Operational Handbooks

TB is largely curable with treatment that is affordable and widely accessible. If a TB treatment regimen is not administered correctly, it may fail to deliver a relapse-free cure, thus increasing transmission and accelerating the emergence of drug resistance. Monitoring the effectiveness of TB treatment is thus critically important in both clinical practice and surveillance, to maximize the quality of individual patient care and the effectiveness of public health action.

Individuals prescribed the longer treatment regimen should be monitored to assess regimen effectiveness and safety, taking into account resistance patterns and challenging clinical conditions, while using less active and more toxic medicines. The WHO framework for aDSM needs to be applied to patients on any MDR-TB regimen, to ensure appropriate action and an acceptable level of monitoring for and prompt response to adverse events – alongside monitoring for treatment outcomes, including early monitoring for treatment failure.

A longer treatment regimen should be proposed mainly when the BpaLM/BpaL or 9-month all-oral regimen cannot be used. Chapter 4 and Chapter 5 discuss the eligibility criteria for these shorter regimens.

A longer regimen is expected to be used in the following situations:

The design of longer regimens (18–20 months) is founded on grouping of medicines recommended for use in longer regimens based on the drug-resistance profile (Table 6.1).

The two variations of the 9-month all-oral MDR/RR-TB regimen recommended by WHO in 2022 (1) are described below.

In settings where the 6-month MDR/RR-TB regimen is not yet available, or implementation of the regimen is not yet feasible, or for patients who are not eligible, selected patients with MDR/RR-TB may benefit from a 9-month all-oral regimen. Several eligibility criteria must be considered for this regimen, with additional considerations for the use of linezolid instead of ethionamide.

This section refers to a treatment regimen for MDR/RR-TB that has a duration of at least 9 months and uses oral agents. The recommendation in the updated 2022 guideline (1) states:

Recommendation 2.1. WHO suggests the use of the 9-month all-oral regimen rather than longer (18-month) regimens in patients with MDR/RR-TB and in whom resistance to fluoroquinolones has been excluded. 

(Conditional recommendation, very low certainty of evidence)

The following subgroup analyses were available to the GDG in considering the eligibility criteria for the BPaLM/BPaL regimen: age, smear status, smoking status, people living with HIV (People with HIV) and previous TB. The GDG also considered the eligibility criteria as stipulated by each of the trials. The resulting considerations when prescribing the BPaLM/BPaL regimen are summarized below.

The slight differences in the treatment duration of the BPaLM and BPaL regimens, as studied in the TB-PRACTECAL and ZeNix trials, were acknowledged and discussed during the GDG meeting, and the panel suggested standardizing treatment duration of BPaLM to 6 months (26 weeks) during programmatic implementation; for BPaL, the possibility of an extension to a total of 9 months (39 weeks) if sputum cultures are positive between months 4 and 6 was suggested.