Drug-resistant tuberculosis treatment

2.3 Justification and evidence
Interest in reducing the duration of treatment for MDR/RR-TB has driven a number of initiatives in 
recent years to treat patients with shorter regimens under programmatic and trial conditions (43–48). 
When used in carefully selected MDR/RR-TB patients who have not been previously exposed or do not 
have additional resistance to second-line medicines, these regimens have been reported to achieve 
relapse-free cure in about 80% of cases or more, even under programmatic conditions (43, 47). In 
2016, on the basis of data from observational studies of the standardized shorter regimens in different 
Asian and African countries, WHO for the first time recommended a standardized 9–12 month 
shorter MDR-TB regimen for eligible patients (10). Subsequently, following the results of a trial – the 
Standard Treatment Regimen of Anti-tuberculosis Drugs for Patients with MDR-TB (STREAM) Stage 
1 trial – a revised recommendation on the use of a shorter MDR-TB regimen was released in 2018, 
following an evidence assessment and ranking of benefits and harms attributed to specific drugs; the 
revision included a recommendation to replace the injectable agent, kanamycin (or capreomycin), 
with amikacin (11). As debate about the excessive adverse effects of injectable agents (especially 
26 
Bedaquiline is usually administered 400 mg orally once daily for the first 2 weeks, followed by 200 mg orally three times per week for 
22 weeks (total duration of 24 weeks). 
NEW RECOMMENDATION

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WHO consolidated 
guidelines 
on
tuberculosis: 
drug-resistant tuberculosis treatment
13
hearing loss) became more prominent through patient advocacy, and new and repurposed oral 
anti-TB drugs became available, the evaluation of new evidence on injectable-free shorter regimens 
from programmatic settings became pivotal, to provide better and safer standards of care for patients 
with drug-resistant
TB.
Availability of data on the programmatic implementation of a shorter, injectable-free treatment 
regimen including bedaquiline in South Africa since 2017 prompted WHO to evaluate the following 
PICO question: 
PICO question 2 (MDR/RR-TB, 2019): In MDR/RR-TB patients, does an all-oral treatment regimen 
lasting 9–12 months and including bedaquiline, safely improve outcomes when compared with 
other regimens conforming to WHO
 
guidelines?