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: Introduction: Daily pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is associated with a small but statistically significant decrease in estimated glomerular filtration rate (eGFR). We assessed the renal safety of on‐demand PrEP with TDF/FTC in HIV‐1 uninfected men. Methods: We used data from the randomized double‐blind placebo‐controlled ANRS‐IPERGAY trial and its open‐label extension conducted between February 2012 and June 2016 among HIV‐uninfected MSM starting on‐demand PrEP. Using linear mixed model, we evaluated the mean eGFR decline from baseline over time and determined risks factors associated with eGFR decline during the study. Results: During the blind phase, with a median follow‐up of 9.4 months, the mean decline slope of eGFR from baseline was −0.88 and −1.53 mL/min/1.73 m[sup.2] per year in the placebo (n = 201) and the TDF/FTC group (n = 198) respectively, with a slope difference of 0.65 mL/min/1.73 m[sup.2] per year (p = 0.27). Including both phases, 389 participants started on‐demand TDF/FTC with a median follow‐up of 19.2 months and a mean decline of eGFR from baseline of −1.14 mL/min/1.73 m[sup.2] per year (p < 0.001). The slope of eGFR reduction was not significantly different in participants with baseline eGFR ≤ 90 mL/min/1.73 m[sup.2] (p = 0.44), age >40 years (p = 0.24) or hypertension (p = 0.21). There was a dose‐response relationship between recent tenofovir exposure and lower eGFR when considering the number of pills taken in the two months prior the visit (eGFR difference of −0.88 mL/min/1.73 m[sup.2] between >15 pills/month vs. ≤15 pills/month, p < 0.01) or plasma tenofovir concentrations at the visit (eGFR difference compared to ≤2 ng/mL: >2 to ≤10ng/mL: −0.98 mL/min/1.73 m[sup.2], >10 to ≤40ng/mL: −1.28 mL/min/1.73 m[sup.2], >40 ng/mL: −1.82 mL/min/1.73 m[sup.2], p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m[sup.2] during the OLE phase. No case of Fanconi syndrome was reported. Conclusions: The renal safety of on‐demand PrEP with TDF/FTC was good. The overall reduction and intermittent exposure to TDF/FTC may explain this good renal safety., Introduction Pre‐exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate (TDF) – emtricitabine (FTC) raises a lot of expectations to hamper HIV epidemic due to its high effectiveness to prevent HIV acquisition [...]

Background: We used the Agence nationale de Recherches sur le sida et les hépatites virales (ANRS)-IPERGAY trial to qualitatively and quantitatively measure drug use among men who have sex with men under preexposure prophylaxis using 2 different methods, to better understand and collectively respond to risky practices., Method: We included 69 volunteers of the ANRS-IPERGAY trial. We measured drug use by 2 methods: (1) drug detection by hair analysis and (2) reported drug use by self-reported drug consumption., Results: New psychoactive substances (NPS) and conventional drugs were detected in 53 of the 69 (77%) volunteers by hair analysis and in 39 of the 69 (57%) volunteers by questionnaires. On the 219 hair segments analyzed, the most commonly used drugs were cocaine in 47 of the 69 (68%), 3,4-methylenedioxymethamphetamine/ecstasy in 31 of the 69 (45%), and NPS in 27 of the 69 (39%). On the 1061 collected questionnaires, the most commonly used drugs were cocaine in 31 of the 69 (45%), 3,4-methylenedioxymethamphetamine/ecstasy in 29 of the 69 (42%), and NPS in 16 of the 69 (23%). Hair analysis detects more conventional drugs and/or NPS use (P < 0.05). Drug use identified by hair was significantly associated with a higher number of sexual partners in the past 2 months (P ≤ 0.001), more often casual partners (P ≤ 0.001), condomless anal sex (P ≤ 0.005), hardcore sexual practices (P ≤ 0.001), a higher number of sexually transmitted infections, and chemsex (P ≤ 0.05)., Conclusions: Self-report drug use by questionnaires remains the reference tool for harm reduction at the individual level because of its feasibility and low cost. However, hair analysis is more sensitive, objectively assessing consumption, and interesting to understand uses and to be able to collectively respond to risky practices with adapted messages., Competing Interests: J.-M.M. reports receiving financial support as an adviser for Gilead Sciences, Merck, Janssen, Bristol-Myers Squibb, and ViiV Healthcare, and research grants from Gilead Sciences and Merck. F.R. reports receiving financial support as an adviser for Gilead Sciences, Merck, Janssen, and ViiV Healthcare, and research grants from Gilead Sciences. B.S. reports receiving support as an adviser for Gilead Sciences, Merck, Janssen, and Bristol-Myers Squibb, and research grants from ANRS, Fondation Pierre Bergé, Gilead Sciences, and Merck. L.C. has received research grants from ViiV Healthcare and Merck, personal fees from Mylan, and nonfinancial support from BMS, Gilead Science, Janssen Cilag, MSD, and ViiV Healthcare. G.P. has received consulting fees from Bristol-Myers Squibb, Boehringer Ingelheim, Tibotec, Nephrotek, Gilead, Roche, MSD, Abbott, and ViiV Healthcare, and research grants from Bristol-Myers Squibb and Gilead Sciences. E.C. reports receiving financial support as an adviser for Janssen, Merck, ViiV, and Novartis, and nonfinancial support from Gilead Sciences. J.C. reports receiving financial support as an adviser for Gilead Sciences, Bristol-Myers Squibb, and AbbVie. L.M. reports receiving grants from ANRS, the Bill & Melinda Gates Foundation, and Gilead. G. Peytavin has received travel grants, consultancy fees, honoraria, or study grants from various pharmaceutical companies, including Gilead Sciences, Janssen, Merck, and ViiV Healthcare. The other authors have no conflicts of interest to disclose., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)