New drug will give hope to HIV positive children
HIV positive children can now benefit from an anti-retroviral drug designed specially for them. Triomune Baby and Junior were developed with funding from the European and Developing Countries Clinical Trials Partnership (EDCTP). The US Food and Drug Administration (FDA) recently gave its tentative approval for the drug, paving the way for it to receive prequalification status from the World Health Organisation (WHO) and making it available for distribution under the President's Emergency Plan for AIDS Relief (PEPFAR) and Clinton Foundation programmes. 'The countries of the world that depend on the WHO Prequalification Programme to help them purchase quality products have benefited immensely by this cooperation between HHS [US Department of Health and Human Services)/FDA and the WHO,' said Dr Howard Zucker, WHO Assistant Director-General for Health and Pharmaceuticals. 'Assuring the quality of products like this one made especially for children in developing economies is a major cornerstone of our battle against the HIV epidemic and of our effort to help assure children have access to quality medicines.' There is an urgent need for AIDS drugs for children. According to the WHO, there are well over 2 million children living with HIV around the world, 90% of them in Sub-Saharan Africa. Most of them acquired the virus in the womb, during birth or while being breastfed. Without treatment, the outlook for these youngsters is bleak; just under a third of children who acquire HIV from their mothers do not live to see their first birthday, and 80% will die by the age of five. Currently there are few HIV drugs formulated specifically for children, so many children are simply given half doses of adult tablets. This often leads to incorrect dosing, and especially under dosing, which increases the risk of the virus developing resistance to the drug. This problem is often compounded by malnutrition, as little is known about the effects of malnutrition on drug levels in the body. Syrup formulations of certain drugs have been developed, but these also have a number of drawbacks. They tend to be foul tasting, have to be taken in large volumes, require refrigeration and have a short shelf life once opened. The new drug, which was developed with EDTCP support, gets round these problems. Triomune Baby and Junior bring together in a single pill three drugs which are commonly used to treat HIV, namely stavudine, lamivudine and nevirapine. It is administered twice daily according to a simple weight-based table, to allow for easy prescribing. The drugs are layered to ensure equal distribution of the drugs if the tablets are snapped in half, and the tablets can also be crushed and dissolved in water for children who cannot swallow pills. The pills can be stored and distributed easily. The new drug should make treatment more readily available to HIV positive children in countries with few resources. According to the WHO, treating children with antiretrovirals from birth can reduce mortality five-fold. Triomune Baby and Junior are manufactured by CIPLA Pharmaceuticals.