FDA Warns of Neural Tube Birth Defects From HIV Drug Dolutegravir

The FDA has issued an alert to the public on neural tube defects affecting babies born to women with HIV being treated with dolutegravir.

According to the agency, there have been serious cases of neural tube birth defects involving the brain, spine, and spinal cord. Neural tube defects occur early in pregnancy when the brain, spinal cord, and related structures do not develop properly.

Preliminary results from an ongoing study in Botswana found that women being treated with dolutegravir at the time of becoming pregnant or early in the first trimester are at a higher risk for the defects. There are no reported cases of babies born with these defects to women who started taking dolutegravir later in their pregnancy.

According to the FDA, patients should not stop taking the treatment without first consulting with a healthcare professional because stopping the treatment can cause the HIV infection to worsen. They state that stopping a dolutegravir-containing regimen while pregnant without switching to alternative HIV treatments can cause the amount of virus to increase and spread HIV to the baby.

They also advise women of childbearing age speak with a healthcare professional about other non-dolutegravir-containing antiretroviral treatments.

The agency provided the following guidance for healthcare professionals:

• Healthcare professionals should weigh the benefits and risks of dolutegravir when prescribing antiretroviral medicines to women of childbearing age. Alternative antiretroviral medicines should be considered. Discuss the relative risks and benefits of appropriate alternative antiretroviral therapies.
• If the decision is made to use dolutegravir in women of childbearing age, healthcare professionals should reinforce the consistent use of effective birth control.
• Perform pregnancy testing before initiating dolutegravir-containing regimens in women of childbearing age to exclude pregnancy.

Dolutegravir was approved in 2013 and is available as a single ingredient product, sold as Tivicay, and as a fixed dose combination tablet with other HIV medications, sold as Juluca and Triumeq.

In January, the National Institutes of Health launched an international study to compare the safety and efficacy of 3 antiretroviral treatments for pregnant women with HIV and their infants. The study compares the World Health Organization’s preferred regimen including efavirenz, lamivudine or emtricitabine, and tenofovir disoproxil fumarate—which is not well-tolerated by all women—to 2 new regimens containing dolutegravir. Clinical trial sites include the United States, Zimbabwe, Botswana, Brazil, Haiti, and South Africa.