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AIDS treatment for Children

Background

Children with HIV/AIDS are dying unnecessarily because of a lack of access to ARV treatment. The problems arise mainly from a lack of cheap feasible diagnostic tests for children under 18 months, lack of trained health personnel and the affordable child-friendly ARV drugs.

Simplified treatment guidelines coupled with a range of fixed-dose combinations of ARVs that require only one or two pills twice a day make it easier to treat HIV/AIDS in adults, but development of simplified drugs for children lags behind. Despite WHO simplified treatment guidelines that specify which drugs to use in children, countries have difficulty in getting simple and affordable combinations of the drugs. Two generic fixed-dose combinations should enter clinical trails this year, and there are frighteningly few second-line ARV drugs available for children in countries with large numbers of infected children.

Children orphaned by AIDS in Botswana (WHO/Eric Miller)

Therefore, WHO is committed to:

• Ensuring children are included in national and international efforts to scale up access to treatment and reach "3 by 5" targets;
• Greater coverage of ARV treatment, co-trimoxazole prophylaxis and comprehensive HIV care for HIV-exposed and HIV-infected infants;
• Increasing access and coverage of PMTCT interventions to prevent infection in children;
• Increased access to ART and HIV care for mothers, fathers and other care givers to propose or prevent orphanhood;

ARV formulations for children

Current global efforts to scale up access to treatment make a clear commitment to including access for infants and children. Existing programme efforts suggest even in successful ART programmes children are often not included. We have relatively little data or accurate forecasting or estimation of the needs for ART among HIV infected children. Of 12000 patients who accessed ART in MSF projects, only 700 (6%) were children (below 15 years) as of March 2004.

The "3 by 5" global target aims to include infants and children in at least 10-15% of all patients accessing ART. Many of the virologic and immunologic principles that underscore the use of ART are similar for all HIV-infected persons, but there are some unique considerations for HIV-infected infants and children. Specific factors related to pharmacokinetic and pharmacodynamics in paediatric populations influence ARV bioavailability. ARV selection and dosage calculations and paediatric specific factors also influence acceptability and adherence to treatment.

• Not all ARVs in current WHO guidelines for children are currently made, or are available, in formulations suitable, palatable, acceptable or feasible for use in for paediatric populations
• Lack of specific guidance on dosage adjustments for weight and age for currently recommended ARVs
• Lack of pharmacokinetic and dynamic data on distribution, metabolism and efficacy & AUC for many ARV drugs in children
• FDCs are not available in paediatric formulations
• Current costs for paediatric formulations are well above the reduced prices achieved for adult ARV formulations
• National and or international regulatory and prequalification procedures may discourage the production of specific paediatric ARV formulations

There are other problems that relate to the ability of national programmes to procure, supply and distribute paediatric formulations that influence the range and scope of paediatric ARV use in countries, and these include:

• Need for supply systems to provide variable small volumes for paediatric use
• Problems with supplies, shelf-lives, distribution and ongoing monitoring of drug quality up to the point of use; and
• Complexity of dispensing to end-user and use by paediatric patients in community settings.

NOTE: The term “supply systems” referred to include the selection, procurement, storage, distribution and use of appropriate paediatric formulations, in this context.

Only a handful of the ARVs in the current WHO guidelines are available in formulations that are affordable, feasible or acceptable for use in infants and young children. Only 11 out of the 18 drugs used to treat adult HIV infection have indications, clear dosage or package inserts for use in children.

The global market for paediatric AIDS drug formulations is not attractive for originator or generic companies; in wealthy countries very few children are being born with HIV, and in developing countries where most of the infected children are, paediatric formulations are not considered a priority or lucrative market. Drug companies have made little progress to date in developing new or reformulating adult tablets and fixed-dose combinations to breakable or chewable tablets. Medicines for children are often beyond the reach of many families, and the cost of treating one child is often as much as six times more than an adult.

UNICEF/WHO Technical Consultation on Paediatric ARV Formulations

In November 2004, WHO and UNICEF held a technical consultation on: "Improving Access to Appropriate Paediatric ARV Formulations".

The aim of this meeting was to review the current status and development in the use of ARVs in HIV-infected infants and young children, with the specific intention of identifying immediate steps to increase access to appropriate antiretroviral formulations.

The meeting included experts from the Elizabeth Glazer Paediatric Foundation, the Clinton Foundation, Colombia University, researchers, pharmaceutical product development experts, the US Health and Human Services, Médecins Sans Frontières, national programme managers and clinical experts of HIV care in children from around the world.

Meeting agenda and presentations

Note: The presentations from the meeting do not necessarily represent WHO positions and are put on the web site for information sharing purposes.