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PROMOTE: No differences in preterm birth, low birth weight in Ugandan women

ATLANTA — No differences were observed in preterm birth rates or low birth weight among treatment-naive women in Uganda assigned to lopinavir-ritonavir or an efavirenz-based combination antiretroviral therapy regimen, according to late-breaker data presented here from the PROMOTE -Pregnant Women and Infant trial.

“The proportion of preterm birth rates in both arms of our study are comparable to the national Ugandan rate of preterm birth,” Deborah Cohan, MD, of the University of California, San Francisco, told Infectious Diseases in Children. “These data offer reassurance about the safety of LPV/r use in pregnancy.”

 

Deborah Cohan

According to background information in the abstract, conflicting data exist on the risk for preterm birth in women assigned protease inhibitor-based ART. For this reason, Cohan and colleagues set out to compare the differences in the risk for preterm birth (<37 weeks), very preterm birth (<32 weeks) and the median gestational age at delivery between Ugandan women assigned lopinavir-ritonavir (n=197; Kaletra, AbbVie) or an efavirenz-based combination ART (n=194) during pregnancy.

The researchers pooled data from Project 2 of the PROMOTE trial, including data on pregnant women and infants. Women were included in this analysis if they delivered a live-born singleton infant or had reached 32 weeks gestation if still pregnant by Jan. 11, 2013.

By Jan. 11, six pregnant women had reached at least 37 weeks gestation; eight pregnant women reached 32 weeks gestation; and there were 346 live-born infants and 357 singleton deliveries.

The overall risk for preterm birth delivery (14.9%) did not differ between treatment arms (15.9% for lopinavir-ritonavir and 13.6% for efavirenz-based combination ART). Very preterm birth delivery did not differ between the treatment arms.

Similarities also were observed in median gestational age at delivery (38.7 weeks for lopinavir-ritonavir vs. 39.2 weeks for efavirenz). Low birth weight prevalence was 16.8% and did not significantly differ among women on lopinavir-ritonavir (17.3%) or efavirenz (16.3%).

“We will be evaluating the risk for placental malaria between women in the two arms of the study,” Cohan said. “We will also be evaluating virologic outcomes (including maternal virologic outcomes as well as in-utero and breastfeeding transmission), immunologic outcomes, clinical progression of HIV disease and maternal and neonatal safety. We are also conducting numerous analyses related to nutritional status of women and infants — one already published in PLOS One.”

For more information:

Cohan D. #183LB. Presented at: 2013 Conference on Retroviruses and Opportunistic Infections; March 3-6; Atlanta.

Disclosure: Cohan reports no relevant financial disclosures.