PI Perspective 25: Federal Guidelines

PI Perspective 25: Federal Guidelines

Project Inform - September, 1998

The recently updated Federal Guidelines for the treatment of children with HIV recommend that infants and children receive combinations that include two nucleoside analogues and a protease inhibitor, and that adolescents be treated based on adult guidelines. The guidelines suggest that all 11 anti-HIV drugs approved for use in adults can also be used in children despite that fact that not all are approved for pediatric use. The following is a summary of the guidelines on how to monitor HIV disease, when to initiate therapy and when to change therapy.

How do you monitor HIV disease in children?

CD4+ cell counts: Tests should be done to establish a `baseline' and then every three months thereafter. "Normal" levels in children depend upon age, and younger children tend to have higher "normal" levels. CD4 percentage (CD4%) is a useful marker of immune status because there is no variability by age.
Viral load levels: Disease progression differs in children—HIV RNA levels are generally low at birth, reach high levels (over 100,000 copies) at two months, and then decline very slowly without any therapy. A viral load change is considered significant if it is greater than 0.7 logs in children less than 2 years or 0.5 logs in children older than 2 years.

When Should Children Start Treatment?

Health Status	Treatment Recommendation
All children with symptoms of HIV disease or clear immune suppression at any age	Begin therapy
All children less than 12 months regardless of general health status	Begin therapy
Children greater than 1 year with no symptoms of HIV disease	Two Options: 1. Start therapy (preferred in all children, OR 2. Defer therapy (alternative) but regularly monitor viral load, CD4+ cell counts and general health

With Which Regimen Should Children Start?

Regimen	Explanation
Preferred	1 protease inhibitor and 2 NARTIs. NARTI combinations that have been well-studied include AZT + 3TC and AZT + ddI
Alternative	Nevirapine (Viramune^®) plus 2 NARTIs
Secondary alternative	2 NARTIs (but the antiviral response may not be long-lasting)

When should children change therapy?

Any of the following should signal the need for a change in therapy:

Less than a 1 log change after 8-12 months on 3-drug combinations OR less than a 0.7 log change on two NARTI combinations.
Repeated detection of HIV RNA in children who previously had undetectable levels.
Persistent increases in viral load levels in children who originally responded to treatment (at least a 0.5 log increase in children older than 2 years and 0.7 log increase in children younger than 2 years).
Persistent decline in CD4+ cell percentage of five percent or more (i.e. 15% down to 10%).
Rapid decrease in absolute CD4+ cell counts.
Clinical disease progression as seen by lack of growth, neurological symptoms or other signs of HIV disease.The principles of thinking about developing a long-term anti-HIV therapy strategy are similar in adults and in children. For more information on developing a long-term antiviral strategy, called the Project Inform Hotline.

Note: Like all aspects of the Federal Guidelines, these recommendations will almost certainly change over time as new information and new therapies become available. The current Guidelines may not even represent the best possible use of existing therapies. However, they do represent the state of the art in our current knowledge about available drugs. Additional studies, even of older drugs, may lead to future revisions. The Guidelines should be used as a starting point for strategies based on proven information, but they are not a substitute or cookbook for the practice of medicine. Physician experience and patient individuality must always be incorporated into medical judgments. It is the duty of every physician treating people with HIV disease to remain abreast of these Guidelines and their future updates, which will always be available through the Project Inform Hotline.

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Always watch for outdated information. This article first appeared in 1998. This material is designed to support, not replace, the relationship that exists between you and your doctor.

©1998. This document is copyrighted by Project Inform, 205 13th Street, #2001, San Francisco, CA 94103. Treatment Hotline: 800-822-7422 (toll-free) or 415-558-9051 (in the San Francisco Bay Area and internationally) All Project Inform materials may be reprinted and/or distributed without prior permission. However, reprints may not be edited and must include the following text: "From Project Inform, for more information contact the Project Inform National HIV/AIDS Treatment Hotline, 800-822-7422." For permission to edit any Project Inform material for further publication, contact David Evans at the Project Inform office.

Project Inform, established in 1985 as a national, non profit, community-based HIV/AIDS treatment information and advocacy organization, serves HIV-infected individuals, their care-givers, and their healthcare and service providers through its national, toll-free treatment hotline, the PI Perspective and other information publications, educational Town Meetings, on-line services and research and drug access advocacy programs. All information is available free of charge; donations are strongly encouraged. For more information, contact the Project Inform National HIV/AIDS Treatment Hotline. Email: web@projinf.org; Website: http://www.projinf.org.

The original of this article can be found at http://www.projinf.org/pub/25/children.html

This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1998. AEGiS.