The study evaluated 4 treatment regimens for MDR-TB:
- 1st regimen or the long regimen was the 20-month locally-used regimen which was recommended by WHO during 2011 to 2018
- 2nd regimen or the 'control' regimen: 9-month (40 weeks) regimen comprising 4 medicines (moxifloxacin, clofazimine, ethambutol, and pyrazinamide) given for 9 months (40 weeks) and supplemented by 3 more medicines (kanamycin, isoniazid, and prothionamide) in the first 4 months (16-weeks) intensive phase of the therapy
- 3rd regimen or all-oral regimen: an all-oral regimen comprising 5 medicines (bedaquiline, clofazimine, ethambutol, levofloxacin, and pyrazinamide) given for 9 months (40 weeks) and supplemented by 2 more medicines (isoniazid and prothionamide) in the first 4 months (16 weeks) intensive phase of the therapy
- 4th regimen: this regimen comprised of 4 medicines (bedaquiline, clofazimine, levofloxacin, and pyrazinamide) given for 6 months (28 weeks) and supplemented by 2 more medicines (isoniazid and kanamycin-injectable) for the first 2 months (8 weeks) intensive phase of the therapy.
The study results show that 82.7% of the participants receiving the all-oral 9-month regimen had a favourable outcome, while 91.0% of the participants receiving the 6-month regimen had a favourable outcome. Also, no concerning safety signals were identified. In addition, fewer participants experienced severe hearing loss in the all-oral regimen (2%) and the 6-month regimen (4%) as compared to the control regimen (8%).
Thus, both bedaquiline-containing regimens (the 9-month oral regimen and the 6-month regimen with 8-weeks of second-line injectable), had superior efficacy compared with the 9-month injectable-containing regimen, with fewer cases of hearing loss.
Responding to a question by CNS in the Press Conference, Dr Rusen said that: "For many patients avoiding an injectable compound will be a priority regardless of length of treatment. In STREAM the 6-month regimen was well tolerated. Hearing loss was reduced but not eliminated. In some settings this may be a treatment option especially where other shorter all oral regimens may not be available or there are other contraindications. We are in a new time for MDR-TB where finally there are new treatment options emerging and programs and communities will have options available to consider."
Key strengths
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