Abstract
There are limited data about combining delamanid and bedaquiline in drug-resistant tuberculosis (DR-TB) regimens. Prospective long-term outcome data, including in HIV-infected persons, are unavailable.
We prospectively followed up 122 South Africans (52.5% HIV-infected) with DR-TB and poor prognostic features between 2014 and 2018. We compared outcomes and safety in those who received a bedaquiline-based regimen (n=82) to those who received a bedaquiline-delamanid combination regimen (n=40).
There was no significant difference in 6-month culture conversion (92.5% versus 81.8%; p=0.26) and 18-month favourable outcome rate (63.4% versus 67.5%; p=0.66) in the bedaquiline versus the bedaquiline-delamanid combination group, despite the latter having more advanced drug resistance (3.7% versus 22.5% resistant >5 drugs; p=0.001) and higher pre-treatment failure rates (12.2% versus 52.5% with pre-treatment MDR-TB therapy failure; p<0.001). Although the proportion of QTcF prolongation was higher in the combination group [>60 ms from baseline (p=0.001) or >450 ms during treatment (p=0.001)], there were no symptomatic cases or drug withdrawal in either group. Results were similar in HIV-infected patients.
A bedaquiline-delamanid combination regimen showed comparable long-term safety, to a bedaquiline-based regimen, in patients with DR-TB irrespective of HIV status. These data inform regimen selection in patients with DR-TB from TB endemic settings.
Footnotes
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Conflict of interest: I have no conflict of interest to declare
Conflict of interest: I have no conflict of interest to declare
Conflict of interest: I have no conflict of interest to declare
Conflict of interest: I have no conflict of interest to declare
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- Received June 16, 2019.
- Accepted October 9, 2019.
- Copyright ©ERS 2019