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CHANGES IN RENAL FUNCTION ASSOCIATED WITH ORAL EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE USE FOR HIV PRE-EXPOSURE PROPHYLAXIS
Author
Affilliation
The Gladstone Institutes. San Francisco, CA, United States of America / University of California. San Francisco, CA, United States of America
Asociación Civil Impacta Salud y Educación. Lima, Peru
University of California. San Francisco, CA, United States of America
University of California. San Francisco, CA, United States of America
The Gladstone Institutes. San Francisco, CA, United States of America
University of California. San Francisco, CA, United States of America / Bridge HIV. San Francisco Department of Public Health. San Francisco, CA, United States of America
Investigaciones Medicas en Salud. Lima, Peru
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil
Fenway Institute. Fenway Health. Boston, MA, United States of America
Chiang Mai University. Faculty of Medicine. Department of Community Medicine. Chiang Mai, Thailand
Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil
University of Cape Town. Desmond Tutu HIV Centre and Department of Medicine. Cape Town, South Africa
Universidade de São Paulo. Escola de Medicina. Divisão de Imunologia Clínica e Alergia. São Paulo, SP, Brasil
National Institute of Allergy and Infectious Diseases. Bethesda, MD, United States of America
The Gladstone Institutes. San Francisco, CA, United States of America / University of California. San Francisco, CA, United States of America
Asociación Civil Impacta Salud y Educación. Lima, Peru
University of California. San Francisco, CA, United States of America
University of California. San Francisco, CA, United States of America
The Gladstone Institutes. San Francisco, CA, United States of America
University of California. San Francisco, CA, United States of America / Bridge HIV. San Francisco Department of Public Health. San Francisco, CA, United States of America
Investigaciones Medicas en Salud. Lima, Peru
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil
Fenway Institute. Fenway Health. Boston, MA, United States of America
Chiang Mai University. Faculty of Medicine. Department of Community Medicine. Chiang Mai, Thailand
Universidade Federal do Rio de Janeiro. Hospital Escola São Francisco de Assis. Projeto Praça Onze. Rio de Janeiro, RJ, Brasil
University of Cape Town. Desmond Tutu HIV Centre and Department of Medicine. Cape Town, South Africa
Universidade de São Paulo. Escola de Medicina. Divisão de Imunologia Clínica e Alergia. São Paulo, SP, Brasil
National Institute of Allergy and Infectious Diseases. Bethesda, MD, United States of America
The Gladstone Institutes. San Francisco, CA, United States of America / University of California. San Francisco, CA, United States of America
Abstract
Objective: Tenofovir disoproxil fumarate (TDF) pre-exposure prophylaxis decreases
sexual acquisition of HIV infection. We sought to evaluate the renal safety of TDF in
HIV-uninfected persons.
Design and methods: The Iniciativa Profilaxis Pre-Exposicio´n (iPrEx) study randomly
assigned 2499 HIV-seronegative men and transgender women who have sex with men
(MSM) to receive oral daily TDF coformulated with emtricitabine (FTC/TDF) or placebo.
Serum creatinine and phosphorus during randomized treatment and after discontinuation
were measured, and creatinine clearance (CrCl) was estimated by the Cockcroft–
Gault equation. Indicators of proximal renal tubulopathy (fractional excretion of
phosphorus and uric acid, urine protein, and glucose) were measured in a substudy.
Results: There was a small but statistically significant decrease in CrCl from baseline in
the active arm, compared to placebo, which was first observed at week 4 (mean change:
2.4 vs. 1.1 ml/min; P¼0.02), persisted through the last on-treatment visit (mean
change: þ0.3 vs. þ1.8 ml/min; P¼0.02), and resolved after stopping pre-exposure
prophylaxis (mean change: 0.1 vs. 0.0 ml/min; P¼0.83). The effect was confirmed
when stratifying by drug detection. The effect of FTC/TDF on CrCl did not vary by race,
age, or history of hypertension. There was no difference in serum phosphate trends
between the treatment arms. In the substudy, two participants receiving placebo had
indicators of tubulopathy.
Conclusions: In HIV-seronegative MSM, randomization to FTC/TDF was associated
with a very mild nonprogressive decrease in CrCl that was reversible and managed with
routine serum creatinine monitoring.
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