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TYPE 1 HUMAN IMMUNODEFICIENCY VIRUS (HIV-1) INCIDENCE, ADHERENCE, AND DRUG RESISTANCE IN INDIVIDUALS TAKING DAILY EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS: POOLED ANALYSIS FROM 72 GLOBAL STUDIES
Author
Landovitz, Raphael J.
Tao, Li
Yang, Juan
Boer, Melanie de
Carter, Christoph
Das, Moupali
Baeten, Jared M.
Liu, Albert
Hoover, Karen W.
Celum, Connie
Grinsztejn, Beatriz
Morris, Sheldon
Wheeler, Darrell P.
Mayer, Kenneth H.
Golub, Sarit A.
Bekker, Linda-Gail
Diabaté, Souleymane
Hoornenborg, Elske
Myers, Janet
Leech, Ashley A.
McCormack, Sheena
Chan, Philip A.
Sweat, Michael
Matthews, Lynn T.
Grant, Robert
Tao, Li
Yang, Juan
Boer, Melanie de
Carter, Christoph
Das, Moupali
Baeten, Jared M.
Liu, Albert
Hoover, Karen W.
Celum, Connie
Grinsztejn, Beatriz
Morris, Sheldon
Wheeler, Darrell P.
Mayer, Kenneth H.
Golub, Sarit A.
Bekker, Linda-Gail
Diabaté, Souleymane
Hoornenborg, Elske
Myers, Janet
Leech, Ashley A.
McCormack, Sheena
Chan, Philip A.
Sweat, Michael
Matthews, Lynn T.
Grant, Robert
Affilliation
UCLA Center for Clinical AIDS Research and Education. Los Angeles, California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Bridge HIV. San Francisco Department of Public Health. San Francisco, California, USA.
US Centers for Disease Control and Prevention. Atlanta, Georgia, USA.
University of Washington. Seattle, Washington, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
UC San Diego Health. San Diego, California, USA.
State University of New York. New Paltz, New York, USA.
Fenway Health and Harvard Medical School. Boston, Massachusetts, USA.
Hunter College. New York, New York, USA.
University of Cape Town. The Desmond Tutu HIV Centre. Cape Town, South Africa.
Centre de Recherche du CHU de Québec-Université Laval. Quebec, Canada.
Public Health Service of Amsterdam. Amsterdam, Netherlands.
Public Health Service of Amsterdam. Amsterdam, Netherlands.
Vanderbilt University School of Medicine. Department of Health Policy. Nashville, Tennessee, USA.
MRC Clinical Trials Unit at University College London. London, United Kingdom.
Brown University. Providence, Rhode Island, USA.
Medical University of South Carolina. Charleston, North Carolina, USA.
The University of Alabama at Birmingham. Birmingham, Alabama, USA.
University of California San Francisco. Department of Medicine. San Francisco, California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Gilead Sciences. Inc. Foster City. California, USA.
Bridge HIV. San Francisco Department of Public Health. San Francisco, California, USA.
US Centers for Disease Control and Prevention. Atlanta, Georgia, USA.
University of Washington. Seattle, Washington, USA.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST e AIDS. Rio de Janeiro, RJ, Brasil.
UC San Diego Health. San Diego, California, USA.
State University of New York. New Paltz, New York, USA.
Fenway Health and Harvard Medical School. Boston, Massachusetts, USA.
Hunter College. New York, New York, USA.
University of Cape Town. The Desmond Tutu HIV Centre. Cape Town, South Africa.
Centre de Recherche du CHU de Québec-Université Laval. Quebec, Canada.
Public Health Service of Amsterdam. Amsterdam, Netherlands.
Public Health Service of Amsterdam. Amsterdam, Netherlands.
Vanderbilt University School of Medicine. Department of Health Policy. Nashville, Tennessee, USA.
MRC Clinical Trials Unit at University College London. London, United Kingdom.
Brown University. Providence, Rhode Island, USA.
Medical University of South Carolina. Charleston, North Carolina, USA.
The University of Alabama at Birmingham. Birmingham, Alabama, USA.
University of California San Francisco. Department of Medicine. San Francisco, California, USA.
Abstract
Background: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. Methods: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. Results: Among 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63-.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/wk, respectively, and the corresponding incidence was 3.9 (95% CI: 2.9-5.3), .24 (.060-.95), .27 (.12-.60), and .054 (.008-.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. Conclusions: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.
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