Section 2. Shorter all-oral bedaquiline-containing regimen for MDR/RR-TB

Further research is needed in the following areas:

• the effectiveness and safety of variants of the shorter MDR-TB treatment regimen, in which the injectable agent is replaced by an oral agent (e.g. bedaquiline) and the total duration is reduced to 6 months or less;
• comparison of the effectiveness of these variants of the shorter regimen would be helpful in:
       – patient subgroups that have often been systematically excluded from studies or country programme cohorts (e.g. children, patients with additional resistance, those with extrapulmonary TB, and pregnant or breastfeeding women);
       – settings where background resistance to drugs other than fluoroquinolones and second-line injectable agents is high (e.g. pyrazinamide or high-level isoniazid resistance);
• additional RCTs and odds ratio on all-oral shorter MDR-TB treatment regimens, also allowing comparison of all-oral shorter regimens to all-oral longer regimens;
• programmatic data from countries other than South Africa;
• data from children, pregnant women, elderly, patients with diabetes and other special populations;
• data on patients presenting with extensive TB disease;
• information on the frequency and mechanisms of bedaquiline resistance acquisition, and the genetic markers that indicate likely resistance; and
• identification of optimal companion drugs that protect bedaquiline and limit the acquisition of bedaquiline resistance, including consideration of the need to protect the long “tail” of potential single drug exposure (given its exceptionally long half-life) if bedaquiline is stopped at the same time as companion drugs.  

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