Dolutegravir-based ART preferable to efavirenz-based ART in pregnancy
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Results of a three-armed trial demonstrated that dolutegravir-based ART regimens are favorable to efavirenz-based regimens among pregnant women with HIV, according to data presented recently at the Conference on Retroviruses and Opportunistic Infections.
WHO recommends dolutegravir as a preferred first- and second-line treatment for HIV in all populations, including pregnant women.
Lameck Chinula, MD, an assistant professor of global women’s health at the University of North Carolina School of Medicine, and colleagues reported results through 50 weeks’ postpartum from a three-armed trial in which 643 HIV-positive pregnant women were randomly assigned at 14 to 28 weeks’ gestational age to receive either dolutegravir with emtricitabine and tenofovir alafenamide fumarate (DTG/FTC/TAF), DTG/FTC/tenofovir disoproxil fumarate (TDF), or efavirenz (EFV)/FTC/TDF.
In all 607 women (94.4%) and 566 of 617 (91.7%) liveborn infants completed the study. Among all infants, 479 (77.6%) breastfed.
The proportion of women with HIV RNA of less than 200 copies/mL was similar in the combined DTG groups (96.3%) and the EFV group (96.4%). Additionally, after 50 weeks’ postpartum, there were no differences between all arms in the estimated probability of maternal and infant adverse events equal or greater than grade 3.
“Combined DTG-containing regimens showed similar high viral suppression to EFV-containing regimen at 50 weeks’ postpartum,” Chinula told Healio. “This is great, as most infants in the study were breastfed and therefore continued to be at risk for HIV infection.”
The estimated probability of infant death was highest among the EFV group (6.9%), compared with those in the DTG/FTC/TDF (2%) group and DTG/FTC/TAF (1%) groups, the researchers reported. There were 18 stillbirths or deaths in the EFV group, 15 in the DTG/FTC/TDF group, and 10 in the DTG/FTC/TAF group.
“Infant deaths were significantly lower in the DTG arms than in the EFV arm, but there were slightly more stillbirths with DTG arms, so when you combine the two outcomes, the difference in infant death was not significant anymore,” Chinula said.
Chinula said the researchers wanted to highlight that DTG-containing regimens are “safe and more effective for viral suppression during pregnancy” and that “through 50 weeks’ postpartum, virologic failure is less common with use of a DTG-containing regimen.”