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

Clin Infect Dis. 2025 Mar 17;80(3):594-601. doi: 10.1093/cid/ciae441.

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.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adenine* / adverse effects
  • Adenine* / analogs & derivatives
  • Adenine* / therapeutic use
  • Adult
  • Alanine
  • Anti-HIV Agents* / adverse effects
  • Anti-HIV Agents* / therapeutic use
  • Blood Glucose* / analysis
  • Emtricitabine / therapeutic use
  • Female
  • HIV Infections* / blood
  • HIV Infections* / drug therapy
  • Humans
  • Lipids* / blood
  • Pregnancy
  • Pregnancy Complications, Infectious* / blood
  • Pregnancy Complications, Infectious* / drug therapy
  • Tenofovir* / adverse effects
  • Tenofovir* / analogs & derivatives
  • Tenofovir* / therapeutic use
  • Uganda
  • Young Adult
  • Zimbabwe

Substances

  • Adenine
  • Anti-HIV Agents
  • Blood Glucose
  • Emtricitabine
  • Lipids
  • Tenofovir
  • tenofovir alafenamide
  • Alanine

Associated data

  • ClinicalTrials.gov/NCT03048422