TPP: For tuberculosis preventive treatment

Indication

Minimum/Acceptable: The regimen is indicated for the treatment of tuberculosis (TB) infection to prevent development of TB disease in at-risk individuals as defined in current WHO guidelines. Preferred/Optimal/Ideal: The regimen is indicated for the treatment of TB infection to prevent development of TB disease in all individuals recognized as being at risk of TB disease, regardless of the drug susceptibility profile of the harboured bacilli population.

Target population

Minimum/Acceptable: Populations with established high risk of progression to TB disease, e.g. HIV-infected adults, adolescents and children aged >=12 months (with unknown or a positive tuberculin skin test) regardless of ART use; HIV-negative children aged < 5 years who are household contacts of people with bacteriologically confirmed pulmonary TB; patients with immunosuppressive conditions such as initiation of anti-TNF treatment, chronic renal failure treated with dialysis, preparation for organ or haematological transplant and silicosis. In all these situations, TB disease is formally ruled out. Preferred/Optimal/Ideal: All individuals in all age groups at risk of TB disease, irrespective of HIV status, whether living in countries with high, medium or low TB incidence, regardless of the drug susceptibility profile of the harboured bacilli population, in whom TB disease has been formally ruled out.

Efficacy

Minimum/Acceptable: A regimen with efficacy not inferior to the current standard of care for treatment of TB infection (e.g. 6H or 3HP). Preferred/Optimal/Ideal: A regimen with efficacy superior to the current standard of care regimen for treatment of TB infection, leading to lifetime protection in areas of low risk of re-infection.

Safety

Minimum/Acceptable:: Safety: Incidence and severity of adverse events better than the current standard of care treatment. Requirement of no more than monthly clinical monitoring and no laboratory monitoring for drug toxicity necessary, except for special populations (e.g. pre-existing kidney or liver disease, diabetes). The target product should not require any additional medication to allay toxicity (e.g. pyridoxine in IPT). Tolerability: The frequency of adverse events leading to treatment cessation should be no worse than with current paired isoniazid and rifamycin regimens (e.g., 3HP, 3HR, 1HP). Preferred/Optimal/Ideal:: Safety: Incidence and severity of adverse events better than the current safest treatment. No requirement for active clinical monitoring or for laboratory monitoring for drug toxicity and preferably no requirement for additional monitoring or encounters for special populations (e.g. pre-existing liver disease, diabetes). The target product should not require any additional medication to allay toxicity (e.g. pyridoxine in IPT). Tolerability: No adverse events leading to treatment cessation.

URL

https://www.who.int/publications/i/item/target-product-profiles-for-tuberculosis-preventive-treatment

Product type

Drug

Status

Active

Safety

Formulation/presentation:: Minimum/Acceptable: Formulation to be oral, with a daily intake as a maximum for all drugs in the regimen, including paediatric forms (dispersible, scored tablets, palatability). If long-acting formulation: injection with or without oral lead-in no more than once a month. Single dissolvable implant for complete course of therapy. Preferred/Optimal/Ideal: Formulation to be oral, without a requirement for weight adjustment, including paediatric forms (dispersible, scored tablets). Ideally, a single pill per day or week for the duration of treatment (depending on daily or weekly formulation). No specific food requirements. Single injection of long-acting formulation without oral lead-in to be given once or twice or a single dissolvable implant with long-lasting protection. Dose regimen:: Minimum/Acceptable: See Formulation/presentation. Preferred/Optimal/Ideal: See Formulation/presentation. Route of administration:: Minimum/Acceptable: See Formulation/presentation. Preferred/Optimal/Ideal: See Formulation/presentation. Duration of treatment:: Minimum/Acceptable: <3 months. Preferred/Optimal/Ideal:<=2 weeks. Stability and storage:: Minimum/Acceptable: For oral regimen, stable to heat, humidity and light, with a shelf life for all drugs >= 2 years. No cold chain required. For injectable, stable in all climate zones. If cold chain required, to be compatible with current vaccine cold chain requirements (2–8 °C). Preferred/Optimal/Ideal: For oral regimen, stable to heat, humidity and light, with a shelf life for all drugs>= 5 years. No cold chain required. For injectable, stable in all climate zones, and no cold chain required.

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