Major Advance in Protecting Newborns: One Nevirapine Dose Cuts Infection in Half
A study in Uganda, sponsored by the U.S. National Institute of Allergy and Infectious Diseases, found that a single oral dose of nevirapine given to an HIV-infected woman in labor, plus one dose to the infant within three days of birth, cut HIV transmission to 13.1%, compared to 25.1% with a similar short course of AZT. Drug cost, based on U.S. wholesale prices, is 200 times less than that of the standard AZT regimen used in developed countries. Treatment begins during labor, so it can be used for women who do not receive prenatal care. In some parts of Africa, up to 30% of pregnant women have HIV, and 25% to 35% of their infants are infected. An estimated 1,800 HIV-infected babies are born every day, and up to 1,000 a day could be saved from infection with the new treatment.To avoid the need to test pregnant women and identify who is HIV-positive--a serious problem in some societies, where confidentiality would be difficult or impossible--pregnant women might be routinely treated in areas of high HIV incidence.
The Uganda study, led by Professor Francis Mmiro from Makerere University and Brooks Jackson from Johns Hopkins University, is continuing to follow the infants for their first 18 months, to confirm the safety of the treatment, and to make sure that the gains are not lost through HIV infection during breast feeding.
Nevirapine, marketed as Viramune(r) in the U.S., was developed by Boehringer Ingelheim Pharmaceuticals and is approved in the U.S. and other countries for treatment of HIV-infected adults, in combination with other antiretrovirals. It is very active against HIV, but viral resistance develops rapidly if it is used alone as a continuous treatment by someone who is already HIV infected.
The new single-dose nevirapine regimen will be used in the U.S. and elsewhere for pregnant women who do not know they are HIV-positive until they begin labor, when it is too late to take the full standard regimen. Also, an ongoing study in the U.S. and Europe is testing whether adding nevirapine provides additional benefit in preventing HIV transmission, over the AZT and other antiretrovirals which most pregnant women are already taking.
