Back to Search
Start Over
Metabolic Effects of Preexposure Prophylaxis With Coformulated Tenofovir Disoproxil Fumarate and Emtricitabine.
- Source :
-
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2018 Jul 18; Vol. 67 (3), pp. 411-419. - Publication Year :
- 2018
-
Abstract
- Background: Antiretroviral drugs have been associated with changes in lipids, fat mass and dat distribution. Tenofovir disoproxil fumarate (TDF) has been shown to have a more favorable metabolic profile than other drugs in its class. However, the metabolic effects of TDF in preexposure prophylaxis (PrEP) are unknown.<br />Methods: We evaluated the effects of TDF/emtricitabine (FTC) on lipids and body composition in a blinded, placebo-controlled PrEP trial. Participants enrolled in a metabolic subcohort (N = 251, TDF/FTC; N = 247, placebo) consented to fasting lipid panels, dual-energy X-ray absorptiometry scans for body composition, and pharmacologic testing of drug metabolites at baseline and every 24 weeks thereafter.<br />Results: Lean body mass was stable and unaffected by TDF/FTC. Body weight increased in both groups but was lower on TDF/FTC through week 72. This difference was explained by lower fat accumulation on TDF/FTC. The net median percent difference (standard error, P value) for TDF/FTC vs placebo at week 24 was -0.8% (0.4%, P = .02), +0.3% (0.4%, P = .46), and -3.8% (1.4%, P = .009) for total, lean, and fat mass, respectively. There was no apparent differential regional fat accumulation on TDF/FTC. Decreases in cholesterol, but not triglycerides, were seen in TDF/FTC participants, with detectable drug levels compared to placebo.<br />Conclusions: TDF/FTC for PrEP showed cholesterol reductions and appeared to transiently suppress the accumulation of weight and body fat compared to placebo. There was no evidence of altered fat distribution or lipodystrophy during daily oral TDF/FTC PrEP.<br />Clinical Trials Registration: NCT00458393.
- Subjects :
- Absorptiometry, Photon
Adiposity
Administration, Oral
Adult
Body Mass Index
Body Weight
Double-Blind Method
Female
HIV Infections drug therapy
Humans
Lipid Metabolism
Lipids blood
Male
Transgender Persons
Young Adult
Anti-HIV Agents administration & dosage
Emtricitabine administration & dosage
Pre-Exposure Prophylaxis
Tenofovir administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1537-6591
- Volume :
- 67
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
- Publication Type :
- Academic Journal
- Accession number :
- 29415175
- Full Text :
- https://doi.org/10.1093/cid/ciy083