February 2, 1999 [The New York Times] Simple Drug Therapy Can Cut AIDS Transmission by Mother to Newborn -------------------------------------------------------- By LAWRENCE K. ALTMAN CHICAGO -- United Nations scientists reported here on Monday that a simple, relatively inexpensive drug treatment can significantly reduce mother-to-infant transmission of the AIDS virus. The results are not as good as those from the standard treatment in Western countries, where prospective mothers infected with the virus receive the drug AZT starting at about the 26th week of pregnancy and their babies take it for the first six weeks of life. But that drug therapy, which can cost $1,000 or more, is far too expensive and complicated for the poor countries of the world where HIV, the AIDS virus, is spreading fastest. The new strategy, which requires taking one pill combining two drugs twice a day, significantly abbreviates the treatment period. It worked about as well whether the women started taking the pills about three weeks before delivery or at the onset of labor, which in many poor countries is the first time expectant mothers seek medical assistance. In either case, the mother and baby took the drugs for only a week after birth. Unlike treatment in industrialized countries, where mothers typically receive an intravenous infusion of anti-AIDS drugs during labor, the treatment described on Monday does not require injections, which may be unsafe in developing countries. Each pill contains two standard anti-HIV drugs: AZT, or zidovudine, and 3TC, or lamivudine. The women took one pill in the morning and the other in the evening. Officials of the United Nations AIDS program, speaking here at a medical conference, said the study was the largest ever conducted of mother-to-child transmission ever conducted. Dr. Joseph Saba, a Unaids official who reported the findings, expressed hope that the new strategy would sharply reduce the number of babies who are born infected with HIV each year. Wihtout drug treatments, as many as a quarter of infants born to infected women turn out to carry the AIDS virus -- about 600,000 a year, health experts estimate. The United Nations estimates that 30 million people in the world are now infected with HIV, and the number is growing. The U.N. study compared women who took three different regimens of the two drug combination with those who took dummy pills, or placebos. Given the existence of treatments known to be effective, the use of placebos in the trials was harshly criticized as unethical. But at a news conference on Monday, Saba said his team could not have obtained the clear-cut results if placebos had not been used in the three-country African study. "We feel we made the right choice and are comfortable with it," Saba said. Officials of the National Institutes of Health and the Centers for Disease Control and Prevention, which were involved in the U.N. studies, have also defended the use of placebos, saying that findings from medical practice in the United States could not be extrapolated to poor countries because of vast differences in their logistics and health care budgets. One of the physicians who had questioned the ethics the study, however, remained critical on Monday. The physician, Dr. Peter Lurie, maintained that the U.N. study could have come to the same conclusions without using placebos. Before the new study, the shortest regimen shown to be effective began during the mother's 36th week of pregnancy, about three to four weeks before delivery. That study, using AZT alone, was conducted in Thailand with U.S. government support, but among women who did not breast-feed their babies. Dr. Kenrad Nelson, an epidemiologist at Johns Hopkins University who was involved in the Thai study, said in an interview that he was "pleasantly surprised" by the new findings. Nelson said he had thought that a longer course of anti-HIV drugs would be needed to show significant benefit. Saba said, "Now we know we can make a difference, even for women who come for care late in pregnancy." The studies, which Saba described on Monday at the Sixth Conference on Retroviruses and Opportunistic Infections, involved more than 1,300 women in five urban areas of South Africa, Tanzania and Uganda. "It is a bit premature to develop policy recommendations based on the new study," Saba said, because findings are expected to become available in the next few months from three additional studies in Africa. Two were conducted in Ivory Coast -- one by scientists from the Centers for Disease Control in Atlanta and the other by French researchers. The third study was conducted in Kenya. Saba said the new strategy "will be cost effective" but did not give dollar figures. Glaxo Wellcome, which manufactures the drugs, has pledged to make them available in poor countries at substantially lower cost. In one group in the U.N. study, 359 infected women took AZT and 3TC for an average of three weeks before delivery, during labor and for the first week after delivery. The baby took the drugs in syrup form for a week. In this group, 328 babies were born uninfected and 31 were infected, for a transmission rate of 8.6 percent. That represented a 50 percent reduction according to a statistical measure known as relative risk. In a second group, 343 women took AZT and 3TC during delivery and they and the baby continued for a week thereafter. There were 306 uninfected babies and 37 infected babies in this group, for a transmission rate of 10.8 percent. That represented a 37 percent reduction in relative risk. In a third group, 351 women took the two drugs only during delivery. There were 289 uninfected babies and 62 infected babies in this group, for a transmission rate of 17.7 percent. This compared with a 17.2 percent rate in a fourth group of 273 women who took only placebo three weeks before delivery, during labor and for one week after. In the placebo group, there were 226 uninfected and 47 infected babies. If the simpler regimen is widely accepted, it will save about seven to 10 of every 100 babies who would have developed AIDS and presumably died from it, Saba said. While the treatment can save some infants from death from AIDS, it will not save their mothers, so the therapy will increase the number of orphans in third world countries, which has led some critics to question its worth. But, Saba said, "that is not a reason to let them die." The transmission rates were evaluated at six weeks after birth. But the study plans to continue following the babies for 18 months because infected mothers can transmit HIV through breast milk. Because of family traditions, the high cost of infant formula and the difficulty of obtaining clean water to prepare it, most women in the study are breast-feeding their babies. Earlier research suggests that the protective effects of the new regimen persist for at least six months. Meanwhile, other speakers from the CDC and the National Institutes of Health said that development of a national strategy involving drug therapy, use of Caesarian sections and other measures could eradicate HIV transmission from mother-to-child in the United States. ------------------------------------------------------------------------