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WHO target product profiles for TB preventive treatment

Title: WHO target product profiles for TB preventive treatment
Authors: Den Boon, S; Lienhardt, C; Zignol, M; Schwartzman, K; Arinaminpathy, N; Campbell, JR; Nahid, P; Penazzato, M; Menzies, D; Vesga, JF; Oxlade, O; Churchyard, G; Merle, CS; Kasaeva, T; Falzon, D
Source: 309 ; 302
Publisher Information: International Union Against Tuberculosis and Lung Disease
Publication Year: 2022
Collection: Imperial College London: Spiral
Description: 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.
Document Type: article in journal/newspaper
Language: English
Relation: International Journal of Tuberculosis and Lung Disease; http://hdl.handle.net/10044/1/112072
DOI: 10.5588/ijtld.21.0667
Availability: http://hdl.handle.net/10044/1/112072; https://doi.org/10.5588/ijtld.21.0667
Rights: This work is licensed under a CC BY 4.0 International license. ; https://creativecommons.org/licenses/by/4.0/
Accession Number: edsbas.B0DE5E1B
Database: BASE