Dolutegravir Now Safe For All Women: WHO

THE World Health Organisation says it is now safe to use dolutegravir as a preferred antiretroviral drug on all populations including pregnant women and those of childbearing potential following new evidence assessing benefits and risks

By Kudakwashe Pembere

Initial studies highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception.  This caused some scepticism of the drug.

This potential safety concern was reported in May 2018 from a study in Botswana that found 4 cases of neural tube defects out of 426 women who became pregnant while taking DTG. Based on these preliminary findings, many countries advised pregnant women and women of childbearing potential to take efavirenz (EFV) instead,” said the WHO in a statement.

New data from two large clinical trials comparing the efficacy and safety of DTG and EFV in Africa have now expanded the evidence base. The risks of neural tube defects are significantly lower than what the initial studies may have suggested.

“The guidelines group also considered mathematical models of the benefits and harms associated with the two drugs; the values and preferences of people living with HIV, as well as factors related to implementation of HIV programmes in different countries, and cost,” the UN Health agency said. “DTG is a drug that is more effective, easier to take and has fewer side effects than alternative drugs that are currently used. DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to EFV and nevirapine-based regimens.”

In 2019, 12 out of 18 countries surveyed by WHO reported pre-treatment drug resistance levels exceeding the recommended threshold of 10%.

“As for any medications, informed choice is important. Every treatment decision needs to be based on an informed discussion with the health provider weighing the benefits and potential risks.

WHO stressed the importance of providing information and options to help women make an informed choice.

“To this end WHO has convened an advisory group of women living with HIV from diverse backgrounds to advise on policy issues related to their health, including sexual and reproductive health. WHO highlights the need to continually monitor the risk of neural tube defects associated with DTG,” WHO said.

As of May 2019, one of the trials named Advance Study found that women who started dolutegravir (DTG)-based ART before conception did not have higher rates of adverse pregnancy outcomes compared with those starting efavirenz (EFV) in South Africa.

“The pregnancy sub study included all women who completed week 48, receiving ART before conception, had gestational age assessment (early ultrasound) and congenital foetal anomaly screening.

“Women in the DTG arms were switched to alternative 
regimens if pregnancy was less than 8 weeks’ gestation.

“Adverse outcomes included: spontaneous abortion, elective termination, preterm delivery, small for gestational age, still birth and neonatal death. The sub study also evaluated neonate HIV status and birth defects.

“There were 78 pregnancies among 625 women participating in ADVANCE (12.5%). Of these 15 (19.2%) were spontaneous abortion, 19 (24.4%) elective abortion, 1 (1.3%) stillbirth, 1 (1.3%) neonatal death, 34 (43.6%) live births and 8 (10.3%) pregnancies were ongoing at the time of analysis,” read part of the findings of the ADVANCE Study.

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