Drug-resistant tuberculosis treatment

Pregnant and lactating women. The intervention regimen contains ethionamide, which is usually 
contraindicated in pregnancy, because animal reproduction studies have shown an adverse effect on 
the fetus and there are no adequate and well-controlled studies in humans. Although more compelling 
evidence is needed on toxicity causes attributed to the use of specific anti-TB drugs during pregnancy 
and lactation, individualized longer regimens can be designed to avoid known toxicities until better 
safety profiles are
established.
Extrapulmonary TB. The evaluated shorter all-oral bedaquiline-containing regimen was also 
implemented in individuals confirmed with MDR/RR-TB and with uncomplicated extrapulmonary TB 
disease. No evidence was available to discern the impact of this regimen in patients with extensive 
TB disease or severe forms of extrapulmonary
TB.
2.5 Implementation considerations
Decisions to start the shorter all-oral bedaquiline-containing regimen in newly diagnosed patients 
should be made through an informed decision-making process that includes patient preference and 
clinical judgement, and with several DST results available before the start of treatment. Patients should 
be informed on the advantages and possible disadvantages, and make an informed decision on the 
regimen of choice. Previous exposure of less than 1 month duration to the second-line medicines 
used in the regimen needs to be ascertained, and can be considered along with any additional DST 
results available. Based on the available evidence, this regimen can be a preferred option for patients 
with confirmed MDR/RR-TB (with at least confirmed resistance to rifampicin), for whom resistance to 
fluoroquinolones has been ruled out, in the following
situations;
• 
without resistance or suspected ineffectiveness of a medicine in the shorter regimen (except 
isoniazid resistance
34
);
• 
without exposure to previous treatment with second-line medicines in the regimen for more than 
1 month (unless susceptibility to these medicines is confirmed); 
• 
with no extensive TB disease and with no severe extrapulmonary TB; 
• 
not pregnant; and 
• 
if a child, aged 6 years or
more.
Those who may benefit from the all-oral longer regimen, designed according to the principles outlined 
in