Photo portrait of a Caucasian man and transgender woman Photo portrait of a Caucasian man and transgender woman

Which PrEP did they choose?

Learn about patients’ choice of PrEP in the HPTN 083 open-label extension.1

HPTN=HIV Prevention Trials Network; PrEP=pre-exposure prophylaxis.

  • HPTN 083

    Trial design

    HPTN 083 (N=4,566) was a randomized, double-blind, controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC 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 TDF/FTC.2

    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 TDF/FTC.

    Primary endpoint: Incidence of HIV-1 infection

    The primary analysis (blinded phase) of HPTN 083 demonstrated the superiority of APRETUDE vs TDF/FTC.2

    • HIV-1 infections occurred 3x more with TDF/FTC vs APRETUDE

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

    Learn more about HPTN 083 efficacy

    Photo collage of 3 people

    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%).

    Learn more about HPTN 083 safety

    CI=confidence interval; ISR=injection-site reaction; TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

Patient choice data

When given the choice, 96% of participants selected APRETUDE over daily oral TDF/FTC in the HPTN 083 OLE1

Pie chart depicting APRETUDE open-label extension data
  • In the OLE, participants were offered the choice of APRETUDE or TDF/FTC
  • Of the 1,698 participants originally included from the US, 803 (47%) continued into the OLE and had regimen choice data available*
  • Individuals preferring an oral method of administration may not have chosen to enroll in HPTN 083

*Patients were told the results of the blinded part of the study, and based on this information, they provided their reason for choosing the regimen at the time of the HPTN 083 OLE entry.

Most participants selected APRETUDE based on preference for a route of administration1

  • Of those who chose TDF/FTC (n=33), the top reason given was “prefer pills and/or don’t like injections” (n=17)
Pie chart depicting APRETUDE open-label extension data
Pie chart depicting APRETUDE open-label extension data

Learn about dosing with APRETUDE

OLE=open-label extension.

Photo portrait of JT, a real patient on APRETUDE compensated by ViiV Healthcare Photo portrait of JT, a real patient on APRETUDE compensated by ViiV Healthcare

“With APRETUDE, now instead of taking a daily pill, I can go ahead and get a shot every 2 months.”

Watch JT talk about APRETUDE

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References:

  1. Clement ME, Wang Z, Fichternbaum C, et al. Pre-exposure prophylaxis product choice in United States participants in HPTN 083. Poster presented at: 30th Conference on Retroviruses and Opportunistic Infections; February 19-22, 2023; Seattle, WA.

  2. 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