Pre-Approval Access to Novel Compounds is an Urgent Priority to Treat People with Strains of Tuberculosis that are Resistant to Bedaquiline, Linezolid, Clofazimine, and/or the Nitroimidazoles

People with extensively drug-resistant tuberculosis (XDR-TB) and others with expanded drug resistance have few options and face long, difficult treatment with older, less-effective, and more toxic drugs. In response to this emergency, front-line clinical providers, civil society organizations, and impacted community members have come together under the banner of the BETTER (Building Expertise Treating TB with Expanded Resistance) Project to develop a best practice field guide to inform treatment and care for people who have TB with expanded resistance.

If left with only commercially available drugs, people with expanded resistance may endure many months and even years of toxic, infective treatment before they are finally sent home to die. This is unacceptable—especially at a time when there are novel compounds with promising phase 2b safety and efficacy data. A growing consensus of experts, including affected community members, argue that these novel drugs should be made available through compassionate use mechanisms for people with limited options for survival. [1]

Time is running out for people with XDR-TB and other expanded resistance. They need access to treatment regimens which may require one or more investigational drugs informed by the best available, albeit incomplete evidence. There is an ethical, as well as public health imperative to make treatment options like these available through a robust informed consent process including shared decision making to people whose only other option is near certain death. The BETTER Project Statement provides principles for equitable, ethical pre-approval access/compassionate use which is a necessary tool for combating DR-TB.

Access the statement: Pre-Approval Access to Novel Compounds is an Urgent Priority to Treat People with Strains of Tuberculosis that are Resistant to Bedaquiline, Linezolid, Clofazimine, and/or the Nitroimidazoles