Recap of the 4th UNITE4TB webinar: Debate on rolling out of new drugs without diagnostic capacity

The speakers for the session were Dr. Daniela Cirillo (Head of the Emerging Bacterial Pathogen Research unit at the San Raffaele Scientific Institute in Milan, Italy) and Dr. Richard Menzies (Director of the McGill World Health Organization (WHO) Collaborating Centre in TB Research at McGill University in Montreal, Canada).

Dr. Cirillo provided an update on the WHO’s guidelines for a 4-month treatment regimen for drug-susceptible TB and a 6-month BPaLM[1] regimen for multidrug-resistant TB (MDR-TB). She noted that fast access to new regimens to improve outcomes and save lives has been prioritized over the appliance of companion diagnostics and that resistance to bedaquiline (used to treat MDR-TB) has been detected and reported with increasing numbers during recent years. Dr. Cirillo raised concerns about the emergence of resistant strains to novel drugs and emphasized the need for companion diagnostics, at least for surveillance, to be implemented when rolling out new regimens. 

In his presentation, Dr. Menzies reviewed the evidence that new regimens are strongly associated with better outcomes and significantly reduce mortality. He showed that the programmatic rollout of bedaquiline in South Africa, where drug susceptibility testing for the drug is not available, has shown substantial improvement in treatment outcomes. He argued that using the most effective regimen immediately saves lives and should not be delayed.

Discussion

The presentations were followed by a debate chaired by Prof. Dr. Raquel Duarte of the Instituto de Saúde Pública da Universidade do Porto (ISPUP) and Prof. Dr. Christoph Lange of the Research Center Borstel – both partners of UNITE4TB. They were joined by three members of the UNITE4TB Young Investigators Group: Dr. Van Le Hong (Oxford University Clinical Research Unit), Dr. Ilze Petermane (Riga East Clinical University Hospital Centre of Tuberculosis and Lung Diseases), and Dr. Tara Ness (Baylor College of Medicine/Texas Children Hospital).

During the debate, Dr. Cirillo stressed that we do not need to prevent access to new drugs but emphasized that a big effort is needed to develop diagnostic tools, conduct surveillance, and implement tests in as many areas as possible. She also noted that it should be the responsibility of drug developers to foster companion diagnostics. Rounding off the discussion, Dr. Menzies added that data from surveillance and cohort studies are needed to track the emergence of resistance.

The webinar was organized by UNITE4TB project partners, ISPUP, and the European Respiratory Society (ERS).

View the webinar recording on the ERS website.

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[1] A combination of bedaquiline, pretomanid, linezolid and moxifloxacin