This just landed in my mailbox. Same studies, different reporting. *************************************** Subject: [84] Early Results Released from African MTCT Trial Author: AF-AIDS <[log in to unmask]> at INTERNET Date: 02/02/99 11:28 Early Data from Mother-to-child HIV Transmission Study in Africa finds Shortest Effective Regimen Ever Geneva, 1 February 1999 UNAIDS Research Points to Important New Strategy for AIDS Prevention in Developing Countries Preliminary findings from the largest clinical trial ever to examine mother-to-child transmission of HIV open the way for a new, simpler strategy for reducing HIV infection among babies in the developing world. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), when an HIV-positive mother begins an antiretroviral regimen at the time of delivery, and she and her newborn follow a postpartum regimen for just one week, the chances of the infant becoming infected are reduced significantly (by 37 percent). Prior to this breakthrough, the shortest regimen proven to be effective began during the mother's 36th week of pregnancy three to four weeks before delivery. "Over half a million babies are infected with HIV every year, most of them in sub-Saharan Africa where access to health care can be limited," said Dr Peter Piot, Executive Director of UNAIDS. "Now we may be able to help women protect their babies, even if they do not come to a hospital or clinic untilvery late in pregnancy." The research, presented today at the Sixth Conference on Retroviruses in Chicago, analysed rates of mother-to-child (also called perinatal, or vertical) transmission among 1357 out of 1792 participants in the UNAIDS PETRA (PErinatalTRAnsmission) trial. The trial, conducted in five urban settings inSouth Africa, Uganda and Tanzania, evaluated three regimens using zidovudine( ZDV, or AZT) and lamivudine (3TC), as compared with placebo. Transmission rates in all trial arms were measured at six weeks after birth.The researchers are still analysing data from the long-term follow-up of infants because HIV can be transmitted through breast milk and the majority of women in the trial practised breastfeeding. However, early reports from other studies among breastfeeding populations indicate that the preventive effects persist for at least 6 months. The babies and mothers in PETRA will be followed for 18 months. Other early PETRA results indicate that the inclusion of a one-week postpartum course of antiretrovirals for mother and baby is crucial. Among women who received only an intrapartum regimen, with ZDV and 3TC taken during labour and delivery, transmission was not at all reduced. In the longest regimen, women started ZDV and 3TC in the 36th week of pregnancy,followed by the intra+ postpartum regimen. Among these women, there was a 50 percent reduction in transmission. Similar findings had emerged earlier from a study among non-breastfeeding TThai women by the Centers for Disease Control andPrevention (CDC) and the Thai Ministry of Public Health (MOPH) in which ZDV alone was given from the 36th week of pregnancy through delivery. "It is vital to develop a range of prevention options for mother-to-child transmission so that countries can cater for women living in different real-life situations", said Dr Awa Coll-Seck, Director of Policy, Strategy and Researchfor UNAIDS. "We hope that as more data are gathered, more public health officials and donors will see the value of investing in mother-to-child transmission programmes in the countries hardest-hit by the AIDS epidemic". In the absence of preventive strategies, mother-to-child transmission rates range from 25 to 35 percent among breastfeeding women. According to estimates, nearly 600,000 babies are infected a year in total. One-third of them acquire HIV through breastfeeding, a risk that is eliminated if the mother uses a replacement method for infant feeding. But for many HIV-positive mothers in developing countries, the risk of their infant dying if not breastfed could be even greater than the risk of transmitting HIV infection through breastmilk. Furthermore, in places where women may be ostracized and even endangered should their HIV-positive status become known, women may choose not to use replacement feeding for fear of being identified as HIV-positive. Hence the need to find prevention methods that are effective for breastfed infants. "As final results come in from this and other mother-to-child transmission studies, public health officials will have more choices available, especially as more information about the dynamics of transmission through breastfeeding emerges", said Dr Joseph Saba, a clinical research specialist at UNAIDS who manages the PETRA trial. Glaxo Wellcome announced last year that it would substantially lower the pricing of AZT for the prevention of mother-to-child transmission based on the CDC Thai trial regimen. In view of the early PETRA results, Glaxo Wellcome has pledged similar public sector preferential pricing for 3TC and Combivir (the fixed-dose combination of AZT and 3TC) in an effort to support this regimen as another option in establishing effective mother-to-child public health programmes in developing countries. The PETRA study is part of an international research effort coordinated by the UNAIDS Informal Working Group on Prevention of Mother-to-Child Transmission of HIV, with membership of all research institutions involved in mother-to-child transmission trials including the CDC, the National Institutes of Health (NIH), and the French Agence Nationale de Recherche sur le Sida (ANRS). The working group has sought to identify the most promising drug regimens for testing and to coordinate trial designs to eliminate duplication of effort and compare results. The following institutions conducted the PETRA trials: In South Africa, the Baragwanath Hospital, University of Witwatersrand, Johannesburg, and King Edward Hospital, University of Natal, Durban; in Tanzania, Muhimbili University and General Hospital, Dar-es-Salaam; and in Uganda, Mulago Hospital, Makerere University, Kampala, and Nsambya Hospital, Kampala. Data management and analysis was conducted by the National AIDS Therapy Evaluation Centre in Amsterdam. The PETRA study has received financial support from Australian AID (Australia), Istituto Superiore di Sanita (Italy), Het AIDS Fonds (Netherlands) and the Swedish Agency for Research Cooperation with Developing Countries(Sweden). For more information, please contact Anne Winter, UNAIDS, Geneva, (+4122)791.4577, Lisa Jacobs, UNAIDS, Geneva, (+41 22) 791.3387 or Karen O'Malley at the Retroviruses Conference in Chicago, (+1 312) 329.7281. You may also visit the UNAIDS Home Page on the Internet for more information about the programme(http://www.unaids.org). ********************************** Pamela Morrison IBCLC, Zimbabwe mailto:[log in to unmask]