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TRUVADA ADHERENCE OBSERVED IN HPTN 083 and HPTN 084

TRUVADA HPTN 083 Adherence Subset

Tertiary objective1:

  • Concentrations in dried blood spots (DBS) were analyzed from a randomly selected subset (n=390) in the TRUVADA arm. Tenofovir concentration measured in DBS reflects TRUVADA use over previous 1-2 months1,2
  • All patients in the study were provided with adherence counseling and support at baseline and at all follow-up visits. Patients who self-reported or had actual returned pill-count evidence of less than 4 doses of TRUVADA per week were provided individualized adherence counseling1
34 percent pie chart. 34 percent pie chart.

34%

of samples appeared to be consistent with patients taking 7 doses per week (≥1250 fmol/punch)2*

These results are descriptive in nature and should not be used to infer clinical significance. Due to varying methods used to assess adherence from this trial, no direct adherence comparison between APRETUDE and TRUVADA should be made.

Individuals should strictly adhere to the dosing schedule for prescribed PrEP.
*72% of samples appeared to be consistent with patients taking at least 4 doses per week (≥700 fmol/punch).2

TRUVADA HPTN 084 Adherence Subset

Secondary objective3:

  • Concentrations in dried blood spots (DBS) were analyzed from a randomly selected subset (n=405) in the TRUVADA arm. Tenofovir concentration measured in DBS reflects TRUVADA use over previous 1-2 months4
  • All patients in the study were provided with adherence counseling and support at baseline and at all follow-up visits. Patients who self-reported or had actual returned pill-count evidence of less than 4 doses of TRUVADA per week were provided individualized adherence counseling3
3 percent pie chart. 3 percent pie chart.

3%

of samples appeared to be consistent with patients taking 7 doses per week (≥1250 fmol/punch)4,5*

These results are descriptive in nature and should not be used to infer clinical significance. Due to varying methods used to assess adherence from this trial, no direct adherence comparison between APRETUDE and TRUVADA should be made.

Adherence challenges for women in sub-Saharan Africa6,7
Women in sub-Saharan Africa often face considerable barriers to daily pill-taking that include stigma as well as the fear of violence from partners, family, and members of the community.

Individuals should strictly adhere to the dosing schedule for prescribed PrEP.
*18% of samples appeared to be consistent with patients taking at least 4 doses per week (≥700 fmol/punch).4

See APRETUDE adherence

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Review safety data from HPTN 083 and HPTN 084

See the data

PMUS-CBTWCNT250022

References:

  1. 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 6.0; May 24, 2023). Accessed February 11, 2025. https://www.hptn.org/sites/default/files/HPTN%20083_FINAL_%205.0_Apr2022.pdf
  2. Landovitz RJ, Donnell D, Clement ME, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. N Engl J Med. 2021;385(7):595-608. doi:10.1056/NEJMoa2101016
  3. HIV Prevention Trials Network. HPTN 084: A phase 3 double blind safety and efficacy study of injectable cabotegravir compared to daily oral TDF/FTC for pre-exposure prophylaxis in HIV-uninfected women (protocol version 5.0; October 6, 2023). Accessed February 28, 2024. https://www.hptn.org/research/studies/hptn084
  4. Delany-Moretlwe S, Hughes JP, Bock P, et al. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomized clinical trial. Lancet. 2022;399(10337):1779-1789. doi:10.1016/S0140-6736(22)00538-4
  5. Data on file, ViiV Healthcare.
  6. Celum CL, Delany-Moretlwe S, Baeten JM, et al. HIV pre-exposure prophylaxis for adolescent girls and young women in Africa: from efficacy trials to delivery. J Int AIDS Soc. 2019;22(suppl 4):e25298. doi:10.1002/jia2.25298
  7. Velloza J, Khoza N, Scorgie F, et al. The influence of HIV-related stigma on PrEP disclosure and adherence among adolescent girls and young women in HPTN 082: a qualitative study. J Int AIDS Soc. 2020;23(3):e25463. doi:10.1002/jia2.25463