Toolkit for research and development of paediatric antiretroviral drugs and formulations

In 2016, an estimated 2.1 million children and 17.8 million women were living with HIV, and yet antiretroviral drug formulations for treating HIV among infants, children, adolescents and pregnant and breastfeeding women remain limited. Although well established legislative and regulatory frameworks support and stimulate the process of developing medicines for children, this process needs to be accelerated to ensure that much-needed antiretroviral formulations are available for children, especially those living in low- and middle-income countries.

This toolkit identifies the challenges and outlines possible solutions for promoting and accelerating timely and high-quality research and development of antiretroviral drug formulations suitable for infants, children, adolescents and pregnant and breastfeeding women. Although this toolkit focuses on HIV medicines, many of the principles outlined here can be applied to treatments for other diseases affecting pregnant women and children.

Contents

Partners:

World Health Organization, International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, PENTA-ID Network, Unitaid, Drugs for Neglected Diseases initiative (DNDi), Clinton Health Access Initiative (CHAI), United Nations Children's Fund (UNICEF), ICAP at Columbia University, Elizabeth Glaser Pediatric AIDS Foundation, Industry Liaison Forum (ILF), President's Emergency Plan for AIDS Relief (PEPFAR), Collaborative Initiative for Paediatric HIV Education and Research (CIPHER), Medicines Patent Pool (MPP).

Editorial team:

The toolkit for research and development of paediatric antiretroviral drugs and formulations was developed under the leadership of the Treatment and care team in the HIV Department, WHO, and supported by the WHO Paediatric Antiretroviral Working Group. The project was led by Martina Penazzato (WHO Paediatric HIV Lead, Geneva, Switzerland) and coordinated by Claire Townsend (WHO consultant, Geneva, Switzerland). Each module was drafted by one or more co-authors (listed in each module), with input from other collaborators and the project team. Designated reviewers reviewed the modules, including at least one member of the Paediatric Antiretroviral Working Group and one external reviewer. Input from representatives of drug manufacturers and regulatory authorities was sought at key stages. For further information please see the main Acknowledgements.

Application developers:

Liam Boggs
Training Manager, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK

Lauren Whelan
Training Assistant, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK

Felicity Baka
Training Assistant, The Global Health Network, Centre for Tropical Medicine & Global Health, University of Oxford, UK