Tuberculosis (TB)

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

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.