By Ed Susman
MEXICO CITY -- August 5, 2008 -- Antiretroviral therapy for pregnant women infected with human immunodeficiency virus (HIV) appears to be relatively safe for their newborn babies, according to findings presented here at the 17th International AIDS Conference (AIDS 2008).
"The drug-adverse reactions [in this study] were mostly of mild to moderate intensity and resulted in no fatalities," said Marilia Santini de Oliveira, MD, Instituto de Pesquisa Clinica Evandro Chagas-Fiocruz, Rio de Janeiro, Brazil. "The efficacy of antiretroviral use for preventing mother-to-child transmission of HIV overcomes the risks of drug adverse reactions."
In a poster presentation here on August 4, Dr. Santini de Oliveira described how she and her colleagues undertook a prospective study from February 2005 to May 2006, enrolling 195 children who had been exposed to antiretroviral therapy before birth and/or in the first few week of life. None of the children were enrolled in other clinical studies. All subjects were followed until 6 months of life.
All of the babies had received antiretroviral treatment, including zidovudine, for a mean time of 6.2 weeks. One hundred fifty babies (over 76%) were exposed to antiretrovirals in the womb for a mean of 13.3 weeks. Two of the 45 children who were not exposed to antiretrovirals (4.4%) were born with HIV infection. One of the 150 children exposed to antiretrovirals in the womb (0.7%) was born with HIV infection.
A total of 34 babies developed 41 adverse drug reactions (21% frequency), Dr. Santini de Oliveira noted. Haematological events occurred at the rate of 21.6 per 1,000 patient-weeks; gastrointestinal events were reported at the rate of 7.5 per 1,000 patient-weeks; hepatological events occurred in 4.2 per 1,000 patient-weeks; and rash was detected at the rate of 0.8 per 1,000 patient-weeks.
The researchers stated that 6 of the adverse drug reactions were severe and 2 were serious.
This study, Dr. Santini de Oliveira stated, will fill an information void: "There are few studies about the safety of antiretroviral use in preventing mother-to-child transmission of HIV, especially in Brazil."
[Presentation title: Safety of Antiretroviral (ARV) Drugs in Children Exposed to HIV During Pregnancy: A Prospective Study in Rio de Janeiro, Brazil. Abstract MOPE0214]
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