WHO target product profiles for TB preventive treatment
File(s)
Author(s)
Type
Journal Article
Abstract
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.
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.
Date Issued
2022-04-01
Date Acceptance
2022-04-01
Citation
International Journal of Tuberculosis and Lung Disease, 2022, 26 (4), pp.302-309
ISSN
1027-3719
Publisher
International Union Against Tuberculosis and Lung Disease
Start Page
302
End Page
309
Journal / Book Title
International Journal of Tuberculosis and Lung Disease
Volume
26
Issue
4
Copyright Statement
This work is licensed under a CC BY 4.0 International license.
License URL
Identifier
https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000830898300004&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=a2bf6146997ec60c407a63945d4e92bb
Subjects
drug treatment
Infectious Diseases
latent TB infection
LATENT TUBERCULOSIS INFECTION
Life Sciences & Biomedicine
prevention
research
Respiratory System
RIFAMPIN
Science & Technology
THERAPY
tuberculosis
Publication Status
Published
Date Publish Online
2022-04-01