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| |  Nelfinavir Acts in HIV-Infected Neonates as in Adults, But Individual Drug Monitoring Still Required: Presented at CROI By Maria Bishop BOSTON, MA -- February 7, 2008 -- Adequate exposure to nelfinavir is undetermined for neonates diagnosed with HIV in the first 2 weeks of life, according to research reported here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). Standard therapeutic drug monitoring is recommended in these youngest patients to ensure adequate exposure, the researchers said. A weight-band dosing regimen for nelfinavir was examined in a study of 22 Brazilian HIV-infected infants led by Mark H. Mirochnick, MD, Director of Neonatology, Boston Medical Center, Boston, Massachusetts. The median per-kilogram dose of nelfinavir in this study was 58.3 mg/kg, where it was being used as part of a combination regimen for the purpose of mother-to-child transmission prophylaxis. Serial plasma samples for nelfinavir concentration were obtained over 12 hours and measured with high-performance liquid chromatography at age 4 to 7 days or 10 to 14 days. Dr. Mirochnick and colleagues observed no pharmacokinetic parameter differences between infants studied on days 4 to 7 versus days 10 to 14. Additionally, the median area under the concentration-time curve from 0 to 12 hours and blood trough concentration analyzed at 12 hours were equivalent in the neonatal subjects to levels observed in adults. The authors noted, however, that there was a great deal of interindividual variability in nelfinavir exposure, which was low in 41% of the neonatal subjects. Given the wide variability in nelfinavir exposure in this study, the authors stated, a further increase in the nelfinavir dose would likely have resulted in some infants with a higher and potentially toxic concentration, while others would have remained with low concentrations. Thus, the dose was not increased during this study. The recommendation was made, therefore, for standard therapeutic drug monitoring during the use of nelfinavir in HIV-infected infants. The optimal postnatal antiretroviral (ART) regimen to prevent mother-to-child HIV transmission in infants born to mothers with no ART during pregnancy also remains unknown, the researchers noted in their poster, which was presented on February 6.
[Presentation title: Nelfinavir Pharmacokinetics With an Increased Dose During the First 2 Weeks of Life. Abstract 571]
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