Dolutegravir: EMA issues precautionary safety advice


  • Dawn O'Shea
  • Univadis Medical News
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

The European Medicines Agency (EMA) is evaluating preliminary results from a recent study which has linked the HIV therapy dolutegravir with cases of neural tube defects in children born to mothers on the treatment at conception.

The observational study, which looked at babies born to 11,558 HIV-infected women in Botswana, found 0.9 per cent of babies born to mothers who conceived on dolutegravir (4 of 426) had a neural tube defect compared with 0.1 per cent of babies (14 of 11,173) born to mothers taking other HIV medicines. No cases were reported in infants born to women who started dolutegravir later during pregnancy.

Reproductive toxicology studies have not shown any relevant findings. Likewise, other data on the use of dolutegravir in pregnancy, including data from the Antiretroviral Pregnancy Registry (APR), clinical trials and post-marketing use have not indicated a risk of neural tube defects.

While the review is ongoing, the EMA has issued the following advice:

Do not prescribe dolutegravir for women of childbearing potential who are trying to become pregnant.

Exclude pregnancy before starting dolutegravir.

Advise women to use effective contraception throughout treatment.

If pregnancy is confirmed in the first trimester, switch to an alternative treatment if possible.