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APRETUDE OFFERED MORE POWERFUL HIV PROTECTION

VS TRUVADA in HPTN 084 study in cisgender women

HPTN=HIV Prevention Trials Network.

  • Trial design and primary endpoint

    Randomized, double-blind, active-controlled superiority trial of the safety and efficacy of APRETUDE vs daily oral TRUVADA1

    APRETUDE HPTN 084 trial design and primary endpoint chart.

    Primary endpoint: Incidence of HIV-1 infection

    Selected inclusion criteria1:

    • HIV-1 negative at screening and enrollment
    • 18 to 45 years old
    • At risk of sexually acquiring HIV-1 infection
    • Negative pregnancy test
    • Use of long-acting contraception

    Selected exclusion criteria1:

    • History of liver disease
    • Pregnant or currently breastfeeding

    *Oral lead-in up to 5 weeks. Study arms included: TRUVADA (300-mg TDF/200-mg FTC) tablet once daily and oral APRETUDE placebo once daily; oral APRETUDE (30-mg) tablet once daily and TRUVADA placebo once daily.

    †Optional oral lead-in, if used, should be taken for at least 28 days.

    TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

  • Selected baseline characteristics

    One of the largest and most diverse prevention studies in cisgender women1-3

    APRETUDE HPTN 084 baseline characteristics table.

    ‡All participants were assigned female sex at birth; 2 identified as transgender male; 3 identified as male.1

    BMI=body mass index; IQR=interquartile range.

SUPERIOR HIV PROTECTION VS TRUVADA IN HPTN 084

Fewer HIV-1 acquisitions
  • Primary endpoint: 90% reduction in the risk of acquiring HIV-1 with APRETUDE (0.15/100 person-years) vs TRUVADA (1.85/100 person-years) (HR [95% CI]: 0.10 [0.04-0.27]; P<0.0001)
  • At the primary analysis, 99.8% of people in the APRETUDE arm and 97.8% of people in the TRUVADA arm remained negative

99.8% of people on APRETUDE remained negative

APRETUDE HPTN 084 fewer HIV-1 acquisitions graphic.

CI=confidence interval; HR=hazard ratio.

  • Seroconversion breakdown

    Infographic of APRETUDE HPTN 084 seroconversion breakdown.

    §Participants did not receive APRETUDE injections.1

    “On-time” was defined as target date ±7 days.4

THE APRETUDE CLINICAL TRIALS WERE STOPPED EARLY DUE TO HIGH EFFICACY VS TRUVADA1,5,6

  • The independent Data and Safety Monitoring Board recommended the study sponsor stop the blinded phase of the trials and share the results6,7

  • According to protocol amendments, study participants were given a choice between either open-label APRETUDE or TRUVADA following the unblinded phase7,8
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Choose the powerful HIV protection of APRETUDE for your patients

See HPTN 084 safety data

CONSISTENT PROTECTION ACROSS PATIENT GROUPS IN HPTN 084

APRETUDE HPTN 084 HIV acquisitions of prespecified subgroups graphic.

The results from these prespecified subgroup analyses were consistent with the overall protective effect of APRETUDE

RESISTANCE DATA

APRETUDE vs. TRUVADA HPTN 084 resistance data table.

HIV-1 RNA testing may allow for earlier detection of HIV, potentially reducing the risk of resistance while on PrEP8

#M184V.

INSTI=integrase strand transfer inhibitor; NRTI=nucleoside/nucleotide reverse transcriptase inhibitor; RAM=resistance-associated mutation.

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APRETUDE has been studied in diverse clinical and real-world populations

Review studies

PMUS-CBTWCNT250019

References:

  1. 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

  2. TRUVADA. Prescribing information. Gilead Sciences, Inc.; 2023.

  3. DESCOVY. Prescribing information. Gilead Sciences, Inc.; 2022.

  4. Data on file. ViiV Healthcare.

  5. 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

  6. HPTN 084 study demonstrates superiority of CAB LA to oral TDF/FTC for the prevention of HIV. News release. The HIV Prevention Trials Network. November 19, 2020. Accessed January 26, 2024. https://www.hptn.org/news-and-events/press-releases/hptn-084-study-demonstrates-superiority-of-cab-la-to-oral-tdfftc-for

  7. Global HIV prevention study to stop early after ViiV Healthcare’s long-acting injectable formulation of cabotegravir dosed every two months shows higher efficacy than daily oral PrEP. News release. ViiV; May 18, 2020. Accessed October 12, 2023. https://viivhealthcare.com/en-us/media-center/news/press-releases/2020/may/global-hiv-prevention-study-to-stop-early-after-viiv-healthcares

  8. HIV Prevention Trials Network. HPTN 084: A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women (protocol version 5.0; October 6, 2023). Accessed February 29, 2024. https://www.hptn.org/research/studies/hptn084

  9. Eshleman S, Fogel JM, Halvas EK, et al. CAB-LA PrEP: Early detection of HIV infection may reduce INSTI resistance risk. Abstract presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Accessed March 1, 2024. https://www.croiconference.org/abstract/cab-la-prep-early-detection-of-hiv-infection-may-reduce-insti-resistance-risk