The Food and Drug Administration (FDA) has issued a safety communication regarding the potential risk of neural tube birth defects associated with dolutegravir, an antiretroviral agent approved to treat HIV infection.
The Agency has received reports of serious neural tube birth defects involving the brain, spine, and spinal cord in babies born to women who received dolutegravir for HIV treatment. Initial findings from an observational study in Botswana showed that women treated with dolutegravir at the time of becoming pregnant or early in the first trimester appeared to be at increased risk for these birth defects; no cases of babies born with neural tube defects have been reported among women who started dolutegravir later in pregnancy.
Dolutegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), is indicated in combination with other antiretrovirals, to treat HIV infection. It is available under the brand name Tivicay (ViiV Healthcare) as well as in a fixed-dose combination with other antiretrovirals under the brand names Juluca (dolutegravir, rilpivirine; ViiV Healthcare) and Triumeq (abacavir, dolutegravir, lamivudine; ViiV Healthcare).
In light of these reports, the FDA recommends that clinicians should weigh the benefits and risks of dolutegravir when prescribing antiretrovirals to women of childbearing age; the risks and benefits of alternative treatments should also be considered. Women of childbearing age should use effective contraception if the decision to use dolutegravir is made. In addition, pregnancy testing should be conducted in women of childbearing age to exclude pregnancy before starting treatment with dolutegravir.
The FDA is continuing to investigate the safety risk and will update the public when more information is available.
For more information call (855) 543-3784 or visit FDA.gov.