Treatment

Patients with susceptibility to fluoroquinolones can be started on the BPaLM regimen for 6 months (26 weeks). In the case of resistance to fluoroquinolones, identified after treatment initiation, moxifloxacin may be discontinued and the regimen can be continued as BPaL. When the regimen is BPaL from the start or is changed to BPaL, it can be extended to a total of 9 months (39 weeks) (continuing from the start of the therapy with BPaLM/BPaL).

The BPaL regimen can be prescribed for those who have proven fluoroquinolone resistance. In cases of possible fluoroquinolone resistance (e.g. a history of >4 weeks of fluoroquinolone use or close contact with a person infected with a fluoroquinolone-resistant strain), it is best to use the BPaLM regimen until DST for fluoroquinolones is available, to decide whether or not moxifloxacin should be continued. Where DST is pending, BPaLM can be commenced, subsequently dropping moxifloxacin from the regimen once fluoroquinolone resistance is confirmed.

Policy and operational documents that govern the main components of the programme will need to be revised. Such documents include the national strategic plan for TB, treatment guidelines and algorithms, diagnostic algorithms, the essential medicines list, regulations (e.g. importation of clofazimine and pretomanid), drug orders and training material. Ideally, the type of regimen used by the patient would be indicated in the register and could be summarized for reporting.

A national MDR-TB expert committee or technical working group (the consilium or its equivalent structure within the NTP) will assist health care providers as early as possible to:

There is a need to improve the quality of patient data using standardized variables, such as data on DST patterns, prescribed treatment, treatment outcomes and adverse drug reactions. The collection and utility of these data are important for future evidence-based recommendations, especially given the lack of RCTs on the management of DR-TB (126). If digital patient records do not already exist, it is important that the programme managers consider their introduction, at least for surveillance and possibly also for case management (146).

Estimates are needed by the NTP and other health care providers, to determine the number of MDR/RR-TB patients eligible for the longer and shorter MDR-TB regimens, to revise the budget accordingly, and to submit the corresponding requests for drug orders, taking into account the existing stock of medicines. These estimates of MDR/RR-TB patients likely to be enrolled are based on current notification trends and an expected increase in line with national and subnational plans.

Management of the supply chain and storage conditions for pharmaceuticals should be reviewed to ensure that TB drug orders are made in good time and are correctly quantified to avoid overstocking or shortages. The NTP must ensure an uninterrupted supply of TB medicines through proper quantification, supply planning and rigorous quarterly monitoring, with a functional early warning system to avoid stock-outs and subsequent treatment interruptions. Similarly, other consumables (e.g.

In November 2020, WHO/GTB convened an online consultation and released new definitions of TB treatment outcomes, which were the same for DS-TB and DR-TB (150, 151).

The principles guiding the update of the definitions were:

Response to treatment is monitored on the basis of monthly sputum smear microscopy, as well as culture, ideally at the same frequency. Monthly culture increased the detection of patients with a true positive bacteriological result when compared with sputum smear microscopy alone; also, it reduced the proportion of patients with a false negative result.