Tuberculosis resistant to the drugs used in current treatment continues to be a determining factor in the global epidemic of tuberculosis. The long treatment time leads to compromised patient compliance, which often does not complete the minimum six months of treatment. Given the current scenario, with increasing rates of multidrug-resistant or extensively drug-resistant tuberculosis, shorter and more effective treatment regimens are essential.
The aim of this study was to evaluate the efficacy and safety of the use of bedaquiline, pretomanide and linezolid in patients with resistant tuberculosis.
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Patients with extensively resistant tuberculosis (XDR TB) – resistant to rifampicin, fluoroquinolone and aminoglycosides – and patients with pre-XDR TB – resistant to rifampicin and fluoroquinolone or aminoglycoside, in addition to rifampicin resistant patients who did not respond to initial treatment or not tolerated alternative treatments due to side effects.
The drugs were administered for 26 weeks and in the case of linezolid, regimens with higher and lower doses were tested. The primary endpoint was the incidence of an unfavorable event such as relapse or treatment failure. Safety was also assessed.
A total of 181 patients were included, most of them XDR or pre-XDR. Among those who received bedaquiline-pretomanide and linezolid at a dose of 1200 mg for 26 weeks had a favorable event in 93% of cases compared with 84% of those who used 600 mg of linezolid. In addition, peripheral neuropathy and spinal cord toxicity occurred more frequently in users of higher doses.
The linezolid dose needed to be changed in about 50% of patients using higher doses. Optic neuritis occurred in new patients, all in the 1200 mg group. At follow-up, patients who used the regimen for nine weeks had greater disease recurrence than patients who received treatment for 26 weeks.
The 600 mg dose of linezolid was associated with less dose modification, no cases of optic neuropathy, and fewer episodes of peripheral neuropathy and myelosuppression. The study has flaws such as a small number of patients and the absence of a control group, however, considering the emergence of MDR TB cases, shortening the treatment, maintaining good adherence and with a low profile of side effects seems to be a promising alternative. In Brazil, the drugs are not yet available for use.
- Multidrug-resistant tuberculosis has increased its incidence over the last few years;
- Treatment time and adherence to treatment are fundamental for the prevention of multidrrresistende cases.
- Treatment regimens with new drugs such as bedaquiline-protomanid and linezolid appear to be promising and have a side effect profile.
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