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WHO target product profiles for TB preventive treatment

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BACKGROUND: The WHO has developed target product profiles (TPPs) describing the most appropriate qualities for future TPT regimens to assist developers in aligning the characteristics of new treatments with programmatic requirements.

METHODS: A technical consultation group was convened by the WHO to determine regimen attributes with greatest potential impact for patients (i.e., improved risk/benefit profile) and populations (i.e., reduction in transmission and TB prevalence). The group categorised regimen attributes as ‘priority´ or ‘desirable´; and defined for each attribute the minimum requirements and optimal targets.

RESULTS: Nine priority attributes were defined, including efficacy, treatment duration, safety, drug–drug interactions, barrier to emergence of drug resistance, target population, formulation, dosage, frequency and route of administration, stability and shelf life. Regimens meeting optimal targets were characterised, for example, as having superior efficacy, treatment duration of ≤2 weeks, and improved tolerability and safety profile compared with current regimens. The four desirable attributes included regimen cost, safety in special populations, treatment adherence and need for drug susceptibility testing in the index patient.

DISCUSSION: It may be difficult for a single regimen to satisfy all characteristics so regimen developers may have to consider trade-offs. Additional operational aspects may be relevant to the feasibility and public health impact of new TPT regimens.

Keywords: drug treatment; latent TB infection; prevention; research; tuberculosis

Document Type: Research Article

Affiliations: 1: Global Tuberculosis Programme, World Health Organization (WHO), Geneva, Switzerland 2: Unité Mixte Internationale TransVIHMI, Unité mixte internationale 233, Institut de recherche pour le développement, Unité 1175, Université de Montpellier, Institut de Recherche pour le Développement (INSERM), Montpellier, France, Epidemiology and Population Health, Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, UK 3: McGill International Tuberculosis Centre, McGill University, Montréal, QC, Canada 4: MRC Centre for Global Infectious Disease Analysis, Imperial College London, London, UK 5: Department of Infectious Disease Epidemiology, Faculty of Medicine, Imperial College London, London, UK 6: Center for Tuberculosis, University of California, San Francisco, CA, USA 7: Department of Global HIV, Hepatitis and Sexually Transmitted Infections Programmes, WHO, Geneva, Switzerland 8: The Aurum Institute, Johannesburg, South Africa, School of Public Health, University of Witwatersrand, Johannesburg, South Africa 9: Special Programme for Research and Training in Tropical Diseases (TDR), Geneva, Switzerland

Publication date: April 1, 2022

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