A non-randomized pragmatic historically controlled trial evaluating the effectiveness and safety of a bedaquiline or a linezolid-based short regimen for rifampicin-resistant tuberculosis.

Autor: Martínez-Campreciós J; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain., Aznar ML; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain. Electronic address: marialuisa.aznar@vallhebron.cat., Zacarias A; Tuberculosis Unit, Hospital Nossa Senhora da Paz, Cubal, 690 Benguela, Angola., Terán R; Tuberculosis Unit, Hospital Nossa Senhora da Paz, Cubal, 690 Benguela, Angola., Nindia A; Laboratory Department, Hospital Nossa Senhora da Paz, Cubal, 690 Benguela, Angola., Espinosa-Pereiro J; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain., Aixut S; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Tuberculosis Unit, Hospital Nossa Senhora da Paz, Cubal, 690 Benguela, Angola., Ramos ME; National program for the control of tuberculosis, Luanda, Angola., Nicolau MJ; National program for the control of tuberculosis, Luanda, Angola., Sulleiro E; Microbiology Department, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain., Tórtola MT; Microbiology Department, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain., Sánchez-Montalvá A; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain; Grupo de Estudio de micobacterias, Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica, Madrid, Spain., Molina I; Infectious Diseases Department, Tropical Medicine and International Health Unit, Vall Hebron University Hospital, Barcelona, 08035 Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades, Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Jazyk: angličtina
Zdroj: The Journal of infection [J Infect] 2024 Oct 17, pp. 106291. Date of Electronic Publication: 2024 Oct 17.
DOI: 10.1016/j.jinf.2024.106291
Abstrakt: Background: Short all-oral regimens for Rifampicin-resistant tuberculosis (ShORRT) have been a turning point in the treatment of drug-resistant tuberculosis. Despite this, access to drugs, stockouts, or adverse effects may limit the use of the recommended regimens.
Methods: Pragmatic non-randomized trial evaluating the efficacy and safety of a ShORRT strategy for the treatment of rifampicin-resistant Tuberculosis (RR-TB) at the Hospital Nossa Senhora da Paz (Angola). The strategy assigned participants to receive a bedaquiline (BDQ) or a linezolid-based (LZF) regimen supplemented with levofloxacin, clofazimine, and cycloserine for up to 9 months.
Results: One hundred and twenty-one participants with pulmonary RR-TB were treated with the ShORRT strategy, 69 received the bedaquiline- and 52 the linezolid-based regimen. Overall, 98 (81%) participants had successful treatment outcomes, which was significantly higher compared to a 20-month historical injectable-based regimen (successful outcome rate including cure and treatment completed: 53.7%) (p < 0.001). No significant differences between treatment success rates (85.5% vs. 75.0%), treatment failure (0.0% vs. 1.9%), death (5.8% vs. 13.5%), or lost to follow-up (LTFU) (8.7% vs. 9.6%) were seen between the BDQ and the LZF-based regimen. Globally, 72 adverse events (AE) occurred in 36 (29.7%) participants. Eighteen (14.9%) of these were grade ≥ 3 and were more frequently observed in those receiving the LZD-based regimen (p =0.02).
Conclusion: The ShORRT strategy with a nine-month BDQ- or LZD-based regimen supports the efficacy of shorter all-oral regimens for the treatment of RR-TB and presents real-world data from schemes without bedaquiline, nitroimidazole, or injectables.
Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest
(Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Databáze: MEDLINE
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