4.2 Composition and duration of the regimen

The regimen evaluated by Study 31 comprised 8 weeks of daily isoniazid, rifapentine, moxifloxacin and pyrazinamide, followed by 9 weeks of daily isoniazid, rifapentine and moxifloxacin (2HPMZ/2HPM)

For this regimen, daily dosing (i.e. 7 days per week, as used in Study 31) is suggested, taking advantage of a treatment supporter or video-supported treatment (VST).

The dose of rifapentine used was fixed at 1200 mg and moxifloxacin at 400 mg. Other medicines were provided at standard recommended doses (Annex 1). The study was based on the regimen with moxifloxacin; therefore, replacement of moxifloxacin by another fluoroquinolone cannot be recommended.

As is the case for other regimens, WHO does not recommend prolonging the regimen beyond the planned duration of 4 months.

The first 2 months of treatment, which includes four drugs, is usually enough for the strong bactericidal activity of this regimen to be effective. Thus, the presence of one or more sputum smear results that are still positive after 2 months usually indicates the presence of dead bacilli; however, in some cases, it might be due to undetected resistance to one or more drugs. If the patient is not improving clinically and radiologically, and drug-resistance or potential failure is suspected, rapid diagnostic testing to exclude this possibility should be undertaken promptly, together with culture and DST, to provide a basis for any adjustment of the treatment strategy

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