WHO target product profiles for TB preventive treatment

Area of Science:

• Public Health
• Infectious Disease Research
• Pharmaceutical Development

Background:

• The World Health Organization (WHO) established Target Product Profiles (TPPs) for tuberculosis preventive therapy (TPT) regimens.
• TPPs guide developers in creating new treatments that align with public health needs and programmatic requirements.

Purpose of the Study:

• To determine key attributes for future TPT regimens with the greatest impact on patients and populations.
• To define minimum requirements and optimal targets for these attributes.

Main Methods:

• A WHO technical consultation group convened to identify and categorize regimen attributes.
• Attributes were classified as 'priority' or 'desirable' based on potential impact.

Main Results:

• Nine priority attributes were defined: efficacy, duration (≤2 weeks optimal), safety, drug interactions, resistance barrier, target population, formulation, dosage, frequency, route, stability, and shelf life.
• Four desirable attributes were identified: cost, safety in special populations, adherence, and need for drug susceptibility testing.
• Optimal regimens offer superior efficacy, shorter duration, and better tolerability than current options.

Conclusions:

• Developing a single TPT regimen that meets all ideal characteristics may require trade-offs.
• Operational feasibility and public health impact are crucial considerations for new TPT regimens.