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Clinical Trial
. 2025 Mar 17;80(3):594-601.
doi: 10.1093/cid/ciae441.

Lipid and Glucose Profiles in Pregnant Women With HIV on Tenofovir-based Antiretroviral Therapy

Ahizechukwu C Eke  1 , Sean S Brummel  2 , Muktar H Aliyu  3 , Lynda Stranix-Chibanda  4   5 , George U Eleje  6 , Ifeanyichukwu U Ezebialu  7 , Violet Korutaro  8 , Deo Wabwire  9 , Allen Matubu  5 , Tapiwa Mbengeranwa  5 , Nahida Chakhtoura  10 , Lameck Chinula  11   12 , Katie McCarthy  13 , Kevin Knowles  14 , Chelsea Krotje  14 , Macrae F Linton  15 , Kelly E Dooley  16 , Paul E Sax  17 , Todd Brown  18 , Shahin Lockman  17   19   20 ; IMPAACT 2010/VESTED Study Team
Collaborators, Affiliations
Clinical Trial

Lipid and Glucose Profiles in Pregnant Women With HIV on Tenofovir-based Antiretroviral Therapy

Ahizechukwu C Eke et al. Clin Infect Dis. .

Abstract

Background: Tenofovir alafenamide (TAF)-based antiretroviral therapy (ART) regimens have been associated with adverse changes in lipid and glucose profiles compared with tenofovir disoproxil fumarate (TDF)-based ART, but data in pregnancy are limited. We evaluated metabolic markers in pregnant women with human immunodeficiency virus (HIV) after starting TAF- versus TDF-based ART.

Methods: We analyzed data within the IMPAACT 2010/VESTED trial, which demonstrated better pregnancy outcomes in pregnant women randomized to initiate TAF/Emtricitabine/Dolutegravir (TAF/FTC + DTG; n = 217) or TDF/FTC + DTG (n = 215). We measured non-fasting plasma concentrations of glucose, total-cholesterol, low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C), lipoprotein (a), and triglycerides from samples collected 8 weeks after enrollment. We employed linear regression models to estimate by-arm mean differences.

Results: In total, 219 participants enrolled in the DTG arms in Zimbabwe and Uganda: 109 in the TAF/FTC + DTG and 110 in the TDF/FTC + DTG arms. At study entry, mean gestational age was 22.6 weeks, median HIV-1 RNA was 711 copies/mL, and mean age was 25.8 years. By 8 weeks, mean total cholesterol was 12 mg/dL higher in women randomized to TAF/ FTC + DTG versus TDF/FTC + DTG (95% confidence interval [CI]: 3.8, 21.1). Pregnant women in the TAF/FTC + DTG arm had higher mean LDL-C (7.1 mg/dL, 95% CI: .2, 14.0), triglycerides (12.3 mg/dL, 95% CI: 1.8, 22.7), lipoprotein (a) (7.3 mg/dL, 95% CI: 1.1, 13.6), and lower mean HDL-C (2.8 mg/dL, 95% CI: .1, 5.6) compared to the TDF/FTC + DTG arm.

Conclusions: Pregnant women randomized to start TAF/FTC + DTG had higher lipids than those randomized to TDF/FTC + DTG within 8 weeks of ART initiation. However, lipid levels were within normal reference ranges.

Trial registration: ClinicalTrials.gov NCT03048422.

Keywords: HIV; hyperlipidemia; metabolic complications; pregnancy; tenofovir.

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Conflict of interest statement

Potential conflicts of interest . A. C. E. (research support from NIH, IMPAACT), S. S. B. (support from NIH, ViiV, and GSK), L. S. C. (research support from IMPAACT), L. C. (research support from NIH, IMPAACT), K. M. (research support from NIH, IMPAACT), K. K. (research support from NIH, IMPAACT), C. K. (research support from NIH, IMPAACT), M. F. L. (support from NIH, Regeneron, Sanofi, Ionis, Novartis, PCORI, AMGEN, RegenXVBIO, Gilead, Bristo, Myers), S. P. (consulting fees from Gilead, Merck, ViiV), T. B. (consulting fees from Merck, Janssen, ViiV, EMD Serono), S. L. (support from the NIH). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

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