Safety of tenofovir disoproxil fumarate-based antiretroviral therapy regimens in pregnancy for HIV-infected women and their infants: A systematic review and meta-analysis


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 relative risk for associations was pooled using a fixed-effects model. RESULTS: Sixteen studies met study inclusion criteria. We found that the rate of preterm (<37 weeks gestation) delivery (RR = 0.90, 95%CI: 0.81-0.99, I= 59%) and stillbirth (RR = 0.60, 95%CI: 0.43-0.84, I = 72.0%) were significantly lower in women exposed (vs. not) TDF-based ART regimen. We found no increased risk in maternal severe (Grade 3) or potentially life-threatening (Grade 4) AEs (RR=0.62;95%CI: 0.30-1.29), miscarriage (RR=1.09; 95%CI: 0.80-1.48), very preterm (<34 weeks gestation) delivery (RR = 1.08, 95%CI: 0.72-1.62), small for gestational age (RR=0.87, 95%CI: 0.67-1.13), low birth weight (RR=0.91;95%CI: 0.80-1.04), very low birth weight (RR=3.18;95%CI: 0.65 to 15.63), congenital anomalies (RR=1.03; 95%CI: 0.83- 1.28), infant adverse outcomes or infant mortality (age >14 days) (RR=0.65; 95%CI: 0.23-1.85), but increased neonatal mortality (age <14 days) risk (RR=5.64, 95%CI: 1.70-18.79) 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 one year. CONCLUSIONS: TDF-based ART in pregnancy appears 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


Nachega JB, Uthman OA, Mofenson LM, Anderson JR, Kanters S, Renaud F, Ford N, Essajee S, Doherty MC, Mills EJ




  • Population(s)
    • Women
    • Children or Youth (less than 18 years old)
    • General HIV+ population
    • Other
  • Engagement and Care Cascade
    • Treatment
  • Prevention
    • Biomedical interventions


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