This protocol covers the next clinical step for patients aged 12 years or older with a body weight above 40 kg who have pulmonary drug-susceptible tuberculosis and are not pregnant, breastfeeding, or postpartum — specifically when the prior first-line 4-month course did not succeed.
Pulmonary DS-TB in a patient aged 12 years or older with body weight above 40 kg — the population eligible for the standard 4-month first-line regimen.
The previous treatment line — the 4-month regimen 2HPMZ/2HPM (isoniazid, rifapentine, moxifloxacin, and pyrazinamide) — did not achieve conversion of sputum smear/culture to negative or the expected clinical and radiological improvement. This protocol describes the step taken after that failure.
The primary treatment target is conversion of sputum smear/culture to negative.
Patients aged 12 years or older with pulmonary DS-TB may receive a 4-month regimen of isoniazid, rifapentine, moxifloxacin and pyrazinamide (2HPMZ/2HPM).
Adults and children aged 12 years or older with a body weight of more than 40 kg and affected by pulmonary DS-TB are eligible for this regimen, including those who are also HIV-positive with a CD4 count of more than 100 cells/mm3 and patients with diabetes.
Although the regimen can be continued while awaiting results of these assessments, once the results are available they will provide the clinician with the evidence to change the regimen or treatment strategy.
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