The World Health Organization (WHO) has unveiled a new framework to guide the development of long-acting injectable medicines for tuberculosis (TB), with the goal of making prevention and treatment simpler and more convenient for patients.
Announced on October 28, the new target regimen profiles describe the characteristics future injectable TB medicines should have, including how often they should be administered, their effectiveness, safety, storage requirements and affordability.
The move addresses one of the challenges associated with tuberculosis care: patients may need to take medicines regularly for months. Long-acting formulations could potentially reduce the frequency of dosing and make it easier for people to complete their prescribed treatment.
For TB prevention, WHO has set an ambitious optimal target of delivering a complete course of preventive treatment through a single injection during one healthcare visit.
For people being treated for active tuberculosis, the organization wants future injectable regimens to last no more than four months and require no more than three dosing visits.
The proposed medicines should also perform at least as well as existing oral regimens. Other desirable characteristics include small injection volumes and formulations that do not require cold-chain storage, which could make distribution and administration easier in areas with limited health infrastructure.
Dr Tereza Kasaeva, Director of WHO’s Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, said long-acting injectables have the potential to make TB prevention and treatment considerably simpler for people who need them.
Several candidates are already entering or approaching clinical development, but WHO’s announcement does not mean a new injectable TB medicine has been approved for immediate use. The profiles instead provide guidance for researchers, pharmaceutical companies and other developers working on future treatments.
WHO developed the targets with input from clinical trial experts, pharmacologists, regulators, national TB programmes, healthcare providers, civil society representatives and people with lived experience of tuberculosis.
The framework also considers affordability and equitable access. According to WHO, future products should be scalable and reasonably priced so that countries with a high burden of TB are able to use them.
WHO noted that the development of injectable options should not bring research into better oral TB medicines to an end. Maintaining different treatment choices would allow patients and healthcare providers to select appropriate options based on individual needs and preferences.
If candidates currently under development eventually meet the required standards in clinical trials, long-acting injections could offer another approach to reducing the treatment burden associated with one of the world’s major infectious diseases.
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