Understating Birth outcomes from mothers and infants, building healthcare by linking exposures South African Pregnancy Exposure Registry.


With the rollout of the new adult and PMTCT treatment guidelines, which include the introduction of dolutegravir (DTG)-based antiretroviral therapy (ART) as first-line HIV treatment in South Africa, the South African National Department of Health requested the establishment of a pregnancy exposure registry. Concerns about the potential risk of neural tube defects (NTDs) associated with DTG use in early pregnancy, initially raised in Botswana in 2018 have diminished over time (dropping from 0.9% initially reported in 2018, to 0,2% in 2020 compared to 0,1% in women on efavirenz (EFV)-based ART at conception) but concerns persist. This translates to a risk of about 1 NTD in 500 pregnancies exposed to DTG in the early weeks of pregnancy.

Other data suggest that DTG initiated later in pregnancy is relatively safe with improved performance over EFV in terms of maternal adverse effects, viral load reduction, and a lower risk of development of drug resistance. The risks of other adverse pregnancy outcomes such as stillbirth, preterm delivery (PTD), neonatal deaths (NNDs) and low birth weight (LBW), described in HIV- and ART exposed infants are important to assess particularly given the known effect of DTG-based ART on weight gain, although no short-term safety issues are described in recent studies evaluating DTG-based ART in pregnant women.


  • Dr Ushma C. Mehta (Principal Investigator)
  • Prof Lee Fairlie (Principal Investigator)
  • Dr Myint Aung (Co-Investigator)
  • Dr Emma Kalk (Co-Investigator)
  • Ottancia B. Mhlongo (Co-Investigator)
  • Dr Dhayendre Moodley (Co-Investigator)
  • Dr Diane Morof (Co-Investigator)
  • Dr Diane Lavies (Co-Investigator)
  • Dr Faeezah Patel (Co-Investigator)
  • Shobna Sawry (Co-Investigator)
  • Dr Karl Technau (Co-Investigator)
  • Dr Michelle Groome (Co-Investigator)

Latest Update

April 2024

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