Updated on 23 July 2012
The collaboration was signed on the eve of the XIX International AIDS Conference at Washington, DC.
Mumbai: The Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development (R&D) organization, has signed a new collaboration with Indian drug manufacturer Cipla to develop and produce an improved first-line antiretroviral (ARV) combination therapy. The collaboration was signed on the eve of the XIX International AIDS Conference in Washington, DC.
The therapy will be specifically adapted to meet the treatment needs of infants and toddlers living with HIV/AIDS. Once delivered, this new paediatric ARV combination could help to accelerate the provision of care to the world's youngest children living with HIV/AIDS, who are at very high risk of dying without treatment. An estimated 3.4 million children have HIV/AIDS, but less than a quarter currently have access to antiretroviral therapy (ART), compared with 54 percent for adults. Without treatment, more than half of children with HIV/AIDS will die before their second birthday, and 80 percent will die before they turn five.
Current therapeutic options for HIV-positive infants and young children are insufficient in certain key circumstances. Although fixed-dose combination dissolvable ‘baby pills' (for example Triomune Baby and Junior produced by Cipla in 2007) are used throughout most of Africa, they are not optimal for the youngest children who have very high levels of virus in their blood and have already been exposed to some of these drugs from their mother. An important alternative drug (lopinavir-ritonavir protease inhibitor) has been used mainly in South Africa, but has problems, including poor taste, impractical multiple liquid preparations that are cumbersome to transport, requirements for refrigeration, high cost, difficulties for caregivers to administer, and negative interactions with tuberculosis (TB) drugs.
The goal of the collaboration between DNDi and Cipla is to develop a 4-in-1 ARV combination product for HIV-infected children under the age of three years, including those who have been exposed to drugs while in the womb, and also those who are co-infected with TB.
Historically, major pharmaceutical companies have invested little in R&D specifically aimed at addressing the needs of young children with HIV/AIDS largely because of the absence of a viable market: the virtual elimination of mother-to-child transmission of HIV in high-income countries means that nearly all HIV-positive children live in low- and middle-income countries, with over 90% in sub-Saharan Africa. The global strategy to eliminate new infant infections through prevention of mother-to-child transmission (PMTCT) by 2015 will be confronted with the reality that some children continue to be infected and urgently need access to early diagnosis and immediate ART with safe, potent, child-friendly treatment combinations.