Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities

Post Date:

2019-07-15

Publication:

Lancet HIV

Summary:

Antiretroviral agents with long-acting properties have potential to improve treatment outcomes substantially for people living with HIV. In November 2017, the Long acting/Extended Release Antiretroviral Resource Program (LEAP) convened a workshop with the aim of shaping the research agenda and promoting early development of long-acting or extended release products for key populations: pregnant and lactating women, children aged up to 10 years, and adolescents aged 10–19 years. Goals included strategies and principles to ensure that the needs of children, adolescents, and pregnant and lactating women are considered when developing long-acting formulations. Research should focus not only on how best to transition long-acting products to these populations, but also on early engagement across sectors and among stakeholders. A parallel rather than sequential approach is needed when establishing adult, adolescent, and paediatric clinical trials and seeking regulatory approval. Pregnant and lactating women should be included in adult clinical trials. Adolescent-friendly trial design is needed to improve recruitment and retention of young people.

Citation:

Nachman S, Townsend CL, Abrams EJ, Archary M, Capparelli E, Clayden P, Lockman S, Jean-Philippe P, Mayer K, Mirochnick M, McKenzie-White J, Struble K, Watts H, Flexner C. Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities. Lancet HIV. 2019 Aug;6(8):e552-e558. doi: 10.1016/S2352-3018(19)30147-X. PMID 31307946.

Collaborators:

Health Sciences Center, SUNY Stony Brook, Pediatrics, New York, NY, USA
ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA
Vagelos College of Physicians & Surgeons, Columbia University, New York, NY, USA
University of Kwa Zulu Natal, Durban, South Africa
Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, CA, USA
HIV i-Base, London, UK
Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana
Department of Immunology and Infectious Diseases, Harvard TH Chan School of Public Health, Boston, MA, USA
Harvard Medical School, Boston, MA, USA
Division of Infectious Diseases, Brigham and Women’s Hospital, Boston, MA, USA
Maternal Adolescent Pediatric Research Branch, DAIDS/NIAID/NIH, Rockville, MD, USA
School of Medicine, Harvard University, Cambridge, MA, USA
Boston University School of Medicine, Boston, MA, USA
Food and Drug Administration, Silver Spring, MD, USA
Office of the Global AIDS Coordinator and Health Diplomacy, Washington, DC, USA