Changes in kidney function among men having sex with men starting on demand tenofovir disoproxil fumarate – emtricitabine for HIV pre‐exposure prophylaxis. Issue 2 (22nd February 2020)

• Record Type: Journal Article
• Authors: Liegeon, Geoffroy; Antoni, Guillemette; Pialoux, Gilles; Capitant, Catherine; Cotte, Laurent; Charreau, Isabelle; Tremblay, Cécile; Cua, Eric; Senneville, Eric; Raffi, François; Meyer, Laurence; Molina, Jean‐Michel
• Other Names: Meyer L investigator.; Capitant C investigator.; Charreau I investigator.; Netzer E investigator.; Leturque N investigator.; Binesse J investigator.; Foubert V investigator.; Saouzanet M investigator.; Euphrasie F investigator.; Carette D investigator.; Guillon B investigator.; Saïdi Y investigator.; Aboulker J P investigator.; Spire B investigator.; Suzan M investigator.; Cattin G investigator.; Demoulin B investigator.; Sagaon‐Teyssier L investigator.; Lorente N investigator.; Doré V investigator.; Choucair E investigator.; Le Mestre S investigator.; Mennecier A investigator.; Etien N investigator.; Simon M C investigator.; Diallo A investigator.; Gibowski S investigator.; Delfraissy J F investigator.; Thompson D investigator.; Sas J investigator.; Pankovitch J investigator.; Klein M investigator.; Anis A investigator.; Molina Jean‐Michel investigator.; Wainberg Mark A investigator.; Trottier Benoit investigator.; Tremblay Cécile investigator.; Baril Jean‐Guy investigator.; Pialoux Gilles investigator.; Cotte Laurent investigator.; Chéret Antoine investigator.; Pasquet Armelle investigator.; Cua Eric investigator.; Hall Nolwenn investigator.; Rozenbaum Willy investigator.; Chidiac Christian investigator.; Delaugerre Constance investigator.; Bajos Nathalie investigator.; Timsit Julie investigator.; Peytavin Gilles investigator.; Fonsart Julien investigator.; Durand‐Zaleski Isabelle investigator.; Meyer Laurence investigator.; Aboulker Jean‐Pierre investigator.; Spire Bruno investigator.; Suzan‐Monti Marie investigator.; Girard Gabriel investigator.; Castro Daniela Rojas investigator.; Préau Marie investigator.; Morin Michel investigator.; Thompson David investigator.; Capitant Catherine investigator.; Mennecier Anaïs investigator.; Choucair Elias investigator.; Doré Véronique investigator.; Simon Marie‐Christine investigator.; Charreau Isabelle investigator.; Otis Joanne investigator.; Lert France investigator.; Diallo Alpha investigator.; Gibowski Séverine investigator.; Rabian Cecile investigator.;
• Is Part Of: Journal of the International AIDS Society. Volume 23:Issue 2(2020)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2020-02-22
• Subjects: PrEP -- on‐demand -- intermittent -- kidney -- eGFR -- tenofovir -- HIV; AIDS (Disease) -- Periodicals; HIV infections -- Periodicals; 616.9792005
• DOI: 10.1002/jia2.25420
• Languages: English
• ISSNs: 1758-2652

Abstract

Abstract: 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 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 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 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 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 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 2, >10 to ≤40ng/mL: −1.28 mL/min/1.73 m 2, >40 ng/mL: −1.82 mL/min/1.73 m 2, p < 0.001). Three participants discontinued TDF/FTC for eGFR < 60 mL/min/1.73 m 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.