The DOI matches its Crossref record; 3 of the 3 references it cites were found in a registry or an index.
Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy
Open accessAbstract
Studies of daily emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) for HIV preexposure prophylaxis (PrEP) in men who have sex with men (MSM) modeled intracellular tenofovir-diphosphate (TFV-DP) in dried blood spots (DBS) to assess adherence and corresponding PrEP outcomes. We conducted a prospective, randomized, crossover pharmacokinetic study of TFV-DP in DBS during 33%, 67%, or 100% of daily dosing under directly observed therapy (DOT). Participants were assigned to two 12-week dosing regimens, separated by a 12-week washout. Forty-eight adults (25 women) from Denver and San Francisco were included. TFV-DP exhibited a median half-life of 17 days, reaching steady state in 8 weeks. TFV-DP was dose proportional with mean (SD) steady-state concentrations of 530 (159), 997 (267), and 1,605 (405) fmol/punch for the 33%, 67%, and 100% arms, respectively. Prior work in MSM demonstrated clinically meaningful TFV-DP thresholds of 350, 700, and 1,250 fmol/punch, which were estimated 25th percentiles for 2, 4, and 7 doses/week. In the present study, corresponding TFV-DP was within 3% of the prior estimates, and subgroups by site, race, and sex were within 14% of prior estimates, although males had 17.6% (95% confidence intervals [CIs], 6.5, 27.4%) lower TFV-DP than females. The thresholds of 350, 700, and 1,250 fmol/punch were achieved by 75% of men taking ≥1.2, 3.2, and 6 doses/week and 75% of women taking ≥0.6, 2.0, and 5.3 doses/week, indicating that lower dosing reached these thresholds for both sexes. In conclusion, TFV-DP arising from DOT was similar to previous estimates and is useful for interpreting PrEP adherence and study outcomes. (This study has been registered at ClinicalTrials.gov under identifier NCT02022657.)
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Cites
Preexposure chemoprophylaxis for HIV prevention in men who have sex with men.
Grant, R. M., Lama, J. R., Anderson, P. L., McMahan, V., Liu, A. Y., Vargas, L., Goicochea, P., Casapía, M., Guanira-Carranza, J. V., Ramirez-Cardich, M. E., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa1011205 · Cited by 5,096
Self-citationTenofovir-based preexposure prophylaxis for HIV infection among African women.
Marrazzo, J. M., Ramjee, G., Richardson, B. A., Gomez, K., Mgodi, N., Nair, G., Palanee, T., Nakabiito, C., van der Straten, A., Noguchi, L., et al. (2015) · New England Journal of Medicine · doi:10.1056/nejmoa1402269 · Cited by 1,296 · cited 1×
“Short half-life moieties (TFV in plasma) suggested poor adherence (30 to 40% detection) in the VOICE and FEMPREP trials among young women, which failed to demonstrate efficacy (2, 3).”
BackgroundLiu, A. Y., Cohen, S. E., Vittinghoff, E., Anderson, P. L., Doblecki-Lewis, S., Bacon, O., Chege, W., Postle, B. S., Matheson, T., Amico, K. R., et al. (2016) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2015.4683 · Cited by 602
Cited by
Twice-Yearly Lenacapavir or Daily F/TAF for HIV Prevention in Cisgender Women
Bekker, L.-G., Das, M., Abdool Karim, Q., Ahmed, K., Batting, J., Brumskine, W., Gill, K., Harkoo, I., Jaggernath, M., Kigozi, G., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2407001 · Cited by 523
Irungu, E. M., Mugwanya, K. K., Mugo, N. R., Bukusi, E. A., Donnell, D., Odoyo, J., Wamoni, E., Peacock, S., Morton, J. F., Ngure, K., et al. (2021) · The Lancet Global Health · doi:10.1016/s2214-109x(21)00391-0 · Cited by 49
Dreyer, A. J., Nightingale, S., Andersen, L. S., Lee, J. S., Gouse, H., Safren, S. A., O’Cleirigh, C., Thomas, K. G. F., & Joska, J. (2023) · AIDS and Behavior · doi:10.1007/s10461-023-03992-7 · Cited by 3
Metadata
- Authors
- Anderson, P. L., Liu, A. Y., Castillo-Mancilla, J. R., Gardner, E. M., Seifert, S. M., McHugh, C., Wagner, T., Campbell, K., Morrow, M., Ibrahim, M., Buchbinder, S., Bushman, L. R., Kiser, J. J., & MaWhinney, S.
- Venue
- Antimicrobial Agents and Chemotherapy
- Publisher
- American Society for Microbiology
- Published
- 2018-01
- Volume
- 62
- Issue
- 1
- ISSN
- 0066-4804 (ISSN-L)
- 1098-6596
- OpenAlex
- W2804196938
- Cited by
- 272
- References
- 3
- FWCI
- 14.86
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Anderson, P. L., Liu, A. Y., Castillo-Mancilla, J. R., Gardner, E. M., Seifert, S. M., McHugh, C., Wagner, T., Campbell, K., Morrow, M., Ibrahim, M., Buchbinder, S., Bushman, L. R., Kiser, J. J., & MaWhinney, S. (2018). Intracellular Tenofovir-Diphosphate and Emtricitabine-Triphosphate in Dried Blood Spots following Directly Observed Therapy. Antimicrobial Agents and Chemotherapy. https://doi.org/10.1128/aac.01710-17
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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