Patients with rifampicin-resistant tuberculosis (TB) and resistance to fluoroquinolones and/or injectables who were treated with bedaquiline in an optimized individualized background regimen experienced high rates of successful treatment outcomes, according to study results published in the European Respiratory Journal.
South African patients age ≥18 years with a laboratory-confirmed diagnosis of pulmonary multi-drug resistant (MDR) TB were treated with bedaquiline and an optimized individualized background regimen that included at least 3 second-line drugs to which the patient’s TB had proven or likely susceptibility. The regimen could include linezolid, clofazimine, pyrazinamide, ethambutol, high-dose isoniazid, p-aminosalicylic acid, capreomycin, kanamycin, levofloxacin, ethionamide, or terizidone. Patients were treated with bedaquiline 400 mg once daily for 2 weeks followed by 200 mg 3 times a week for 22 weeks along with the optimized background regimen.
Of the 200 study participants, 101 were men, 99 were women, and mean age was 34 years. A total of 87 had laboratory-confirmed MDR TB, 33 had pre-extensively drug-resistant TB (injectable), and 78 had pre-extensively drug-resistant TB (fluoroquinolones). Laboratory results for 2 participants were unavailable. Clofazimine was administered to 164 patients, levofloxacin to 166 patients, and linezolid to 128 patients as part of the background regimen. In the study, 134 participants were living with HIV. In the primary outcome, 146 patients had a favorable outcome. Of those patients, 139 were cured and 7 successfully completed treatment. Of the 87 patients with the most extensive resistance, 70 had a successful outcome.
“[I]t is not the addition of a single medication to a regimen for the treatment of MDR TB or [extensively drug-resistant] TB that will prove to be the game changer but rather the design of new regimens combining as many of the new and repurposed agents including linezolid, carbapenem, and other companion drugs if we are to decrease the morbidity and mortality associated with rifampicin resistant TB,” the researchers concluded.
Ndjeka N, Schnippel K, Master I, et al. High treatment success rate for multidrug-resistant and extensively drug-resistant tuberculosis using a bedaquiline-containing treatment regimen [published October 25, 2018]. Eur Respir J. doi:10.1183/13993003.01528-2018