Target Regimen Profiles for TB Treatment

There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB drug regimens (hereafter referred as Target Regimen Profiles- TRPs) intends to assist drug regimen developers towards important features and align these with patient and programmatic needs at country level. The proposed TRPs, which are based on prioritized characteristics, encompass the needs of end-users, care providers and policy-makers to have shorter, less toxic, and operationally feasible regimens.

The novelty of the TRP approach is to have the goal of a treatment regimen in mind very early in the process of drug development. Based on the idea that TB drug research and development (R&D) is moving towards developing and testing TB regimens rather than individual drugs, a set of targets is needed based on prioritized characteristics and representing the needs of end users. Aimed at the pharmaceutical industry, research institutions, product development partnerships, donors, non-governmental organizations (NGOs) and civil society organizations (CSOs), TRPs align targets and specifications for developers with the view of achieving shorter, less toxic, operationally feasible and cheaper regimens.