Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA.
Emory School of Medicine, Emory University, Atlanta, GA.
J Acquir Immune Defic Syndr. 2020 Jan 1;83(1):47-55. doi: 10.1097/QAI.0000000000002190.
South Africa has among the highest incidence of multidrug-resistant tuberculosis (MDR-TB) and more than 70% of patients are HIV co-infected. MDR-TB treatment is associated with frequent adverse events (AEs). Although guidelines recommend concurrent treatment of MDR-TB and HIV, safety data on concurrent therapy are limited.
We conducted a prospective observational study of MDR-TB patients with and without HIV-coinfection in South Africa between 2011 and 2015. Participants received standardized MDR-TB and HIV regimens. Participants were followed monthly for the duration of MDR-TB therapy and screened for clinical and laboratory AEs. Audiometry was performed monthly during the intensive phase; color discrimination testing was performed every 2 months.
We enrolled 150 HIV-infected and 56 HIV-uninfected participants. Nearly all experienced at least one clinical (93%) or laboratory (96%) AE. The most common clinical AEs were peripheral neuropathy (50%) and difficulty sleeping (48%); the most common laboratory AEs were hypokalemia (47%) and decreased creatinine clearance (46%). Among 19 clinical and lab AEs examined, there were no differences by HIV status, except for diarrhea (27% HIV-infected vs. 13% HIV-uninfected, P = 0.03). Hearing loss was experienced by 72% of participants (8% severe loss). Fourteen percent experienced color discrimination loss (4% severe loss). There were no differences in frequency or severity of hearing or vision loss by HIV status.
AEs were common, but not more frequent or severe among MDR-TB/HIV co-infected participants receiving concurrent antiretroviral therapy. Given the favorable treatment outcomes associated with concurrent treatment, antiretroviral therapy initiation should not be delayed in MDR-TB patients with HIV-coinfection.
南非的耐多药结核病（MDR-TB）发病率居世界首位，超过 70%的患者同时感染 HIV。MDR-TB 治疗常伴有频繁的不良反应（AE）。尽管指南建议同时治疗 MDR-TB 和 HIV，但同时治疗的安全性数据有限。
我们在 2011 年至 2015 年间，在南非对 MDR-TB 合并与不合并 HIV 感染的患者进行了一项前瞻性观察性研究。参与者接受了标准化的 MDR-TB 和 HIV 治疗方案。在 MDR-TB 治疗期间，参与者每月接受一次随访，并筛查临床和实验室 AE。强化期每月进行一次听力测试；每两个月进行一次颜色辨别测试。
我们纳入了 150 名 HIV 感染者和 56 名 HIV 阴性者。几乎所有参与者都经历过至少一次临床（93%）或实验室（96%）AE。最常见的临床 AE 是周围神经病（50%）和睡眠困难（48%）；最常见的实验室 AE 是低钾血症（47%）和肌酐清除率降低（46%）。在检查的 19 种临床和实验室 AE 中，除腹泻（27%的 HIV 感染者和 13%的 HIV 阴性者，P=0.03）外，HIV 状态无差异。72%的参与者出现听力损失（8%为严重损失）。14%的参与者出现色觉丧失（4%为严重丧失）。HIV 状态与听力或视力丧失的频率或严重程度无差异。
AE 很常见，但在接受同时抗逆转录病毒治疗的 MDR-TB/HIV 合并感染患者中，并不比单独感染 HIV 的患者更频繁或更严重。鉴于同时治疗与有利的治疗结局相关，不应因 HIV 合并感染而延迟 MDR-TB 患者开始抗逆转录病毒治疗。
