Bradshaw Law, LLC
Bradshaw Law, LLC

HIV Drugs May Be Linked to Birth Defects

HIV Drugs May Be Linked to Birth Defects

According to a warning from the Food and Drug Administration (FDA), adverse cases of neural tube birth defects that affect the spinal cord, spine, and brain have been reported in babies born to women who were taking antiretroviral medicine dolutegravir to treat HIV. Preliminary results from an observational study carried out in Botswana found that among 426 women who were using the drug when they conceived, four infants were born with the defects.

Those at higher risk for neural tube birth defects are women early in their first trimester. This is the stage where the spinal cord, brain, and related structures form and these drugs tend to inhibit proper formation. However, in the study, there are no reported cases of neural tube defects in babies born to women starting a dolutegravir-containing regimen.

Dolutegravir is an FDA-approved drug that’s combined with several other antiretroviral medicines to treat HIV and is available under the brand names Juluca, Tivicay, and Triumeq. Dolutegravir works by blocking an HIV enzyme known as integrase, preventing the virus from dividing and can also help reduce the amount of the virus in the body. The HIV infection can become worse if a patient stops taking dolutegravir without first consulting with a prescriber.

What Are the Recommendations of the FDA?

  • Patients who are already pregnant should not stop their regimen without switching to alternative antiretroviral medicines because that increases the risk of the virus multiplying and spreading to the baby. Health care practitioners should weigh the risks and benefits when the drug is prescribed to women of childbearing age.
  • Women using antiretroviral medicines or those who wish to be started on the drugs should be enlightened about the potential risk of neural tube defects.
  • Those who are already pregnant or are planning to conceive should consult with their healthcare professional to determine if there are better treatment options.
  • Since neural tube defects can happen even before many women know that they are pregnant, women of childbearing age should get tested for pregnancy before a dolutegravir-containing regimen is recommended.
  • If dolutegravir drugs are to be used, health care practitioners should reinforce an effective birth control method.

The FDA had also warned against the use of PREZCOBIX to treat pregnant women with HIV attributable to substantially lower exposure to cobicistat and darunavir during pregnancy.