One of the Stop TB Partnership’s seven Working Groups, the Working Group on New Drugs (WGND) is a network of experts committed to accelerating the development of effective and affordable new therapies for TB. The WGND acts as a forum to facilitate global collaborations and joint projects for the development of new TB drugs and promotes coordination of all stakeholders in this process.
The mission of the Working Group on New TB Drugs is to accelerate the discovery and development of new drugs for the treatment of tuberculosis by bringing together the stakeholders in TB Drug Development, including the patients themselves.
In response to the call to action urging global health actors and the TB community to form a consortium with the objective of meeting time-bound, concrete targets for scaling up use of new drugs in treatment for drug-resistant TB (DR-TB), World Health Organization (WHO) put the proposal on the agenda for the Global Drug-resistant TB Initiative (GDI) meeting in April, which was the catalyst to set up the DR-TB Scale-Up Treatment Action Team (DR-TB STAT) consisting of key global TB organizations, including civil society representatives. DR-TB STAT is now a task force within the Global Drug-Resistant TB Initiative (GDI), and its targets remain the same as outlined in the call to action, including:
- Quickstart access to new drugs – Ensure at least 500 patients are started on regimens that include bedaquiline by July 2015, and at least 500 patients are started on regimens that include delamanid by January 2016 as a way of demonstrating tangible commitment to getting drugs to patients as larger scale-up efforts are planned.
- Optimize DR-TB treatment – Provide technical assistance for implementation plans for the top 25 endemic countries by 2016, ensure the two new TB drugs are part of routine treatment in 20 countries by the end of 2016 and 52 countries by the end of 2019 and ensure that key re-purposed drugs are in use by the national TB programs.
- Prioritize regulatory approvals – Ensure that the two new drugs have been filed for registration in 25 countries by the beginning of 2016 and 52 countries by 2017, and that the drugs are registered for use, or import waivers are in place, by 2016.
The Critical Path to TB Drug Regimens (CPTR) initiative aims to speed the development and impact of new and markedly improved drug regimens and rapid drug-susceptibility tests for tuberculosis. Co-founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the TB Alliance, CPTR is a collaboration of leading international pharmaceutical and diagnostic companies, public health experts, civil society organizations, and regulatory authorities from around the world.
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.
This guide is for people who have tuberculosis (TB), people who are at risk for it, and the people who take care of them. It explains what global standards are for TB prevention, treatment, and care, so you can know what services you have the right to receive.
This 2018 Pipeline Report is Treatment Action Group’s annual review of therapeutics, diagnostics, vaccines, and preventive technologies in development for HIV, hepatitis C virus (HCV), and tuberculosis, along with immune-based and gene therapies and research toward a cure for HIV.
This guide—updated from the original version put out by Treatment Action Group in 2013—summarizes updated efficacy, safety, and access information about bedaquiline, an essential medication in the treatment of multidrug-resistant TB (MDR-TB). We wrote this guide to provide information about bedaquiline and its important role in MDR-TB treatment to people with MDR-TB, their caregivers, and their advocates so they can make informed choices and call for bedaquiline to be available, accessible, and affordable for all who need it.
Bedaquiline is now recommended as a core part of drug-resistant TB treatment, but price is a major concern to ensuring all who need treatment with bedaquiline receive it. The public has made significant investments in the development and introduction of bedaquiline, which should be reflected in the price of bedaquiline.
TAG’s “Reality Check” (document linked above) outlines the public’s investments in the development of bedaquiline and the publicly supported incentives from which Janssen, the drug’s sponsor and a subsidiary of Johnson & Johnson, has benefited. The “Reality Check” also dispels myths that have been circulated among members of the global TB community and used to justify pricing bedaquiline out of the reach of TB programs and patients.
This guide provides a brief summary of safety and efficacy data for those drugs currently in use for TB (some of which have been approved for other diseases but are used off-label for TB), and suggests advocacy points for activists. Available in Russian, English and Spanish.
An Activist’s Guide to Tuberculosis Diagnostic Tools provides an overview of the different tests and strategies for detecting TB, including their benefits and limitations. The guide also makes recommendations for how activists and clinicians can contribute to improved TB diagnosis. Available in Russian, English and Spanish.