5.2 Composition and duration of the regimen

The regimen evaluated by the SHINE trial comprised 2 months of daily isoniazid, rifampicin and pyrazinamide, with or without ethambutol (2HRZ(E)), followed by daily isoniazid and rifampicin (2HR).

In the SHINE trial, ethambutol was included in the first 2 months of treatment, depending on the local policy in place at the recruitment site, for both the 4-month regimen and the comparator 6-month regimen. All CALHIV in the SHINE trial received ethambutol in the first 2 months of treatment (regardless of which regimen they received). It is therefore preferred that CALHIV who receive the 4-month regimen receive ethambutol for the first 2 months of treatment, irrespective of the background prevalence of HIV. In addition, it is recommended that ethambutol be added to the 4-month regimen for the first 2 months in settings with a high background prevalence of isoniazid resistance or HIV infection. Also, for this regimen, daily dosing (i.e. 7 days per week), ideally under direct observation, is suggested, taking advantage of a treatment supporter or VST.

The doses are the same as those recommended for the 6-month regimen 2HRZE/4HR (Annex 1).

Treatment should be continued for 6 months or should be modified in children and adolescents who have not responded clinically (i.e. have not demonstrated weight gain or resolution of TB symptoms) after 4 months of treatment. These people should be evaluated carefully for DR-TB, nonTB-related disease (e.g. malignancy or HIV-related lung disease) and poor treatment adherence. The first 2 months of treatment, which includes three or four drugs, is usually enough for the strong bactericidal activity of this regimen to be effective. If the patients are sputum smear negative (or paucibacillary) and no cavities are present in CXR, then the presence of one or more sputum smear results that are positive after 2 months may indicate undetected resistance to one or more drugs. If the patient is not improving clinically and radiologically (e.g. cavities appear), and drug-resistance or potential failure are suspected, rapid diagnostics to exclude this should be done promptly together with culture and DST, to provide a basis for any adjustment of the treatment strategy.

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