INSERM, U897 and ISPED, Université Victor Segalen, Bordeaux, France.
BMC Infect Dis. 2010 Oct 22;10:303. doi: 10.1186/1471-2334-10-303.
In France, it is estimated that 24% of HIV-infected patients are also infected with HCV. Longitudinal studies addressing clinical and public health questions related to HIV-HCV co-infection (HIV-HCV clinical progression and its determinants including genetic dimension, patients' experience with these two diseases and their treatments) are limited. The ANRS CO 13 HEPAVIH cohort was set up to explore these critical questions.To describe the cohort aims and organization, monitoring and data collection procedures, baseline characteristics, as well as follow-up findings to date.
Inclusion criteria in the cohort were: age > 18 years, HIV-1 infection, chronic hepatitis C virus (HCV) infection or sustained response to HCV treatment. A standardized medical questionnaire collecting socio-demographic, clinical, biological, therapeutic, histological, ultrasound and endoscopic data is administered at enrollment, then every six months for cirrhotic patients or yearly for non-cirrhotic patients. Also, a self-administered questionnaire documenting socio-behavioral data and adherence to HIV and/or HCV treatments is administered at enrollment and yearly thereafter.
A total of 1,175 patients were included from January 2006 to December 2008. Their median age at enrollment was 45 years and 70.2% were male. The median CD4 cell count was 442 (IQR: 304-633) cells/μl and HIV RNA plasma viral load was undetectable in 68.8%. Most participants (71.6%) were on HAART. Among the 1,048 HIV-HCV chronically co-infected patients, HCV genotype 1 was predominant (56%) and cirrhosis was present in 25%. As of January, 2010, after a median follow-up of 16.7 months (IQR: 11.3-25.3), 13 new cases of decompensated cirrhosis, nine hepatocellular carcinomas and 20 HCV-related deaths were reported, resulting in a cumulative HCV-related severe event rate of 1.9/100 person-years (95% CI: 1.3-2.5). The rate of HCV-related severe events was higher in cirrhotic patients and those with a low CD4 cells count, but did not differ according to sex, age, alcohol consumption, CDC clinical stage or HCV status.
The ANRS CO 13 HEPAVIH is a nation-wide cohort using a large network of HIV treatment, infectious diseases and internal medicine clinics in France, and thus is highly representative of the French population living with these two viruses and in care.
在法国,估计有 24%的 HIV 感染者同时感染 HCV。目前,针对 HIV-HCV 合并感染的临床和公共卫生问题(包括 HIV-HCV 的临床进展及其决定因素,如遗传维度、患者对这两种疾病及其治疗的体验)的纵向研究有限。ANRS CO 13 HEPAVIH 队列的成立是为了探索这些关键问题。本文旨在描述队列的目标和组织、监测和数据收集程序、基线特征以及迄今为止的随访结果。
该队列的纳入标准为:年龄>18 岁,HIV-1 感染,慢性丙型肝炎病毒(HCV)感染或对 HCV 治疗有持续应答。在入组时,我们采用标准化的医学问卷收集社会人口学、临床、生物学、治疗、组织学、超声和内镜数据,然后每 6 个月对肝硬化患者进行监测,每年对非肝硬化患者进行监测。此外,我们还在入组时和入组后每年发放一份自我管理问卷,记录社会行为数据以及 HIV 和/或 HCV 治疗的依从性。
2006 年 1 月至 2008 年 12 月期间,共纳入了 1175 例患者。入组时,患者的中位年龄为 45 岁,70.2%为男性。中位 CD4 细胞计数为 442(IQR:304-633)个/μl,68.8%的 HIV RNA 血浆病毒载量不可检测。大多数参与者(71.6%)正在接受抗逆转录病毒治疗。在 1048 例 HIV-HCV 慢性合并感染患者中,HCV 基因型 1 占主导地位(56%),25%的患者存在肝硬化。截至 2010 年 1 月,中位随访 16.7 个月(IQR:11.3-25.3)后,报告了 13 例失代偿性肝硬化新发病例、9 例肝细胞癌和 20 例 HCV 相关死亡,导致 HCV 相关严重事件累积发生率为 1.9/100 人年(95%CI:1.3-2.5)。肝硬化患者和 CD4 细胞计数较低的患者 HCV 相关严重事件发生率较高,但与性别、年龄、饮酒、CDC 临床分期或 HCV 状态无关。
ANRS CO 13 HEPAVIH 是一个全国性队列,使用法国的一个大型 HIV 治疗、传染病和内科诊所网络,因此非常代表法国同时感染这两种病毒并接受治疗的人群。