HPTN=HIV Prevention Trials Network.
HPTN 083 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)
§An initial analysis showed 13 incident infections in the APRETUDE arm (hazard ratio [95% CI]: 0.34 [0.18-0.62]). Retrospective testing showed 1 of the 13 to be a prevalent infection, resulting in 12 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 083
Cumulative events are the overall number of HIV infections in each arm over time.5
HPTN 083 Resistance Profile
Resistance mutations
- Of the incident and prevalent infections in the APRETUDE arm, INSTI resistance-associated mutations (RAMs) were detected in 4 and 1 participant(s), respectively4
- Of the incident and prevalent infections in the TDF/FTC arm, NRTI RAMs were detected in 4 and 2 participants, respectively4
HPTN 083 Adherence Subset Analysis
Based on an analysis of tenofovir concentrations in dried blood spots from a randomly selected subset of 390 participants in the TDF/FTC arm (tertiary endpoint)1
28% 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.
4 or more doses per week are anticipated to provide high levels of rectal protection against HIV-1 acquisition.1
fmol=femtomole.
View expert discussion from colleagues
Watch Dr Theo Hodge discuss the efficacy and safety of APRETUDE.
Real HCP compensated by ViiV Healthcare.
CBTWCNT230041
References:
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
Injectable cabotegravir compared to TDF/FTC for PrEP in HIV-uninfected men and transgender women who have sex with men. ClinicalTrials.gov identifier: NCT02720094. Published March 25, 2016. Updated September 23, 2022. Accessed August 2, 2023. https://clinicaltrials.gov/ct2/show/record/NCT02720094
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
Marzinke MA, Grinsztejn B, Fogel JM, et al. Characterization of human immunodeficiency virus (HIV) infection in cisgender men and transgender women who have sex with men receiving injectable cabotegravir for HIV prevention: HPTN 083. J Infect Dis. 2021;224(9):1581-1592. doi:10.1093/infdis/jiab152
HIV Prevention Trials Network. HPTN 083: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men (protocol version 4.0; February 10, 2021). Accessed August 2, 2023. https://www.hptn.org/research/studies/hptn083#views-field-field-public-files