Drug-resistant tuberculosis treatment

4.4 Subgroup considerations
Children. Children (aged 0–13 years) were excluded from the Nix-TB study; therefore, no analysis 
specific to this subgroup of patients could be performed. It is recommended that children with 
pulmonary MDR/RR-TB with additional resistance to fluoroquinolones be given the same consideration 
for longer treatment regimens as adults, to include components with a safety profile that is better 
established. Bedaquiline is currently only recommended for children aged 6 years and above.
51
Additional data on the use of BPaL in eligible children would be useful, and this may be a feature of 
carefully planned and monitored future research. 
People living with HIV. PLHIV represented half of those enrolled in the Nix-TB study; however, it 
was impossible to perform any adjusted stratified analyses for PLHIV, owing to the small sample size. 
51 
Based on the results of an RCT conducted by the manufacturer, the US FDA has extended approval for the use of bedaquiline for children 
aged 5 years and above. However, these data have not yet been assessed by
WHO.

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WHO consolidated 
guidelines 
on
tuberculosis: 
drug-resistant tuberculosis treatment
49
PLHIV were eligible to enrol in the Nix-TB study if they had a CD4 count of more than 50 cells/µL and 
if they were using permitted antiretroviral medications.
52
It is important to note drug–drug interactions 
when administering TB and HIV medications in combination, including the documented interactions 
between bedaquiline and efavirenz (see also (36)). Efavirenz also reduces pretomanid exposures 
significantly – therefore, an alternative antiretroviral agent should be considered if pretomanid or the 
BPaL regimen is to be used (94). Regimens including zidovudine should be used with special caution 
because zidovudine and linezolid may both cause peripheral nerve toxicity, and they are known to 
have myelosuppression cross toxicity.