Ensuring Safe Options For Treating HIV During Pregnancy: Is This Déjà Vu?

become aware they are pregnant for several weeks. It is these early weeks of pregnancy when teratogenic drugs are most dangerous to a fetus. Nevertheless, women wanted to have access to this treatment.

In an effort to protect mothers from harming their developing fetus through the use of Efavirenz or Atripla, we required women of childbearing age to sign a consent committing to using barrier contraception (e.g. condoms, diaphragm). The goal was to not become pregnant while taking it.

But in 2012, a report by the World Health Organization conducted an intensive evaluation of over a decade of birth data and found very little harm with the use of Efavirenz in pregnancy. Wow! It took almost 14 years to show safety. The drug was now recommended for pregnancy and expanded treatment options in developing countries.

So now, the drug Dolutegravir is becoming increasingly available in developing countries. Dolutegravir combined with FTC and tenofovir started being used in the African country of Botswana. HIV+ women giving birth in Botswana were being carefully monitored for birth outcomes. In 2018, there were reports of babies being born to women taking Dolutegravir who developed the same birth defect we thought to be caused by Efavirenz. Initially, there were four babies born with defects out of 426 births.

The rate was low (0.9%) but still about 9 times higher than the normal rate, which is very low (about 0.1% in Botswana). For many clinicians and scientists, this seemed like Deju Vu. We revisited the history with Efavirenz. Was this effect real? What would this mean for HIV treatment in Africa where we desperately needed new, effective treatment options? And why didn’t we see this birth defect in other groups of pregnant women who had received dolutegravir?

In considering this last question, we must be mindful that

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