US launches drive to find better HIV treatments for children in poorest countries

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United States' First Lady Laura Bush announced yesterday that the US government is to lead an international public-private partnership to increase the range of HIV drugs available for treatment with children. The US administration will work with innovator and generic pharmaceutical companies, UNICEF and UNAIDS to tackle barriers to effective treatment of children, especially the absence of formulations that can be used for paediatric treatment in resource-limited settings.

The initiative forms part of the President’s Emergency Plan for AIDS Relief (PEPFAR), and will work to identify scientific obstacles to treatment for children and take practical steps to address key barriers, the US State Department’s Global AIDS Coordinator siad yesterday. For example, making available tables of standardised dose ranges by weight could simplify dosing management of infected children and enable non-experts to assess whether a child is in the appropriate dose range. In resource-poor settings where equipment, facilities, and trained staff are limited, such tables could be vital.

The partners will share best practices on the scientific issues surrounding dosing of antiretrovirals (ARVs) for paediatric applications and develop systems for clinical and technical support to facilitate rapid regulatory review, approval, manufacturing and availability of pediatric ARV formulations.

Glossary

paediatric

Of or relating to children.

generic

In relation to medicines, a drug manufactured and sold without a brand name, in situations where the original manufacturer’s patent has expired or is not enforced. Generic drugs contain the same active ingredients as branded drugs, and have comparable strength, safety, efficacy and quality.

formulation

The physical form in which a drug is manufactured or administered. Examples of formulations include tablets, capsules, powders, and oral and injectable solutions. A drug may be available in multiple formulations.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

malaria

A serious disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. People who get malaria are typically very sick with high fevers, shaking chills, and flu-like illness. 

Two companies involved with the partnership released information on their activities in the paediatric HIV field.

GlaxoSmithKline said it is currently assessing the development of scored tablets for use in children for the company's key anti-retrovirals (Epivir, Ziagen, and Combivir). Using a scored tablet could simplify treatment, if the right dose could be administered efficiently and safely to children in the appropriate weight range. GSK is in further discussions with both the US Food and Drug Administration and the European Medicines Evaluation Agency to move this project forward.

Abbott said it is developing a lower-dose paediatric tablet formulation of its protease inhibitor lopinavir/ritonavir (Kaletra), and that it is providing the liquid formulations of ritonavir and lopinavir at the lowest price of any liquid protease inhibitor formulation, including both generic and branded products. The company also highlights its donation of 3.4 million free HIV antibody tests to programmes designed to prevent mother to child HIV transmission in Africa and other poor countries.

Generic manufacturers involved in the partnership include Aspen Pharmacare, Aurobindo Pharma, Cipla, Emcure and Ranbaxy, all of which have paediatric antiretroviral development programmes.

Comment

Generic and branded manufacturers agree that one of the biggest obstacles to the development of paediatric formulations suitable for use in resource-limited settings is the absence of a clearly defined market for the products, and a lack of reliable information on the future demand for these products. The US government’s initiative needs to be met with the creation by the international community of an Advance Market Commitment mechanism that can underwrite paediatric HIV treatment in the same way that AMCs have already been proposed as a means of stimulating vaccines against diseases such as malaria.