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.

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Volume: 79

Issue: 5

Year of Publication: 2024

Affiliated Institutions:  UCLA Center for Clinical AIDS Research and Education, Los Angeles, 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. Instituto Nacional de Infectologia Evandro Chagas/Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil. 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. The Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa. Centre de Recherche du CHU de Québec-Université Laval, Quebec, Canada. Public Health Service of Amsterdam, Amsterdam, Netherlands. Department of Health Policy, Vanderbilt University School of Medicine, 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. Department of Medicine, University of California San Francisco, San Francisco, California, USA.

Abstract summary 

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.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.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.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.

Authors & Co-authors:  Landovitz Raphael J RJ Tao Li L Yang Juan J de Boer Melanie M Carter Christoph C Das Moupali M Baeten Jared M JM Liu Albert A Hoover Karen W KW Celum Connie C Grinsztejn Beatriz B Morris Sheldon S Wheeler Darrell P DP Mayer Kenneth H KH Golub Sarit A SA Bekker Linda-Gail LG Diabaté Souleymane S Hoornenborg Elske E Myers Janet J Leech Ashley A AA McCormack Sheena S Chan Philip A PA Sweat Michael M Matthews Lynn T LT Grant Robert R

Study Outcome 

Source Link: Visit source

Statistics
Citations :  Baeten  JM, Haberer  JE, Liu  AY, Sista  N. Preexposure prophylaxis for HIV prevention: where have we been and where are we going?  J Acquir Immune Defic Syndr  2013; 63:S122-9.
Authors :  26
Identifiers
Doi : 10.1093/cid/ciae143
SSN : 1537-6591
Study Population
Male,Female
Mesh Terms
Humans
Other Terms
HIV-1;emtricitabine;pre-exposure prophylaxis;tenofovir disoproxil fumarate
Study Design
Study Approach
Country of Study
Publication Country
United States