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and Hepatitis.com Coverage of the
50th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC 2010)
Raltegravir Is Safe with No Dosage Changes Needed during Pregnancy
B.M. Best from the University of California San Diego and colleagues looked at raltegravir pharmacokinetic data for pregnant women with HIV in their third trimester, comparing it with previously obtained historical data for non-pregnant individuals.
Raltegravir displays marked absorption and disposition variability in non-pregnant adults, the researchers noted as background, but information about raltegravir pharmacokinetics during pregnancy has not been available.
This analysis included pharmacokinetic data from 10 women in the IMPAACT P1026s study, collected from the third trimester of pregnancy until 6 weeks after delivery (post-partum). Maternal blood plasma samples were collected before dosing and at 1, 2, 4, 6, 8, and 12 hours after dosing. Umbilical cord blood and maternal blood were also collected at the time of delivery.
Pregnant Women took the standard adult dose of 400 mg twice-daily. In non-pregnant adults, the target 12-hour raltegravir concentration (C12h), or minimum therapeutic level (estimated 10th percentile), is > 35 ng/mL, with a median of 63 ng/mL.
with previous reports, raltegravir pharmacokinetics showed extensive
variability," the study investigators concluded. "Raltegravir
exposure was not consistently altered during third trimester compared
to post-partum and historical data, and the standard dose appears appropriate