Low Risk of Proximal Tubular Dysfunction Associated With Emtricitabine-Tenofovir Disoproxil Fumarate Preexposure Prophylaxis in Men and Women

被引：35

作者：

Mugwanya, Kenneth ^{[1
,2
,10
]}

Baeten, Jared ^{[1
,2
,3
]}

Celum, Connie ^{[1
,2
,3
]}

Donnell, Deborah ^{[4
]}

Nickolas, Thomas ^{[5
]}

Mugo, Nelly ^{[2
,11
]}

Branch, Andrea ^{[7
]}

Tappero, Jordan ^{[9
]}

Kiarie, James ^{[12
]}

Ronald, Allan ^{[13
]}

Yin, Michael ^{[6
]}

Wyatt, Christina ^{[8
]}

机构：

[1] Univ Washington, Dept Epidemiol, Seattle, WA 98195 USA

[2] Univ Washington, Dept Global Hlth, Seattle, WA 98195 USA

[3] Univ Washington, Dept Med, Seattle, WA USA

[4] Fred Hutchinson Canc Res Ctr, Vaccine & Infect Dis Div, 1124 Columbia St, Seattle, WA 98104 USA

[5] Columbia Univ, Dept Med, Med Ctr, Div Nephrol, New York, NY USA

[6] Columbia Univ, Dept Med, Med Ctr, Div Infect Dis, New York, NY USA

[7] Icahn Sch Med Mt Sinai, Dept Med, Div Liver Dis, New York, NY 10029 USA

[8] Icahn Sch Med Mt Sinai, Dept Med, Div Nephrol, New York, NY 10029 USA

[9] Ctr Dis Control & Prevent, Div Global Hlth Protect, Ctr Global Hlth, Atlanta, GA USA

[10] Makerere Univ, Sch Publ Hlth, Div Dis Control, Kampala, Uganda

[11] Kenya Govt Med Res Ctr, Nairobi, Kenya

[12] Univ Nairobi, Dept Obstet & Gynecol, Nairobi, Kenya

[13] Univ Manitoba, Dept Med, Winnipeg, MB, Canada

来源：

JOURNAL OF INFECTIOUS DISEASES | 2016年 / 214卷 / 07期

基金：

比尔及梅琳达.盖茨基金会;

关键词：

PrEP; TDF toxicity; proximal tubular dysfunction; TDF nephrotoxicity; ACUTE-RENAL-FAILURE; ACUTE KIDNEY INJURY; HIV-INFECTION; ANTIRETROVIRAL PROPHYLAXIS; BANGKOK TENOFOVIR; AFRICAN WOMEN; PHOSPHATE; EXPOSURE; REABSORPTION; NOMOGRAM;

D O I：

10.1093/infdis/jiw125

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Objective. Tenofovir disoproxil fumarate (TDF) is associated with proximal tubular dysfunction (tubulopathy) when used in the treatment of human immunodeficiency virus (HIV) infection. We evaluated whether TDF causes tubulopathy when used as HIV preexposure prophylaxis (PrEP) and whether tubulopathy predicts clinically relevant decline (>= 25%) in the estimated glomerular filtration rate (eGFR). Methods. A subgroup analysis of the Partners PrEP Study, a randomized, placebo-controlled trial of daily oral TDF, alone or with emtricitabine (FTC), in HIV-uninfected African men and women (Clinicaltrials.gov NCT00557245). Tubulopathy was assessed in concurrently obtained urine and serum samples at the 24-month or last on-treatment visit, predefined as = 2 of the following: tubular proteinuria, euglycemic glycosuria, increased urinary phosphate, and uric acid excretion. Results. Of 1549 persons studied (776 receiving FTC-TDF, 773 receiving placebo), 64% were male, and the median age was 37 years. Over a median 24 months of study-drug exposure, the frequency of tubulopathy was 1.7% for FTC-TDF versus 1.3% for placebo (odds ratio, 1.30; 95% confidence interval,.52-3.33; P = .68); Tubulopathy occurred in 2 of 52 persons (3.8%) with versus 3 of 208 (1.4%) without >= 25% eGFR decline (adjusted odds ratio, 1.39; .10-14.0; P > .99). Conclusions. Daily oral FTC-TDF PrEP was not significantly associated with tubulopathy over the course of 24 months, nor did tubulopathy predict clinically relevant eGFR decline.

引用

页码：1050 / 1057

页数：8