For HIV-1–negative, at-risk adults and adolescents weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1. See full Indication.

Efficacy

APRETUDE was studied in 2 of the most diverse, comprehensive HIV-1 prevention trials (HPTN 083 and HPTN 084) to date. Together, these 2 trials included approximately 8000 participants from around the world in cooperation with the National Institute of Allergy and Infectious Diseases through the HPTN.1,2 Click below to see the trial design and efficacy and safety results.

Designed to include key populations who are disproportionately impacted by HIV1-4

• All study participants were at high risk for acquiring HIV through sex1,2

HPTN 083

HPTN 083

Cisgender men and transgender women who have sex with men
Noninferiority trial with the prespecified ability to test for superiority
• 43 sites around the world (N=4566)1

Gender and sexuality1:
- 87% of participants were MSM
- 13% were TGW

Age1
- 68% were <30 years old

Race1
- 50% in the US were Black/African American

HPTN 084

HPTN 084

Cisgender women 
Superiority trial
• 20 sites around sub-Saharan Africa (N=3224)2

Age2
- 50% were <25 years old

Other characteristics2
- 55% had ≥2 sex partners

HPTN=HIV Prevention Trials Network; MSM=men who have sex with men; PrEP=pre-exposure prophylaxis; TGW=transgender women.

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 December 8, 2022. 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 December 8, 2022. 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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