The Drugs for Neglected Diseases initiative (DNDi) has launched a new product development programme to address the unmet needs of children with HIV/AIDS.

The DNDi effort was announced at the 6th International AIDS Society (IAS) Conference on HIV Pathogenesis, Treatment and Prevention in Rome, Italy. The Geneva-based not-for-profit will work with partners to develop an affordable first-line paediatric HIV therapy that is easy to administer, better tolerated by children than current drugs, heat-stable, easily dispersible, and dosed once daily or less frequently.

The formulation envisaged must also carry minimal risk of developing resistance, be compatible with drugs for tuberculosis (TB), and be suitable for infants and very young children, with minimum requirements for weight adjustment, DNi noted. Its first priority will be an improved first-line protease inhibitor-based regimen for children under three years of age, irrespective of prior exposure to antiretroviral drugs.

This reflects the consensus reached after in-depth needs assessment and consultation with HIV/AIDS experts, including contributions from endemic countries such as South Africa, Uganda, Cote d’Ivoire and Thailand, as well as from public-sector research institutions like the US National Institutes of Health, the UK’s Medical Research Council and the Agence Nationale de Recherche sur le Sida in France.

Needs overlooked

According to DNDi executive director Dr Bernard Pécoul, there are “millions” of children with HIV/AIDS in low- and middle-income countries whose needs are overlooked in research and development strategies, “ largely because they are poor and voiceless and do not represent a lucrative market”.

Since HIV transmission in young children has to a great extent been eliminated in high-income countries due to effective prevention of mother-to-child transmission, there is little market incentive for pharmaceutical companies to develop antiretroviral (ARV) drugs adapted for children, DNDi said.

The World Health Organization (WHO) recommends immediate antiretroviral therapy for all HIV-positive children under two years of age, but “the safety and correct dosing of key ARVs have not been established in very young children, and appropriate child-adapted formulations do not exist”, DNDi added.

Currently available paediatric ARV formulations are unpalatable for these children and impractical for caregivers, as they consist of multiple liquid preparations that have to be adjusted according to weight, it noted. A further complication is undesirable interactions with drugs for TB.

Dr. Gottfried Hirnschall, director of the WHO’s HIV/AIDS Department said only 28% of children in need of HIV treatment were receiving it at the end of 2009.

DNDi’s paediatric HIV programme will be led by Dr Marc Lallemant, former head of the Programs for HIV Prevention and Treatment (PHPT), a clinical research consortium between Chiang Mai University in Thailand, Harvard School of Public Health in the US and France’s Institut de Recherche pour le Développement.