Drug-resistant tuberculosis treatment

Section 4. The BPaL regimen for MDR-TB with additional 
fluoroquinolone resistance
Further research is needed in the following
areas:
• 
the efficacy, safety and tolerability of BPaL compared with other all-oral
regimens;
• 
data from other regions and countries (beyond South
Africa);
• 
description of the mechanism and molecular markers of pretomanid resistance, and surveillance for 
the development of resistance with adequate consideration paid to the impact of selected
mutations;
• 
documenting the full adverse event profile of pretomanid, and the frequency of relevant adverse 
events, with a focus on hepatotoxicity and reproductive toxicity in humans (the reproductive toxicities 
of pretomanid have been signalled in animal studies, but the potential effects of this medicine on 
human fertility have not been adequately
evaluated);
• 
exploring the relative efficacy (and added value in multidrug regimens) of pretomanid and 
delamanid; and
• 
optimal dose and duration of linezolid use in drug-resistant TB regimens (ZeNix study). 

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WHO consolidated 
guidelines 
on
tuberculosis: 
drug-resistant tuberculosis treatment
75
Section 5. Monitoring patient response to MDR-TB treatment 
using culture
Further research is needed in the following
areas:
• 
analysis of the predictors and biomarkers of treatment failure (related to strain, regimen and host), 
and of the bacteriological response, in the following important subgroups, which would help to 
identify more resource-saving options and reduce the time needed to make
decisions:
–
patients aged under 15
years;
–
patients with extrapulmonary disease (different
forms);
–
patients on shorter MDR-TB regimens (standardized or all-oral
variants);
• 
continuing to assess the potential role of future-generation rapid molecular testing beyond 
diagnostic testing to also monitor the treatment response; and
• 
evaluation of the engineering challenges to implementing more affordable liquid culture
systems.