Antiretroviral treatment of HIV infection in infants and children in resource-limited settings, towards universal access:
Recommendations for a public health approach (2005 revision)
DRAFT, October 2005
Web-based public review, 3 - 12 November 2005
WHO convened a Technical Reference Group (TRG) on Paediatric HV Care and Treatment in order to accelerate and further develop future work in relation to diagnosis and treatment of paediatric HIV. A technical consultation was held in Geneva, Switzerland, on 21-22 June 2005 to review the existing WHO 'Scaling up ART in resource-limited settings: treatment guidelines for a public health approach; 2003 revision' (Considerations for the treatment of children, pages 31-42). The TRG was asked to assess new data and experience of scaling up paediatric ART and HIV care and make recommendations for revisions of the current WHO guidelines. The participants of the consultation also considered the need to harmonize the guidelines with the Adult and Prevention of Mother to Child Transmission (PMTCT) ARV guidelines, and to simplify guidelines to facilitate implementation at country level.
The TRG established a writing committee who have since then worked independently to produce drafts of subsequent sections of the final document. The revised recommendations are different from existing WHO recommendations (see below) and based upon considerable re-formulation, relying upon examination of existing evidence and data. Where existing data is insufficient to make recommendations, the writing group members through continuous discussions have developed expert consensus. These revised recommendations have subsequently been synthesized and developed into the present draft WHO document.
This revised document has been shared with the entire TRG and is herewith available for two weeks of web-based public consultation, prior to a final technical consultation of the writing committee on 17-18 November 2005. At this consultation, the writing committee will review feedback from the wider TRG consideration of the revisions and the feedback from the public consultation process. Approval and endorsement of the final complete set of recommendations taking into consideration the external public review will be the outcome of the meeting. Publication of the final WHO document is foreseen for the soonest possible date.
Key changes in the 2005 review
These revised draft guidelines contain significant expansion and revision as requested by national and international partners. Key changes are as follows:
- A section on the diagnosis of HIV infection in infants has been introduced, including the presumptive diagnosis of severe HIV disease for situations where definitive diagnosis of HIV is unavailable
- The revised WHO clinical and immunological classification of HIV has been included
- The criteria for 'when to start treatment' have been extensively revised; the recommendations for initiating ART according to age-related immunological markers have been changed to better reflect the rapidly changing age-related risk of mortality.
- The guidelines are more comprehensive in relation to TB/HIV, HIV/malnutrition, HIV/adolescents, and strategies for situations where 2nd line regimens are failing - areas neglected in the 2003 recommendations.
- The principles of 1st and 2nd line ARV regimens remain the same. However,
o ABC has been introduced as a possible component of the recommended 1st line regimen; a triple NRTI regimen, i.e. AZT/d4T+3TC+ABC, is suggested as an alternative 1st line regimen for special circumstances.
o In 2nd line treatment, additional discussion of PI options is included.
Web-based review process
Reviewers are invited to provide their comments, as appropriate, on this final draft document in the table below. In general, feedback should reflect the reviewer’s clinical and research experiences in the areas they are most familiar with and that are indicated in this table. Comments may;
- Point to the reviewer’s different clinical experience or provide data related to recommendations provided;
- Provide new data that may further support or refute recommendations
- Highlight important gaps, errors or lack of clarity in the draft guidance;
- Provide opinion on more general features such as length/detail, layout and usefulness/user friendliness.
In order to ensure time for synthesizing the feedback received prior to the TRG meeting, reviewers are asked to kindly complete and send the table (attached Word document) to paediatricART@who.int no later than 12 November 2005.
Donwload draft recommendations [pdf 605kb]
Download table for review [doc 39kb]