'Those who cannot remember the past are condemned to repeat it': Drug-susceptibility testing for bedaquiline and delamanid

International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases
Claudio U KöserKatharina Kranzer

Abstract

Despite being fundamental to all treatment decisions, the breakpoints that define susceptibility and resistance to conventional anti-tuberculosis (TB) drugs were traditionally defined based on expert opinion as opposed to modern microbiological principles. As a result, the breakpoints for several key drugs (i.e. amikacin, levofloxacin, and moxifloxacin) were too high, resulting in the systematic misclassification of a proportion of resistant strains as susceptible. Moreover, a recent systematic review of clinical outcome data prompted the World Health Organization (WHO) to make significant changes to its treatment guidelines. For example, capreomycin and kanamycin are no longer recommended for TB treatment because their use correlates with worse clinical outcomes. This history notwithstanding, robust breakpoints still do not exist for bedaquiline and delamanid six years after their approval. This was compounded by the fact that access to both agents for drug-susceptibility testing had initially been restricted. It is incumbent upon the European Medicines Agency, the United States Food and Drug Administration, and WHO to ensure that drug developers generate the necessary data to set breakpoints as a prerequisite for the approval...Continue Reading

Citations

Jul 3, 2019·Antimicrobial Agents and Chemotherapy·Arash GhodousiDaniela Maria Cirillo
Dec 10, 2019·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Emily A KendallClaudia M Denkinger
Feb 14, 2020·American Journal of Respiratory and Critical Care Medicine·Sönke AndresFlorian P Maurer
Jun 24, 2020·Antimicrobial Agents and Chemotherapy·Claudio U KöserPaolo Miotto
Jun 11, 2020·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Thi Van Anh NguyenJan-Willem C Alffenaar
Sep 2, 2020·Antimicrobial Agents and Chemotherapy·Martina L ReichmuthPeter M Keller
Feb 25, 2021·Emerging Infectious Diseases·Hamzah Z FarooqVlad Nikolayevskyy
Jan 26, 2020·The Journal of Infection·Irina V PeretokinaDanila V Zimenkov

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