Early Study Results Link Tivicay to Neural Tube Birth Defects

Published on July 27, 2018 by Laurie Villanueva

Pregnant women who were taking Tivicay at conception may be more likely to have a child with neural tube defects compared to those treated with other, non-dolutegravir-based HIV medications, according to preliminary findings of an ongoing study.

How Was the Study Conducted?

The research, which was recently presented at the  International AIDS Conference and published in the New England Journal of Medicine, involved 89,000 pregnant women – both HIV positive and non-infected – who gave birth in eight of Botswana’s largest maternity wards from August 2014 to May 2018.

Though Tivicay was not initially included in the study, Botswana switched its first-line antiretroviral therapy from an efavirenz-based regimen to a dolutegravir-based regimen in mid-2016.

The development prompted the study authors to include Tivicay in their research.

What Were the Findings for Tivicay and Birth Defects?

During the course of the study, 86 babies were born with a neural tube birth defect, including:

  • 61 babies to 66,057 HIV-negative mothers.
  • 4 babies to 426 HIV-positive mothers treated with Tivicay
  • 3 babies to 5,787 HIV-positive mothers treated with efavirenz-based therapies
  • 14 babies to 11,300 HIV-positive mothers treated with other medications

Though Tivicay was associated with just 4 instances of neural tube birth defects, the rate is actually 9-times higher compared to the other HIV drugs included in the study.

Since the May 2018 cut-off date, no birth defects have been observed in 170 additional babies born to women taking Tivicay at conception.  When those births were included in the data, the rate of dolutegravir-associated neural tube defects dropped to 6.7%.  However, that is still 6-times higher compared to the rate observed with other HIV medications.

“In conclusion, we found a potential early signal for an increased prevalence of neural-tube defects in association with dolutegravir-based antiretroviral therapy from the time of conception,” the researchers wrote. “Our study is ongoing, and more data are needed to confirm or refute this signal, given the small number of events and the small difference in prevalence.”

FDA Investigating Possible Link Between Tivicay and Neural Tube Birth Defects

Tivicay (dolutegravir) was approved by the U.S. Food & Drug Administration (FDA) in 2013.   The agency has since approved two dolutegravir-based combination drugs to treat HIV, Juluca and Triumeq.

The preliminary findings of the Botswana study prompted the FDA to issue a safety alert in May.

Pregnant women who are currently being treated with Tivicay or other dolutegravir-containing drugs should not stop taking their medication without talking to their doctor. However, women being considered for dolutegravir therapy should tell their healthcare provider if they are pregnant or plan on becoming pregnant.

Women of child-bearing age should use a reliable method control while taking Juluca, Tivicay, or Triumeq. These women should also undergo a pregnancy test before they begin treatment with any of these HIV medications.

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