Tenofovir Alafenamide for HIV Preexposure Prophylaxis: What Can We DISCOVER About Its True Value?
Authors: Douglas S. Krakower, Demetre C. Daskalakis, Judith Feinberg, Julia L. Marcus
Journal: Annals of Internal Medicine (2020)

Ideas and Opinions18 February 2020Tenofovir Alafenamide for HIV Preexposure Prophylaxis: What Can We DISCOVER About Its True Value?Douglas S. Krakower, MD, Demetre C. Daskalakis, MD, Judith Feinberg, MD, and Julia L. Marcus, PhDDouglas S. Krakower, MDBeth Israel Deaconess Medical Center, Harvard Medical School, Harvard Pilgrim Health Care Institute, and The Fenway Institute, Boston, Massachusetts (D.S.K.)Search for more papers by this author, Demetre C. Daskalakis, MDNew York City Department of Health and Mental Hygiene, New York, New York (D.C.D.)Search for more papers by this author, Judith Feinberg, MDWest Virginia University, Morgantown, West Virginia (J.F.)Search for more papers by this author, and Julia L. Marcus, PhDHarvard Medical School, Harvard Pilgrim Health Care Institute, and The Fenway Institute, Boston, Massachusetts (J.L.M.)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/M19-3337 Author Insight Video - Demetre C. Daskalakis, MD, and Judith Feinberg, MD In this video, Demetre C. Daskalakis, MD, and Judith Feinberg, MD, offer additional insight into the article, "Tenofovir Alafenamide for HIV Preexposure Prophylaxis: What Can We DISCOVER About Its True Value?" SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In early 2019, the U.S. government launched the Ending the HIV Epidemic initiative, which aims to reduce HIV incidence by 90% before 2030. Daily preexposure prophylaxis (PrEP) with a single pill containing tenofovir disoproxil fumarate with emtricitabine (TDF–FTC) virtually eliminates sexual HIV transmission, and scale-up of PrEP is a critical component of the federal initiative. Before TDF–FTC was used for PrEP, it was a cornerstone of HIV treatment, but it has been largely replaced by tenofovir alafenamide with emtricitabine (TAF–FTC), a newer regimen that was believed to be equally effective but safer. As we embark on a national effort to ...References1. Hare CB, Coll J, Ruane P, et al. The phase 3 DISCOVER study: daily F/TAF or F/TDF for HIV preexposure prophylaxis [Abstract]. In: Abstract eBook for Conference on Retroviruses and Opportunistic Infections, Seattle, Washington, 4–7 March 2019. CROI Foundation/IAS–USA; 2019:41. Abstract no. 104LB. Google Scholar2. Spinner CD, Brunetta J, Shalit P, et al. DISCOVER study for HIV pre-exposure prophylaxis (PrEP): F/TAF has a more rapid onset and longer sustained duration of HIV protection compared with F/TDF [Abstracts]. In: Oral abstracts of the 10th IAS conference on HIV science, 21–24 July 2019, Mexico City, Mexico. J Int AIDS Soc. 2019;22 Suppl 5:e25327. Abstract no. TUAC0403LB. [PMID: 31339004] doi:10.1002/jia2.25327 Google Scholar3. Goldstein RH, Walensky RP. Where were the women? Gender parity in clinical trials. N Engl J Med. 2019. [PMID: 31665574] doi:10.1056/NEJMp1913547 CrossrefMedlineGoogle Scholar4. U.S. Food and Drug Administration. FDA briefing document: meeting of the Antimicrobial Drugs Advisory Committee, August 7, 2019. Accessed at www.fda.gov/media/129607/download on 8 October 2019. Google Scholar5. Mocroft A, Kirk O, Reiss P, et al; EuroSIDA Study Group. Estimated glomerular filtration rate, chronic kidney disease and antiretroviral drug use in HIV-positive patients. AIDS. 2010;24:1667-78. [PMID: 20523203] doi:10.1097/QAD.0b013e328339fe53 CrossrefMedlineGoogle Scholar6. Gallant JE, Staszewski S, Pozniak AL, et al; 903 Study Group. Efficacy and safety of tenofovir DF vs stavudine in combination therapy in antiretroviral-naive patients: a 3-year randomized trial. JAMA. 2004;292:191-201. [PMID: 15249568] CrossrefMedlineGoogle Scholar7. Venter WDF, Moorhouse M, Sokhela S, et al. Dolutegravir plus two different prodrugs of tenofovir to treat HIV. N Engl J Med. 2019;381:803-15. [PMID: 31339677] doi:10.1056/NEJMoa1902824 CrossrefMedlineGoogle Scholar8. Pilkington V, Hill A, Hughes S, et al. How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP [Editorial]. J Virus Erad. 2018;4:215-24. [PMID: 30515300] CrossrefMedlineGoogle Scholar9. U.S. Food and Drug Administration. Descovy for HIV pre-exposure prophylaxis: Antimicrobial Drugs Advisory Committee meeting briefing document. 4 July 2019. Accessed at www.fda.gov/media/129609/download on 8 October 2019. Google Scholar10. Walensky RP, Horn TH, Paltiel AD. The epi-TAF for tenofovir disoproxil fumarate? Clin Infect Dis. 2016;62:915-8. [PMID: 26658300] doi:10.1093/cid/civ1000 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Beth Israel Deaconess Medical Center, Harvard Medical School, Harvard Pilgrim Health Care Institute, and The Fenway Institute, Boston, Massachusetts (D.S.K.)New York City Department of Health and Mental Hygiene, New York, New York (D.C.D.)West Virginia University, Morgantown, West Virginia (J.F.)Harvard Medical School, Harvard Pilgrim Health Care Institute, and The Fenway Institute, Boston, Massachusetts (J.L.M.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M19-3337.Corresponding Author: Douglas S. Krakower, MD, Division of Infectious Diseases, Beth Israel Deaconess Medical Center, 110 Francis Street, Boston, MA 02215; e-mail, [email protected]harvard.edu.Current Author Addresses: Dr. Krakower: Beth Israel Deaconess Medical Center, 110 Francis Street, Boston, MA 02215.Dr. Daskalakis: New York City Department of Health and Mental Hygiene, 42-09 28th Street, New York, NY 11101.Dr. Feinberg: West Virginia University, 930 Chestnut Ridge Road, Morgantown, WV 26505.Dr. Marcus: Harvard Medical School and Harvard Pilgrim Health Care Institute, 401 Park Drive, Suite 401, Boston, MA 02215.Author Contributions: Conception and design: D.S. Krakower, D.C. Daskalakis, J. Feinberg, J.L. Marcus.Analysis and interpretation of the data: D.S. Krakower, D.C. Daskalakis, J. Feinberg, J.L. Marcus.Drafting of the article: D.S. Krakower, D.C. Daskalakis, J. Feinberg, J.L. Marcus.Critical revision of the article for important intellectual content: D.S. Krakower, D.C. Daskalakis, J. Feinberg, J.L. Marcus.Final approval of the article: D.S. Krakower, D.C. Daskalakis, J. Feinberg, J.L. Marcus.Administrative, technical, or logistic support: D.S. Krakower.This article was published at Annals.org on 14 January 2020. PreviousarticleNextarticle Advertisement Author Insight Video - Demetre C. Daskalakis, MD, and Judith Feinberg, MD In this video, Demetre C. Daskalakis, MD, and Judith Feinberg, MD, offer additional insight into the article, "Tenofovir Alafenamide for HIV Preexposure Prophylaxis: What Can We DISCOVER About Its True Value?" FiguresReferencesRelatedDetailsSee AlsoTenofovir Alafenamide for HIV Preexposure Prophylaxis Diana Brainard and Scott McCallister Tenofovir Alafenamide for HIV Preexposure Prophylaxis Douglas S. Krakower , Demetre C. Daskalakis , Judith Feinberg , and Julia L. 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Walensky, MD, MPH, Tim Horn, MS, Nicole C. McCann, BA, Kenneth A. Freedberg, MD, MSc, and A. David Paltiel, MBA, PhDImplementing PrEP in the pharmacy 18 February 2020Volume 172, Issue 4Page: 281-282KeywordsDrugsFood and Drug AdministrationHIVHIV preventionMale male sexual contactPharmacokineticsPopulation statisticsPreexposure prophylaxisSafetyWeight gain ePublished: 14 January 2020 Issue Published: 18 February 2020 Copyright & PermissionsCopyright © 2020 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...