scholarly journals Tenofovir Disoproxil Fumarate-Associated Fanconi Syndrome in an Human Immunodeficiency Virus (HIV)-Uninfected Man Receiving HIV Pre-Exposure Prophylaxis

2017 ◽  
Vol 4 (3) ◽  
Author(s):  
Soheb Khan ◽  
Connie A Funk ◽  
Katya Corado ◽  
Sheldon Morris ◽  
Michael P Dube
Keyword(s):  
Human Immunodeficiency Virus ◽  
Tenofovir Disoproxil Fumarate ◽  
Fanconi Syndrome ◽  
Immunodeficiency Virus ◽  
Exposure Prophylaxis

scholarly journals Is Emtricitabine-Tenofovir Disoproxil Fumarate Pre-exposure Prophylaxis for the Prevention of Human Immunodeficiency Virus Infection Safer Than Aspirin?

2016 ◽  
Vol 3 (1) ◽  
Author(s):  
Noah Kojima ◽  
Jeffrey D. Klausner
Keyword(s):  
Human Immunodeficiency Virus ◽  
Gastrointestinal Bleeding ◽  
Hiv Infection ◽  
Tenofovir Disoproxil Fumarate ◽  
African Women ◽  
Health Study ◽  
Heterosexual Couples ◽  
Preexposure Prophylaxis ◽  
Immunodeficiency Virus ◽  
Exposure Prophylaxis

Abstract Background.  The safety and effectiveness studies of emtricitabine-tenofovir disoproxil fumarate (FTC-TDF) for human immunodeficiency virus (HIV) infection pre-exposure prophylaxis (PrEP) in men and women showed that daily use reduced the risk of HIV acquisition, but there still may concerns about safety. Methods.  A narrative review was done in September 2015 comparing the 5 major studies on PrEP for HIV infection—Preexposure Prophylaxis Initiative (N = 2499; 3324 person-years), Partners Preexposure Prophylaxis (N = 4747; 7830 person-years), TDF2 (N = 1219; 1563 person-years), Preexposure Prophylaxis Trial for HIV Prevention among African Women (N = 2056; 1407 person-years), and Vaginal and Oral Interventions to Control the Epidemic (N = 4969; 5509 person-years)—and the 2 major studies on aspirin safety—Physicians' Health Study (N = 22 071; over 110 000 person-years) and the Women's Health Study (N = 39 876; approximately 400 000 person-years). The numbers needed to harm (NNH) were calculated for FTC-TDF for HIV infection PrEP and aspirin. Results.  The NNH for FTC-TDF in men who have sex with men and transgender women was 114 for nausea and 96 for unintentional weight loss; in heterosexual couples, the NNH was 68 for moderate decreased absolute neutrophil count. For aspirin, the NNH was 909 for major gastrointestinal bleeding, 123 for any gastrointestinal bleeding, and 15 for any bleeding problems in men. In women, the NNH for easy bruising was 10. Conclusions.  We conclude that FTC-TDF for PrEP for HIV infection favorably compares with aspirin in terms of user safety. Although long-term studies are needed, providers should feel reassured about the safety of short- and medium-term PrEP for HIV infection with FTC-TDF.

scholarly journals Fanconi Syndrome Leading to Hypophosphatemic Osteomalacia Related to Tenofovir Use

2021 ◽  
Vol 13 (2) ◽  
pp. 448-453
Author(s):  
Mana Rao ◽  
Liam Dadey ◽  
Thomas Glowa ◽  
Peter Veldkamp
Keyword(s):  
Human Immunodeficiency Virus ◽  
Hiv Infection ◽  
Proximal Tubule ◽  
Tenofovir Disoproxil Fumarate ◽  
Fanconi Syndrome ◽  
Muscular Weakness ◽  
Fanconi’S Syndrome ◽  
Glucose Phosphate ◽  
Immunodeficiency Virus ◽  
Hypophosphatemic Osteomalacia

Tenofovir disoproxil fumarate (TDF) is used worldwide to treat and prevent Human Immunodeficiency Virus (HIV) infection. Fanconi syndrome is a complication of TDF use and is characterized by inadequate reabsorption of glucose, phosphate and protein in the proximal tubule of the kidney which may eventually lead to osteomalacia manifested by symptoms of pain, muscular weakness and difficulty ambulating. We present a patient with severe osteomalacia due to progressive and unrecognized Fanconi’s syndrome, who responded rapidly to TDF withdrawal, oral phosphate repletion and calcitriol. With the widespread use of TDF-containing antiviral regimens, it is critically important that physicians adhere to screening recommendations to detect early Fanconi syndrome, and recognize symptoms of osteomalacia as a serious complication.

scholarly journals A Randomized Switch From Nevirapine-Based Antiretroviral Therapy to Single Tablet Rilpivirine/Emtricitabine/Tenofovir Disoproxil Fumarate in Virologically Suppressed Human Immunodeficiency Virus-1-Infected Rwandans

2016 ◽  
Vol 3 (3) ◽  
Author(s):  
Sean E. Collins ◽  
Philip M. Grant ◽  
Francois Uwinkindi ◽  
Annie Talbot ◽  
Eric Seruyange ◽  
...  
Keyword(s):  
Human Immunodeficiency Virus ◽  
Antiretroviral Therapy ◽  
Tenofovir Disoproxil Fumarate ◽  
Sub Saharan Africa ◽  
Current Therapy ◽  
Virologic Suppression ◽  
Open Label ◽  
Immunodeficiency Virus ◽  
Sub Saharan ◽  
Hiv 1

Abstract Background.  Many human immunodeficiency virus (HIV)-infected patients remain on nevirapine-based antiretroviral therapy (ART) despite safety and efficacy concerns. Switching to a rilpivirine-based regimen is an alternative, but there is little experience with rilpivirine in sub-Saharan Africa where induction of rilpivirine metabolism by nevirapine, HIV subtype, and dietary differences could potentially impact efficacy. Methods.  We conducted an open-label noninferiority study of virologically suppressed (HIV-1 ribonucleic acid [RNA] < 50 copies/mL) HIV-1-infected Rwandan adults taking nevirapine plus 2 nucleos(t)ide reverse-transcriptase inhibitors. One hundred fifty participants were randomized 2:1 to switch to coformulated rilpivirine-emtricitabine-tenofovir disoproxil fumarate (referenced as the Switch Arm) or continue current therapy. The primary efficacy endpoint was HIV-1 RNA < 200 copies/mL at week 24 assessed by the US Food and Drug Administration Snapshot algorithm with a noninferiority margin of 12%. Results.  Between April and September 2014, 184 patients were screened, and 150 patients were enrolled; 99 patients switched to rilpivirine-emtricitabine-tenofovir, and 51 patients continued their nevirapine-based ART. The mean age was 42 years and 43% of participants were women. At week 24, virologic suppression (HIV-1 RNA level <200 copies/mL) was maintained in 93% and 92% in the Switch Arm versus the continuation arm, respectively. The Switch Arm was noninferior to continued nevirapine-based ART (efficacy difference 0.8%; 95% confidence interval, −7.5% to +12.0%). Both regimens were generally safe and well tolerated, although 2 deaths, neither attributed to study medications, occurred in participants in the Switch Arm. Conclusions.  A switch from nevirapine-based ART to rilpivirine-emtricitabine-tenofovir disoproxil fumarate had similar virologic efficacy to continued nevirapine-based ART after 24 weeks with few adverse events.

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