EFFICACY

Proven efficacy and effectiveness

VOCABRIA + REKAMBYS is the only complete long-acting regimen for HIV-1 with proven efficacy in clinical trials and real-world effectiveness for long-term virologic suppression[1–6]

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Up to 3 years of efficacy data in the clinical trial setting[1–3]

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Up to 2 years of effectiveness data in the real-world setting[4–6]

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*Potential overlap between real-world cohorts cannot be ruled out.[7]

Efficacy of 2-monthly VOCABRIA + REKAMBYS has been investigated in multiple clinical trials, including SOLAR, CARES and ATLAS-2M*[1–3]

Discover SOLAR:

A head-to-head switch study comparing 2-monthly VOCABRIA + REKAMBYS with regular daily oral therapy with BIC/FTC/TAF.[1]

  • View key outcomes from SOLAR

    Non-inferior efficacy, with less frequent dosing vs regular daily oral therapy.

    For people living with HIV, confidence in treatment efficacy is important.[7,8]

    Data from the SOLAR trial confirmed that 2-monthly VOCABRIA + REKAMBYS was non-inferior to regular daily oral therapy with BIC/FTC/TAF.[1]

    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).[1]

    *12% non-inferiority margin.[1]

Discover CARES:

A 96-week phase IIIb study comparing VOCABRIA + REKAMBYS with regular daily oral therapy in sub-Saharan Africa.[2]

  • View key outcomes from CARES

    Sustained efficacy, in diverse populations.

    Advancing HIV care means offering an effective treatment option that meets specific needs of people living with HIV.[7,8] The CARES clinical trial explored the efficacy of 2-monthly VOCABRIA + REKAMBYS in a population comprising a majority of Black, female and NNRTI-treatment experienced people living with HIV in Uganda, Kenya and South Africa.[2]

    The CARES primary endpoint was met: 2-monthly VOCABRIA + REKAMBYS was non-inferior to daily oral therapy at Week 48 (ITT-E: 96% [n=246/255] with plasma HIV-1 RNA <50 copies/mL vs 97% [n=250/257], respectively; adjusted difference = -0.8% [95% CI: -3.7%, 2.3%]; -10% non-inferiority margin).[9]

    Prescribing information for DOVATO (dolutegravir/lamivudine) can be found here

    *Participants in the daily oral therapy arm received once daily TDF + 3TC or FTC + DTG, NVP or EFV.[2]
†-10% non-inferiority margin.[2]

Discover ATLAS-2M*:

A large, phase IIIb, open-label, non-inferiority study investigating the efficacy, safety, and durability of VOCABRIA + REKAMBYS over 3 years.[3]

  • View key outcomes from ATLAS-2M

    Demonstrated durability, backed by 3-year data.

    For those navigating long-term HIV management, reliable, sustained efficacy is important.[8,10]

    87% of participants remained on and were virologically suppressed with 2-monthly VOCABRIA + REKAMBYS after 3 years in ATLAS-2M**[3]

    The ATLAS-2M primary endpoint was met: 2-monthly VOCABRIA + REKAMBYS was virologically (plasma HIV-1 RNA ≥50 copies/mL) non-inferior to monthly VOCABRIA + REKAMBYS at Week 48 (1.7% vs 1.0%, respectively).[3]

    *QM CABOTEGRAVIR + RILPIVIRINE is not available in the UK.

    **At the Week 152 data cutoff, 87% (n=452/522) of participants remained in the 2-monthly VOCABRIA + REKAMBYS arm; 13% (n=70/522) of participants discontinued the study of which 12% (n=65/522) were due to treatment withdrawal. The most common reason for treatment withdrawal in the 2-monthly arm was AEs (4% [n=23/522]).[3]

Learn more about the safety and tolerability profile of VOCABRIA + REKAMBYS

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Effectiveness of VOCABRIA + REKAMBYS was investigated in multiple studies of real-world cohorts, including: OPERA, COMBINE-2 C2C and RELATIVITY[4–6]

Discover OPERA:

A real-world cohort study assessing the effectiveness of VOCABRIA + REKAMBYS, across the US.[4]

  • View key outcomes from OPERA cohort

    High effectiveness, large US cohort.

    This large observational study demonstrates high effectiveness consistent with clinical trials, in the diverse, routine settings of the US.[4]

Discover COMBINE-2 C2C:

A real-world utilisation and effectiveness study of VOCABRIA + REKAMBYS.[5]

  • View key outcomes from COMBINE-2 C2C cohort

    High effectiveness, in a pan-European study.

    Extending the real-world evidence base, the COMBINE-2 C2C study demonstrated consistent effectiveness at Month 6, Month 12 and Month 24, within the diverse patient populations and clinical practices in Europe.[5]

Discover RELATIVITY:

A real-world cohort study of the effectiveness of VOCABRIA + REKAMBYS across diverse Spanish population.[6]

  • View key outcomes from RELATIVITY cohort

    Consistent effectiveness demonstrated over 13 months.

    The RELATIVITY study demonstrated that VOCABRIA + REKAMBYS was effective across a diverse real-world population of people living with HIV in Spain, showing effectiveness for a wide range of individuals with varying characteristics and lived experiences.[6]

    RELATIVITY primary endpoint was treatment effectiveness, defined as the proportion of patients discontinuing LAI therapy for any reason, including loss of virological suppression (HIV-RNA >50 copies/mL) during follow-up, regardless of formal failure criteria.

Learn more about the real-world impact of VOCABRIA + REKAMBYS on people living with HIV

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*QM CABOTEGRAVIR + RILPIVIRINE is not available in the UK

3TC=lamivudine; ABC=abacavir; ART=antiretroviral therapy; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; CI=confidence interval; DTG=dolutegravir; EFV=efavirenz; FTC=emtricitabine; HIV=human immunodeficiency virus; HIV-1=human immunodeficiency virus type 1; IQR=interquartile range; ITT-E=intention-to-treat exposed; mITT-E=modified intention-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; NVP=nevirapine; RNA=ribonucleic acid; TDF=tenofovir disoproxil fumarate.

References:

  1. 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.
  2. 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
  3. 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.
  4. Sension M, Hsu RK, Fusco JS, et al. Few differences in persistence and virologic outcomes across age groups among CAB+RPV LA users: Findings from the OPERA Cohort. Presented at: ID Week; October 19-22, 2025; Atlanta, Georgia, USA. Poster P-371.
  5. Pozniak A, Sridhar G, Assoumou L, et al. High Virologic Suppression and few Virologic Failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at: The 13th International AIDS Society (IAS) Conference; Kigali, Rwanda. Poster EP0171.
  6. Buzón-Martín L, Montes ML, Galindo Puerto MJ, et al. A prospective assessment of the efficacy and durability of long-acting cabotegravir and rilpivirine in individuals with HIV in Spain (RELATIVITY study). J Antimicrob Chemother. 2025. doi:10.1093/jac/dkaf389.
  7. Taramasso L, Andreoni M, Antinori A, et al. Pillars of long-term antiretroviral therapy success. Pharmacol Res. 2023;196:106898. doi: 10.1016/j.phrs.2023.106898.
  8. Kasten MJ. Primary Care of the Person Living with HIV. Pathogens. 2022 22;11(4):380. doi: 10.3390/pathogens11040380.
  9. Kityo C, Mambule IK, Musaazi J, et al. Switch to long-acting cabotegravir and rilpivirine in virologically suppressed adults with HIV in Africa (CARES): week 48 results from a randomised, multicentre, open-label, non-inferiority trial. Lancet Infect Dis. 2024;24(10):1083–1092. doi: 10.1016/S1473-3099(24)00289-5.
  10. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents With HIV. 2016. Available at: https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/treatment-goals. Accessed December 2025.

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-250007 | March 2026

Prescribing Information

Adverse event reporting

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.