RT Journal Article
SR Electronic
T1 Safety of prolonged treatment with bedaquiline in programmatic conditions
JF ERJ Open Research
JO erjor
FD European Respiratory Society
SP 00685-2021
DO 10.1183/23120541.00685-2021
VO 8
IS 2
A1 Dzmitriy Zhurkin
A1 Elmira Gurbanova
A1 Jonathon R. Campbell
A1 Dick Menzies
A1 Svetlana Setkina
A1 Hennadz Hurevich
A1 Varvara Solodovnikova
A1 Dzmitry Viatushka
A1 Alan Altraja
A1 Alena Skrahina
YR 2022
UL http://openres.ersjournals.com/content/8/2/00685-2021.abstract
AB Bedaquiline is now considered a first-line medicine for treatment of rifampicin-resistant tuberculosis (RR-TB). We evaluated the safety of treatment with bedaquiline for longer than 190 days in individuals with RR-TB under programmatic conditions.In a prospective cohort study enrolling pulmonary RR-TB patients, we initiated bedaquiline-based treatment at a tertiary hospital in Belarus. We defined standard bedaquiline use as <190 days and prolonged as ≥190 days. We recorded adverse events (AEs) and classified their seriousness and relation to bedaquiline. Our primary outcome in regression analyses was the incidence of serious AEs occurring within 5 months of bedaquiline cessation. We used generalised estimating equations to estimate the adjusted incidence rate ratio (aIRR) of serious AEs between the prolonged and standard bedaquiline groups.We enrolled 113 patients, 83 (73%) of whom received standard and 30 (27%) received prolonged treatment. A total of 2030 AEs occurred during treatment. Of these, 63 (3.1%) were serious AEs occurring within 5 months of bedaquiline cessation; QTcF prolongation was the most common bedaquiline-related serious AE. The incidence of serious AEs per 100 person-months was 5.4 (3.9 to 7.2) in the standard group and 4.4 (2.6 to 7.0) in the prolonged group. In adjusted analyses, serious AEs were no different (aIRR: 0.82, 95% CI 0.42–1.61) in the prolonged group. One patient in the standard bedaquiline group died of acute cardiopulmonary failure deemed possibly related to bedaquiline.Prolonged use of bedaquiline under programmatic conditions appears safe. Clinicians should carefully monitor QTcF interval since its prolongation was commonly observed.This study demonstrated that prolonged use of bedaquiline under programmatic conditions appears to be safe. However, clinicians should carefully monitor QTcF interval throughout treatment with bedaquiline due to proven risk of QTcF prolongation. https://bit.ly/36UHHc3