4.3 Subgroup considerations


In the IPD review, only 2% of Hr-TB patients were children; thus, a separate estimate of effect for paediatric patients was not possible. However, there is no reason why the results and recommendations cannot be extrapolated from adults to children, considering that the regimen components have been standard paediatric TB medicines for many years.

Patients with extensive disease

Although the IPD analysis did not provide evidence for duration of treatment extension, the prolongation of the 6(H)REZ–levofloxacin regimen to more than 6 months could be considered on an individual basis for patients with extensive disease (94). Prolongation of treatment may increase the risk of adverse events in some cases (see Section 1.5).

People living with HIV

The effect of longer duration TB treatment among People with HIV with and without ART has been studied among patients with drug-susceptible TB (95). In these cases, relapse has been reported to be 2.4 times higher in People with HIV who were not on ART and who received 6 months of treatment than in patients in whom treatment was prolonged (up to 9 months). In patients with drug-susceptible TB initiated on ART, no significant benefit from prolonging rifampicin-containing regimens for over 6 months has been observed (37). In the current analysis, only a limited number of patients received ART; nonetheless, in TB patients with HIV coinfection, the first priority is to ensure that they are started on ART within 8 weeks of TB treatment initiation (regardless of CD4 count), in accordance with WHO guidelines (96). The 6(H)REZ–levofloxacin regimen is therefore recommended in People with HIV.

Extrapulmonary disease

No data were available for patients with exclusive extrapulmonary Hr-TB. The regimen composition proposed is likely to be effective even in these patients. However, the treatment of patients with extrapulmonary TB should be designed in close consultation with appropriate specialists (e.g. infectious disease physicians and neurologists), to decide upon individual variations in treatment duration and supportive care, as needed.

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