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 Educational Program
Tuesday, May 30, 2023 1:15 PM EDT
Virtual Event

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

Calendar Icon

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 084
Read more »
Checkmark Icon

Confident

Adherence You can Confirm With as Few as 6 In-office Injections Per Year

Read more »
Chart Icon

Inclusive

The Most Diverse and Comprehensive Participant Population in HIV Prevention Trials Conducted to Date1,2*†

  • Designed to include the key populations impacted by HIV-11,2
    • 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
Read more »

*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. 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.

After optional oral lead-in and initiation injections given 1 month apart for 2 consecutive months.

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.

You may also be interested in

Patient Access
Patient support options are available for prescribed APRETUDE.
Get Patient Support →
Resources
View the resource library to get more information about APRETUDE.
Review Resources→
Get Updates
Sign up to get the latest updates from our APRETUDE & ViiV community.
Contact Us →
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 Practice

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

CBRWCNT210020

CBTWCNT210018

CBTWCNT220013