Leishmaniasis Research and Treatment Centre, University of Gondar, Gondar, Ethiopia.
MRC Tropical Epidemiology Group, London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS Negl Trop Dis. 2019 Feb 21;13(2):e0007132. doi: 10.1371/journal.pntd.0007132. eCollection 2019 Feb.
The long-term treatment outcome of visceral leishmaniasis (VL) patients with HIV co-infection is complicated by a high rate of relapse, especially when the CD4 count is low. Although use of secondary prophylaxis is recommended, it is not routinely practiced and data on its effectiveness and safety are limited.
A prospective cohort study was conducted in Northwest Ethiopia from August 2014 to August 2017 (NCT02011958). HIV-VL patients were followed for up to 12 months. Patients with CD4 cell counts below 200/μL at the end of VL treatment received pentamidine prophylaxis starting one month after parasitological cure, while those with CD4 count ≥200 cells/μL were followed without secondary prophylaxis. Compliance, safety and relapse-free survival, using Kaplan-Meier analysis methods to account for variable time at risk, were summarised. Risk factors for relapse or death were analysed.
Fifty-four HIV patients were followed. The probability of relapse-free survival at one year was 50% (95% confidence interval [CI]: 35-63%): 53% (30-71%) in 22 patients with CD4 ≥200 cells/μL without pentamidine prophylaxis and 46% (26-63%) in 29 with CD4 <200 cells/μL who started pentamidine. Three patients with CD4 <200 cells/μL did not start pentamidine. Amongst those with CD4 ≥200 cells/μL, VL relapse was an independent risk factor for subsequent relapse or death (adjusted rate ratio: 5.42, 95% CI: 1.1-25.8). Except for one case of renal failure which was considered possibly related to pentamidine, there were no drug-related safety concerns.
The relapse-free survival rate for VL patients with HIV was low. Relapse-free survival of patients with CD4 count <200cells/μL given pentamidine secondary prophylaxis appeared to be comparable to patients with a CD4 count ≥200 cells/μL not given prophylaxis. Patients with relapsed VL are at higher risk for subsequent relapse and should be considered a priority for secondary prophylaxis, irrespective of their CD4 count.
患有人类免疫缺陷病毒（HIV）合并内脏利什曼病（VL）的患者，其长期治疗结局较为复杂，复发率较高，尤其是在 CD4 计数较低时。虽然推荐使用二级预防措施，但并未常规实施，且其有效性和安全性的数据有限。
本前瞻性队列研究于 2014 年 8 月至 2017 年 8 月在埃塞俄比亚西北部进行（NCT02011958）。对 HIV-VL 患者进行长达 12 个月的随访。VL 治疗结束时 CD4 细胞计数低于 200/μL 的患者在寄生虫学治愈后一个月开始接受喷他脒预防治疗，而 CD4 计数≥200 细胞/μL 的患者则不进行二级预防。使用 Kaplan-Meier 分析方法总结了依从性、安全性和无复发生存率，该方法考虑了可变的风险时间。分析了复发或死亡的风险因素。
对 54 例 HIV 患者进行了随访。一年无复发生存率为 50%（95%置信区间[CI]：35-63%）：22 例 CD4≥200 细胞/μL 且未接受喷他脒预防治疗的患者中为 53%（30-71%），29 例 CD4<200 细胞/μL 且开始接受喷他脒治疗的患者中为 46%（26-63%）。3 例 CD4<200 细胞/μL 的患者未开始使用喷他脒。在 CD4≥200 细胞/μL 的患者中，VL 复发是随后复发或死亡的独立风险因素（调整后的风险比：5.42，95%CI：1.1-25.8）。除了一例被认为可能与喷他脒有关的肾功能衰竭外，没有药物相关的安全性问题。
HIV 合并 VL 患者的无复发生存率较低。给予 CD4 计数<200 细胞/μL 的患者喷他脒二级预防的无复发生存率似乎与未接受预防治疗的 CD4 计数≥200 细胞/μL 的患者相当。VL 复发的患者有更高的复发风险，应被视为二级预防的优先对象，而与 CD4 计数无关。
