Schnippel K, et al. - Researchers analyzed patient data from the South African rifampicin-resistant tuberculosis case register (EDRweb) to compare mortality in patients on standard regimens vs on regimens including bedaquiline. Outcomes showed a large reduction in mortality in patients with drug-resistant tuberculosis in correlation to bedaquiline-based treatment regimens vs the standard regimen.

Methods

• Researchers performed this retrospective cohort study via analyzing patient data from the South African rifampicin-resistant tuberculosis case register (EDRweb), and identifying additional mortality using the national vital statistics register.
• Exclusion was performed of the patients who started treatment before July 1, 2014, or after March 31, 2016; patients younger than 15 years or older than 75 years; patients without documented rifampicin resistance, and patients with pre-extensively drug-resistant tuberculosis (multidrug-resistant tuberculosis with further resistance to a second-line injectable or fluoroquinolone).
• Patients who received bedaquiline in treatment regimens were compared to those who did not, regarding all-cause mortality.
• Kanamycin or capreomycin and moxifloxacin was given to the patients who did not receive bedaquiline, as core medicines in their regimen.
• Estimation was performed of hazard ratios for mortality separately for multidrug-resistant or rifampicin-resistant tuberculosis and extensively drug-resistant tuberculosis and adjusted using propensity score quintile strata for the potential confounders of sex, age, HIV and antiretroviral therapy status, history of prior tuberculosis, valid identification number, and year and province of treatment.

Results

• Between July 1, 2014, and March 31, 2016, the EDRweb displayed 24,014 tuberculosis registered cases; 19,617 of these patients initiated treatment and met the analysis eligibility criteria.
• As per findings, 743 (4·0%) of 18 542 patients with multidrug-resistant or rifampicin-resistant tuberculosis and 273 (25·4%) of 1075 patients with extensively drug-resistant tuberculosis received a bedaquiline-containing regimen.
• Death was reported of 128 (12·6%) patients among 1016 who received bedaquiline and 4612 (24·8%) patients among 18,601 who received the standard regimens.
• Compared with standard regimens, bedaquiline led to a reduction in the risk of all-cause mortality for patients with multidrug-resistant or rifampicin-resistant tuberculosis (hazard ratio [HR] 0·35, 95% CI 0·28–0·46) and extensively drug-resistant tuberculosis (0·26, 0·18–0·38).