Weight Changes and Adverse Pregnancy Outcomes With Dolutegravir- and Tenofovir Alafenamide Fumarate-Containing Antiretroviral Treatment Regimens During Pregnancy and Postpartum

Clin Infect Dis. 2024 Jun 14;78(6):1617-1628. doi: 10.1093/cid/ciae001.

Abstract

Background: We evaluated associations between antepartum weight change and adverse pregnancy outcomes and between antiretroviral therapy (ART) regimens and week 50 postpartum body mass index in IMPAACT 2010.

Methods: Women with human immunodeficiency virus (HIV)-1 in 9 countries were randomized 1:1:1 at 14-28 weeks' gestational age (GA) to start dolutegravir (DTG) + emtricitabine (FTC)/tenofovir alafenamide fumarate (TAF) versus DTG + FTC/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF. Insufficient antepartum weight gain was defined using Institute of Medicine guidelines. Cox-proportional hazards regression models were used to evaluate the association between antepartum weight change and adverse pregnancy outcomes: stillbirth (≥20 weeks' GA), preterm delivery (<37 weeks' GA), small size for GA (<10th percentile), and a composite of these endpoints.

Results: A total of 643 participants were randomized: 217 to the DTG + FTC/TAF, 215 to the DTG + FTC/TDF, and 211 to the EFV/FTC/TDF arm. Baseline medians were as follows: GA, 21.9 weeks; HIV RNA, 903 copies/mL; and CD4 cell count, 466/μL. Insufficient weight gain was least frequent with DTG + FTC/TAF (15.0%) versus DTG + FTC/TDF (23.6%) and EFV/FTC/TDF (30.4%). Women in the DTG + FTC/TAF arm had the lowest rate of composite adverse pregnancy outcome. Low antepartum weight gain was associated with higher hazard of composite adverse pregnancy outcome (hazard ratio, 1.44 [95% confidence interval, 1.04-2.00]) and small size for GA (1.48 [.99-2.22]). More women in the DTG + FTC/TAF arm had a body mass index ≥25 (calculated as weight in kilograms divided by height in meters squared) at 50 weeks postpartum (54.7%) versus the DTG + FTC/TDF (45.2%) and EFV/FTC/TDF (34.2%) arms.

Conclusions: Antepartum weight gain on DTG regimens was protective against adverse pregnancy outcomes typically associated with insufficient weight gain, supportive of guidelines recommending DTG-based ART for women starting ART during pregnancy. Interventions to mitigate postpartum weight gain are needed.

Keywords: HIV; adverse pregnancy outcomes; antepartum weight change; postpartum weight; women's health.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adenine / adverse effects
  • Adenine / analogs & derivatives
  • Adenine / therapeutic use
  • Adult
  • Alanine / therapeutic use
  • Anti-HIV Agents* / adverse effects
  • Anti-HIV Agents* / therapeutic use
  • Female
  • HIV Infections* / drug therapy
  • HIV-1 / drug effects
  • Heterocyclic Compounds, 3-Ring* / administration & dosage
  • Heterocyclic Compounds, 3-Ring* / adverse effects
  • Heterocyclic Compounds, 3-Ring* / therapeutic use
  • Humans
  • Oxazines* / therapeutic use
  • Piperazines*
  • Postpartum Period*
  • Pregnancy
  • Pregnancy Complications, Infectious* / drug therapy
  • Pregnancy Complications, Infectious* / virology
  • Pregnancy Outcome*
  • Pyridones*
  • Tenofovir* / adverse effects
  • Tenofovir* / analogs & derivatives
  • Tenofovir* / therapeutic use
  • Weight Gain / drug effects
  • Young Adult

Substances

  • Tenofovir
  • Heterocyclic Compounds, 3-Ring
  • Oxazines
  • dolutegravir
  • Pyridones
  • Piperazines
  • tenofovir alafenamide
  • Anti-HIV Agents
  • Alanine
  • Adenine