Delamanid for rifampicin-resistant tuberculosis: a retrospective study from South Africa.
Eur Respir J
; 51(6)2018 06.
Article
en En
| MEDLINE
| ID: mdl-29724920
Experience with delamanid (Dlm) is limited, particularly among HIV-positive individuals. We describe early efficacy and safety data from a programmatic setting in South Africa.This was a retrospective cohort study of patients receiving Dlm-containing treatment regimens between November 2015 and August 2017. We report 12-month interim outcomes, sputum culture conversion (SCC) by months 2 and 6, serious adverse events (SAEs) and QT intervals corrected using the Frederica formula (QTcF).Overall, 103 patients were initiated on Dlm; 79 (77%) were HIV positive. The main indication for Dlm was intolerance to second-line anti-tuberculosis (TB) drugs (n=58, 56%). There were 12 months of follow-up for 46 patients; 28 (61%) had a favourable outcome (cure, treatment completion or culture negativity). Positive cultures were found for 57 patients at Dlm initiation; 16 out of 31 (52%) had SCC within 2â
months and 25 out of 31 (81%) within 6â
months. There were 67 SAEs reported in 29 patients (28%). There were four instances of QTcF prolongation >500â
ms in two patients (2%), leading to permanent discontinuation in one case; however, no cardiac arrhythmias occurred.This large cohort of difficult-to-treat patients receiving Dlm for rifampicin-resistant TB treatment in a programmatic setting with high HIV prevalence had favourable early treatment response and tolerated treatment well. Dlm should remain available, particularly for those who cannot be treated with conventional regimens or with limited treatment options.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Oxazoles
/
Tuberculosis Pulmonar
/
Tuberculosis Resistente a Múltiples Medicamentos
/
Nitroimidazoles
/
Antituberculosos
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
Límite:
Adult
/
Female
/
Humans
/
Male
País/Región como asunto:
Africa
Idioma:
En
Revista:
Eur Respir J
Año:
2018
Tipo del documento:
Article
País de afiliación:
Sudáfrica
Pais de publicación:
Reino Unido