印度早期婴儿诊断（EID）项目下诊断出的18个月以下HIV阳性婴儿的临床结局：一项混合方法研究。

Clinical outcomes among HIV positive babies below 18 months of age, diagnosed under the Early Infant Diagnosis (EID) programme, India: a mixed-methods study.

作者信息

Kamble Suchit, Gawde Nilesh, Bembalkar Shilpa, Goel Noopur, Thorwat Mohan, Nikhare Kalyani, Kamble Sushmita, Brahme Radhika, Pawar Swapna, Kubavat Harsh, Kushwaha Bhawanisingh, Verma Vinita, Das Chinmoyee, Gangakhedkar Raman

机构信息

ICMR-National Institute of Translational Virology and AIDS Research, Pune, India.

Tata Institute of Social Sciences, Mumbai, India.

出版信息

Lancet Reg Health Southeast Asia. 2025 Feb 6;34:100540. doi: 10.1016/j.lansea.2025.100540. eCollection 2025 Mar.

DOI:10.1016/j.lansea.2025.100540

PMID:40007744

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11849106/

Abstract

BACKGROUND

Early Anti-Retroviral Therapy (ART) initiation among infants with perinatally acquired HIV is known to impact clinical outcomes and survival. Early Infant Diagnosis (EID) was initiated in programme settings in India in 2010. Its impact on the clinical outcomes of infants covered under the programme and associated determinants have not been reported.

METHODS

This was a mixed-methods study. Quantitative clinical data of 310 children on ART with HIV diagnosis before 18 months of age was collected from the treatment cards across 30 ART centres from 11 states of India using a retrospective cohort design. A total of 67 In-depth interviews with healthcare providers and managers helped to understand the underlying causes.

FINDINGS

Out of 310 infants, 200 (64.5%) were on ART, and 36 (11.6%) were lost to follow-up, and 25 (8.1%) had died. The median age at HIV diagnosis was 231.5 (130, 405) days, and the median age at ART initiation was 309 (198, 456) days. Three-year survival was 91%. Baseline CD4 count less than 1500 cells/mm had a higher hazard for mortality (hazard ratio 11.39 (CI: 1.45, 89.45), p = 0.021) as well as for either mortality or development of opportunistic infections (hazard ratio 4.87 (CI: 1.56, 15.15), p = 0.006). WHO clinical stages III and IV had hazard ratios of 2.42 ((CI: 1.43, 4.09), p = 0.001) for mortality and 1.92 ((CI: 1.28, 2.88), p = 0.001) for death or development of opportunistic infections. Demand-side issues such as stigma and discrimination at family, community, and societal levels, desperation about the survival of the child, supply-side factors such as remote access to paediatric ART centres, and lack of paediatric ART medicine formulations were associated with ART treatment.

INTERPRETATION

Overall survival was good for those who continued on treatment, but mortality was high for those with poor immunological and clinical parameters. Retention in care needs to be ensured for better clinical outcomes.

FUNDING

The study was commissioned by the National AIDS Control Programme (T.11020/98/2014-NACO (R&D)) and funded through The Global Fund Against AIDS, TB and Malaria (GFATM) grant.

摘要

背景

已知对围产期感染艾滋病毒的婴儿尽早开始抗逆转录病毒治疗（ART）会影响临床结局和生存情况。2010年印度在项目实施地区启动了早期婴儿诊断（EID）。其对该项目覆盖的婴儿临床结局及相关决定因素的影响尚未见报道。

方法

这是一项混合方法研究。采用回顾性队列设计，从印度11个邦30个ART中心的治疗卡片中收集了310名18个月龄前确诊感染艾滋病毒且正在接受ART治疗儿童的定量临床数据。对医疗服务提供者和管理人员进行了67次深入访谈，以了解其潜在原因。

结果

在310名婴儿中，200名（64.5%）正在接受ART治疗，36名（11.6%）失访，25名（8.1%）死亡。艾滋病毒诊断时的中位年龄为231.5（130，405）天，开始ART治疗时的中位年龄为309（198，456）天。三年生存率为91%。基线CD4细胞计数低于1500个/mm有更高的死亡风险（风险比11.39（CI：1.45，89.45），p = 0.021），以及死亡或发生机会性感染的风险（风险比4.87（CI：1.56，15.15），p = 0.006）。世界卫生组织临床分期III和IV的死亡风险比为2.42（（CI：1.43，4.09），p = 0.001），死亡或发生机会性感染的风险比为1.92（（CI：1.28，2.88），p = 0.001）。家庭、社区和社会层面的耻辱感和歧视等需求方问题、对儿童生存的绝望情绪、获得儿科ART中心服务不便等供应方因素以及缺乏儿科ART药物剂型均与ART治疗相关。