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Medically reviewed by Dr. Kimberly Langdon Cull, M.D. on Sept. 22, 2023

Dolutegravir produces more frequent viral suppression during delivery than current antiretroviral therapy regimens, including raltegravir and atazanavir-ritonavir.

The medical literature contains limited data on the safety and efficacy of dolutegravir antiretroviral therapy (ART) versus current therapy regimens for managing human immunodeficiency virus type 1 (HIV-1) infection during pregnancy. 

A recent study published in the New England Journal of Medicine compared dolutegravir-based and non-dolutegravir-based ART regimens for HIV-1-infected pregnant women enrolled in the Pediatric HIV/AIDS Cohort Study.

Study Population

Of the total study sample, 120 participants had received dolutegravir, 464 had received atazanavir–ritonavir, 86 had received raltegravir, 159 had received elvitegravir, 185 had received darunavir–ritonavir, and 243 had received rilpivirine. The median age at conception was 29 years, and approximately 51% of the pregnancies were in participants who had started ART before conception.

Antiretroviral Therapy and Viral Suppression at Delivery

Approximately 96.7% of the patients who received dolutegravir demonstrated viral suppression at the time of delivery. The viral suppression was 89.8% for patients receiving elvitegravir–cobicistat, 84.0% for patients receiving atazanavir–ritonavir, 89.2% for patients receiving raltegravir, and 90.1% for patients receiving darunavir–ritonavir. 

According to the results of the adjusted analysis for the probability of viral suppression at the time of delivery, dolutegravir administration was related to a higher estimated probability of viral suppression at the time of delivery compared to atazanavir–ritonavir and elvitegravir–cobicistat. For patients who took dolutegravir before conception, the probability of viral suppression at the time of delivery was lower in raltegravir than dolutegravir but higher in rilpivirine than dolutegravir.

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Antiretroviral Therapy and Adverse Birth Outcomes

The risks of premature birth, small for gestational age, and low birth weight in infants of mothers receiving different ART regimens initially ranged from 13.6% to 17.6%, 9.1% to 12.5%, and 11.9% to 16.7%, respectively. The risks for severe and adverse birth outcomes ranged from 0% to 4.2% and 22.6% to 27.9%, respectively. Among the ART regimens, 15 of the 20 preterm infants had very low weights at birth. There were four cases of perinatal HIV transmission.

Impact of Dolutegravir on Congenital Anomalies and Birth Outcomes
Three major congenital anomalies developed in the group of infants born to mothers taking dolutegravir before conception or during the first trimester. The risks of adverse birth outcomes were relatively higher in participants who started ART regimens after conceiving than in participants who initiated ART before conception.  


Patel, K., Huo, Y., Jao, J., Powis, K. M., Williams, P. L., Kacanek, D., Yee, L. M., Chadwick, E. G., Shiau, S., Jacobson, D. L., Brummel, S., Sultan-Beyer, L., Kahlert, C., Zash, R., & Seage, G. R. (2022). Dolutegravir in Pregnancy as Compared with Current HIV Regimens in the United States. The New England Journal of Medicine, 387(9), 799–809. https://doi.org/10.1056/nejmoa2200600