Introduction:

a fundamental problem in the treatment of drug-resistant tuberculosis has been the long duration of treatment regimens; globally successful treatment rates are less than 60%. The World Health Organization has proposed that through operational research new shortened all-oral regimens be tested for the treatment of rifampicin-resistant and multidrug-resistant tuberculosis.

Objectives:

a pilot study was conducted to determine the efficacy of a 4-drug all-oral regimen, through the conversion time of the culture, and the safety based on the presence of adverse reactions grade ≥ 3.

Material and methods:

twenty-six consecutive patients who have received this regimen, were included. Rigorous clinical and bacteriological follow-up was carried out to evaluate efficacy and safety.

Results:

the culture conversion time from the start of treatment was 1.42 ± 0.82 months (six weeks) and the smear microscopy conversion time was 1.75 ± 0.95 months (seven weeks). Regarding the safety of the regimen, 73.1% of the patients reported some type of adverse effect.

Conclusions:

this all-oral regimen shows excellent effectiveness with culture conversion within two months and by including three drugs with sterilizing activity (bedaquiline, levofloxacin, and clofazimine), it offers the possibility of reducing the duration of treatment, which could reduce losses to follow-up. The toxicity of the regimen is significant, and its implementation requires expert management in drug-resistant TB, and rigorous clinical and laboratory monitoring.