Anti-TB drug research and development is focusing increasingly on testing TB drug regimens rather than on individual drugs. The development of Target Regimen Profiles (TRPs) will give guidance to the developers of TB drug regimens and help align the regimens with patients’ and programmatic needs at country level. This approach is expected to lead to the introduction of shorter, less toxic, and operationally feasible treatment regimens. KNCV welcomes this, having been closely involved in the consensus process and engaged in preparing a road map for implementation.
In July 2016, KNCV’s Technical Director Michael Kimerling participated in the consensus meeting in Geneva that outlined the strategic thinking on the future treatment of TB. The outcome of this meeting is summarized in the Report ‘Consensus meeting for finalization of Target Regimen Profiles for TB treatment‘. KNCV has been involved in this consultation process for several years, initially with the participation of Professor Frank Cobelens, at the time Scientific Director of KNCV, and more recently Dr. Michael Kimerling, who focuses on the country adoption and policy-making perspective.
As Dr. Kimerling explains, it is very important that KNCV is involved in this process, both as a significant implementor of TB program innovation and care globally, and in the light of KNCV’s role in research and global policy development:
“The July consensus is a milestone achievement in different ways. Firstly, going forward, the discussion on TB treatment will be on drug regimen development instead of single TB drugs only; and secondly, we now have a mechanism in place that can start the thinking and planning process with relevant stakeholders, including drug developers, under coordination by the World Health Organization.”
Michael Kimerling: “We have defined three proposed target regimen profiles: one TRP for the treatment of drug-susceptible TB, one TRP for drug-resistant (rifampicin-resistant) TB, and thirdly, we have defined a TRP, called the pan-TB TRP, that will prepare a universal regimen for all new TB, drug-susceptible as well as drug-resistant TB. This will be the ideal drug regimen.”
KNCV is not itself involved in the testing of the drug regimens directly – these are being tested primarily through the TB Alliance and other clinical trials consortia. Instead, KNCV represents the view from the field and the perspective of implementers in terms of what treatment strategies are needed and how best to justify, introduce and adopt these regimens to achieve the best success in implementation.
“As an organization with its primary focus on the treatment of TB, KNCV undertakes to support the thinking process, and to be a voice at the table, thinking downstream from a field or end-user perspective. We are transitioning from questions around traditional drug development and testing to ones of evaluation and operationalization. The Task Force is now engaged in preparing a road map for adoption and implementation. This constitutes an important workstream toward achieving the goals of the END TB strategy.”
Michael Kimerling is enthusiastic about this development “because we are now thinking in terms of regimens and the challenges associated with this instead of single drug introduction. I am glad we are looking at TB treatment issues from the perspective of what is needed at the program level instead of from the viewpoint of the drug development cycle alone. I’m excited because the discussion is really about what countries need to be able to tackle their own epidemic rather than about what industry is producing, drug by drug.”