Dolutegravir in Pregnancy as Compared with Current HIV Regimens in the United States

N Engl J Med. 2022 Sep 1;387(9):799-809. doi: 10.1056/NEJMoa2200600.


Background: Data on the effectiveness and safety of dolutegravir-based antiretroviral therapy (ART) for human immunodeficiency virus type 1 (HIV-1) infection in pregnancy as compared with other ART regimens commonly used in the United States and Europe, particularly when initiated before conception, are limited.

Methods: We conducted a study involving pregnancies in persons with HIV-1 infection in the Pediatric HIV/AIDS Cohort Study whose initial ART in pregnancy included dolutegravir, atazanavir-ritonavir, darunavir-ritonavir, oral rilpivirine, raltegravir, or elvitegravir-cobicistat. Viral suppression at delivery and the risks of infants being born preterm, having low birth weight, and being small for gestational age were compared between each non-dolutegravir-based ART regimen and dolutegravir-based ART. Supplementary analyses that included participants in the Swiss Mother and Child HIV Cohort Study were conducted to improve the precision of our results.

Results: Of the pregnancies in the study, 120 were in participants who received dolutegravir, 464 in those who received atazanavir-ritonavir, 185 in those who received darunavir-ritonavir, 243 in those who received rilpivirine, 86 in those who received raltegravir, and 159 in those who received elvitegravir-cobicistat. The median age at conception was 29 years; 51% of the pregnancies were in participants who started ART before conception. Viral suppression was present at delivery in 96.7% of the pregnancies in participants who received dolutegravir; corresponding percentages were 84.0% for atazanavir-ritonavir, 89.2% for raltegravir, and 89.8% for elvitegravir-cobicistat (adjusted risk differences vs. dolutegravir, -13.0 percentage points [95% confidence interval {CI}, -17.0 to -6.1], -17.0 percentage points [95% CI, -27.0 to -2.4], and -7.0 percentage points [95% CI, -13.3 to -0.0], respectively). The observed risks of preterm birth were 13.6 to 17.6%. Adjusted risks of infants being born preterm, having low birth weight, or being small for gestational age did not differ substantially between non-dolutegravir-based ART and dolutegravir. Results of supplementary analyses were similar.

Conclusions: Atazanavir-ritonavir and raltegravir were associated with less frequent viral suppression at delivery than dolutegravir. No clear differences in adverse birth outcomes were observed with dolutegravir-based ART as compared with non-dolutegravir-based ART, although samples were small. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others.).

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-HIV Agents* / adverse effects
  • Anti-HIV Agents* / therapeutic use
  • Atazanavir Sulfate / adverse effects
  • Atazanavir Sulfate / therapeutic use
  • Cobicistat / adverse effects
  • Cobicistat / therapeutic use
  • Cohort Studies
  • Darunavir / adverse effects
  • Darunavir / therapeutic use
  • Female
  • HIV Infections* / drug therapy
  • HIV Protease Inhibitors* / adverse effects
  • HIV Protease Inhibitors* / therapeutic use
  • HIV-1*
  • Heterocyclic Compounds, 3-Ring* / adverse effects
  • Heterocyclic Compounds, 3-Ring* / therapeutic use
  • Humans
  • Infant, Newborn
  • Oxazines* / adverse effects
  • Oxazines* / therapeutic use
  • Piperazines* / adverse effects
  • Piperazines* / therapeutic use
  • Pregnancy
  • Premature Birth* / chemically induced
  • Pyridones* / adverse effects
  • Pyridones* / therapeutic use
  • Quinolones / adverse effects
  • Quinolones / therapeutic use
  • Raltegravir Potassium / adverse effects
  • Raltegravir Potassium / therapeutic use
  • Rilpivirine / adverse effects
  • Rilpivirine / therapeutic use
  • Ritonavir / adverse effects
  • Ritonavir / therapeutic use
  • United States


  • Anti-HIV Agents
  • HIV Protease Inhibitors
  • Heterocyclic Compounds, 3-Ring
  • Oxazines
  • Piperazines
  • Pyridones
  • Quinolones
  • Raltegravir Potassium
  • elvitegravir
  • Atazanavir Sulfate
  • dolutegravir
  • Rilpivirine
  • Cobicistat
  • Ritonavir
  • Darunavir