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

Nahida Chakhtoura, Todd Brown, Macrae F Linton, Chelsea Krotje, Tapiwa Mbengeranwa, Allen Matubu, Deo Wabwire, Violet Korutaro, Ifeanyichukwu U Ezebialu, George U Eleje, Lameck Chinula, Ahizechukwu C Eke, Paul E Sax, Katie McCarthy, Kelly E Dooley, Shahin Lockman, Sean S Brummel, Muktar H Aliyu, Lynda Stranix-Chibanda, Kevin Knowles

Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America 2025;80(3):594-601

PMID: 39219495

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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.

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Address: Division of Maternal Fetal Medicine, Department of Gynecology and Obstetrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; Department of Health Policy and Vanderbilt Institute for Global Health, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Child and Adolescent Health Unit, Faculty of Medicine and Health Sciences, University of Zimbabwe, Harare, Zimbabwe.; Faculty of Medicine and Health Sciences, University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.; Department of Obstetrics and Gynecology, Nnamdi Azikiwe University Teaching Hospital, Nnewi, Anambra State, Nigeria.; Department of Obstetrics and Gynecology, Chukwuemeka Odumegwu Ojukwu University Teaching Hospital, Amaku, Anambra State, Nigeria.; Baylor College of Medicine Children's Foundation Uganda, Kampala, Uganda.; Makerere University-Johns Hopkins University Research Collaboration, Kampala, Uganda.; Faculty of Medicine and Health Sciences, University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland, USA.; Division of Global Women's Health, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Department of Obstetrics and Gynecology, UNC Project Malawi, Lilongwe, Malawi.; FHI 360, Durham, North Carolina, USA.; Frontier Science Foundation, Amherst, New York, USA.; Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Division of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.; Department of Immunology and Infectious Diseases, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.; Botswana Harvard Health Partnership, Gaborone, Botswana.

DOI: 10.1093/cid/ciae441

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MeSH Terms: Adult, Female, Humans, Pregnancy, Young Adult, Adenine, Anti-HIV Agents, Blood Glucose, Emtricitabine, HIV Infections, Lipids, Pregnancy Complications, Infectious, Tenofovir, Uganda, Zimbabwe, Alanine