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 is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart. Adherence to the dosing schedule is strongly recommended.

APRETUDE is

the first and only long-acting injectable PrEP option1

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SUPERIOR

Significantly lower incidence of HIV-1 infection vs daily oral PrEP proven in 2 double-blind clinical trials1-3*†

  • 69% (P=0.0003) and 90% (P<0.0001) lower incidence of HIV-1 infection in HPTN 083 and HPTN 084
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CONFIDENT

Adherence you can confirm with as few as 6 in-office injections per year1‡

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INCLUSIVE

The most diverse and comprehensive participant population in HIV prevention trials conducted to date1-3*†

  • Designed to include the key populations impacted by HIV-12,3
    • 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 Latinx people
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*HPTN 083 (N=4566) was a randomized, double-blind, placebo-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 have evidence of high-risk behavior for HIV-1 infection. The primary endpoint was the rate of incident HIV-1 infections among participants randomized to daily oral cabotegravir and intramuscular injections of APRETUDE every 2 months compared with daily oral TDF/FTC (corrected for early stopping). The trial included the prespecified ability to test for superiority of APRETUDE over TDF/FTC.1 The primary analysis showed a 66% reduction in the risk of acquiring HIV-1 infection, hazard ratio (95% CI) 0.34 (0.18, 0.62). Further testing revealed 1 of the infections on APRETUDE to be prevalent yielding a 69% reduction in the risk of HIV-1 incident infection relative to TDF/FTC, hazard ratio (95% CI) 0.31 (0.16-0.58); incidence rate 0.37/100 person-years vs 1.22/100 person-years for TDF/FTC.

HPTN 084 (N=3224) was a randomized, double-blind, placebo-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 the rate of incident HIV-1 infections among participants randomized to oral cabotegravir and injections of APRETUDE compared with oral TDF/FTC (corrected for early stopping). The primary analysis showed an 88% reduction in the risk of acquiring HIV-1 infection, hazard ratio (95% CI) 0.12 (0.05, 0.31). Further testing revealed 1 of the infections on APRETUDE to be prevalent yielding a 90% reduction in the risk of HIV-1 incident infection relative to TDF/FTC, hazard ratio (95% CI) 0.10 (0.04-0.27); APRETUDE incidence rate 0.15/100 person-years vs 1.85/100 person-years for TDF/FTC.1

After optional oral lead-in and initiation injections.1

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.

CI=confidence interval; FTC=emtricitabine; HPTN=HIV Prevention Trials Network; TDF=tenofovir disoproxil fumarate.

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"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?

For Your Practice

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Clinical Trials

Learn more about 2 of the most diverse and inclusive HIV prevention trials to date

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Safety

Review risk and side effects information, including safety and tolerability data, for APRETUDE

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Dosing

Get information on dosing and administering APRETUDE, as well as potential drug interactions

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References:

  1. APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021. 
  2. Landovitz RJ, Donnell D, Clement C, et al; for the HPTN 083 Study Team. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385:595-608. doi:10.1056/NEJMoa2101016 
  3. Delany-Moretlwe S; HPTN 084 Study Team. Long acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: interim results from HPTN 084. Presented at: HIV R4P Virtual Conference; January 27, 2021. Abstract LB1479.

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