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| |  Enfuvirtide Appears Safe, Prevents Transmission of HIV to Newborns in Emergent Cases: Presented at CROI By Ed Susman BOSTON, MA -- February 7, 2008 -- Faced with late-presenting pregnant women with high blood levels of HIV and no antenatal prophylaxis, doctors used enfuvirtide to protect the infants from contracting the disease. In all 12 cases -- including 1 woman who presented the day before giving birth -- the newborns were delivered without any case of mother-to-child-transmission reported. "In this investigation, enfuvirtide (T-20) in combination with other antiretroviral drugs has been a successful and safe prophylaxis in late pregnancy," said Annette Haberl, MD, Director, HIV Center, Zentrum der Inneren Medizin, Mediziniche Klinik II, Johann Wolfgang Goethe-Universitat, Frankfurt, Germany. "The use of enfuvirtide in pregnant women might be a useful option, particularly with regard to late presenters, multidrug-resistant virus, and premature delivery." Dr. Haberl presented the series in a poster session on February 4 here at the 15th Conference on Retroviruses and Opportunistic Infections (CROI). "Successful mother-to-child transmission prophylaxis is based on reduction of maternal viral load to undetectable levels," Dr. Haberl said. "Late presenters, pretreated patients with multidrug-resistant virus, and pregnancy complications require special short-term antiretroviral intervention in late pregnancy." "Enfuvirtide is characterized by rapid activity and might therefore be an option to intensify antiretroviral therapy close to delivery," she added. The 6 women had viral loads that had not been successfully suppressed before delivery. Three of the women present for prenatal management after 32 weeks' gestation. Three women had pregnancy complications resulting in premature birth. All children were born by caesarean section, which is known to reduce the risk of mother-to-child-transmission when performed electively. The women were treated with enfuvirtide combined with at least three other antiretroviral drugs. The mean duration of treatment for enfuvirtide was 17 days before delivery, but ranged from 1 to 57 days. Mean viral load before treatment with enfuvirtide was 87,600 copies/mL but ranged from an almost undetectable level of 70 copies /mL to 1,000,000 copies/mL. Mean viral load at delivery was 236 copies/mL, ranging from undetectable to 1,780 copies/mL. The babies were delivered at an average of 37 weeks of gestation, and their mean weight was 2,710 g. In 8 of the 12 children, blood samples were collected for pharmacokinetic analysis. Dr. Haberl said the mean maternal plasma concentration of enfuvirtide was 1,460 ng/mL, but in all 8 of the babies tested the enfuvirtide concentration was less than 200 ng/mL, which indicates there was no transplacental distribution of the drug, Dr. Haberl said. "No enfuvirtide-related adverse events were observed in any mothers or children," she said. "There has been no case of vertical HIV transmission in the 12 children."
[Presentation title: Use of Enfuvirtide in HIV+ Pregnant Women. Abstract 627b]
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