The preliminary results from Pediatric ACTG Protocol 185 are consistent with accumulating information from other studies in the United States. For example, in North Carolina, mother-to-child transmission rates have decreased from 21% in 1993 to 6% in 1996 with use of AZT; in New York City, rates have similarly decreased to 5% for infected women who have received the antenatal, intrapartum and newborn AZT regimen. Additionally, in France, transmission rates have decreased from 14% prior to the use of AZT to 5% in women receiving AZT.
The Pediatric ACTG Protocol 185 results provide important strong additional support to the existing Public Health Service recommendations that all pregnant women enter prenatal care early and be offered HIV testing. All HIV-infected pregnant women should be offered the Pediatric ACTG Protocol 076 regimen of antenatal, intrapartum and newborn AZT for the purpose of reducing transmission risk, and the now standard AZT regimen for reduction of perinatal transmission should be part of whatever treatment an infected woman receives during pregnancy for her own health.
No short-term serious side effects in either women or infants were observed in either Pediatric ACTG Protocol 185 or 076. However, information on long-term safety of antiretroviral drugs in pregnancy is lacking. Long-term follow-up is recommended for all infants exposed to antiretroviral treatments in utero or as newborns, and is being provided for infants born in Pediatric ACTG perinatal clinical trials through other protocols in the Pediatric ACTG.
Because almost all HIV-infected women in the United States will be receiving antiretroviral therapy during pregnancy, it will not be possible to address the role of HIVIG in reducing perinatal transmission in a timely fashion. However, in areas of the world in which HIVIG may be a more practical option, it is possible that this question could be addressed. It is still unknown whether passive immuni
Contact: Robert Bock
NIH/National Institute of Child Health and Human Development