Consolidated Guidelines

Annex 3. GRADE summary of evidence tables

Older terminology used in the context of TPT, such as latent TB infection (LTBI) and active TB, has been retained in the original text of the tables.

PICO 1: What is the prevalence of TB infection, the risk of progression to TB disease and the cumulative prevalence of TB disease among household contacts without HIV in different age groups in high TB incidence countries?

Is the prevalence of TB disease and TB infection higher among household contacts without HIV than in the general population in different age groups in high TB incidence countries?

1.6 Monitoring and evaluation

Patients who receive BPaLM/BPaL need to be tested at baseline and then monitored during treatment using schedules of relevant clinical and laboratory testing. If feasible, it is also important to follow up patients 12 months after the completion of treatment for possible relapse, including with sputum culture and smear.

4.5 Monitoring and evaluation

Patients who receive the (H)REZ–levofloxacin regimen need to be monitored during treatment, using schedules of clinical and laboratory testing. The definitions to use when assigning outcomes are the same as those used for drug-susceptible TB (79). Signs of non-response or treatment failure should be followed up with DST for rifampicin resistance and, if possible, for fluoroquinolones and pyrazinamide.

4.4 Implementation considerations

Case scenarios

Implementing these recommendations requires the (H)REZ–levofloxacin regimen to be administered only in patients in whom resistance to isoniazid has been confirmed and resistance to rifampicin has been excluded. Preferably, testing for resistance to fluoroquinolones (and, if possible, to pyrazinamide) is also done before starting treatment. It is envisaged that the treatment regimen for Hr-TB will apply in the following situations:

4.3 Subgroup considerations

Children

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