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Published on: April 16, 2013
Concentrations of protease inhibitors in cord blood after in utero exposure
Mark Mirochnick1, Alex Dorenbaum, Diane Holland
1Boston University School of Medicine, and Statistical and Data Analysis Center/Harvard School of Public Health, Boston, MA, USA.
Insights
Prenatal protease inhibitor (PI) use resulted in low fetal drug concentrations in cord blood. This may reduce toxicity risks but potentially offers insufficient protection against HIV-1 transmission.
Area of Science:
- Pharmacology
- Neonatal Health
- Infectious Disease
Background:
- Protease inhibitors (PIs) are crucial in managing HIV-1 infection.
- Prenatal exposure to antiretroviral therapy (ART) is common in pregnant women with HIV-1.
- Understanding fetal drug exposure is vital for assessing safety and efficacy.
Purpose of the Study:
- To quantify protease inhibitor concentrations in cord blood from infants exposed prenatally.
- To evaluate the implications of fetal PI exposure on potential toxicity and HIV-1 transmission.
Main Methods:
- Retrospective analysis of cord blood samples from a clinical trial (PACTG 316).
- Measurement of protease inhibitor concentrations using a validated assay.
- Inclusion of samples from women receiving various PI-based ART regimens during pregnancy.
Main Results:
- Most cord blood samples showed PI concentrations below the assay's lower limit of detection.
- All samples from indinavir and saquinavir users had undetectable PI levels.
- Significant proportions of samples from ritonavir and nelfinavir users also had undetectable PI concentrations.
Conclusions:
- Low fetal PI concentrations may mitigate teratogenic and toxic effects.
- Insufficient fetal drug levels might compromise protection against transplacental or intrapartum HIV-1 transmission.
- Further research is needed to optimize ART regimens for pregnant women to ensure both maternal and infant health.
Objective:
To determine the concentrations of protease inhibitors in cord blood after prenatal protease inhibitor use by pregnant women.
Design:
Retrospective analysis of samples collected in a clinical trial.
Methods:
Protease inhibitor concentrations were measured in cord blood samples collected from women enrolling in the PACTG 316 study who were receiving prenatal protease inhibitor antiretroviral therapy.
Results:
In cord blood samples from 68 women treated with protease inhibitors during pregnancy, the concentration of these drugs was below the assay lower limit of detection in most samples, including all samples from women receiving indinavir (n = 21) and saquinavir (n = 8), 5 of 6 samples (83%) from women receiving ritonavir and 24 of 38 samples (63%) from women receiving nelfinavir.
Conclusions:
Low protease inhibitor concentrations in the fetus decrease the likelihood of teratogenic and toxic effects of these drugs but could fail to provide protection from transplacental or intrapartum transmission of HIV-1.
