There are limited data on 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 African patients (52.5% HIV-infected) with DR-TB and poor prognostic features between 2014 and 2018. We examined outcomes and safety in those who received a bedaquiline-based regimen (n=82) compared 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 to at least five drugs; p=0.001) and higher pre-treatment failure rates (12.2% versus 52.5% with pre-treatment multidrug-resistant TB therapy failure; p<0.001). Although the proportion of prolongation of the QT interval corrected using Fridericia's formula 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 withdrawals in either group. Results were similar in HIV-infected patients. A bedaquiline–delamanid combination regimen showed comparable long-term safety compared 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. A bedaquiline–delamanid combination regimen in drug-resistant tuberculosis patients with poor prognostic factors showed comparable efficacy and safety to those in a bedaquiline-based regimen http://bit.ly/32j7Fyo

中文翻译：

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一种含有贝达喹啉和德拉马尼的方案与贝达喹啉治疗耐药结核病患者的比较

关于在耐药结核病 (DR-TB) 方案中联合使用德拉马尼和贝达喹啉的数据有限。无法获得包括 HIV 感染者在内的前瞻性长期结果数据。我们前瞻性地随访了 2014 年至 2018 年间 122 名患有 DR-TB 且预后不良的南非患者（52.5% HIV 感染者）。我们检查了接受基于贝达喹啉方案的患者（n=82）的结局和安全性谁接受了贝达喹啉-德拉马尼联合方案（n = 40）。贝达喹啉与贝达喹啉-德拉马尼联合组的 6 个月培养转化率（92.5% 对 81.8%；p=0.26）和 18 个月良好结果率（63.4% 对 67.5%；p=0.66）没有显着差异，尽管后者具有更严重的耐药性（3.7% vs 22.5% 对至少五种药物耐药；p=0. 001) 和更高的治疗前失败率（12.2% 与治疗前耐多药结核病治疗失败的 52.5%；p<0.001）。尽管使用 Fridericia 公式校正的 QT 间期延长的比例在联合组中较高（距基线 >60 ms (p=0.001) 或治疗期间 >450 ms (p=0.001)），但没有出现症状病例或药物任一组的提款。结果在 HIV 感染患者中相似。与基于贝达喹啉的方案相比，贝达喹啉-德拉马尼联合方案在 DR-TB 患者中显示出相当的长期安全性，无论 HIV 状态如何。这些数据为来自 TB 流行地区的 DR-TB 患者的治疗方案选择提供信息。