We enrolled patients in ACTG 076 to test the hypothesis that treatment with AZT during pregnancy and labor, and in the infant, would reduce the risk of vertical transmission.
Between 1996 and 2016, approximately 500 HIV-infected women delivered at Boston Medical Center with vertical transmission identified in only 6 (1.2%) infants; without ACTG 076, we would have expected 125!
(10) In 1994, while there was an existing protocol from the AIDS Clinical Trial Group 076 (ACTG 076
) for preventing MTCT, high antiretroviral (ARV) costs and insufficient infrastructure placed it out of reach of most of the HIV-infected population in the developing world.
(1) Approximately 477 HIV-positive pregnant women participated in the AIDS Clinical Trial Groups 076 (ACTG 076) study which showed a near sixty-seven percent decrease in transmission of HIV from mother to child when the mother was given zidovudine (AZT) during the last two trimesters of pregnancy and the child received AZT for the first six weeks after birth.
The ACTG 076 clinical trials showed that mothers who received AZT treatment during the last two trimesters of pregnancy and whose babies then received AZT for six weeks after birth had an eight percent chance of transferring the HIV infection to the child, while those who were not treated had approximately a twenty-five percent chance.
The landmark ACTG 076
clinical trial demonstrated that when mothers took AZT (Retrovir) during pregnancy, the transmission rate was reduced from 25% to 8%.
The landmark 1994 study known as ACTG 076
showed that a three-part regimen of zidovudine given to a patient during pregnancy and labor and to the infant for the first 6 weeks of life decreased the HIV transmission rate by 68%.
Since publication of the ACTG 076
trial, several studies have confirmed and extended these initial results (14,16-30).
In a study of pregnant women, ACTG 076
, the estimated risk of mother-to-child transmission of HIV was less than 8% in zidovudine-treated infants (antenatal, perinatal, and neonatal drug administration) versus almost 25% in the placebo group.
In the developing world, where on average the annual health budget is approximately $10 per person, the complex ACTG 076 regimen, which costs approximately $1,000 per pregnancy, is simply not an option.
Data from the original ACTG 076 trial in the United States showed transmission to be 8 percent in the treated group compared to 25 percent in the placebo group, representing about 70 percent reduction in transmission risk.
In the study, known as ACTG 076
, AZT therapy was initiated in the second or third trimester and continued during labor, and infants were treated for six weeks following birth.