Safety of Tenofovir Disoproxil Fumarate–Based Antiretroviral Therapy Regimens in Pregnancy for HIV-Infected Women and Their Infants: A Systematic Review and Meta-Analysis

Details

• Alternative Title:
  J Acquir Immune Defic Syndr
• Personal Author:
  Nachega, Jean B. ; Uthman, Olalekan A. ; Mofenson, Lynne M. ; Anderson, Jean R. ; Kanters, Steve ; Renaud, Francoise ; Ford, Nathan ; Essajee, Shaffiq ; Doherty, Meg C. ; Mills, Edward J.
• Description:
  Background:
  
  There are limited data on adverse effects of tenofovir disoproxil fumarate (TDF)-based antiretroviral therapy (ART) on pregnant women and their infants.
  
  Methods:
  
  We conducted a systematic review of studies published between January 1980 and January 2017 that compared adverse outcomes in HIV-infected women receiving TDF- vs. non–TDF-based ART during pregnancy. The risk ratio (RR) for associations was pooled using a fixed-effects model.
  
  Results:
  
  Seventeen studies met the study inclusion criteria. We found that the rate of preterm (<37 weeks gestation) delivery (RR = 0.90, 95% confidence interval [CI]: 0.81 to 0.99, I2 = 59%) and stillbirth (RR = 0.60, 95% CI: 0.43 to 0.84, I2 = 72.0%) were significantly lower in women exposed (vs. not) to TDF-based ART regimen. We found no increased risk in maternal severe (grade 3) or potentially life-threatening (grade 4) adverse events (RR = 0.62; 95% CI: 0.30 to 1.29), miscarriage (RR = 1.09; 95% CI: 0.80 to 1.48), very preterm (<34 weeks gestation) delivery (RR = 1.08, 95% CI: 0.72 to 1.62), small for gestational age (RR = 0.87, 95% CI: 0.67 to 1.13), low birth weight (RR = 0.91; 95% CI: 0.80 to 1.04), very low birth weight (RR = 3.18; 95% CI: 0.65 to 15.63), congenital anomalies (RR = 1.03; 95% CI: 0.83 to 1.28), infant adverse outcomes or infant mortality (age >14 days) (RR = 0.65; 95% CI: 0.23 to 1.85), but increased neonatal mortality (age <14 days) risk (RR = 5.64, 95% CI: 1.70 to 18.79) with TDR-based ART exposure. No differences were found for anthropomorphic parameters at birth; one study reported minor differences in z-scores for length and head circumference at age 1 year.
  
  Conclusions:
  
  TDF-based ART in pregnancy seems generally safe for women and their infants. However, data remain limited and further studies are needed, particularly to assess neonatal mortality and infant growth/bone effects.
  
  
• Subjects:
  Critical Review HIV Pregnancy Tenofovir Toxicity
• Source:
  J Acquir Immune Defic Syndr. 2017; 76(1):1-12.
• Pubmed ID:
  28291053
• Pubmed Central ID:
  PMC5553236
• Document Type:
  Journal Article
• Funding:
  D43 TW010340/TW/FIC NIH HHS/United States ; U2G GH001536/GH/CGH CDC HHS/United States ; UM1 AI069521/AI/NIAID NIH HHS/United States
• Volume:
  76
• Issue:
  1
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha256:8912c76491b61651b6130727b9a696bfaaad85f2c4ef38315afca39c3a2a171b
• Download URL:
  https://stacks.cdc.gov/view/cdc/49136/cdc_49136_DS1.pdf
• File Type:
  [PDF - 711.48 KB ]