥200 copies/mL.1
- One patient who was included as a CVF did not meet the protocol-defined criteria but was included due to a viral load ≥200 copies/mL measured at study site using a non-protocol–specified assay.1,3
ATLAS-2M: Confirmed virologic failure
CVF with resistance observed in patients receiving CABENUVA in ATLAS-2M1-4
As a prespecified secondary endpoint, patients who met the protocol-defined CVF criteria (14/1045) were tested for emergent INSTI (cabotegravir) or NNRTI (rilpivirine) substitutions conferring resistance by 152 weeks3
All clinical isolates from patients who failed with resistance (exploratory analysis)3,4
- Maintained phenotypic susceptibility to multiple ARVs including dolutegravir, bictegravir, boosted PIs, and/or nearly all NNRTIs
- 13 of the 14 patients who failed re-suppressed on oral, highly active retroviral therapy
- 1 patient who failed to achieve re-suppression reported poor adherence to PI-based ARV therapy
- One patient who was included as CVF did not meet the protocol-defined criteria but was included due to a viral load ≥200 copies/mL measured at study site using a non-protocol specified assay.3,4
- Suspected virologic failure time point.4
CABENUVA access and affordability
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ARV=antiretroviral; ATV=atazanavir; BMI=body mass index; CI=confidence interval; CVF=confirmed virologic failure; FDA=Food and Drug Administration; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; ITT-E=intent-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; W=Week.
References:
- Overton ET, Richmond G, Rizzardini G, 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. 2020;396(10267):1994-2005. doi:10.1016/S0140-6736(20)32666-0
- Data on file. ViiV Healthcare group of companies. Durham, NC.
- Overton ET, Richmond G, Rizzardini G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with human immunodeficiency virus 1 type 1 infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b, noninferiority study. Clin Infect Dis. 2023;76(9):1646-1654.
- Jaeger H, Overton ET, Richmond G, et al. Long-acting cabotegravir and rilpivirine dosed every 2 months in adults with HIV-1 infection (ATLAS-2M), 96-week results: a randomised, multicentre, open-label, phase 3b, non-inferiority study. Lancet HIV. 2021;8(11):e679-e689. doi:10.1016/S2352-3018(21)00185-5
PMUS-CBRWCNT240060