Rifampicin-resistant tuberculosis in Spain

Abstract

Objective: The aim of the study was to analyse the characteristics of rifampicin-resistant tuberculosis patients in Spain.

Methods: This was an ambispective observational study of a multicentre cohort of patients diagnosed between January 2019 and July 2023 in most Autonomous Communities (retrospective period 2019-2020, prospective 2021-2023).

Results: 94 patients were included; 83 (88.3%) had pulmonary tuberculosis. The mean age was 38.00±17.8 years; 67 (71.3%) were male, 62 (66.0%) were from countries other than Spain, six (6.4%) were HIV-infected and 24 (25.5%) had previously treated tuberculosis. Nine patients had rifampicin-resistant tuberculosis (RR-TB), 75 multidrug-resistant tuberculosis (MDR-TB), nine pre-extensively drug-resistant tuberculosis (pre-XDR-TB) and one XDR-TB. Treatment included bedaquiline in 39 (41.5%) patients, linezolid in 87 (92.6%), fluoroquinolones in 82 (87.2%), clofazimine in 64 (68.0%) and delamanid in 27 (28.7%). Treatment was supervised by experts in 63 cases (67.0%). In 43 patients (45.7%), there were difficulties obtaining authorisation for drug prescription (bedaquiline or delamanid). 21 patients (22.3%) had difficulties understanding the treatment. The final treatment outcomes were cured in 60 cases (63.8%), treatment completed in 23 (24.5%), deaths in 3 (3.2%), with 2 due to tuberculosis, loss to follow-up in five (5.3%) and not evaluated in three (3.2%). No treatment failures occurred. Successful outcomes were achieved in 83 patients (88.3%). MDR-TB compared with pre-XDR-TB (OR 8.77, 95% CI 1.42-45.55; p=0.01) and no treatment comprehension difficulties (OR 10.61, 95% CI 2.78-40.48; p=0.001) were both associated with successful outcomes.

Conclusions: Most patients achieved successful outcomes with individualised regimens guided predominantly by experts. Patients with pre-XDR-TB and those with comprehension difficulties had significantly reduced success rates.