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APRETUDE HAS BEEN STUDIED IN DIVERSE CLINICAL AND REAL-WORLD POPULATIONS

STUDIED IN DIVERSE CLINICAL AND REAL-WORLD POPULATIONS

  • Registrational trials

    Registrational trials

    HPTN 083 (N=4566)1

    • Safety and efficacy of APRETUDE vs TRUVADA for HIV prevention in cisgender men and transgender women
    • 87% CGM, 13% TGW; 18% Latinx (in the US), 50% Black (in the US)

    HPTN 084 (N=3224)2

    • Safety and efficacy of APRETUDE vs TRUVADA for HIV prevention in cisgender women
    • >99% CGW; 97% Black
    Special populations

    HPTN 083-01 and HPTN 084-01 (Adolescents) (N=62)

    • Safety of APRETUDE in adolescents
    • 12 to <18 years of age, weighing ≥35 kg

    HPTN 084 OLE (Pregnancy) (N=325)3

    • Initial evaluation of APRETUDE safety during pregnancy
    • 100% CGW

    Because insufficient data exist to adequately assess risk, APRETUDE should only be used in pregnancy if the expected benefit outweighs the potential risks to the fetus.

  • Real-world evidence/implementation studies

    Real-world evidence/implementation studies

    OPERA (N=764)4

    • On-time dosing, HIV testing, and HIV incidence with APRETUDE
    • 13% CGW; 29% Black, 29% Hispanic

    MHS San Francisco (N=111)5

    • Retention and adherence with APRETUDE in an urban safety-net clinic
    • 65% CGM, 19% CGW, 5% TGW, 10% Nonbinary

    UC San Diego (N=187)6

    • Implementing APRETUDE in a large, academic, hospital-based, urban HIV clinic
    • 91% CGM, 9% CGW; 47% White, 3% Black, 32% Mixed/other, 40% Hispanic

    Howard Brown (N=270)7

    • Clinical characteristics and outcomes of APRETUDE at a large PrEP clinic in the Midwest
    • 80% CGM, 9% TGW, 6% Nonbinary; 3% CGW, 2% TGM; 37% Non-Hispanic White, 25% Non-Hispanic Black, 24% Hispanic, 6% Asian, 6% Multiracial, 6% Not reported

    CAN Community Health Network (N=155)8

    • Retention with APRETUDE in 26 outpatient clinics in the US
    • 76% CGM, 17% CGW, 1% TGM, 3% TGW, 3% Other; 29% White, 34% Black, 21% Hispanic, 4% Not provided

    TRIO (N=526)9

    • APRETUDE utilization over the first 5 years of US availability, including adherence, persistence, HIV incidence, and safety of APRETUDE
    • 77% CGM, 14% CGW, 9% Transgender; 48% White, 32% Black, 13% Other, 7% Unknown

    PILLAR (N=201)10

    • Characterization of patient experiences with APRETUDE
    • 94% MSM, 6% TGM; 23% Black, 69% Not Black, 9% Missing/unknown, 39% Hispanic, 60% Not Hispanic, <2% Missing/unknown

    EBONI (N=92)11

    • Assessment of HCP perceptions when identifying, counseling, and supporting APRETUDE use in Black women
    • 28% CGM, 57% CGW, 7% Other, 8% Prefer not to answer, 1% Nonbinary; 44% Black

    Kaiser Permanente (N=180)12

    • Retention and adherence with APRETUDE in two large integrated healthcare systems
    • 92% CGM, 7% CGW, 1% Unknown; 30% White, 19% Black, 34% Hispanic, 11% Other, 6% Unknown

    Whitman-Walker Health (N=129)13

    • Retention with APRETUDE in an urban PrEP clinic
    • 52% White, 30% Black, 22% Hispanic; 81% MSM, 11% TGW, 1% CGW

Talk to a ViiV Healthcare resource to learn more about the real-world studies of APRETUDE

Speak to a resource

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Review safety data from HPTN 083 and HPTN 084

See the data

PMUS-CBTWCNT250019

References:

  1. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016

  2. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022;399(10337):1779-1789. doi:10.1016/S0140-6736(22)00538-4

  3. Delany-Moretlwe S; HPTN 084 Study Team. Initial evaluation of injectable cabotegravir (CAB-LA) safety during pregnancy in the HPTN 084 open-label extension. Presented at: IAS; July 25, 2024.

  4. Mills AM, Brunet L, Frost KR, et al. Real world data on on-time dosing, HIV testing and HIV acquisition from the OPERA cohort. Presented at IDWeek; October 19, 2024. https:///www.natap.org/2024/IDWeek/IDWeek_20.htm

  5. Heise MJ. High retention and adherence with rapid long-acting injectable PreP implementation in an urban safety-net clinical population. Presented at HIVR4P; October 6-10, 2024. https://www.natap.org/2024/HIVR4P/HIVR4P_28.htm

  6. Turner C, Wagner GA, Pfeil A, et al. Implementing long-acting cabotegravir for HIV PrEP in a large academic hospital-based urban HIV clinic. Presented at HIVR4P; October 6-10, 2024. https://www.natap.org/2024/HIVR4P/HIVR4P_10.htm

  7. Hazra A, Schneider J, Murray M, et al. Insurance type drives cabotegravir delays: real-world long-acting PrEP outcomes in the Midwest US. Poster presented at CROI; March 3-6, 2024. https://www.croiconference.org/wp-content/uploads/sites/2/posters/2024/1241.pdf

  8. Altamirano A, Shukla P, Barnett SK. Early real-world experience of long-acting cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP) in a large community-based clinic network (CAN Community Health): utilization and PrEP persistence. Poster presented at: OFID; October 13, 2023.

  9. Ramgopal M, Brown C, Frick A, et al. Real-world use of cabotegravir long-acting for pre-exposure prophylaxis (PrEP): data from Trio Health cohort. Presented at IDWeek; October 16-19, 2024. https://ViiVhcmedinfo.com/medical-congress/idweek-2024/

  10. Holder H, et al. Patient Experiences at Month 6 after Initiation of Cabotegravir Long-Acting (CAB LA) for PrEP in the First Male Gender Concordant Implementation Science Trial (PILLAR) in the US. Poster presented at IDWeek; October 18, 2024.

  11. Baker DM, Nelson KL, Mocherla S, et al. Change in healthcare professionals’ identification, counseling, and adherence with black women for long-acting cabotegravir (CAB LA) for PrEP across women’s health, primary care, and infectious disease states: findings from the EBONI study. Poster presented at IDWeek; October 19, 2024. https://www.natap.org/2024/IDWeek/IDWeek_18.htm

  12. Traeger M, Leyden W, Volk J, et al. Long-acting cabotegravir PrEP uptake and persistence in a large U.S. Healthcare system. Presented at: CROI; March 12, 2025. https://www.natap.org/2025/CROI/croi_38.htm

  13. Patel RR, Golden M, Eric Kelley, et al. Feasibility of long-acting injectable cabotegravir PrEP initiation and administration by community health workers and early aspects of the PrEP injection care continuum in a primary care center in Washington, D.C. Presented at: IAS; 23-26 July 2023. https://www.prepwatch.org/resources/feasibility-of-long-acting-injectable-cabotegravir-prep-initiation-and-administration-by-community-health-workers-and-early-aspects-of-the-prep-injection-care-continuum-in-a-primary-care-center-in-wa/