EFFICACY

Confirmed virologic failure

Low virologic failure rate with VOCABRIA + REKAMBYS as demonstrated in clinical trials and real-world settings[1–6]

Low rates of virologic failure seen in clinical trials and real-world cohorts[1–6]

Most people who experienced virologic failure, re-suppressed on single tablet regimens, including INSTIs[1,2,5,6]

Low incidence of CVF among participants with previous viral blips or LLV[7]

Low virologic failure rate in clinical trials

CVF definitions

SOLAR and ATLAS-2M: two consecutive viral load measurements of HIV-1 RNA ≥200 copies/mL.[1,3]
 CARES: two consecutive viral load measurements of HIV-1 RNA ≥200 copies/mL, taken 4–6 weeks apart.[2]

*mITT-E population: n=2; ITT-E population: n=1 (excluded from the mITT-E population due to critical findings related to non-compliance to protocol entry requirements at one study site).[1]
†Participants in the daily oral therapy arm received once daily TDF + 3TC or FTC + DTG, NVP or EFV.[2]
#QM CABOTEGRAVIR + RILPIVIRINE is not available in the UK

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).[2]

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

The ATLAS‑2M primary endpoint was met: 2-monthly VOCABRIA and REKAMBYS was non-inferior to 1M VOCABRIA and REKAMBYS at Week 48 (ITT-E: 2% [n=9/522] with plasma HIV‑1 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]

Low virologic failure rate in real-world settings

CVF definitions

OPERA and COMBINE-2 C2C: two viral load measurements of HIV-1 RNA ≥200 copies/mL or one viral load measurement of HIV-1 RNA ≥200 copies/mL and discontinuation within 4 months.[4,5,9]
RELATIVITY: In an attempt to reflect heterogeneity in clinical practice, no definition of virological failure or a concrete follow-up pattern were imposed on investigators in the RELATIVITY cohort study.[6]

*CVF is reported in participants with ≥1 follow-up viral load measurement.[4,5]

Find out more about the efficacy and effectiveness of VOCABRIA + REKAMBYS in clinical trials and real-world studies

Most people living with HIV who experienced CVF, re-suppressed on single tablet regimens

Re-suppression regimens following CVF

The frequency of viral blips was similar with both VOCABRIA + REKAMBYS and oral ART, and viral blips were not associated with CVF[7]

A pooled, post hoc analysis of phase III/IIIb VOCABRIA + REKAMBYS clinical trials (N=2,506) through 12 months demonstrated similar rates of, and outcomes following, viral events* with both VOCABRIA + REKAMBYS and daily oral therapy.†[7]

CVF with previous viral blips:
VOCABRIA + REKAMBYS: n=0/97
Daily oral therapy: n=1/61

CVF with previous LLV:
VOCABRIA + REKAMBYS: n=1/18
Daily oral therapy: n=0/1

CVF definitions

CVF defined as two consecutive viral load measurements of HIV-1 RNA ≥200 copies/mL.[7]
Viral blip defined as a single viral load measurement between 50 and <200 copies/mL, with adjacent measurements of <50 copies/mL.[7]
LLV defined as ≥2 consecutive viral load measurements between 50 and <200 copies/mL.[7]

*Incidence of viral events were analysed in participants receiving VOCABRIA + REKAMBYS (n=1,692) vs daily oral therapy (n=814) in FLAIR (Week 48), ATLAS (Week 48), ATLAS 2M (Week 48) and SOLAR (Month 12). Viral load assessments were completed monthly in FLAIR and ATLAS, and every-2-months in ATLAS-2M and SOLAR.[7]
†Oral regimens were: DTG/ABC/3TC (n=283; FLAIR [participants with side effects to this therapy, or who were positive for HLAB*5701, received DTG + 2 non-ABC NRTIs]), BIC/FTC/TAF (n=223; SOLAR), and various standard oral therapies (n=308; ATLAS).[7]

Discover why more than 90% of people living with HIV chose a complete long-acting regimen over daily oral therapy in the SOLAR study

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3TC=lamivudine; ABC=abacavir; BIC/FTC/TAF=bictegravir/emtricitabine/tenofovir alafenamide; CVF=confirmed virologic failure; DTG=dolutegravir; EFV=efavirenz; FTC=emtricitabine; HIV=human immunodeficiency virus; HIV-1=human immunodeficiency virus type 1; INSTI=integrase strand transfer inhibitor; IQR=interquartile range; ITT-E=intention-to-treat exposed; LLV=low-level viraemia; mITT-E=modified intention-to-treat exposed; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; NVP=nevirapine; PI=protease inhibitor; 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. doi: 10.1093/cid/ciad020.
  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. Thornhill J, Garside L, Okoli C, et al. Similar Virologic Outcomes and Frequency of Isolated Viraemic Events (Blips, Low-Level Viraemia and Suspected Virologic Failure) Between Oral and Long-Acting Antiretroviral Therapy: A Pooled Analysis of Phase 3/3b Cabotegravir + Rilpivirine Long-Acting Studies. Presented at: HIV Drug Therapy Glasgow; November 10–13, 2024; Glasgow, Scotland. Poster P040
  8. VOCABRIA (cabotegravir) 600 mg suspension for injection Summary of Product Characteristics (SmPC).
  9. ViiV Healthcare Non-Interventional Study Protocol. C2C: COMBINE-2 for Cabotegravir+Rilpivirine LA Regimen – A Prospective Cohort Study to Monitor Effectiveness, Adherence and Resistance. Available at: https://catalogues.ema.europa.eu/sites/default/files/document_files/viiv-215160-protocol-orig-redact.pdf. 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.