Daijiworld Media Network - USA
USA, Oct 29: The World Health Organization (WHO) has released new target regimen profiles to guide the development of long-acting injectable medicines for tuberculosis (TB) prevention and treatment, aiming to reduce the burden of prolonged daily medication and make care more convenient and accessible.
TB prevention and treatment often require patients to take oral medicines every day for several months. Maintaining adherence throughout these lengthy regimens can be challenging for patients and healthcare systems. Long-acting injectable medicines could offer an alternative by reducing the frequency of medication administration.
The newly released target regimen profiles outline the essential and optimal characteristics that future injectable treatments should meet to ensure safety, effectiveness and practical delivery.
The guidelines are intended to support pharmaceutical companies, academic researchers, product developers, civil society organisations, donors and communities affected by TB. They establish minimum requirements for products worth pursuing, alongside optimal targets that reflect desirable and realistically achievable outcomes.
For TB preventive treatment, WHO aims for a complete course to be delivered through a single injection during one healthcare visit. For active TB disease, the target is a treatment regimen lasting no more than four months, with three or fewer dosing encounters.
The profiles also emphasise practical administration. Trained healthcare workers should be able to administer the injections at the lowest feasible level of the health system. The medicines should require small injection volumes and no cold-chain storage, while demonstrating efficacy and safety at least comparable to existing oral treatments.
The guidance also addresses clinical trial design, treatment burden, scalability, equitable access, transparent pricing and affordability.
The profiles were developed by a WHO-convened Scientific Target Regimen Profile Development Group comprising clinical trial specialists, pharmacologists, regulators, national TB programme representatives, people with lived experience of TB and civil society organisations.
The group's work drew on a landscape analysis, public consultations, surveys of communities and healthcare providers, focus group discussions and a multicountry discrete choice experiment.
While long-acting injectables could offer significant improvements in TB care, WHO stressed that research into better oral treatments must continue. Future treatment services should respect individual preferences and ensure that people who do not want injections can access suitable alternatives.
The new profiles provide a framework for developing more convenient TB prevention and treatment options while keeping safety, effectiveness, affordability and patient choice at the centre of future innovation.