Target product profiles for tuberculosis preventive treatment
Overview
Background
Tuberculosis (TB) is a major yet preventable global health problem, with an estimated 10 million people developing TB and 1.5 million people dying every year worldwide, making it the leading infectious disease cause of death worldwide. One quarter of the global population is estimated to be infected with Mycobacterium tuberculosis. Treatment of TB infection, also known as TB preventive treatment (TPT), aims to prevent the development of TB disease, and is one of the critical components to achieve the ambitious targets of the WHO End TB Strategy. At the United Nations High-level Meeting on TB in 2018, countries committed to provide TPT to at least 30 million people in 2018-2022.
Although TPT has been available for more than 60 years and in spite of strong evidence of its effectiveness its uptake and scale-up have been slow, mainly due to the limitations of available diagnostic assays and TPT regimens (long duration of treatment, cost, toxicity, adherence issues and operational aspects). The availability of and access to new drugs or regimens that can be administered for a shorter time and with fewer adverse events than the current 6-12 month TB preventive strategies is essential to ensure wider-scale implementation.
Overview
The aim of the target product profiles (TPPs) for TPT is to identify the product attributes to be considered in developing the best, most suitable TB prevention treatments. These TPPs are expected to assist developers in aligning the characteristics of new treatment regimens and developers' performance and operational targets with national requirements. This document describes priority and desirable regimen characteristics and outlines the minimal and optimal levels of acceptable performance for these attributes. In addition, it provides use case scenarios. The document is intended primarily for the pharmaceutical industry, academia, research institutions, product development partnerships, technical agencies, state and nongovernmental bodies, civil society organizations and donors.
