First year of #PrEP implementation in #France with daily or on-demand #tenofovir disoproxil fumarate/emtricitabine (J Antimicrob Chemother., abstract)

[Source: Journal of Antimicrobial Chemotherapy, full page: (LINK). Abstract, edited.]

First year of pre-exposure prophylaxis implementation in France with daily or on-demand tenofovir disoproxil fumarate/emtricitabine

M Siguier, R Mera, G Pialoux, M Ohayon, L Cotte, N Valin, J Ghosn, E Cua, C Pintado, J Chas, G Barriere, F Durand, J M Molina

Journal of Antimicrobial Chemotherapy, dkz220, https://doi.org/10.1093/jac/dkz220

Published: 20 June 2019

 

Abstract

Background

In January 2016, the French Medicine Agency initiated a Temporary Recommendation for Use (TRU) to allow the use of oral intake of tenofovir disoproxil fumarate and emtricitabine for pre-exposure prophylaxis (PrEP) in adults at high risk of HIV. We report the results of the first year of PrEP implementation in France.

Methods

Data were collected by physicians using a secured web subject-monitoring interface, with two forms: an initiation form, with patients’ baseline characteristics, and an HIV seroconversion form. Univariate and adjusted multivariate analysis using a logistic regression model were performed to identify baseline factors associated with on-demand PrEP regimen prescription.

Results

From 4 January 2016 to 28 February 2017, 3405 subjects were enrolled, with 2774 initiation forms completed; 98.1% were male and 96.9% were MSM. An on-demand regimen was prescribed to 57% of subjects. Older age (OR for participants older than 50 years = 1.76, 95% CI 1.35–2.3, P < 0.001) and site of prescription (OR of former IPERGAY sites = 2.28, 95% CI 1.84–2.83, P < 0.001) were associated with on-demand prescription. Those reporting sexually transmitted infection (STI) and condomless anal sex with at least two different partners were less likely to receive on-demand PrEP (OR = 0.68, 95% CI 0.57–0.82 and 0.75, 95% CI 0.57–0.98, respectively; P < 0.05 for all). Four breakthrough HIV infections were reported during the study, in the context of PrEP interruption or acute infection at the time of PrEP initiation.

Conclusions

In a real-life setting in France, PrEP was used, either daily or on-demand, mostly by MSM, with breakthrough infections being rare.

Issue Section: ORIGINAL RESEARCH

Keywords: HIV/AIDS; PrEP; Antivirals.

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#Tenofovir disoproxil fumarate associated #Fanconi #syndrome in an #HIV uninfected man receiving HIV #PrEP (Open Forum Infect Dis., abstract)

[Source: Open Forum Infectious Diseases, full page: (LINK). Abstract, edited.]

Tenofovir disoproxil fumarate associated Fanconi syndrome in an HIV uninfected man receiving HIV pre-exposure prophylaxis

Short title: Fanconi syndrome during PrEP

Soheb KHAN1, Connie A. FUNK1, Katya CORADO2, Sheldon MORRIS3, Michael P. DUBE1

1 University of Southern California Keck School of Medicine, Los Angeles, CA; 2 Los Angeles; Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles CA; 3 University of California at San Diego School of Medicine, San Diego CA.

Corresponding author: Michael P. Dubé, MD, USC Keck School of Medicine, 1300 N. Mission Road, Room 349, Los Angeles CA 90033, Phone: (323) 343-8288, E-Mail: mdube@usc.edu

Accepted Manuscript / Word count: 819

Keywords: Tenofovir, PrEP, Fanconi, renal dysfunction

Support: California HIV Research Program

 

INTRODUCTION

Tenofovir disoproxil fumarate (TDF) has been used worldwide in antiretroviral regimens of HIV infected patients since being approved by the U.S. Food and Drug Administration in 2001. TDF can cause renal tubular dysfunction and reduced renal function [1]. In its fully developed form, TDF renal dysfunction is associated with hypophosphatemia, renal phosphate wasting and other features of Fanconi syndrome [1]. Cases of TDF-associated Fanconi syndrome have been reported predominantly among patients with HIV infection [1]. There has been no excess risk of renal tubular toxicity with TDF-emtricitabine (TDF-FTC) detected in large placebo controlled trials of HIV pre-exposure prophylaxis (PrEP) [2, 3]. One other well-documented likely Fanconi syndrome has been reported in an online supplement to the latter paper [3]. Herein, we report an additional case of this previously described phenomenon.

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Keywords: HIV/AIDS; Antivirals; PrEP; Tenofovir; Fanconi Syndrome.

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