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.
the first and only long-acting injectable PrEP option1
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
Adherence you can confirm with as few as 6 in-office injections per year1‡
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
*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.
"With CABENUVA injections, I feel a sense of independence from not having to take a pill at the same time every day and fearing that I missed it.
Instead of stressing about daily treatment, I can focus on treatment once a month. Even though it's just a few seconds a day to take a pill, I now don't have to remember to take my HIV treatment until my next appointment."
— Mark, clinical trial participant and patient ambassador
Patient experiences with CABENUVA after receiving 1 month of oral lead-in of cabotegravir and rilpivirine. Individual patient experiences are not indicative of all patient experiences or clinical trial results.
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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
Learn more about 2 of the most diverse and inclusive HIV prevention trials to date
Review risk and side effects information, including safety and tolerability data, for APRETUDE
Get information on dosing and administering APRETUDE, as well as potential drug interactions
- APRETUDE [package insert]. Research Triangle Park, NC: ViiV Healthcare; 2021.
- 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
- 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.