On 7 April 2014, the Director-General: Health, Ms P Matsoso and the Executive Director: DNDi, Dr Bernard Pécoul, signed a Partnership Agreement on Improving Access to Paediatric HIV Treatment in South Africa. DNDi’s paediatric HIV project, in partnership with Cipla Ltd., and with the support of the UNITAID, in addition to the French Development Agency (AFD), Médecins Sans Frontières/Doctors Without Borders (MSF), and the UBS Optimus Foundation, is to develop two 4-in-1 lopinavir-based fixed dose combinations as well as a solid formulation of ritonavir booster that are suitable for young children infected with HIV, as well as with tuberculosis and HIV. These formulations, ultimately, will be in solid ‘granular’ form that is palatable and requires no refrigeration, alleviating much of the current treatment burden on the children, their mothers and caregivers, and healthcare workers.
Despite huge progress worldwide over the past ten years in the fight for wider access to antiretroviral therapy (ART), children have often been left behind. An estimated 3.4 million children live with HIV, but only about a third of them, at best, have access to treatment. There is an urgent need to ensure the scale up of treatment without delay and the research and development of new, more adapted treatments recommended by the World Health Organization. However, because there is little incentive for companies to develop formulations for these children, this field of research requires strong public leadership and innovative models for drug development.
The Partnership Agreement specifically aims to ensure that clinical studies can begin rapidly to prepare a transition from the current alcohol-based liquid formulation to new formulations. This would indeed provide the evidence necessary to ensure rapid approval, introduction, and accessibility of treatment for infants and young children with HIV in South Africa and beyond.
The agreement was signed during a workshop on ‘Improving Access to Paediatric HIV Treatment in South Africa’, which brought together government representatives, experts, and international organizations, to raise awareness of the problems with treating HIV in children with current treatments (formulations, access, IP and regulatory barriers), and to discuss mechanisms on how to accelerate development and delivery of new treatments.