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Subject:
From:
Pamela Morrison IBCLC <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Wed, 3 Feb 1999 15:54:51 +0200
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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
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