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New Study of Raltegravir in Pregnancy at ICAAC 2013

One of the most striking success stories of the HIV epidemic is the near elimination of vertical transmission of HIV in the developed world. This remarkable feat has been accomplished through universal HIV testing in pregnancy and use of combination ART in infected mothers. Optimal control of HIV in pregnancy requires knowledge of how pregnancy affects the pharmacokinetics of ARVs and adequate information on the safety of treatment for both mother and child. Raltegravir (RAL) is an effective well-tolerated antiretroviral that is guidelines-preferred for non-pregnant patients, but currently designated for use only in special circumstances in pregnancy. RAL is classified by the FDA as pregnancy category C because of supernumerary rib formation after high dose exposures in rats. Safety data in human pregnancy is sparse. Therefore, additional studies of the safety and efficacy of RAL in pregnancy are needed. Jeantils et al reported on 31 pregnant women seen at a specialty clinic in Paris who used raltegravir during pregnancy. The women used RAL mostly because of intolerance or poor adherence to a previous regimen. The majority (74%) began RAL in the 3rd trimester. The median viral load before RAL was 17,765 copies/mL, falling to 41 after a median of 71 days on RAL. Transplacental penetration of RAL was very good with a cord/maternal blood ratio of 3.48. No adverse effects were identified in either the mothers or newborns, including fetal malformations, but only 5 women used RAL in the first trimester. No baby acquired HIV, but since 64% of the women were receiving protease inhibitors, all received peripartum AZT, 65% had caesarean section and all newborns were treated with 4 weeks of ART, the contribution of RAL to prevention is hard to assess. The authors reviewed data from the Antiretroviral Pregnancy Registry, finding 3 malformations after 119 first trimester exposures to RAL and 6 malformations after 109 second or third trimester exposures. A case of apparent RAL-induced hepatitis was reported in one pregnant woman. It takes many years to accumulate sufficient data on the safety and efficacy of drugs used in pregnancy, so clinicians should be slow to change established practices in this clinical setting. This report makes a small but encouraging contribution towards establishing raltegravir as an option for use in a broader range of pregnant women with HIV.

Jeantils V, Messaouden H, Carbillon L. Pregnancy and a Regimen Containing Raltegravir: a Pilot Study on the Materno-Foetal Safety. 53rd ICAAC, Denver CO, Sept 10-13, 2013, Abstract H-1463.

Source: Reporting from Denver for the PRN News: David H Shepp, MD