APRETUDE is administered as an intramuscular injection by an HCP every 2 months after 2 initiation injections administered 1 month apart. Adherence to the dosing schedule is strongly recommended.
INDICATION
APRETUDE is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.

APRETUDE: the first and only long-acting injectable PrEP option

SUPERIOR

Significantly lower incidence of HIV-1 infection vs a daily oral PrEP (TDF/FTC) proven in 2 double-blind clinical trials1,2*†

  • 69% (P=0.0003) and 90% (P<0.0001) lower incidence of HIV-1 infection in HPTN 083 and HPTN 0841,2
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CONFIDENT

Adherence you can confirm with as few as 6 in-office injections per year

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INCLUSIVE

The most diverse and comprehensive participant population in HIV prevention trials conducted to date

  • Designed to include the key populations impacted by HIV-11-4

Trials included cisgender men and transgender women who have sex with men, and cisgender women, with the majority under age 30. In the US, trials included Black/African American and Latino people1

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*HPTN 083 (N=4566) was a randomized, double-blind, active-controlled noninferiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in HIV-1–uninfected men and transgender women who have sex with men and who have evidence of high-risk behavior for HIV-1 infection. The primary endpoint was rate of incident HIV-1 infection. The trial included the prespecified ability to test for superiority of APRETUDE over TDF/FTC.

HPTN 084 (N=3224) was a randomized, double-blind, active-controlled superiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in adult, uninfected, cisgender women at risk of acquiring HIV-1. The primary endpoint was rate of incident HIV-1 infection.

After optional oral lead-in and initiation injections.

3TC=lamivudine; ABC=abacavir; ARV=antiretroviral; CI=confidence interval; DTG=dolutegravir; FDA=Food and Drug Administration; HBV=hepatitis B virus; HLA-B=human leukocyte antigen complex B; INSTI=integrase strand transfer inhibitor; ITT-E=intent-to-treat efficacy; NNRTI=non-nucleoside reverse transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor; PI=protease inhibitor.

HPTN=HIV Prevention Trials Network; PrEP=pre-exposure prophylaxis; TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

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Patient Access
Patient support options are available for prescribed APRETUDE.
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Not actual patient.
"I try to take my PrEP regularly since I don't always know the history of my partners. Sometimes I don't have it with me, so I don't always take it daily like I should. I worry I'm not as protected as I should be. Is there another option?"
Do you have someone like this in your practice on PrEP?
Not actual patient
Not actual patient.

For your medical practice

Clinical Trials
Learn more about 2 of the most diverse and inclusive HIV prevention trials to date.​ 1,2
View Studies →
Safety
Review risk and side effect information, including safety and tolerability data, for APRETUDE
Review Safety Info →
Dosing
Get information on dosing and administering APRETUDE, as well as potential drug interactions
Learn More →

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. Delany-Moretlwe S, Hughes JP, Bock P, et al; HPTN 084 study group. 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. HIV diagnoses. Centers for Disease Control and Prevention. Updated October 28, 2022. Accessed March 3, 2023. https://www.cdc.gov/hiv/
    statistics/overview/in-
    us/diagnoses.html
  4. In Danger: Global AIDS Update 2022. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2022. Accessed March 3, 2023. https://www.unaids.org/en/
    resources/documents/2022
    /in-danger-global-aids-update

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. Delany-Moretlwe S, Hughes JP, Bock P, et al; HPTN 084 study group. 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. HIV diagnoses. Centers for Disease Control and Prevention. Updated October 28, 2022. Accessed March 3, 2023. https://www.cdc.gov/hiv/statistics/overview/in-us/diagnoses.html
  4. In Danger: Global AIDS Update 2022. Joint United Nations Programme on HIV/AIDS (UNAIDS); 2022. Accessed March 3, 2023. https://www.unaids.org/en/resources/documents/2022/in-danger-global-aids-update

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