Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis
Treatment of drug-resistant tuberculosis with bedaquiline in a high HIV prevalence setting: an interim cohort analysis
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DOI：
10.5588/ijtld.14.0944
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发表时间：
2015-08-01
影响因子：
4
通讯作者：
Pillay, Y.
中科院分区：
文献类型：
--
作者：
Ndjeka, N.;Conradie, F.;Pillay, Y.
背景：南非有广泛耐药结核病（XDR-TB）的巨大负担；只有15%的广泛耐药结核病患者获得成功治疗。目的：描述贝达喹啉（BDQ）在南非BDQ临床准入计划中的安全性和有效性。设计：一项中期队列分析。结果：在2013年3月至2014年7月（随访至2014年8月）入组的首批91例患者中，54例（59%）感染了人类免疫缺陷病毒（HIV）。中位CD4细胞计数为239个细胞/ μ l，所有患者在BDQ开始时都在接受抗逆转录病毒治疗（ART）；33例为广泛耐药结核，41例为广泛耐药前期结核，伴氟喹诺酮类药物耐药性，17例为广泛耐药前期结核，伴注射药物耐药性。91例患者中，58例（64%）完成了24周BDQ治疗，28例仍在BDQ治疗，3例失访，1例死亡，1例房颤后BDQ停药。在随访6个月的63例患者中，48例（76%）在开始BDQ后培养转化或仍为培养阴性。每月监测QTcF，有3名受试者QTcF超过500 ms；这三个国家都解决了这个问题。结论：南非接受BDQ治疗的患者（包括抗逆转录病毒治疗的艾滋病毒感染者和前广泛耐药结核病和广泛耐药结核病患者）的中期安全性和培养转化结果表明，BDQ可能既有效又安全。
BACKGROUND: South Africa has a large burden of extensively drug-resistant tuberculosis (XDR-TB); only 15% of XDR-TB patients have successful outcomes.OBJECTIVE: To describe the safety and effectiveness of bedaquiline (BDQ) in the South African BDQ Clinical Access Programme.DESIGN: An interim cohort analysis.RESULTS: Of the first 91 patients enrolled between March 2013 and July 2014 (with follow-up until August 2014), 54 (59%) were human immunodeficiency virus (HIV) infected. The median CD4 count was 239 cells/mu l, and all patients were on antiretroviral therapy (ART) at initiation of BDQ; 33 had XDR-TB, 41 were pre-XDR-TB with fluoroquinolone resistance and 17 were pre-XDR-TB with resistance to an injectable. Of the 91 patients, 58 (64%) had completed 24 weeks of BDQ, 28 were still on BDQ, 3 were lost to follow-up, 1 had died and 1 had BDQ withdrawn following atrial fibrillation. Of the 63 patients with 6 months follow-up, 48 (76%) had either culture-converted or remained culture-negative after initiation of BDQ. QTcF was monitored monthly and exceeded 500 ms in three participants; this resolved in all three.CONCLUSION: Interim safety and culture conversion outcomes for patients accessing BDQ in South Africa, including HIV-infected patients on ART and patients with pre-XDR- and XDR-TB, suggest that BDQ may be both efficacious and safe.