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WHO issued recommendations on the use of antiretroviral drugs for the prevention of mother-to-child transmission of HIV (MTCT) in 2000. Those recommendations need to be reassessed in the context of rapidly expanding ARV treatment programmes using simplified and standardized regimens. In addition considerable experience implementing MTCT-prevention programmes in resource-limited settings has been accumulated, as well as further evidence on the safety and effectiveness of different ARV regimens. Drug resistance induced by short-course MTCT-prevention regimens has been a concern since early 2000. Any potential impact on future treatment options for the mother’s HIV disease was considered at that time primarily a theoretical concern as it was unlikely that many women who had participated in an MTCT-prevention programme would have access to ARV therapy. However, as MTCT prevention and ARV treatment and MTCT-prevention programmes are expanding and MTCT-prevention programmes used to identify women in need of treatment (either immediately or at some subsequent time), potential resistance becomes a far greater concern. Unfortunately solid evidence on which to base decisions is lacking, yet it is not possible to delay recommendations until ongoing and planned research is complete. WHO has therefore initiated a reassessment of existing recommendations and is issuing these Draft 2004 Recommendations to guide the use of antiretroviral (ARV) drug regimens for the prevention of mother to child transmission (MTCT) of HIV infection, in the context of scaling up ARV treatment programmes. This guidance is mainly addressed to policy makers and programme managers in developing countries.
The guidelines summarize existing evidence on the use of ARV drugs for MTCT prevention and make recommendations on the use of ARV drug regimens for this purpose in the context of increased access to ARV treatment, highlighting different clinical scenarios:
- Newly diagnosed HIV-infected pregnant women without indication for ARV treatment
- Newly diagnosed HIV-infected pregnant women with indications for ARV treatment
- Newly diagnosed HIV-infected pregnant women with indications for ARV treatment who did not initiate therapy during pregnancy
- HIV infected pregnant women newly diagnosed at the time of delivery, and
- HIV infected women on ARV treatment for their own disease
This document is part of a series of modules comprising guidelines for the care, treatment, and support of HIV-infected women and their children in resource-constrained settings being developed by the World Health Organization and its partners.
We would appreciate receiving your comments and suggestions on this document via a specific WHO electronic address arvmtctguidelines@who.int or by mail to “ARV MTCT Guidelines”, c/o Sophie Merlet, Department of Reproductive Health and Research, World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland, fax number +41 22 791 4171. All comments must be received in Geneva before Monday 26 January. Your comments will be considered at an expert consultation of scientists, policy-makers, programme managers, and partners to be convened by WHO 5 - 6 February 2004 to finalize the recommendations. The updated recommendations will be released in the first quarter of 2004.
The major point for discussion at the consultation will be how to balance the efficacy and effectiveness of different ARV regimens to reduce the rate of MTCT with their safety and therapeutic efficacy to the mother (including questions of drug resistance) and their practicality to ensure high coverage and sustainability of MTCT-prevention programmes. Particular questions for consideration include:
- Under what circumstances should single-dose nevirapine be used or should it be avoided as far as possible?
- Should single-dose nevirapine be used in labour as an addition to other ARV drugs such as zidovudine or zidovudine + lamivudine (“boosting” with nevirapine)?
- Should a short course of the triple-combination of zidovudine + lamivudine + nevirapine be considered in all pregnant women to prevent transmission even if they do not yet require therapy?
- What are the optimal prophylaxis regimens for infants according to the ARV regimen taken by the mother?
- What are the risks, benefits and practicalities of competing recommendations and strategies?
Comments and views on these issues will also be welcome in advance of the consultation (address for comments as above).
The World Health Organization wishes to express its gratitude to François Dabis and Marie-Louise Newell for the Ghent-IAS Group on HIV in Women and Children who developed the first draft of this document. WHO would like to thank also experts who gave extensive comments on the first draft (in alphabetical order): Elaine Abrams, Ellen Cooper, Wafaa El Sadr, Lynne Mofenson, Allan Rosenfield, Nathan Shaffer, Jeffrey Stringer and Catherine Wilfert. The following members of WHO contributed to the writing of the guidelines (in alphabetical order): Inam Chitsike, Halima Dao, Isabelle de Vincenzi, Isabelle de Zoysa, Tim Farley, Charlie Gilks and Jos Perriëns.
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