Researchers Identify a Simple Inexpensive Drug Regimen which is Highly Effective in Preventing HIV in Infants of Mothers with the Disease

JUL-13-1999 13:10 OD/NIPID/NIH 3014964409 P. 02/04
2
Finding affordable interventidhs for developing countries is key to curtailing the global
AIDS epidemic. In parts of the hardest-hit area, sub-Saharan Africa, up to 30 percent of
pregnant women are infected with HIV, and 25 to 35 percent of their infants will be born
infected. The UNAIDS estimates that approximately 1,800 HIV-infected babies are born every
day in developing countries.
Unfortunately, the standard AZT regimen used to prevent perinatal HIV transmission in
the United States is too expensive and impractical for widewpread use in developing countries
where many women may not receive prenatal care.
Based on average U.S. wholesale costs, the cost of drug used in the nevirapine regimen
in the current study is approximately 200 times cheaper than the long-course AZT used in the
United States, and almost 20 times cheaper than a short course of AZT given to the mother
during the last month of pregnancy - a regimen tested in Thailand by the Centers for Disease
Control and Prevention and reported effective in 1998.
The Uganda study investigators, part of the NIAID-supported HIV Prevention Trials
Network (HIVNET), opened the trial two years ago at Mulago Hospital, affiliated with Makerere
University, in Kampala, Uganda. They completed enrollment last April. All women entered into
the study were in their ninth month of pregnancy. None had taken antiretroviral drugs while
pregnant.
The study, known as HIVNET 012, compared the safety and efficacy of two different
short-course regimens of antiviral drugs administered late in pregnancy. The women were
assigned at random to receive either a 200-mg dose of oral nevirapine at the onset of labor,
followed by a 2--mg/kg oral dose given to their babies within three days of birth; or a 800-mg
dose of ALT at the onset of labor, and 300-mg doses every three hours thereafter during labor.
The infants born to mothers in the AZT! group received 4 mg/kg given twice daily for the first
week of fife. Both drugs appeared to be safe and well-tolerated.
For the interim analysis, the study team looked at data fromt 618 mothers (308 receiving
AZT and 310 receiving nevirapine) and their infants.