Viral suppression with oral ART was the first step, now it’s time to take your patients further
The VOLITION study showed that people living with HIV naive to treatment valued being empowered with the option to switch to VOCABRIA + REKAMBYS soon after achieving virologic suppression with oral ART.[9]
The VOLITION study insights highlight that people living with HIV value having a choice early in their treatment journey[9]
The SOLAR primary endpoint was met: 2-monthly VOCABRIA + REKAMBYS was non-inferior to BIC/FTC/TAF at Month 12 (mITT-E: 1% [n=5/447] with plasma HIV-1 RNA ≥50 copies/mL vs 0.4% [n=1/223], respectively; adjusted difference = 0.7% [95% CI: -0.7%, 2.0%]; 4% non-inferiority margin).[3]
CARLOS primary endpoint: 86% (n=301/351) of participants achieved HIV-1 RNA <50 copies/mL at Month 12 (defined as last available viral load at the injection 7 date ±12-week window).[10]
VOLITION co-primary study endpoints: Median time to virologic suppression (HIV-1 RNA <50 copies/mL) from baseline with DTG/3TC was 4.1 (95% CI: 4.1, 4.3) weeks. The proportion of participants receiving VOCABRIA + REKAMBYS with HIV-1 RNA <50 copies/mL per Snapshot algorithm at Month 11 results are not yet reported.[9]
*Participants in the 2-monthly VOCABRIA + REKAMBYS arm reporting preference vs daily oral therapy in SOLAR (secondary endpoint; mITT-E population; 90% [n=382/425] vs 5% [n=21/425], respectively, and 5% [n=22/425] reporting no preference), and CARLOS (99% [n=235/238] vs 1% [n=3/238] reporting no preference).[3,8]
Explore how VOCABRIA + REKAMBYS may benefit people living with HIV, beyond viral suppression:
Prescribing Information and Adverse Event Reporting for DOVATO (dolutegravir/lamivudine) is available here.
ART=antiretroviral therapy; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; CI=confidence interval; DTG/3TC=dolutegravir/lamivudine; HIV=human immunodeficiency virus; HIV-1=human immunodeficiency virus type 1; mITT-E=modified intention-to-treat exposed; RNA=ribonucleic acid.
References:
- VOCABRIA (cabotegravir) 600 mg suspension for injection Summary of Product Characteristics (SmPC).
- REKAMBYS (rilpivirine) 900 mg suspension for injection Summary of Product Characteristics (SmPC).
- Ramgopal MN, Castagna A, Cazanave C, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised open-label, phase 3b, non-inferiority trial. Lancet HIV. 2023;10(9):e566–e577. doi: 10.1016/S2352-3018(23)00136-4.
- Kityo C, Mambule IK, Musaazi J. et al. Cabotegravir and rilpivirine for treatment of HIV infection in Africa: week 96 results from the phase 3b randomized, open-label, noninferiority CARES trial. Nat Med. 2025. https://doi.org/10.1038/s41591-025-04041-7.
- 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 randomized, multicentre, open-label, phase 3b, non-inferiority study. Published in Lancet. 2021; Vol. 396, Issue 10267, Pages 1994–2005. DOI: 10.1016/S0140-6736(20)32666-0.
- Muccini C, Capra N, Lolatto R, et al. Two-years efficacy and safety of long-acting cabotegravir and rilpivirine in the SChoLART study. Presented at: The Italian Conference on AIDS and Antiviral Research (ICAR); May 21–23, 2025; Padua, Italy. Oral presentation 0C35.
- John M, Williams L, Nolan G, et al. Real-world use of long-acting cabotegravir and rilpivirine: 12-month results of the injectable Antiretroviral therapy feasibility study (JABS). Published in HIV Medicine. 2024; Vol. 25, Issue 8, Pages 935–945. DOI: 10.1111/hiv.13647.
- Wyen C, Noe S, Jonsson-Oldenbüttel C, et al. 24-Month Outcomes of Cabotegravir Plus Rilpivirine Long-Acting Every 2 Months in a Real-World Setting: Effectiveness, Adherence to Injections, and Patient-Reported Outcomes From People With HIV-1 in the German CARLOS Study. Presented at: The 13th International AIDS Society (IAS) Conference; July 13–17, 2025; Kigali, Rwanda. Poster TUPEB035.
- Felizarta F, Gutner C, Jonsson-Oldenbüttel C, et al. The Power of Choice: Strong Preference for CAB+RPV LA Following Rapid Suppression With DTG/3TC in Newly Diagnosed People Living With HIV. Presented at: The 13th International AIDS Society (IAS) Conference; July 13–17, 2025; Kigali, Rwanda. Poster EP0170.
- Jonsson-Oldenbüttel C, Noe S, Wyen C, et al. 12-Month Outcomes of Cabotegravir Plus Rilpivirine Long-Acting Every 2 Months in a Real-World Setting: Effectiveness, Adherence to Injections, and Patient-Reported Outcomes From People With HIV-1 in the German CARLOS Study. Presented at: The 25th International AIDS Conference; July 22–26, 2024; Munich, Germany. Poster TUPEB095.
- Okoli C, Brough G, Allan B, et al. Shared Decision Making Between Patients and Healthcare Providers and its Association with Favorable Health Outcomes Among People Living with HIV. AIDS Behav. 2021;25(5):1384–1395. doi: 10.1007/s10461-020-02973-4.
- Keelson SA, Addo JO, Amoah J. The impact of patient engagement on service quality and customer well-being: an introspective analysis from the healthcare providers’ perspective. Cogent Public Health. 2024;11(1):2340157. doi: 10.1080/27707571.2024.2340157.
REKAMBYS (rilpivirine long-acting), including the trademark, is owned by the Janssen Pharmaceutical Companies and used under license by the ViiV Healthcare group of companies. All other trademarks are owned or licensed by the ViiV Healthcare group. ©2025 ViiV Healthcare group of companies or its licensor. All rights reserved.
PM-GB-CBR-WCNT-250010 | March 2026
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellowcard in the Google Play or Apple App store. Adverse events should also be reported to GSK via the GSK Reporting Tool or on 0800 221441.