Both the FDA and European Medicines Agency said Friday that they were investigating reports of serious cases of neural tube birth defects involving the brain, spine, and spinal cord in babies born to women treated with GlaxoSmithKline's HIV drug dolutegravir as part of an ongoing observational study. Dolutegravir, anintegrase inhibitor approved in the US in 2013 and in Europe in 2014 as a single-ingredient product under the brand name Tivicay, is also sold as a fixed-dose combination therapy under the brand names Juluca (dolutegravir/rilpivirine) and Triumeq (abacavir/dolutegravir/lamivudine).
The EMA noted that preliminary results from the study, which is examining 11 558 HIV-infected women in Botswana, found that 0.9 percent of babies whose mothers became pregnant while taking dolutegravir exhibited a neural tube defect, versus 0.1 percent of babies exposed to other HIV drugs in the womb. Meanwhile, the FDA noted that "to date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy." Final results from the study are anticipated in about a year.
As a precaution, the EMA recommended that dolutegravir-containing drugs should not be prescribed to women seeking to become pregnant, and that women with the potential to become pregnant should use effective contraception while using therapies containing dolutegravir. Meanwhile, both agencies urged healthcare professionals to advise women of childbearing age about the possible risks of neural tube defects when a dolutegravir-containing regimen is used at the time of contraception or early in pregnancy.
GlaxoSmithKline, which markets Tivicay, Juluca and Triumeq via its majority-owned ViiV Healthcare unit, commented "there is no known mechanism linking dolutegravir with these types of birth defects and there are no relevant findings in pre-clinical studies." The drugmaker also noted that "animal models are generally predictive of drug-induced birth defects and it is very unusual to see an effect in humans if no evidence is observed in animal models."
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