Priority setting for research on HIV/AIDS

 

WHO conducts regular consultations to assess the pipeline for new medicines and diagnostics and provide guidance on research priorities to ensure that key research questions are answered.

Key research priorities with respect to medicines include ensuring that data on safety and efficacy are generated for populations living with HIV in low- and middle-income countries (LMICs), including pregnant and lactating women, patients receiving co-treatment for common comorbiditites (notably tuberculosis), adolescents and children. 

Examples of outcomes of recent WHO consultations include the following papers:

• What we have learned from antiretroviral treatment optimization efforts over the last 5 years?
• Optimizing switching strategies to simplify antiretroviral therapy: the future of second-line from a public health perspective
• Enhanced and timely investigation of ARVs for use in pregnant women
• Optimizing pharmacology studies in pregnant and lactating women using lessons from HIV: a consensus statement
• Current and future priorities for the development of optimal HIV drugs 
• Prioritising the most needed paediatric antiretroviral formulations: the PADO4 list
• The HIV drug optimization agenda: promoting standards for earlier investigation and approvals of antiretroviral drugs for use in adolescents living with HIV 
• Enhanced and timely investigation of ARVs for use in pregnant women

For diagnostics, research priorities relate to ensuring that diagnostics meet the specifications for use in LMICs, with a particular emphasis on diagnostic integration and point-of-care test technologies that can be used at lower levels of the health system.

In 2017, a global research prioritization process for children and adolescents was conducted by WHO in collaboration with the Collaborative Initiative for Paediatric HIV Education and Research (CIPHER) of the International AIDS Society (IAS). Outcomes of this process are available here:

• A global research agenda for paediatric HIV.  J Int AIDS Soc 2018
• A global research agenda for adolescents living with HIV.  J Int AIDS Soc 2018
  

Progress in the development and introduction of paediatric formulations is poor in LMICs for key infectious diseases, including HIV/AIDS. WHO has supported the development of The Global Accelerator for Paediatric Formulations (GAP-f), which aims to accelerate research, development, regulatory filing, introduction, and uptake of prioritized paediatric antiretrovirals in age-appropriate formulations. For more information see:

• Catalysing the development and introduction of paediatric drug formulations for children living with HIV: a new global collaborative framework for action. Lancet HIV 2018 
• Toolkit for research and development of paediatric antiretroviral drugs and formulations

WHO also supports the establishment of research priorities for implementation science research. In particular, WHO has partnered with an international cohort collaboration – the International Epidemiology Databases to Evaluate AIDS (IeDEA) – to understand progress and challenges in the global response to HIV/AIDS and establish future research priorities.