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HPTN 084 clinical trial

A clinical trial in cisgender women.

HPTN=HIV Prevention Trials Network.

  • HPTN 084 Trial Design

    Flowchart depicting APRETUDE trial design

    Primary endpoint: Incidence of HIV-1 infection

    HPTN 084 (N=3,224) was a randomized, double-blind, controlled superiority trial of the safety and efficacy of APRETUDE compared with daily oral TDF/FTC for HIV-1 prevention in adult cisgender women.1

    Selected inclusion criteria1:

    • Cisgender women, 18 to 45 years old
    • HIV-1 negative at screening and enrollment
    • At risk of sexually acquiring HIV-1 infection
    • Negative pregnancy test
    • Use of long-acting contraception

    Selected exclusion criteria:

    • History of liver disease1,2
    • Pregnant or currently breastfeeding1

    *Oral lead-in up to 5 weeks. Study arms included: TDF/FTC (300-mg TDF/200-mg FTC) tablet once daily and oral cabotegravir placebo once daily; oral cabotegravir (30-mg) tablet once daily and TDF/FTC placebo once daily.

    †Optional oral lead-in, if used, should be taken for at least 28 days.
    TDF/FTC=tenofovir disoproxil fumarate/emtricitabine.

  • HPTN 084 Selected Baseline Characteristics¹

    Table depicting baseline characteristics in HPTN 084
    • At baseline, >99% of participants were non-white cisgender women and ~50% were <25 years of age1

    ‡All participants were assigned female sex at birth; 2 identified as transgender male; 3 identified as male.1

    BMI=body mass index; IQR=interquartile range.

HPTN 084 Efficacy

In a clinical study (double-blind phase)

APRETUDE delivered superior efficacy with significantly lower incidence of HIV-1 infection vs a daily oral PrEP (TDF/FTC)

Image depicting APRETUDE efficacy Image depicting APRETUDE efficacy

Incident HIV-1 infections

  • TDF/FTC: 36 in 1,946 person-years (1.85/100 person-years)

  • APRETUDE: 3§ in 1,960 person-years (0.15/100 person-years)

  • Hazard ratio (95% CI): 0.10 (0.04-0.27); P<0.0001

Resistance

  • Of the infections in the APRETUDE arm, no major INSTI resistance-associated mutations (RAMs) were detected
  • Of the incident infections in the TDF/FTC arm, NRTI RAMs were detected in 1 of the participants3

§An initial analysis showed 4 incident infections in the APRETUDE arm (hazard ratio [95% CI]: 0.12 [0.05-0.31]). Retrospective testing showed 1 of the 4 to be a prevalent infection, resulting in 3 incident infections.

CI=confidence interval; INSTI=integrase strand transfer inhibitor; NRTI=nucleoside/nucleotide reverse transcriptase inhibitor; PrEP=pre-exposure prophylaxis.

Cumulative incidence of HIV-1 infections in HPTN 084

Cumulative events are the overall number of HIV infections in each arm over time.4

Graph depicting APRETUDE efficacy in HPTN 084

See HPTN 084 safety data

  • HPTN 084 Trial Subgroups

    Based on an analysis of prespecified subgroups and populations

    APRETUDE demonstrated a consistent protective benefit across age and BMI groups vs
a daily oral PrEP (TDF/FTC)

    Incidence of HIV-1 infection by age

    Table depicting APRETUDE efficacy by age subgroups

    Incidence of HIV-1 infection by BMI

    Table depicting APRETUDE efficacy by body mass index (BMI) subgroups

HPTN 084 Resistance Profile

Resistance mutations3

Table depicting APRETUDE resistance mutations
  • No resistance-associated mutations (RAMs) were detected in participants receiving APRETUDE3
  • Of the infections in the APRETUDE arm, no major INSTI RAMs were detected
  • Of the incident infections in the TDF/FTC arm, NRTI RAMs were detected in 1 of the participants3

HPTN 084 Adherence Subset Analysis

Pie chart depicting weekly doses taken by participants on daily oral PrEP

Based on an analysis of tenofovir concentrations in dried blood spots from a randomly selected subset of 405 participants in the TDF/FTC arm (secondary endpoint)1

82% of participants appeared to take ≤4 TDF/FTC doses per week1

Figure shows the proportion of participants with drug concentrations measured in dried blood spots reflecting ≤4 doses/week (<700 fmol/punch) or 4-7 doses/week (≥700 fmol/punch) tenofovir use over the previous 1 to 2 months.1

Individuals should strictly adhere to the recommended dosing schedule for prescribed PrEP.

CDC guidelines recommend cisgender women taking daily oral PrEP be 100% adherent, meaning 7 days a week.5

CDC=Centers for Disease Control and Prevention; fmol=femtomole.

Photo portrait of a Black man Photo portrait of a Black man

Review data from HPTN 083, the clinical trial in cisgender men and transgender women who have sex with men.

See the data

View expert discussions

Watch Dr Zandraetta Tims-Cook discuss the efficacy and safety of APRETUDE.

See Dr Tims-Cook

Real HCP compensated by ViiV Healthcare.

Video still of Dr Tims-Cook, an African American female physician

CBTWCNT230041

References:

  1. 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

  2. Evaluating the safety and efficacy of long-acting injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women. ClinicalTrials.gov identifier: NCT03164564. Published May 23, 2017. Updated March 28, 2023. Accessed August 2, 2023.
https://clinicaltrials.gov/ct2/show/NCT03164564

  3. Eshleman SH, Fogel JM, Piwowar-Manning E, et al. Characterization of HIV infections in women who received injectable cabotegravir or tenofovir disoproxil fumarate/emtricitabine for HIV prevention: HPTN 084. J Infect Dis. 2022;225(10):1741-1749. doi:10.1093/infdis/jiab57

  4. HIV Prevention Trials Network. HPTN 084: A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC) for Pre-Exposure Prophylaxis in HIV-Uninfected Women (protocol version 3.0; August 12, 2021). Accessed August 2, 2023. https://www.hptn.org/research/studies/hptn084#views-field-field-public-files

  5. Centers for Disease Control and Prevention. HIV Surveillance Report, 2020. Vol 33. May 2022. Updated May 24, 2022. Accessed August 2, 2023. https://www.cdc.gov/hiv/library/reports/hiv-surveillance/vol-33/index.html