Innovation to Impact: Right diagnosis – Right treatment

The KNCV New Drugs & Regimens Initiative
The availability of new drugs and regimens, coupled with rapid, highly sensitive and specific molecular tests to detect tuberculosis (TB) and various forms of drug resistant TB (DR-TB), offer the opportunity for early and correct triaging of patients to the least toxic, shortest regimens designed according to local drug resistance patterns. The regimen may need to be further adapted for a small proportion of patients after final drug sensitivity test (DST) results are known.

Introduction of this right diagnosis to right treatment concept is expected to benefit:

  • Patients and their families as patients have better access to effective treatment with the lowest possible level of side effects earlier in their disease process, with better chance for cure and less sequelae, resulting in an overall better quality of life and fewer costs;
  • Health systems as this means shorter diagnostic delay, and on average, less toxic, shorter and possibly cheaper treatments that are easier to administer and result in less attrition of patients during the diagnostic and treatment processes, leading to better success rates;
  • Public health as earlier diagnosis and more effective treatment is likely to result in reduced transmission and reduction in creation of additional drug resistance, eventually yielding a reduction in the overall burden of DR-TB.

Current WHO guidance focuses on the use of new drugs and regimens for specific categories of multidrug-resistant TB (MDR-TB) patients, application of different levels of pharmacovigilance and suggestions for operational research (OR). Further studies are needed to help determine the best possible use of these medicines, in the framework of TB elimination, including use as treatment of latent TB infection (LTBI) or fully oral MDR regimens. This is a matter of urgency, as the potential misuse of these new medicines means that resistance could develop and prematurely close the window of opportunity for the deployment of these new medicines for TB elimination.

The primary aim of the Initiative is to coordinate the timely, locally appropriate programmatic use of new drugs and regimens (ND&R) in KNCV-supported countries, making optimal use of potential synergies for:

  • Implementation and operational research to evaluate and optimize approaches, including supporting mechanisms;
  • Cross-learning among the different KNCV-led and collaborative projects;
  • Training and capacity building.

The second aim of the Initiative is to design and contribute to studying the optimal use of any new drugs and regimens, enabling countries to more rapidly adopt new products in the context of programmatic management of DR-TB.

The Initiative uses standards-driven and evidence-based approaches to ensure close coordination with stakeholders from community to local to global levels. The emphasis is on local and regional capacity building, especially through involvement of regional Green Light Committees (rGLCs) and local technical assistance partners. Evaluation is based on program performance indicators, routine surveillance and OR. The initiative will also provide a link between TB drug resistance and the wider global antimicrobial resistance (AMR) agenda.

The Initiative has focal persons for programmatic approaches, operational research, clinical management, capacity building and networking, data management, drug management, access to rapid diagnostics and private sector engagement.
As of January 2016, the Initiative oversees and supports activities in 24 countries.