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Emtricitabine and tenofovir alafenamide vs emtricitabine and tenofovir disoproxil fumarate for HIV pre-exposure prophylaxis (DISCOVER) primary results from a randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial
Open accessAbstract
Background Tenofovir alafenamide shows high antiviral efficacy and improved renal and bone safety compared with tenofovir disoproxil fumarate when used for HIV treatment. Here, we report primary results from a blinded phase 3 study evaluating the efficacy and safety of pre-exposure prophylaxis (PrEP) with emtricitabine and tenofovir alafenamide versus emtricitabine and tenofovir disoproxil fumarate for HIV prevention.Methods This study is an ongoing, randomised, double-blind, multicentre, active-controlled, phase 3, non-inferiority trial done at 94 community, public health, and hospital-associated clinics located in regions of Europe and North America, where there is a high incidence of HIV or prevalence of people living with HIV, or both. We enrolled adult cisgender men who have sex with men and transgender women who have sex with men, both with a high risk of acquiring HIV on the basis of their self-reported sexual behaviour in the past 12 weeks or their recent history (within 24 weeks of enrolment) of bacterial sexually transmitted infections. Participants with current or previous use of PrEP with emtricitabine and tenofovir disoproxil fumarate were not excluded. We used a computer-generated random allocation sequence to randomly assign (1:1) participants to receive either emtricitabine (200 mg) and tenofovir alafenamide (25 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir alafenamide group), or emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg) tablets daily, with matched placebo tablets (emtricitabine and tenofovir disoproxil fumarate group). As such, all participants were given two tablets. The trial sponsor, investigators, participants, and the study staff who provided the study drugs, assessed the outcomes, and collected the data were masked to group assignment. The primary efficacy outcome was incident HIV infection, which was assessed when all participants had completed 48 weeks of follow-up and half of all participants had completed 96 weeks of follow-up. This full analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug and had at least one post-baseline HIV test. Non-inferiority of emtricitabine and tenofovir alafenamide to emtricitabine and tenofovir disoproxil fumarate was established if the upper bound of the 95·003% CI of the HIV incidence rate ratio (IRR) was less than the prespecified non-inferiority margin of 1·62. We prespecified six secondary bone mineral density and renal biomarker safety endpoints to evaluate using the safety analysis set. This analysis set included all randomly assigned participants who had received at least one dose of the assigned study drug. This trial is registered with ClinicalTrials.gov, NCT02842086, and is no longer recruiting.Findings Between Sept 13, 2016, and June 30, 2017, 5387 (92%) of 5857 participants were randomly assigned and received emtricitabine and tenofovir alafenamide (n=2694) or emtricitabine and tenofovir disoproxil fumarate (n=2693). At the time of the primary efficacy analysis (ie, when all participants had completed 48 weeks and 50% had completed 96 weeks) emtricitabine and tenofovir alafenamide was non-inferior to emtricitabine and tenofovir disoproxil fumarate for HIV prevention, as the upper limit of the 95% CI of the IRR, was less than the prespecified non-inferiority margin of 1·62 (IRR 0·47 [95% CI 0·19-1·15]). After 8756 person-years of follow-up, 22 participants were diagnosed with HIV, seven participants in the emtricitabine and tenofovir alafenamide group (0·16 infections per 100 person-years [95% CI 0·06-0·33]), and 15 participants in the emtricitabine and tenofovir disoproxil fumarate group (0·34 infections per 100 person-years [0·19-0·56]). Both regimens were well tolerated, with a low number of participants reporting adverse events that led to discontinuation of the study drug (36 [1%] of 2694 participants in the emtricitabine and tenofovir alafenamide group vs 49 [2%] of 2693 participants in the emtricitabine and tenofovir disoproxil fumarate group). Emtricitabine and tenofovir alafenamide was superior to emtricitabine and tenofovir disoproxil fumarate in all six prespecified bone mineral density and renal biomarker safety endpoints.Interpretation Daily emtricitabine and tenofovir alafenamide shows non-inferior efficacy to daily emtricitabine and tenofovir disoproxil fumarate for HIV prevention, and the number of adverse events for both regimens was low. Emtricitabine and tenofovir alafenamide had more favourable effects on bone mineral density and biomarkers of renal safety than emtricitabine and tenofovir disoproxil fumarate.Funding Gilead Sciences.
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“The successful development and widespread adoption of these prophylactics has been considered a public health triumph, drastically reducing the spread of HIV, and dramatically improving quality of life (Mayer et al., 2020).”
From The Need for Biological Countermeasures to Mitigate the Risk of Space Radiation-Induced Carcinogenesis, Cardiovascular Disease, and Central Nervous System Deficiencies (2022) · cites this paper as Mayer et al., 2020
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“For example, individuals at high-risk of contracting the human immunodeficiency virus (HIV) routinely take the prophylactic tenofovir with emtricitabine formulations (daily oral administration) that prevent (and treat) HIV infection.”
From The Need for Biological Countermeasures to Mitigate the Risk of Space Radiation-Induced Carcinogenesis, Cardiovascular Disease, and Central Nervous System Deficiencies (2022) · cites this paper as Mayer et al., 2020
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“This paradigm has since evolved, as prophylactic compound approaches have been shown to improve health outcomes in healthy populations which are at risk.”
From The Need for Biological Countermeasures to Mitigate the Risk of Space Radiation-Induced Carcinogenesis, Cardiovascular Disease, and Central Nervous System Deficiencies (2022) · cites this paper as Mayer et al., 2020
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Items 101–200 of 428
Preexposure Prophylaxis (PrEP) for HIV
Spinelli, M. A., Ngure, K., & Gandhi, M. (2024) · JAMA · doi:10.1001/jama.2024.16984 · Cited by 15
Prabhu, S. R., & Wagoner, N. V. (2022) · doi:10.1002/9781119826781.ch5 · Cited by 15
Bruxvoort, K. J., Schumacher, C. M., Towner, W. J., Jones, J. L., Contreras, R., Grant, D. L., & Hechter, R. C. (2021) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000002668 · Cited by 14
Erenrich, R. K., Braun, R., Torres-Mendoza, D. M., Stevenson, O. L., Doan, T.-H. P., & Klausner, J. D. (2023) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000003375 · Cited by 15
Brummel, S. S., Stringer, J., Mills, E., Tierney, C., Caniglia, E. C., Colbers, A. P. H., Chi, B. H., Best, B. M., Gaaloul, M. E., Hillier, S. L., et al. (2022) · Journal of the International AIDS Society · doi:10.1002/jia2.25917 · Cited by 14
Cespedes, M., Das, M., Yager, J., Prins, M., Krznaric, I., de Jong, J., Xiao, D., Shao, Y., Wong, P., Kintu, A., et al. (2022) · Transgender Health · doi:10.1089/trgh.2022.0048 · Cited by 14
“33 High variability was observed across all groups, potentially owing to variations in adherence, creatinine clearance, and/or dosing with or without food, as these were not able to be accounted for in this analysis.”
Self-citationJung, C., Hunter, A., Saleh, M., Quinn, G. P., & Nippita, S. (2023) · Open Access Journal of Contraception · doi:10.2147/oajc.s368621 · Cited by 14
“However, these medications have not yet been studied in those at risk for HIV acquisition through receptive vaginal sex.(27)”
BackgroundZhang, L., Wang, J., & von Kleist, M. (2021) · PLoS Computational Biology · doi:10.1371/journal.pcbi.1009295 · Cited by 10
“the recent DISCOVER trial evaluating the efficacy of 39 emtricitabine plus tenofovir alafenamide (Descovy) against Truvada was conducted over 40 8756 person-years [10], yielding as little as 22 evaluable data points (infections).”
BackgroundMethodLiégeon, G., Delaugerre, C., & Molina, J. (2024) · Infectious Disease Clinics of North America · doi:10.1016/j.idc.2024.04.003 · Cited by 14
Self-citationGoldwirt, L., Bauer, R., Liégeon, G., Charreau, I., Delaugerre, C., Cotte, L., Pialou, G., Cua, É., Laghzal, A., Buschman, L., et al. (2021) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkab253 · Cited by 13
Self-citationThimm, M. A., Livingston, A. G., Ramroop, R., & Eke, A. C. (2022) · Journal of AIDS and HIV Treatment · doi:10.33696/aids.4.026 · Cited by 13
“From a pharmacodynamic (PD) perspective, TAF’s median TFV concentrations exceeds its 90% effective concentration (EC90) 1–2 hours after a single dose, whereas TDF does not exceed this threshold until after approximately 3 days of daily dosing [9].”
BackgroundHIV Pre-Exposure Prophylaxis: New and Upcoming Drugs to Address the HIV Epidemic
Rivera, C. G., Zeuli, J. D., Smith, B. L., Johnson, T. M., Bhatia, R., Otto, A. O., & Temesgen, Z. (2023) · Drugs · doi:10.1007/s40265-023-01963-9 · Cited by 15
“Approval was based on results of the DISCOVER trial, showing non-inferiority of daily TAF/FTC against TDF/FTC with a more favorable kidney and bone density toxicity profile [4].”
Anno 2021: Which antivirals for the coming decade?
Groaz, E., Clercq, E. D., & Herdewijn, P. A. (2021) · Annual reports in medicinal chemistry · doi:10.1016/bs.armc.2021.09.004 · Cited by 13
“(DISCOVER trial), which led to its FDA approval in 2019 for at-risk uninfected adults and adolescents.(135)”
Yager, J., Brooks, K. M., Brothers, J., Mulligan, K. M., Landovitz, R. J., Reirden, D. H., Glenny, C., Malhotra, M., Anderson, P. L., & Hosek, S. (2022) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2022.0043 · Cited by 13
Self-citationAdvancing HIV prevention using tenofovir-based pre-exposure prophylaxis
Karim, S. S. A., Baxter, C., & Karim, Q. A. (2022) · Antiviral Therapy · doi:10.1177/13596535211067589 · Cited by 12
Obesity in HIV infection: host-pathogen interaction
Savinelli, S., Kelly, N. E. W., Feeney, E. R., O'Shea, D. B., Hogan, A. E., Overton, E. T., LANDAY, A. L., & Mallon, P. W. G. (2022) · AIDS · doi:10.1097/qad.0000000000003281 · Cited by 12
“A greater mean weight gain was described in individuals taking either TAF/FTC (DISCOVER trial) [38] or the INSTI Cabotegravir (HPTN 083 trial) [39], compared with TDF/FTC (Table 2).”
BackgroundResultUgarte, A., de la Mora, L., Hernández, D. G., Martínez‐Rebollar, M., de Lazzari, E., Torres, B., Inciarte, A., Ambrosioni, J., Chivite, I., Solbes, E., et al. (2022) · Infectious Diseases and Therapy · doi:10.1007/s40121-022-00733-6 · Cited by 12
“However, an increase in STI incidence after PrEP initiation has not been observed in all cohorts, so there are discrepancies about this association [18, 19].”
BackgroundGreenwell, K. F., Fugit, R. V., Nicholson, L., & Wright, J. L. (2023) · AIDS and Behavior · doi:10.1007/s10461-023-04084-2 · Cited by 12
Cooney, E. E., Footer, K. H. A., Glick, J. L., Passaniti, A., Howes, M., & Sherman, S. G. (2023) · AIDS Research and Therapy · doi:10.1186/s12981-023-00556-6 · Cited by 13
“Pre-exposure prophylaxis (PrEP) represents a highly efficacious HIV prevention strategy when adherence is high [21].”
BackgroundOrtiz, R. C., Knerler, S. A., Fridman, L. B., Mercado, A., Price, A. C., Rosado‐Franco, J. J., Wilkins, H. N., Flores, B. R., Orsburn, B. C., & Williams, D. W. (2024) · Fluids and Barriers of the CNS · doi:10.1186/s12987-023-00507-3 · Cited by 11
“…caution to people without HIV who are prescribed these medications for pre-exposure prophylaxis (PrEP), as FTC and either the disoproxil fumarate or alafenamide formulations of TFV are co-administered in Truvada ® and Descovy ® , respectively, the FDA approved drugs for HIV prevention [158–161].”
Weight Gain and Antiretroviral Therapy
Bailin, S. S., & Koethe, J. R. (2024) · Infectious Disease Clinics of North America · doi:10.1016/j.idc.2024.04.005 · Cited by 12
HTLV-1 Transmission and HIV Pre-exposure Prophylaxis: A Scoping Review
Bradshaw, D., & Taylor, G. P. (2022) · Frontiers in Medicine · doi:10.3389/fmed.2022.881547 · Cited by 12
John, S. A., Sizemore, K. M., Jimenez, R. H., Jones, S. S., Petroll, A. E., & Rendina, H. J. (2022) · JMIR Public Health and Surveillance · doi:10.2196/31237 · Cited by 12
“By contrast, PrEP is a 2-drug combination using emtricitabine with either tenofovir disoproxil fumarate or tenofovir alafenamide [21].”
Donnell, D. J., Gao, F., Hughes, J. P., Hanscom, B. S., Corey, L., Cohen, M. S., Edupuganti, S., Mgodi, N. M., Rees, H., Baeten, J. M., et al. (2023) · Journal of the International AIDS Society · doi:10.1002/jia2.26118 · Cited by 12
Sepodes, B. M. N., Rocha, J. P., Batista, J., Figueira, M. E., Dráfi, F., & Torre, C. (2021) · Frontiers in Medicine · doi:10.3389/fmed.2021.722247 · Cited by 11
Dunn, D. T., Stirrup, O., McCormack, S., & Glidden, D. V. (2023) · BMC Medical Research Methodology · doi:10.1186/s12874-023-01970-0 · Cited by 11
“Analysis was performed on a log-incidence scale, with the aim of preserving 50% of the effect of TDF-FTC; non-inferiority would be concluded if the upper 97.5% confidence limit for the rate ratio (TAF-FTC versus TDFFTC) was less than 1.62 [17].”
BackgroundMethodInfluentialKauppinen, K. J., Aho, I., Sjöblom, N., Tynninen, O., Suomalainen, A., Schwab, U., Zhao, F., Arkkila, P. E. T., & Sutinen, J. (2024) · Clinical Infectious Diseases · doi:10.1093/cid/ciae374 · Cited by 11
“TDF also decreases plasma lipid concentrations when added as a single agent [11], or when compared to TAF among people with HIV (PWH) [12, 13] or among HIV-negative subjects when used for preexposure prophylaxis (PrEP) [5].”
Biello, K. B., Chan, P. A., Holcomb, R., Ndoye, C. D., Valente, P. K., Maynard, M. A., Gandhi, M., Mayer, K. H., & Mimiaga, M. J. (2023) · AIDS and Behavior · doi:10.1007/s10461-023-04050-y · Cited by 11
Self-citationMcGowan, I., Ayudhya, R. P. K. N., Brand, R. M., Marzinke, M. A., Hendrix, C. W., Johnson, S., Piper, J. M., Holtz, T. H., Curlin, M. E., Chitwarakorn, A., et al. (2021) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2021.0115 · Cited by 11
PrEP Discontinuation In A US National Cohort Of Sexual And Gender Minority Populations, 2017–22
Guo, Y. J., Westmoreland, D. A., D’Angelo, A. B., Mirzayi, C. A., Dearolf, M. H., Carneiro, P. B., Ray, M. A., Pantalone, D. W., Carrico, A. W., Patel, V. V., et al. (2024) · Health Affairs · doi:10.1377/hlthaff.2023.00867 · Cited by 10
Unigwe, I. F., Goodin, A. J., Lo‐Ciganic, W., Cook, R. L., Janelle, J. W., & Park, H. (2024) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofae569 · Cited by 11
Driving progress towards PrEP equity: Key changes in the 2025 BASHH / BHIVA UK PrEP guidelines
Clutterbuck, D., Brady, M., & Rodger, A. J. (2025) · HIV Medicine · doi:10.1111/hiv.70043 · Cited by 9
“Several studies have confirmed that TFV-DP is lower in rectal tissues after TAF compared with TDF [61, 62]; in spite of this, clinical equivalence was demonstrated in the randomized controlled Phase 3 clinical trial DISCOVER comparing daily TAF-FTC to TDF-FTC in GBMSM and TGW [63].”
Brokus, C. J., Kattakuzhy, S. M., Gayle, B., Narayanan, S., Davis, A., Cover, A. A., Eyasu, R., Ebah, E., Ogbumbadiugha-Weekes, O., Hoffmann, J. D., et al. (2021) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofab658 · Cited by 10
“However, investigational studies of cabotegravir and tenofovir alafenamide/FTC as PrEP have excluded PWID to date [42, 45].”
BackgroundPrEP Familiarity, Interest, and Usage Among 364 Black and Hispanic Adults in Indiana
Campbell, J. T., Adams, O. R., Bennett‐Brown, M., Woodward, B., Gesselman, A. N., & Carter, G. A. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.810042 · Cited by 10
Lee, M., Wu, P.-F., Chen, T.-I., Chan, C., Lin, H.-H., Huang, Y., Chen, H., Lin, Y.-T., & Chen, C. (2022) · JHEP Reports · doi:10.1016/j.jhepr.2022.100634 · Cited by 10
“Tenofovir-containing ART is an effective pre-exposure prophylaxis against HIV 25 and HBV. 26 A serological follow-up study demonstrated that tenofovir-containing ART had an excellent protective effect against incident HBV, 26 which may explain the reduced HCC risk among PLWH without neonatal HBV…”
Karim, Q. A., Archary, D., Barré‐Sinoussi, F., Broliden, K., Cabrera, C., Chiodi, F., Fidler, S. J., Gengiah, T. N., Herrera, C., Kharsany, A. B. M., et al. (2022) · Frontiers in Immunology · doi:10.3389/fimmu.2022.1055042 · Cited by 10
“More recently, the combination of TAF/FTC has been approved as PrEP for both MSM and trans-gender women, following the results of the DISCOVER study which showed that TAF/FTC was non-inferior to TDF/FTC for HIV prevention (IRR 0·47 [95% CI 0·19-1·15] at the time of the primary efficacy analysis) (53).”
ResultPico-Espinosa, O. J., Hull, M., Gaspar, M., Lachowsky, N. J., Grace, D., Truong, R., Mohammed, S. S., MacPherson, P., Woodward, K., & Tan, D. H. S. (2023) · BMC Public Health · doi:10.1186/s12889-023-16065-0 · Cited by 10
DISCOVER: much accomplished, but not yet for all
Spiegel, H. M. L. (2020) · The Lancet · doi:10.1016/s0140-6736(20)31530-0 · Cited by 10
Hepatotoxicity of contemporary antiretroviral drugs
Rivera, C. G., Otto, A. O., Zeuli, J. D., & Temesgen, Z. (2021) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0000000000000706 · Cited by 10
Treatment of hepatitis delta and HIV infection
Soriano, V., de Mendoza, C., Treviño, A., Ramos, J. M., Moreno‐Torres, V., Corral, O. J., & Barreiro, P. (2022) · Liver International · doi:10.1111/liv.15345 · Cited by 10
Cirrincione, L. R., Grieve, V. L. B., Holloway, J., & Marzinke, M. A. (2022) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.2801 · Cited by 10
The Real PURPOSE of PrEP — Effectiveness, Not Efficacy
Walensky, R. P., & Baden, L. R. (2024) · New England Journal of Medicine · doi:10.1056/nejme2408591 · Cited by 10
Overcoming structural barriers to diffusion of HIV pre-exposure prophylaxis
Magnus, M., Yellin, H., Langlands, K., Balachandran, M., Turner, M., Jordan, J. A., Ramin, D., Kuo, I. C., & Siegel, M. (2023) · The Journal of Medicine Access · doi:10.1177/27550834231214958 · Cited by 9
“There can be actual exclusion from the study design, as was seen with the DISCOVER trial, 2 which excluded cisgender women from the trial and has resulted in cisgender women only having access to two current PrEP agents.”
ResultCoyle, R. P., Morrow, M., Mann, S., Mainella, V., Ellis, S. L., Schwab, S. K., Coppinger, C., Barker, N., Ellison, L., Zheng, J., et al. (2024) · Clinical Infectious Diseases · doi:10.1093/cid/ciae212 · Cited by 9
Self-citationAre We Hitting the Target? HIV Pre-Exposure Prophylaxis from 2012 to 2020 in the OPERA Cohort
Mounzer, K., Fusco, J. S., Hsu, R. K., Brunet, L., Vannappagari, V. X., Frost, K. R., Shaefer, M. S., Rinehart, A. R., Rawlings, K., & Fusco, G. (2021) · AIDS Patient Care and STDs · doi:10.1089/apc.2021.0064 · Cited by 9
Self-citationButler, S. K., Kislovskiy, Y., Bunge, K. E., & Wiesenfeld, H. C. (2021) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2021.12.263 · Cited by 9
Bunting, S. R., Feinstein, B., Calabrese, S., Hazra, A., Sheth, N., Wang, G., & Garber, S. S. (2022) · Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000003072 · Cited by 10
Vartak, R., Jablonski, J. A., Deore, B., Mediouni, S., Sanhueza, C., Valente, S. T., & Patel, K. R. (2022) · International Journal of Biological Macromolecules · doi:10.1016/j.ijbiomac.2022.08.211 · Cited by 9
Godinez, H., Xu, Q., McMann, T., Li, J., & Mackey, T. K. (2023) · Frontiers in Public Health · doi:10.3389/fpubh.2023.1073813 · Cited by 9
Zhu, Y., Gao, F., Glidden, D. V., Donnell, D. J., & Janes, H. (2023) · Clinical Trials · doi:10.1177/17407745231203327 · Cited by 9
Ultra-Long-Acting Antivirals as Chemical Vaccines to Prevent Viral Diseases
Soriano, V., Edagwa, B., de Mendoza, C., Barreiro, P., Corral, O. J., Treviño, A., & Gendelman, H. E. (2022) · Future Microbiology · doi:10.2217/fmb-2021-0254 · Cited by 9
Avihingsanon, A., Chetchotisakd, P., Kiertiburanakul, S., Ratanasuwan, W., Siripassorn, K., Supparatpinyo, K., Martin, H., Wang, H., Wong, T., & Wang, H. Y. (2022) · HIV Medicine · doi:10.1111/hiv.13386 · Cited by 9
Doxycycline Postexposure Prophylaxis for STIs in Women — Uncertain Benefit, Urgent Need
Marrazzo, J. M. (2023) · New England Journal of Medicine · doi:10.1056/nejme2311948 · Cited by 9
Guimarães, N. S., Magno, L., Monteiro, G. M. B., Ramos, I. C. N., de Castro, C. T., Rossi, T. R. A., Pereira, M. E., & Dourado, I. C. (2023) · BMC Infectious Diseases · doi:10.1186/s12879-023-08693-z · Cited by 9
“Additionally, through a manual search, seven studies were selected [29–35] and nine studies were updated [26, 36–43].”
MethodInfluentialCost-effectiveness of Cabotegravir Long-Acting for HIV Pre-exposure Prophylaxis in the United States
Brogan, A. J., Davis, A. E., Mellott, C. E., Fraysse, J., Metzner, A. A., & Oglesby, A. K. (2024) · PharmacoEconomics · doi:10.1007/s40273-023-01342-y · Cited by 9
“…were assumed to require no medical management. b HIV incidence values for CAB–LA were based on post hoc analyses that excluded baseline HIV infections [9, 10]. c HIV incidence for FTC/TAF was set at parity with FTC/TDF for MSM and TGW based on the noninferiority finding in the DISCOVER trial [47].”
MethodWatson, D. L., Listerud, L., Drab, R., Lin, W., Momplaisir, F. M., & Bauermeister, J. A. (2024) · Journal of the International AIDS Society · doi:10.1002/jia2.26211 · Cited by 8
Sherriff, N., Mirandola, M., Silva, R., Cordioli, M., Sawyer, A., Gios, L., Zorzi, A., Huber, J., Vera, J. H., Richardson, D., et al. (2024) · BMC Infectious Diseases · doi:10.1186/s12879-024-09019-3 · Cited by 8
“During the study period, PrEP was readily available in the UK clinic site as a consequence of a national research trial of PrEP [37].”
BackgroundYiğit, İ., Henna Budhwani, P., Rainer, C., Claude, K., Muessig, K. E., & Hightow‐Weidman, L. (2024) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000003474 · Cited by 8
Hillier, S. L., Bekker, L., Riddler, S. A., Hendrix, C. W., Badal‐Faesen, S., Macdonald, P., Nair, G., Lombaard, J. J., Caraco, Y., Peer, A., et al. (2025) · The Journal of Infectious Diseases · doi:10.1093/infdis/jiaf222 · Cited by 8
“Adherence remains a challenge for daily oral PrEP [5, 6], the vaginal ring is discreet but not widely accessible outside Africa [7–13], and long-acting injectable PrEP requires administration by healthcare providers [14, 15].”
Biomedical Interventions for HIV Prevention and Control: Beyond Vaccination
Liao, Y., Wen, Z., Shi, M., Zou, H., & Sun, C. (2025) · Viruses · doi:10.3390/v17060756 · Cited by 11
The changing landscape of HIV epidemiology and management
Hamilton, W. L., & Aliyu, D. (2025) · Clinical Medicine · doi:10.1016/j.clinme.2025.100520 · Cited by 10
Patel, Y. S., Doshi, A., Levesque, A. E., Lindor, S., Moranville, R., Okere, S., Robinson, D., Taylor, L., Lustberg, M. E., & Malvestutto, C. (2023) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2023.0008 · Cited by 8
“34–45 The mechanism behind this observation remains unknown; however, weight suppression by TDF has been suggested as a possible mechanism.”
Huang, Y., Zhang, L., Karuna, S., Andrew, P., Juraska, M., Weiner, J. A., Angier, H. E., Morgan, E., Azzam, Y., Swann, E. M., et al. (2023) · Nature Communications · doi:10.1038/s41467-023-43399-5 · Cited by 9
Self-citationLiu, A., Alleyne, C.-D., Doblecki‐Lewis, S., Koester, K. A., Gonzalez, R., Vinson, J., Scott, H. M., Buchbinder, S., & Torres, T. S. (2024) · JMIR Formative Research · doi:10.2196/54073 · Cited by 8
“Preexposure prophylaxis (PrEP) with a daily pill of Truvada (tenofovir disoproxil fumarate/emtricitabine) [1-6] or Descovy (tenofovir alafenamide/emtricitabine) [7] has demonstrated high efficacy for HIV prevention, and these are the most commonly prescribed PrEP regimens in the United States [8].”
BackgroundObesity and diabetes in people of African ancestry with HIV
Cechin, L., Norcross, C., Oliveira, A., Hopkins, D., McGowan, B. M., & Post, F. A. (2022) · HIV Medicine · doi:10.1111/hiv.13413 · Cited by 8
Self-citationGerwen, O. T. V., Yiğit, İ., Crockett, K. B., & Turan, B. (2022) · AIDS and Behavior · doi:10.1007/s10461-022-03883-3 · Cited by 9
“Two of the currently FDA-approved PrEP drugs that are available are daily oral pills [4, 5].”
BackgroundPersonalizing prevention: Advances in pharmacotherapy for HIV prevention
Brizzi, M. B., Sherman, E. M., Green, S. B., Nowicki, D. N., Drwiega, E. N., Nicol, M. R., Chastain, D. B., Sahloff, E. G., Truong, W. R., Cluck, D. B., et al. (2023) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.2796 · Cited by 8
Marcus, J. L., Levine, K., Irie, W. C., Solleveld, P., Mayer, K. H., & Krakower, D. (2021) · Open Forum Infectious Diseases · doi:10.1093/ofid/ofab372 · Cited by 8
“However, TAF/FTC is now recommended for people with an estimated creatinine clearance (CrCl) <60 mL/minute, which is the minimum threshold for use of TDF/FTC [2, 4, 5].”
BackgroundMethodInfluentialSelf-citationGravett, R. M., Long, D. M., Biello, K. B., Mayer, K. H., Krakower, D., Hill-Rorie, J., Lillis, R., Whiteside, Y. O., & Elopre, L. E. (2025) · JAIDS Journal of Acquired Immune Deficiency Syndromes · doi:10.1097/qai.0000000000003651 · Cited by 7
Self-citationBroadening access to tenofovir alafenamide for the treatment and prevention of HIV-1 infection
Osuala, E. C., Naidoo, A., Dooley, K. E., Naidoo, K., & Perumal, R. (2023) · Expert Review of Clinical Pharmacology · doi:10.1080/17512433.2023.2251387 · Cited by 7
“The DISCOVER trial, a phase 3 randomized, double-blind study evaluated the efficacy and safety of daily FTC/TAF in preventing HIV infection among men and transgender women who have sex with men at risk of HIV-1 infections [58,59].”
Wohl, D. A., Spinner, C. D., Flamm, J., Hare, C. B., Doblecki‐Lewis, S., Ruane, P. J., Molina, J., Mills, A., Brinson, C. C., Ramgopal, M. N., et al. (2024) · The Lancet HIV · doi:10.1016/s2352-3018(24)00130-9 · Cited by 7
Self-citationZewdie, K., Muwonge, T. R., Ssebuliba, T., Bambia, F., Nampewo, O., Stein, G., Mugwanya, K. K., Thomas, K. K., Wyatt, C. M., Yin, M. T., et al. (2024) · AIDS · doi:10.1097/qad.0000000000003988 · Cited by 8
Hughes, C. (2021) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0000000000000703 · Cited by 7
Cranston, R., Brown, E. R., Bauermeister, J. A., Dunne, E. F., Hoesley, C. J., Ho, K. S., Johnson, S., Lucas, J. P., Domínguez‐Islas, C., Gundacker, H. M., et al. (2021) · AIDS Research and Human Retroviruses · doi:10.1089/aid.2021.0071 · Cited by 7
Academic Detailing to Increase Prescribing of HIV Pre-exposure Prophylaxis
Krakower, D., Naja-Riese, G. M., Edelstein, Z. R., Gandhi, A. D., Wahnich, A., & Fischer, M. A. (2021) · American Journal of Preventive Medicine · doi:10.1016/j.amepre.2021.05.030 · Cited by 7
The predictive value of macaque models of preexposure prophylaxis for HIV prevention
Garcia-Lerma, J. G., McNicholl, J. M., & Heneine, W. (2022) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0000000000000738 · Cited by 7
Kacel, E. L., Pankey, T. L., Vencill, J. A., Heredia, D., González, C. A., Ruddy, K. J., & Ehlers, S. L. (2022) · Annals of LGBTQ Public and Population Health · doi:10.1891/lgbtq-2021-0013 · Cited by 7
Pico-Espinosa, O. J., Hull, M., MacPherson, P., Grace, D., Lachowsky, N. J., Gaspar, M., Mohammed, S. S., Truong, R., & Tan, D. H. S. (2023) · CMAJ Open · doi:10.9778/cmajo.20220113 · Cited by 8
“2 Whereas concerns about adverse effects might be mitigated by providing more information about PrEP, the collective memory of adverse effects related to HIV treatment and medical mistrust may be important contributing factors to such concerns.”
Zhou, H. C., Zhu, Y.-Y., Gao, Y., Chu, Z., Chen, S., Liu, M., Jiang, Y., Hu, Q., & Shang, H. (2023) · The Lancet Regional Health - Western Pacific · doi:10.1016/j.lanwpc.2023.100922 · Cited by 7
Study design approaches for future active-controlled HIV prevention trials
Donnell, D. J., Kansiime, S., Glidden, D. V., Luedtke, A. R., Gilbert, P. B., Gao, F., & Janes, H. (2023) · Statistical Communications in Infectious Diseases · doi:10.1515/scid-2023-0002 · Cited by 7
“…in the DISCOVER trial (ClinicalTrials.gov #NCT02842086), an active-controlled trial comparing two oral PrEP regimens, and HPTN 083, an active-control trial comparing oral and injectable PrEP, where high STI rates were noted in both arms of these studies while low HIV incidence was observed [3, 61].”
Pharmacotherapy considerations in transgender individuals living with human immunodeficiency virus
Badowski, M. E., Britt, N. S., Huesgen, E. C., Lewis, M. M., Miller, M. M., Nowak, K., Sherman, E. M., & Smith, R. O. (2021) · Pharmacotherapy The Journal of Human Pharmacology and Drug Therapy · doi:10.1002/phar.2499 · Cited by 7
Mugwanya, K. K., Saina, M., Mugo, N., MaWhinney, S., Morrow, M., Schaafsma, T. T., Donnell, D. J., Glidden, D. V., Ngure, K., Brown, C., et al. (2025) · PLoS Medicine · doi:10.1371/journal.pmed.1004732 · Cited by 6
Self-citationMizushima, D., Gatanaga, H., & Oka, S. (2024) · Global Health & Medicine · doi:10.35772/ghm.2024.01043 · Cited by 6
Advancing PrEP for HIV prevention: innovations and the imperative to preserve comprehensive care
Algarin, A. B., & Shrader, C. (2025) · BMC Global and Public Health · doi:10.1186/s44263-025-00125-1 · Cited by 6
“This pivotal study was followed by the DISCOVER trial in 2019, which introduced a second daily regimen (tenofovir alafenamide/emtricitabine) associated with fewer bone and renal side effects [2].”
Bunting, S. R., Hazra, A., & Sheth, N. K. (2020) · Journal of Gay & Lesbian Mental Health · doi:10.1080/19359705.2020.1855007 · Cited by 6
Bonner, R., Stewart, J., Upadhyay, A., Bruce, R. D., & Taylor, J. L. (2022) · Journal of the International Association of Providers of AIDS Care (JIAPAC) · doi:10.1177/23259582211073393 · Cited by 6
Else, L., Penchala, S. D., Pillay, A.-D. A. P., Seiphetlo, T. B., Lebina, L., Callebaut, C., Minhas, S., Morley, R., Rashid, T. G., Martinson, N. A., et al. (2022) · Pharmaceutics · doi:10.3390/pharmaceutics14061285 · Cited by 6
“Whilst TDF-emtricitabine (FTC) has been evaluated in many trials and risk groups, TAF-FTC PrEP has only been evaluated in one PrEP efficacy clinical trial [2,3].”
BackgroundSelf-citationSafety of oral tenofovir disoproxil - emtricitabine for HIV preexposure prophylaxis in adults
Liégeon, G. (2022) · Current Opinion in HIV and AIDS · doi:10.1097/coh.0000000000000747 · Cited by 6
Sekiya, R., Muramatsu, T., Ichiki, A., Chikasawa, Y., Bingo, M., Yotsumoto, M., Hagiwara, T., Amano, K., & Kinai, E. (2022) · Journal of Infection and Chemotherapy · doi:10.1016/j.jiac.2022.10.014 · Cited by 6
Gerwen, O. T. V., & Blumenthal, J. S. (2023) · PubMed Central · Cited by 6
Antiretroviral drug exposure in urethral and glans surface sampling of the penis
Haaland, R. E., Fountain, J. J., Dinh, C. T., Lupo, L. D., Martin, A. M., Conway-Washington, C., Hall, L., Kelley, C. F., Garcia-Lerma, J. G., & Heneine, W. (2021) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkab155 · Cited by 6
“5 11 Likewise, dosing with the daily oral tenofovir alafenamide and emtricitabine combination was shown to be effective at preventing HIV acquisition among MSM. 12 While detailed pharmacological studies are routinely performed using biopsies and mucosal swabs of the female genital and anorectal tracts to evaluate drug…”
BackgroundInfluentialCampbell, L. J., Ibrahim, F., Barbini, B., Samarawickrama, A., Orkin, C. M., Fox, J., Waters, L. J., Gilleece, Y. C., Tariq, S., Post, F. A., et al. (2021) · HIV Medicine · doi:10.1111/hiv.13215 · Cited by 6
“More recently, evidence has emerged that TDF may have weight- restricting properties in individuals without HIV infection taking TDF as pre- exposure prophylaxis (PrEP) [14,15], and in people with HIV taking TDFcontaining ART [16].”
BackgroundSelf-citationImplementing a National PrEP Program:How Can We Make It Happen?
Malebranche, D. J., Watriss, A. L., & Dangerfield, D. T. (2022) · The Journal of Law Medicine & Ethics · doi:10.1017/jme.2022.36 · Cited by 6
Haaland, R. E., Fountain, J. J., Martin, A. M., Dinh, C. T., Holder, A. N., Edwards, T. E., Lupo, L. D., Hall, L., Conway-Washington, C., Massud, I., et al. (2022) · Journal of Antimicrobial Chemotherapy · doi:10.1093/jac/dkac419 · Cited by 6
Tao, J., Pavlick, E., Grondin, A., Bustamante, J. D., Martin, H., Parent, H., Fenn, N. Q., Almonte, A. A., Maguire-Wilkerson, A., Gu, M., et al. (2025) · Journal of Medical Internet Research · doi:10.2196/79671 · Cited by 5
Pérez‐González, A., Represa, M., Coll, P., Potel, C., Rodríguez-Rivero, S., Flores, E. V., Vázquez-Estévez, C., Ocampo, A., Pousada, G., & Poveda, E. (2022) · Frontiers in Public Health · doi:10.3389/fpubh.2022.1005622 · Cited by 5
Self-citationPrEParing for the End of the HIV Epidemic—A Public Health Imperative
Bedimo, R., & Jodlowski, T. Z. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.30195 · Cited by 5
D’Avanzo, P. A., Shourya, S., Brin, M., Kaw, S., Kay, E. S., Batey, D. S., Radix, A. E., Belkind, U., Tanner, M. R., Galindo, C. A., et al. (2024) · AIDS Education and Prevention · doi:10.1521/aeap.2024.36.1.33 · Cited by 5
HIV preexposure prophylaxis in adolescents and young adults: an update
Camfield, C., Evans, Y. N., & Kumbhakar, R. G. (2024) · Current Opinion in Pediatrics · doi:10.1097/mop.0000000000001357 · Cited by 5
“In contrast to the TDF-containing oral PrEP regimen, TAF-FTC contains a pro-drug of tenofovir – tenofovir alafenamide – that achieves higher intracellular concentrations than TDF [12].”
BackgroundOglesby, A. K., Germain, G., Metzner, A. A., Laliberté, F., MacKnight, S. D., Hilts, A., Swygard, H., & Duh, M. S. (2024) · AIDS Patient Care and STDs · doi:10.1089/apc.2024.0158 · Cited by 5
“13 14 – 18 Notably, medication adherence was a critical determinant of ef fi cacy in these trials, 18 – 21 and current guidelines emphasize the importance of adherence support when providing PrEP.”
Influential
Metadata
- Authors
- Mayer, K. H., Molina, J.-M., Thompson, M. A., Anderson, P. L., Mounzer, K. C., De Wet, J. J., DeJesus, E., Jessen, H., Grant, R. M., Ruane, P. J., Wong, P., Ebrahimi, R., Zhong, L., Mathias, A., Callebaut, C., Collins, S. E., Das, M., McCallister, S., Brainard, D. M., Brinson, C., Clarke, A., Coll, P., Post, F. A., & Hare, C. B.
- Affiliations
- Harvard University (US)
- Inserm (FR)
- AIDS Research Consortium of Atlanta (US)
- University of Colorado Anschutz (US)
- Philadelphia Fight (US)
- Orlando Immunology Center (US)
- University of California, San Francisco (US)
- Ruane Medical (US)
- Gilead Sciences (United States) (US)
- National Health Service (GB)
- IrsiCaixa (ES)
- King's College Hospital NHS Foundation Trust (GB)
- Kaiser Permanente San Francisco Medical Center (US)
- Corresponding author
- Das, Moupali
- ORCID
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2020-07
- Volume
- 396
- Issue
- 10246
- Pages
- 239-254
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC9665936
- OpenAlex
- W3045256412
- Cited by
- 428
- References
- 61
- Citations by year
- 2026: 38 · 2025: 68 · 2024: 72 · 2023: 76 · 2022: 88 · 2021: 72 · 2020: 13
- FWCI
- 8.17
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Gilead Sciences
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS drug development and treatment
- Life Sciences › Immunology and Microbiology › Virology › HIV Research and Treatment
- Keywords
- HIV pre-exposure prophylaxis, tenofovir alafenamide, tenofovir disoproxil fumarate, emtricitabine, HIV prevention, non-inferiority, men who have sex with men, transgender women, renal safety, bone safety, antiviral efficacy, sexually transmitted infections
- MeSH terms
- Emtricitabine, Tenofovir, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination, Sexual and Gender Minorities, Adenine, Adult, Double-Blind Method, Europe, Female, Humans, Male, North America, Placebos, Safety, HIV-1, HIV Infections, Prevalence, Treatment Outcome, Homosexuality, Male, Anti-HIV Agents, Pre-Exposure Prophylaxis
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