Portrait of a Black man with a beard on a purple background

In both open-label extensions of the HPTN 083 and HPTN 084 trials,

SEE WHICH PrEP OPTION MOST PATIENTS CHOSE BETWEEN APRETUDE AND TRUVADA

HPTN=HIV Prevention Trials Network.

  • HPTN 083

    Trial design

    HPTN 083 (N=4566) was a randomized, double-blind, controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TRUVADA for HIV-1 prevention in adult cisgender men and transgender women who have sex with men. The trial included the prespecified ability to test for superiority of APRETUDE over TRUVADA.1

    After the blinded and unblinded phases of HPTN 083 were completed, participants were given the option of continuing into the open-label extension, where they could choose to receive either APRETUDE or TRUVADA.

    Primary endpoint: Incidence of HIV-1 infection

    The primary analysis (blinded phase) of HPTN 083 demonstrated the superiority of APRETUDE vs TRUVADA.1

    • HIV-1 infections occurred >3X more with TRUVADA vs APRETUDE

    • 69% reduction in the risk of acquiring HIV-1 infection with APRETUDE (0.37/100 person-years) vs TRUVADA (1.22/100 person-years) (hazard ratio [95% CI]: 0.31 [0.16-0.58]; P=0.0003)

    HPTN 083 efficacy

    Portrait of a Black man, a Caucasian man, and a Black woman

    The most common adverse reactions (all grades) observed in at least 1% of subjects receiving APRETUDE in the blinded phase of HPTN 083 were ISRs (82%), diarrhea (4%), headache (4%), pyrexia (4%), fatigue (4%), sleep disorders (3%), nausea (3%), dizziness (2%), flatulence (1%), and abdominal pain (1%).

    HPTN 083 safety

    CI=confidence interval; ISR=injection-site reaction.

PATIENT CHOICE DATA IN HPTN 083

When given the choice in the HPTN 083 open-label extension, nearly all participants selected APRETUDE over TRUVADA2

HPTN 083 patient choice data for APRETUDE versus TRUVADA
  • Participants were told the results of the blinded study phase and offered the choice of APRETUDE or TRUVADA2,3
  • Of the 1698 participants originally included from the US, 803 (47%) continued into the open-label extension and had regimen choice data available2
  • Individuals preferring an oral method of administration may not have chosen to enroll in HPTN 0832

Help patients consider all available PrEP options

  • HPTN 084

    Trial design

    HPTN 084 (N=3224) was a randomized, double-blind, active-controlled superiority trial of the safety and efficacy of APRETUDE vs daily oral TRUVADA for HIV prevention in cisgender women.4

    After the blinded and unblinded phases of HPTN 084 were completed, participants were given the option of continuing into the open-label extension, where they could choose to receive either APRETUDE or TRUVADA.4

    Primary endpoint: Incidence of HIV-1 infection

    The primary analysis (blinded phase) of HPTN 084 demonstrated the superiority of APRETUDE vs TRUVADA.

    • HIV-1 infections occurred 12X more with TRUVADA vs APRETUDE

    • 90% reduction in the risk of acquiring HIV-1 infection with APRETUDE (0.15/100 person-years) vs TRUVADA (1.85/100 person-years) (hazard ratio [95% CI]: 0.10 [0.04-0.27]; P<0.0001)

    HPTN 084 efficacy

    Portrait of two Black women on a purple background

    The most common adverse reactions (all grades) observed in at least 1% of subjects receiving APRETUDE in the blinded phase of HPTN 084 were ISRs (38%), headache (12%), nausea (4%), dizziness (4%), diarrhea (4%), upper respiratory tract infection (4%), fatigue (3%), vomiting (2%),  decreased appetite (2%), abdominal pain (2%), somnolence (2%), myalgia (2%), rash (2%), sleep disorders (1%), and back pain (1%).

    HPTN 084 safety

PATIENT CHOICE DATA IN HPTN 084

When given the choice in the HPTN 084 open-label extension, most participants selected APRETUDE over TRUVADA3

HPTN 084 patient choice data for APRETUDE versus TRUVADA
  • Participants were told the results of the blinded study phase and offered the choice of APRETUDE or TRUVADA5
  • Of the 3028 participants originally included from 7 countries in sub-Saharan Africa, 2472 (81%) continued into the open-label extension and had regimen choice data available3
  • Individuals preferring an oral method of administration may not have chosen to enroll in HPTN 0845

Help patients consider all available PrEP options

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Watch JT's story about his PrEP journey and decision to start taking APRETUDE.

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Compensated by ViiV Healthcare.

PMUS-CBTWCNT240041

References:

  1. Landovitz RJ, Donnell D, Clement ME, et al; HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016
  2. Clement ME, Zhe W, Fichtenbaum C, et al. Pre-exposure prophylaxis product choice in US participants in HPTN 083. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 19-22, 2023; Seattle, Washington. Accessed March 1, 2024. https://www.croiconference.org/abstract/pre-exposure-prophylaxis-product-choice-in-us-participants-in-hptn-083
  3. 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 February 9, 2024. https://viivhealthcare.com/en-us/media-center/news/press-releases/2020/may/global-hiv-prevention-study-to-stop-early-after-viiv-healthcares
  4. 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
  5. HPTN 084 Study Demonstrates Superiority of CAB LA to Oral TDF/FTC for the Prevention of HIV in cisgender women in sub-Saharan Africa. HIV Prevention Trials Network. Accessed January 26, 2024. https://www.hptn.org/sites/default/files/inline-files/HPTN%20084%20DSMB%20FAQ_V1.0_8Nov2020_0.pdf