Etravirine could be a safe and effective option during pregnancy, a small case series presented to the 12th European AIDS Conference in Cologne suggests.
Good blood levels of the drug were seen in all five women who received the drug. None of their infants were infected with HIV, nor were there any serious birth abnormalities.
Etravirine (Intelence) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that provides an important treatment option for patients who have resistance to other NNRTIs.
It is not currently licensed for use during pregnancy. Permission on compassionate grounds was obtained for its use in five women with very limited HIV treatment options. Laboratory studies in animals suggest that the drug is safe during pregnancy, and a study involving pregnant women (NCT00855335) is currently underway.
In the meantime, this case series provided investigators to gain a better understanding of the pharmacokinetics, safety and effectiveness of this drug during pregnancy. They therefore monitored blood concentrations of the drug, and gathered information on the health of the infants.
Etravirine was taken in combination with a background regimen of other antiretroviral drugs, and in all cases darunavir/ritonavir. 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. This therefore suggested that no dose modification is necessary during pregnancy.
Information was not provided on maternal viral load at the time of delivery. However, three of the women had caesarean deliveries which implies that they had a detectable viral load at this time.
The women had a total of six infants (one set of twins). All received prophylaxis to prevent HIV transmission, and none were infected with the virus.
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.
The investigators were encouraged by these outcomes, and a more comprehensive understanding of the use of etravirine will be provided by the ongoing clinical study
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.