New tuberculosis (TB) drugs (bedaquiline and delamanid) and shorter treatment regimens for drug-resistant TB have in recent years been recommended by the World Health Organization (WHO).
In combination with the use of new, rapid and more accurate diagnostic tests for TB, it is now possible to quickly determine and prescribe the most appropriate TB treatment for each individual patient (“Right diagnosis, right treatment”). This offers new hope to hundreds of thousands of multidrug-resistant TB patients who can now benefit from a test that quickly identifies eligibility for the shorter treatment regimen, and who can then complete treatment in half the time and at nearly half the cost. Until recently, these patients would have had to follow a treatment of almost two years, with a toxic combination of older drugs.
However, the new drugs are not yet widely available. To help accelerate their availability, KNCV Tuberculosis Foundation has created the “New Drugs and Regimens Initiative”. KNCV is closely involved in introducing the new drugs, particularly bedaquiline, and in applying the WHO guidelines for the use of shorter TB regimen for patients with drug-resistant TB. In addition, KNCV supports the sustainable implementation of the newer and rapid TB diagnostic tests for the timely diagnosis of drug-resistant TB and determination of drug-resistance patterns.
Right Diagnosis, Right Treatment
With early and correct triaging* of patients using these new diagnostic tests, drugs and regimens, we can now offer drug-resistant TB patients the least toxic, shortest drug regimens, or a regimen tailored to their needs, applying what is known about local TB drug resistance patterns and their own previous drug treatment.
The concept of “Right Diagnosis, Right Treatment” has great benefits at all levels:
- To patients with drug-resistant TB, who will have better access to effective treatment with lowest possible level of side effects and provided earlier in their disease. In addition, this should result in reduced cost of treatment and an improved quality of life for the patients and their families.
- To health systems, as this means that patients are diagnosed earlier, and on average need less toxic, shorter and less costly treatments that are also easier to administer. As a result, more patients should complete the treatment, leading to overall better rates of treatment success;
- To overall public health, as earlier diagnosis and more effective treatment reduce the risk of TB disease transmission and prevent the development of additional drug resistance. This will eventually reverse the growing burden of drug-resistant TB in a country.
KNCV’s New Drugs and Regimens Initiative
The primary aim of KNCV’s New Drugs and Regimens Initiative is to coordinate and lead the timely, locally appropriate and programmatic use of new drugs and treatment regimens in countries supported by KNCV. KNCV’s involvement is in the areas of programmatic implementation, strengthening existing services and scaling up the use of the new drugs and regimens, research, evaluation, cross-learning, and capacity building.
As trials with the new drugs are still ongoing, these drugs are not yet part of the standard WHO-recommended core regimen for patients with drug-resistant TB who do not qualify for a shorter treatment regimen. However, KNCV supports that, under specific conditions, patients who are not eligible for a shorter regimen should qualify for treatment tailored to the individual patient, which includes the new drugs.
Reporting side effects
KNCV helps countries prepare to introduce the new drugs and shorter regimens, and also the required pharmacovigilance* systems that ensure the timely diagnosis, management and reporting of side effects of new drugs to assess their safety.
KNCV’s role in implementation science is also important. Experience of programmatic introduction of these new drugs and regimens is urgently needed to help determine the best possible use of the drugs and regimens, especially as their potential misuse could lead to the development of further drug resistance. After waiting for 40 years for the development of new TB drugs, this would be a severe setback and would further delay the ultimate goal of eliminating TB. In helping countries to plan for the introduction of these new drugs and regimens, KNCV also enables countries to learn how to rapidly adopt new products and approaches not just for the programmatic management of drug-resistant TB, but more widely for TB care and control.
Support to countries
KNCV has developed an implementation plan for the introduction of new drugs and regimens within the framework of the Challenge TB Project. This plan guides countries step-wise through the process of programmatic introduction of new drugs and regimens. It defines key activities leading to national scale-up of the new drugs and regimens. These include: political engagement, adaptation of national strategy and policies, preparation of sites, enrolment of patients, and programmatic monitoring and evaluation. This systematic approach will assist countries to assess their state of readiness, to identify and fill gaps, and to monitor the progress of introducing the new drugs and regimens.
Under the New Drugs and Regimens Initiative, KNCV coordinates closely with stakeholders at all levels from the community, to the local, and to the global level. KNCV emphasizes the building of local and regional capacity, especially through the involvement of the regional Green Light Committees and local technical assistance partners.
Under the Initiative, KNCV works via focal persons who are placed at the country, regional and global level. These focal persons are responsible for programmatic approaches, operational research, clinical management, capacity building and networking, data management, drug management, access to rapid diagnostics and private sector engagement.
In 2016, the New Drugs and Regimens Initiative is overseeing and supporting activities in 22 countries and 1 regional project.
* Patient triage is the process of rapidly determining the best treatment for patients based on their specific needs as compared to the anticipated benefit they will receive from such care.
• * Pharmacovigilance is defined as the science and activities relating to detecting, assessing, understanding and preventing the adverse effects of pharmaceutical drugs, or any other drug-related problem.