Dolutegravir in pregnancy as compared with current HIV regimens in the United States. New England Journal of Medicine
Patel et al. on behalf of the Pediatric HIV/AIDS Cohort Study and the Swiss Mother and Child HIV Cohort Study aimed to evaluate viral suppression at delivery and adverse birth outcomes in persons with HIV infection whose initial regimen in pregnancy included dolutegravir as compared with those whose initial regimen included other contemporary antiretroviral therapy (ART) drugs commonly prescribed in the United States and Europe.
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.
In conclusion, this study contributes data on the effectiveness and safety of contemporary, commonly used integrase inhibitors, protease-inhibitors, and NNRTIs during pregnancy. The study-results provide evidence suggesting that atazanavir–ritonavir and raltegravir provide less HIV viral suppression at delivery than dolutegravir and support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible.