Efavirenz is absolutely safe for HIV-positive women during pregnancy
An analysis of 25,000 pregnancy cases of HIV-positive women from 2002 to 2015 by specialists at the University of Geneva. demonstrated that the incidence of birth defects among newborns after a mother took the drug efavirenz was not statistically different, and in some cases was even lower than when using other ARV drugs. The results were published this week in the journal JAIDS.
As experts explain, until now, there were concerns about the use of efavirenz during pregnancy due to the results of animal studies and the small number of reported cases of fetal neural tube defects during the first three months of pregnancy.
However, a significant amount of data accumulated during the use of the drug, showed that concerns about the health of pregnant women and newborns are groundless.
A systematic review and meta-analysis of 23 studies in 2014 showed that efavirenz treatment during the first three months of pregnancy did not increase the risk of abnormalities during childbirth (relative risk of 0.78, 95% confidence interval, 0.56-1.08). The overall incidence of abnormalities in newborn babies exposed to efavirenz was 1.6%, which is comparable with the data presented in the general population of most countries.
In the new study covering the period from 2002 to 2015, cohorts from Belgium, Denmark, Germany, Ireland, Italy, the Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Thailand, Ukraine and the United Kingdom were used.
According to experts, in 1,200 cases of pregnancy (4.8%), the mother received efavirenz during conception or during the first three months after it; in 7537 cases (30.2%) - not efavirenz; and in 16226 (65%) - did not receive antiretroviral treatment.
After birth, 412 children with anomalies were recorded. Their overall prevalence was 1.7%.
Among children exposed to efavirenz, the prevalence of birth defects (1.6%, 95% CI 0.96–2.5%) was not statistically different from newborns whose mothers took other ARTs (2.4%, 95% CI 2, 1–2.8%), or did not take therapy at all (1.3%, 65% CI 1.1–1.5%).
After adjusting for other factors that could distort the results, the risk of birth defects was 40% lower in children exposed to efavirenz than in those who experienced other antiretroviral drugs (adjusted odds ratio of 0.61, 95% confidence interval, 0 36 -1.03).
“In general, our results have demonstrated evidence of the safety of efavirenz when it is used during pregnancy [...],” concluded study author Professor Martinez de Tejada.
Efavirenz remains one of the most widely used antiretroviral drugs among women of reproductive age and pregnant women, especially in low- and middle-income countries.
Due to the fact that WHO does not recommend dutegravir to be prescribed to pregnant women because of previously obtained data indicating an increased risk of fetal neural tube defects, efavirenz is now increasingly being used as the first-line antiretroviral drug.