Small case series looks at etravirine during pregnancy

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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.

Glossary

detectable viral load

When viral load is detectable, this indicates that HIV is replicating in the body. If the person is taking HIV treatment but their viral load is detectable, the treatment is not working properly. There may still be a risk of HIV transmission to sexual partners.

reverse transcriptase

A retroviral enzyme which converts genetic material from RNA into DNA, an essential step in the lifecycle of HIV. Several classes of anti-HIV drugs interfere with this stage of HIV’s life cycle: nucleoside reverse transcriptase inhibitors and nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). 

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

caesarean section

Method of birth where the child is delivered through a cut made in the womb.

pharmacokinetics (PK)

How drugs are processed and used in the body, including how they are absorbed, metabolised, distributed and eliminated.

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

References

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.