Pregnancy

Etravirine has received only minimal study in pregnant women and is not currently licensed for use during pregnancy. If a woman becomes pregnant while on etravirine, she should consult her healthcare provider about its use during pregnancy.

Laboratory studies in animals suggest that the drug is safe during pregnancy, and a case study has been presented of five pregnant women who received the drug through compassionate access due to limited options.1 Three of the women took therapy for their entire pregnancy, the other two during the third trimester only.

Monitoring of peak, trough and steady-state concentrations of etravirine showed that these were comparable to those seen in non-pregnant adults, suggested that no dose modification is necessary during pregnancy. None of their infants were infected with HIV. One infant was born with a minor abnormality to the right ear, but was healthy in all other respects. No birth abnormalities were observed in the other five babies. 

A larger study of etravirine use in pregnant women (NCT00855335) is currently underway.

References

  1. Izurieta P et al. Safety and pharmacokinetics of etravirine in pregnant HIV-infected women. 12th European AIDS Conference, Cologne, abstract PE 4.1/6, 2009
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