Summary statement on WHO recommendations on ARV medicines for treating and preventing HIV infections in younger children
30 November 2006 - WHO is issuing new recommendations on which ARV formulations are needed for safe and effective treatment of HIV infection in infants and young children.
Working with a group of international paediatric ARV experts, WHO examined a number of existing ARV products, including recently developed d4T fixed dose combination (FDC) formulations, and possible new ideal FDC formulations. FDC formulations are ones in which two or three different ARV drugs are combined in a single pill to greatly simplify treatment regimens.
WHO is now calling on the pharmaceutical industry, international drug regulatory authorities and other international partners to secure the development, 'fast track' approval and affordable access to a range of ARV medicines for young children.
The new d4T-based FDCs, if of proven quality, could be a major step forward for national ARV programmes that provide treatment for young infants and children. It is also hoped that they will lead to better drug adherence and help speed up scale up of HIV care and treatment for children.
WHO also calls on pharmaceutical companies to go further, and develop a new range of AZT-based paediatric FDC formulations, and other single ARV drug products. If developed, the range of products specified could offer significant advantages to children and their caregivers, and and provide much simpler options for treatment programmes.
A range of financing options, including the Global Fund to Fight AIDS, TB and Malaria (GFATM) and UNITAID, an initiative launched earlier this year by Brazil, Chile, France, Norway and the United Kingdom, offer exciting opportunities to overcome some of the existing financial barriers to production and procurement of the recently developed d4T products and other desired paediatric ARVs products. UNITAID, for example, plans to negotiate multi-year large-volume purchasing programmes with the pharmaceutical companies. An initial focus will be on paediatric products for HIV.
WHO has developed guidelines on antiretroviral treatment for children. In addition, it has been working with UNICEF and international paediatric HIV experts to find ways to address the current gaps and obstacles to ensure the prevention of new infections, follow-up for HIV-exposed children, and optimal care and treatment for HIV-positive children.
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