Canadian Drug Regulator Warns of Possible Birth Defect Risk with Tivicay, Juluca & Triumeq

Published on June 14, 2018 by Sandy Liebhard

Health Canada has issued a new warning regarding the potential risk of serious birth defects in babies born to women treated with dolutegravir-containing HIV drugs, including Tivicay, Juluca, and Triumeq.

The Canadian warning comes just weeks after the U.S. Food & Drug Administration (FDA) issued a similar alert.

Dolutegravir and Neural Tube Birth Defects

Dolutegravir is sold under the brand-name Tivicay. It is also one of the ingredients in the combination drugs Juluca and Triumeq. Approved by the FDA 2013, dolutegravir works by blocking integrase, an HIV enzyme, to prevent the virus from multiplying and can reduce the amount of HIV in the body.

The FDA and Health Canada warnings were released after preliminary results of the Tsepamo study in Botswana suggested a possible increased risk of neural tube defects in infants treated with dolutegravir at conception or early in the first trimester.

Neural tube defects, such as spina bifida, anencephaly, and Chiari malformation, affect the brain and spinal cord and are known to occur during the first month of pregnancy.

“The preliminary analysis of the ongoing Tsepamo observational study in Botswana reported 4 cases of NTD out of 426 pregnancies in women who became pregnant while taking dolutegravir. This represents an incidence of about 0.9% compared to about 0.1% in patients receiving other non-dolutegravir treatments,” the Health Canada alert stated. “No infant born to a woman who started dolutegravir during pregnancy had a NTD (N=0/2824).”

The Tsepamo study is ongoing and will continue for the next 9 months. It is expected that data from another 600 women who became pregnant while they were using dolutegravir-containing drugs will be captured during that time.

Doctors Advised to Avoid Dolutegravir in Women of Child Bearing Potential

Health Canada is advising health care professionals to:

• Avoid prescribing dolutegravir in women of child bearing potential (WOCBP), who are trying to become pregnant, unless a suitable alternative treatment option is not available.
• Consider the risk and benefits of prescribing dolutegravir in WOCBP.
• Perform pregnancy testing in WOCBP before initiating treatment.
• Advise women who are taking dolutegravir to avoid getting pregnant and use effective contraception throughout the treatment.
• Switch to an alternative treatment when a pregnancy is confirmed in the first trimester while a woman is taking dolutegravir.

Women who are using a dolutegravir-containing drug should not stop taking it without first talking to their health care professional, as doing so could cause their HIV infection to worsen.

Women planning to become pregnant and taking dolutegravir should discuss treatment options with their doctor before becoming pregnant. Women who are currently being treated with Tivicay, Juluca, or Triumeq should avoid getting pregnant and use an effective method of birth control.

Those who become pregnant while taking dolutegravir should consult with their doctor right away.