EFFICACY

Efficacy summary

Rely on the proven efficacy and real-world effectiveness of VOCABRIA + REKAMBYS for long-term virologic suppression[1–6]

Comparable efficacy vs daily regular oral therapy, including BIC/FTC/TAF[1,2]

Long-term, proven and durable efficacy, up to 3 years, across diverse populations and settings[1–3]

Consistent effectiveness in real-world studies[4–6]

~30,000 people living with HIV have received VOCABRIA + REKAMBYS across clinical trials and real-world cohorts*[7]

3,436 people living with HIV in Phase II/III/IIIb studies

29,902 people living with HIV in real-world cohorts

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

High rates of virologic suppression across clinical trials and real-world settings[1–6]

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]

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).[8]

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

The ATLAS-2M primary endpoint was met: 2-monthly VOCABRIA + REKAMBYS was non-inferior to 1M VOCABRIA + REKAMBYS at week 48 (ITTE: 2% (n=9/522) with plasma HIV RNA ≥50 copies /mL vs 1% (n=5/523), respectively; adjusted difference 0.8% (95% CI: -0.6% to 2.2%); 4% non-inferiority margin).[3]

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

‡For OPERA and COMBINE-2 C2C, virologic suppression rate is for last plasma HIV-1 RNA <50 copies/mL (in participants with ≥1 follow-up viral load measurement in OPERA).[4,5]
§Individuals with follow-up viral load of plasma HIV-1 RNA <50 copies/mL at each timepoint: 96.5% (n=1827) at Month 3, 96.6% (n=1163) at Month 5, 97.7% (n=1275) at Month 7, 96.4% (n=947) Month 9, 97.0% (n=831) at Month 13, 97.2% (n=537) at Month 15, 96.7% (n=422) at Month 17, 96.5% (n=376) at Month 19, 100% (n=73) at Month 23, and 96.5% (n=1872) at Month 25.[6]

Learn more about the efficacy and effectiveness of VOCABRIA + REKAMBYS from clinical trials and real-world cohorts

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3TC=lamivudine; ABC=abacavir; 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; 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. Data on File. Number of people with HIV that have received VOCABRIA + REKAMBYS in clinical trials and real-world studies. November 2025. REF-300078. ViiV Healthcare group of companies.
  8. 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.

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.