Target regimen profiles for long-acting injectables for tuberculosis prevention and treatment

Overview

Long-acting injectables (LAIs) could shift the burden of adherence from people taking tuberculosis (TB) medicines to the health system that delivers them, and several LAI candidates for TB are now entering or approaching clinical development. This document sets out WHO target regimen profiles (TRPs) for LAIs for TB preventive treatment and for the treatment of TB disease. For each characteristic it defines a minimal requirement, which a product must meet to be worth pursuing, and an optimal requirement, the most desirable yet realistically achievable target.

The profile for TB preventive treatment aims at a full course given as a single injection at one encounter. The profile for TB disease aims at a regimen of no more than 4 months, given in three or fewer dosing encounters. Both call for injections given at the lowest feasible level of the health system, small injection volumes, no cold chain, and efficacy and safety at least as good as those of current oral regimens. The document also sets out the trade-offs between characteristics and addresses trial design, overall treatment burden, scalability, equitable access, transparent pricing and cost. The profiles were developed by a Scientific TRP Development Group, informed by a landscape analysis, public consultation, and community and provider surveys, focus groups and a discrete choice experiment. They are intended for the pharmaceutical industry, academia, research institutions, product development partners, TB-affected communities, civil society organizations and donors.