Tuberculosis (TB)

Introduction and rational use of new drugs/regimens for the treatment of tuberculosis in countries

TB treatment and care

Background

A patient is taking tuberculosis medicines, Russia
WHO

Much progress has been made in research and development of new drugs for TB over the last decade. A series of Phase II and III trials of shortened treatment of drug-sensitive TB including repurposed drugs (eg. fluoroquinolones) or new dosages of known drugs (eg. rifamycin, rifapentine) are presently on-going, with earliest results expected in 2013. Two novel drugs are being evaluated in Phase IIb and III trials for the treatment of multi-drug resistant (MDR) TB, and dossiers have been submitted to regulatory authorities for authorization of licensure. Lastly, novel drug combinations for shortened treatment of drug-sensitive (DS) and/or drug-resistant (DR) TB, including new or re-purposed drugs, are under investigation.

The likely introduction of new drugs or drug regimens for the treatment of DS- or DR-TB will have a series of public health implications, particularly regarding:

  • the responsible use of new drugs as part of set combination regimens for the treatment of DS- and/or DR-TB;
  • the programmatic feasibility and cost-effectiveness of newly-developed treatments;
  • the capacity to monitor scaled-up use of new drugs, and conduct surveillance of drug-resistance;
  • the prevention of emergence of new drug resistance.

In this context, the WHO Strategic and Technical Advisory Group on Tuberculosis (STAG-TB) endorsed in June 2012 a plan to develop necessary updates in policy guidance for the treatment of TB, once results of drug trials become available or drugs are being granted license for market access by regulatory authorities, and foster the optimal uptake and rational use of new TB drugs within defined regimens in programmatic conditions.

A new era in TB treatment

The landscape of drug development for treatment of tuberculosis (TB) has evolved dramatically over the last ten years. A series of Phase II and III trials of shortened treatment of drug-susceptible (DS) TB including repurposed drugs (e.g. fluoroquinolones) or new dosages of known drugs (e.g. rifamycin, rifapentine) are presently on-going, with earliest results expected in 2013/14. For the first time in nearly 50 years, two new molecular entities proposed for the treatment of Multi-Drug Resistant (MDR) TB are currently making their way through the regulatory pathway in the EU and the US. These two novel drugs are presently in Phase IIb and III trials for the treatment of multidrug-resistant MDR-TB and dossiers have been submitted for registration by these regulatory authorities. Therefore, regulators in other countries will soon face the decision whether to approve these drugs for treatment of pulmonary MDR-TB. Additionally, other new compounds and novel combinations of drugs are being investigated for the treatment of DS and/or MDR/XDR-TB. Treatment shortening regimens as well as substitution compounds for existing regimens are being investigated.

In this context, the WHO Strategic and Technical Advisory Group on Tuberculosis (STAG-TB) endorsed in June 2012 a plan to develop necessary policy guidance for the introduction and use of new TB drugs within recommended regimens. The plan also calls for WHO to support the optimal uptake of new TB drugs/regimens, once results of drug trials become available and drugs are granted license for market access by regulatory authorities, and foster the optimal uptake and rational use of new TB drugs within defined regimens in programmatic conditions.

Task Force for New Drug Policy Development

Following a WHO Expert Meeting organized in June 2011 in Geneva to examine the potential implications and consequences of the introduction of new or repurposed drugs for the treatment of DS and MDR-TB in the market, and the subsequent recommendations from the WHO Strategic and Technical Advisory Group on Tuberculosis (STAG-TB), a plan has been set-up to develop new policy recommendations for the treatment of TB taking into account recent advances in drug development, and prepare for optimal uptake of new TB drugs in programmatic conditions. Subsequent to this, a Task Force for new drug policy development was established to advise and contribute to the development of a strategic plan and monitor completion of activities listed in the plan.

A first meeting of the Task Force took place in April 2012 in Geneva with the objective of outlining an overall strategic plan describing the detail of activities to be carried out for the development of new guidance for TB treatment of TB, with clear indication of timelines and expected outputs.

The second Meeting of the Task Force was organized to finalize information notes and prepare the policy development framework that will help guide the roll-out of new drugs/regimens for TB treatment.