Nachega JB, et al. – Authors in this systematic review and meta–analysis investigated adverse effects of tenofovir disoproxil fumarate (TDF)–based antiretroviral therapy (ART) on pregnant women and their infants. 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.

Methods

• A systematic review was performed 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.
• Authors pooled the risk ratio (RR) for associations using a fixed-effects model.

Results

• Authors identified 17 studies meeting the inclusion criteria.
• Significantly lower 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%) was observed in women exposed (vs. not) to TDF-based ART regimen.
• Findings revealed 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.
• They identified no differences for anthropomorphic parameters at birth; one study reported minor differences in z-scores for length and head circumference at age 1 year.