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EFFICACY
ATLAS-2M Study Design
IT STARTS WITH PROVEN EFFICACY
Every-2-month VOCABRIA + REKAMBYS demonstrated non-inferior efficacy to daily oral therapy with BIC/FTC/TAF in SOLAR, and sustained efficacy over 3 years in ATLAS-2M.1-3
ATLAS-2M was a large, phase IIIb, open-label, non-inferiority study2-6
Adult HIV-1 participants virologically suppressed for ≥6 months taking either:
*1 cabotegravir 30 mg tablet and 1 rilpivirine 25 mg tablet taken once daily with a meal for at least 28 days.2,3
†Every-2-month dosing: cabotegravir initiation and continuation injections, 600 mg (3 mL); rilpivirine initiation and continuation injections, 900 mg (3 mL).2,3
‡Monthly dosing: cabotegravir initiation injection, 600 mg (3 mL), continuation injections, 400 mg (2 mL); rilpivirine initiation injection, 900 mg (3 mL), continuation injections, 600 mg (2 mL).2,3
Every-2-month VOCABRIA + REKAMBYS maintains a high level of viral suppression over 3 years2-6
The ATLAS-2M primary endpoint was met: Every-2-month VOCABRIA + REKAMBYS was virologically (plasma HIV-1 RNA ≥50 copies/mL) noninferior to monthly VOCABRIA + REKAMBYS at Week 48 (1.7% [n=9/522] vs 1.0% [n=5/523], respectively).2-4
ATLAS-2M PLASMA HIV-1 RNA <50 COPIES/ML2-6
(secondary endpoint; 10% non-inferiority margin)
*Adjusted for baseline stratification factors.2-4
Low incidence of CVF at 3 years6
ATLAS-2M CVF and overall resistance-associated mutations at Week 1526-8
Participants with CVF retained options for fully active oral regimens (e.g. boosted PI regimens)6
ATLAS-2M included a range of participants2-6
*One participant had a non protocol-defined virologic failure. This participant met the suspected virologic failure criterion at Week 48 with an HIV-1 RNA value of 918 copies/mL; however, virologic failure was not confirmed at the Week 48 retest result (39 copies/ mL). At Week 56, HIV-1 RNA was elevated again at 1,038 copies/mL.6
†Suspected virologic failure time point.6
‡Baseline mutations assessed in peripheral blood mononuclear cells; virologic failure mutations assessed in plasma HIV-1 RNA at suspected virologic failure timepoint (first of the two consecutive timepoints where HIV-1 RNA levels are ≥200 copies/mL).8
ARV=antiretroviral; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; BMI=body mass index; CAB=cabotegravir; CI=confidence interval; CVF=confirmed virologic failure; HBV=hepatitis B virus; HIV-1=human immunodeficiency virus type 1; INI=integrase inhibitor; IQR=interquartile range; ITT-E=intention-to-treat exposed; mITT-E=modified intention-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; PI=protease inhibitor; PLHIV=people living with HIV; RNA=ribonucleic acid; RPV=rilpivirine.
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety and tolerability of switching to long-acting cabotegravir + rilpivirine versus continuing bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed adults with HIV, 12 month results (SOLAR): A randomised open-label, phase 3b non-inferiority trial. The Lancet HIV. 2023. Published Online 8th August 2023. https://doi.org/10.1016/S2352-3018(23)00136-4
- VOCABRIA Summary of Product Characteristics. ViiV Healthcare; 2024. Available at: https://www.medicines.ie/medicines/vocabria-600-mg-prolonged-release-suspension-for-injection-35220/spc
- REKAMBYS Summary of Product Characteristics. Janssen-Cilag International NV; 2024. Available at: https://www.medicines.ie/medicines/rekambys-35258/spc
- 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. The Lancet. 2021;396(10267):1994−2005. doi:10.1016/S0140-6736(20)32666-0.
- 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. The Lancet HIV. 2021;8(11):e679–e689. doi:10.1016/S2352-3018(21)00185-5.
- 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 (HIV-1) infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b noninferiority study. Clin Infect Dis. 2023;76(9):1646–1654. doi: 10.1093/cid/ciad020.
- 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 (HIV-1) infection: 152-week results from ATLAS-2M, a randomized, open-label, phase 3b noninferiority study. Clin Infect Dis. 2023;76(9):1646–1654. doi: 10.1093/cid/ciad020. Supplementary data.
- 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. The Lancet. 2021;396(10267):1994−2005. doi:10.1016/S0140-6736(20)32666-0. Supplementary data.
Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.
▼ These medicinal products are subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
REKAMBYS (rilpivirine long acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under licence by the ViiV Healthcare group of companies.
All other trademarks are owned by the ViiV Healthcare group, or its licensor.
©2024 GSK group of companies. All rights reserved.
Date of Preparation: February 2024 PM-IE-CBR-WCNT-240002
