May 20, 2014

Darunavir and congenital malformations

Query 13-01: Darunavir and congenital malformations.

This research was funded by the Drug Safety and Effectiveness Network (DSEN) and conducted by the following investigators: Anick Bérard, Odile Sheehy, Jinping Zhao, Michal Abrahamowicz, Mona Loutfy, Isabelle Boucoiran, Sasha Bernatsky. 


  • With more HIV-positive women becoming pregnant on combination antiretroviral therapies, concerns have been raised over their possible teratogenic effects.

Study aim:

  • To quantify the risk of major congenital malformations associated with gestational combination antiretroviral use.

Study description:

  • Using data from the Quebec Pregnancy Cohort between 1998 and 2015, we included women covered by the provincial drug plan with a singleton live birth. Antiretroviral exposures were considered alone or in combinations if occurring during the first trimester. MCM diagnosed in the first year of life were identified in the RAMQ and MedEcho databases. Crude and adjusted odds ratios (aOR) with 95% confidence intervals (95% CI) were calculated for overall MCM and each organ-specific outcome separately using generalized estimating equations (GEE) models.

Study findings:

  • Adjusting for potential confounders, including maternal HIV status, antiretroviral therapy use during the first trimester of pregnancy was not associated with MCM risk (aOR=0.59, 95%CI 0.33, 1.06).
  • Antiretroviral combination use during the first trimester was associated with an increased risk of defects of the small intestine (aOR 10.32, 95%CI 2.85, 37.38).


  • The authors conducted a population-based cohort study to evaluate the risk of congenital malformations (MCM) in pregnant women exposed to antiretroviral therapy.
  • Our data suggest that the use of antiretroviral therapy during the first trimester was not associated with the risk of overall MCM but was associated with an increased risk of defects of the small intestine.

Results were discussed at the June 2015 Reseau Quebecois de Recherche sur les Medicaments (RQRM) meeting and the Teratology Society meeting in June 2015.

Berard A, Sheehy O, Zhao J, Abrahamowicz M, Loutfy M, Boucoiran I, Bernatsky S. Antiretroviral combination use during pregnancy and the risk of major congenital malformations. AIDS. 2017 Oct;31(16):2267-2277.

For more information, contact: Autumn Neville, Research Coordinator.