GlaxoSmithKline (GSK) announced that it had gained approval from the European Commission for a new indication for use in children and infants of its HIV fixed-dose combination medicine, Combivir (lamivudine/3TC and Zidovudine/AZT). Previously, Combivir has only been prescribed for use in adults and children over 12 years of age, the shift to new weight based prescribing will allow Combivir to be used in much younger children. Approvals have also been granted to new scored-tablet formulations of Combivir , Epivir (lamivudine/3TC) and Ziagen (abacavir) for use in children weighing more than 14kg, part of GSK's ongoing efforts to fight HIV/AIDS in children.
Whilst liquid forms of HIV medicines are currently available and are the only way to treat infants and babies, these can be difficult to administer and to store, especially in developing countries. Liquids often do not combine multiple medicines in one solution, so as a child is taking multiple drugs, each has to be administered separately.
This lack of "easy to use" paediatric formulations creates another hurdle for physicians who already face difficulties in treating children living with HIV, including diagnosis and monitoring the infection.
The World Health Organization (WHO) launched a new initiative to "make medicines child size" highlighting the need for medicines to be better tailored to the needs of children. GSK supports this initiative, which amongst other issues calls for further research and development of combination pills for HIV/AIDS, and hopes that these approvals reflect the company's commitment.
Experts at WHO and UNICEF have identified that access to a tablet form of these medicines could improve treatment options for children able to swallow tablets. Tablets are often easier to store and distribute, and also less complicated to administer - particularly when two or three medicines are combined in one pill.
"Many children living with HIV around the world, still do not have access to antiretroviral treatment. Despite liquid formulations of our key HIV medicines being available for use in children at a not-for-profit price to the world's poorest countries, there remain many barriers to access effective treatment," said JP Garnier, CEO GlaxoSmithKline. "We hope that the scored-tablets, when available, will improve the treatment of children living with this devastating disease."
Following the approval and provision of a Certificate of Pharmaceutical Product by the European regulatory authority, GSK will progress the registration of these products for use in developing countries.
The new scored tablet formulation can be dosed and administered more easily, for example a child weighing approximately 20kg could be given half a tablet of Combivir in the morning and the second half in the evening in combination with another ARV, instead of needing to receive 8ml of Epivir solution twice a day plus 12ml of Retrovir (zidovudine/AZT) solution three times daily.
In addition, as part of continued efforts to improve the treatment of children in developing countries, GSK has committed to support four paediatric clinical studies in resource-poor countries to determine the best ways to expand access to treatment in those situations. In 2007, it is estimated that 2.5 million children live with HIV around the world; nearly ninty per cent of these children live in sub-Saharan Africa.
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