The standard six-month TB treatment regimen described in Table 2 was established through a series of clinical trials from the 1960s–1980s.6,8 Extensive clinical trial data support this regimen and TB programs have considerable experience in using and adapting this regimen in populations with TB disease. For this reason, it remains the recommended TB regimen for TB disease susceptible to first-line medications.2,26
Table 2. Recommended treatment regimens for known or suspected drug-susceptible pulmonary TB.
(first two months)
|Suspected drug susceptible a|
|Preferred regimen||INHb RMP PZA EMB c daily d||INH RMP EMB daily for 4 months|
|Alternative regimene||INH RMP EMB daily||INH RMP EMB daily for 7 months|
|Alternative regimenf||INH RMP PZA EMB daily||INH RMP EMB 3x per weekg for 4 months|
|Alternative regimenf||INH RMP EMB daily||INH RMP EMB 3x per weekg for 7 months|
|Known drug susceptible|
|Preferred regimen||INH RMP PZA daily d||INH RMP daily for 4 months|
|Alternative regimene||INH RMP EMB daily||INH RMP daily for 7 months|
|Alternative regimenf||INH RMP PZA daily||INH RMP 3x per weekg for 4 months|
|Alternative regimene , f||INH RMP EMB daily||INH RMP 3x per weekg for 7 months|
Abbreviations: TB, tuberculosis; INH, isoniazid; RMP, rifampin; PZA, pyrazinamide; EMB, ethambutol; DOT, directly observed therapy .
a INH: isoniazid, RMP: rifampin, PZA: pyrazinamide, EMB: ethambutol.
b No known risk factors for drug resistance and culture pending or culture not performed.
c Add Pyridoxine 25-50mg/day for all people taking isoniazid at risk of peripheral neuropathy.
d In both four-drug regimens here, EMB can be discontinued if strain is confirmed drug susceptible on culture.
e Daily defined as 7 days/week or minimum 5 days/week with DOT.
f For use when PZA is not indicated or two months of PZA therapy is not completed.
g DOT required with all intermittent regimens.
Recently, a new four-month regimen composed of daily rifapentine, INH, PZA and moxifloxacin was compared to the standard 6-month regimen in a randomized, multinational phase 3 trial in people with pulmonary TB susceptible to INH, RMP and fluoroquinolones.21 The 4-month regimen was statistically non-inferior to the standard six-month regimen, but rates of failure and relapse were higher with this regimen. Notably, in per protocol 95% analysis (which removed participants who did not complete 95% of treatment doses unless the reasons for incomplete treatment were death or treatment failure), the rate of unfavourable outcome was 5.8% in participants taking the four-month regimen versus 2.7% in participants taking the control (standard 6-month) regimen. Given these findings, concerns have been raised by the WHO regarding implementation in programmatic settings.26 Nonetheless, the WHO Global TB Programme Guidelines Development Group reviewed the study data for the four-month regimen, and supported its use as a possible alternative to the standard 6-month regimen.26 More outcome data, including data from programmatic settings, would be required, however, to recommend this regimen routinely.
We strongly recommend that standard therapy for patients with drug-sensitive pulmonary TB disease or expected drug-sensitive pulmonary TB (with pending drug susceptibility testing results) include isoniazid, rifampin, pyrazinamide and ethambutol for the first 2 months followed by isoniazid and rifampin for 4 more months (good evidence).
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