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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