背景:移民,主要是无证和低收入难民,丙型肝炎病毒(HCV)感染的高风险,但是是一个难以接触和治疗的人群。该研究的目的是评估直接抗病毒治疗HCV感染的测试和治疗模型的有效性,这些移民来自低收入和居住在意大利南部。
方法:前瞻性,多中心,基于四个阶段计划的合作研究(教育咨询,筛选,联系护理和治疗)是在意大利南部设计的;该研究于2018年6月开始,由于意大利爆发SARS-CoV2感染,于2020年2月停止,并于2021年2月恢复至2021年11月。在通过血液或性假名HCV筛查传播的传染病的教育咨询之后,向在一级临床中心之一观察到的所有无证移民和低收入难民提供了筛查。将HCV-RNA阳性受试者转诊至传染病(ID)的三级单位之一,并且用索非布韦-维帕他韦治疗12周疗程,并且在直接抗病毒剂(DAA)治疗结束后观察12周。
方法:对于描述性分析,分类变量报告为绝对数和相对频率.如果呈正态分布,则将连续变量总结为平均值和标准偏差(SD),或作为中位数和四分位数范围(IQR),如果不是正态分布。我们对分类变量使用Pearson卡方或Fisher精确检验,对连续变量使用Studentt检验或Mann-Whitney检验。P值<0.05被认为是统计学上显著的。使用SPSS21.0进行分析。
结果:在研究期间观察到的3501名移民中,3417(97.6%)同意进行筛查;185(4.7%)抗HCV阳性,其中,HCV-RNA阳性53例(28.6%)。在这53个科目中,48例(90.5%)被转诊到ID单元并开始DAA治疗。HCV-RNA阳性受试者年龄较大[中位数36岁(IQR:32-21)vs27.19岁(IQR:30.5-19.25);P=0.001],男性频率较低[35(66.03%)对119(90.1%),P<0.0001]比血清阴性参与者。他们更频繁地来自东欧(70.8%)在意大利停留的时间更长[在意大利停留数月,平均值±SD:51.02±52.84vs25.7±42.65,P=0.001],接受了更多年的教育[接受了更多年的教育,平均值±SD:9.61±2.81vs7.10±4,P=0.0001]。HCV-RNA阳性受试者较少报告穿刺,纹身和部落疤痕是危险因素(23.6%)。在这48名开始DAA的HCVRNA阳性受试者中,47例(97.9%)在DAA治疗后的随访中显示出持续的病毒学应答和1例退出。没有受试者有任何不良事件。
结论:这种HCV筛查和与护理联系的模型似乎可以有效地消除难以接触和治疗的人群中的HCV感染,例如无证移民和低收入难民。文化调解人参与研究使移民和医生之间更好的互动成为可能,从大量的受试者中可以明显看出。从公共卫生和医疗保健的角度来看,消除移民中的HCV将产生长期的积极影响,通过减少可能发生HCV相关并发症如肝硬化和肝细胞癌的人数,并减少HCV在宿主地区的循环他们,就像意大利的情况一样,HCV感染的地方性低。
BACKGROUND: Migrants, mainly undocumented and low-income refugees, are at high risk of hepatitis C virus (HCV) infection, but are a difficult-to-reach and to-treat population. The aim of the
study was to evaluate the effectiveness of a test and treat model with direct-acting antiviral for HCV infection in these migrants coming from low-income and living in southern Italy.
METHODS: A prospective, multicenter, collaborative
study based on a four-phase-program (educational counseling, screening, linkage-to-care and treatment) was designed in southern Italy; the
study started in June 2018, was stopped in February 2020 because of the outbreak of SARS-CoV2 infection in Italy and was resumed in February 2021 until November 2021. After educational counseling on infectious diseases that are transmitted through blood or sexually pseudonymized HCV screening was offered to all undocumented migrants and low-income refugees observed at one of the 1st level clinical centers. The HCV-RNA-positive subjects were referred to one of the 3rd level units of Infectious Diseases (ID) and treated with a 12-week course of
sofosbuvir-velpatasvir and observed for 12 weeks after the end of direct antiviral agents (DAA) treatment.
METHODS: For the descriptive analysis, the categorical variables were reported as absolute numbers and relative frequencies. Continuous variables were summarized as mean and standard deviation (SD) if normally distributed, or as a median and interquartile range (IQR) if not normally distributed. We used Pearson chi-square or Fisher\'s exact test for categorical variables and Student\'s t test or Mann-Whitney test for continuous variables. A P value < 0.05 was considered to be statistically significant. Analyses were performed with SPSS 21.0.
RESULTS: Of the 3501migrants observed in the
study period, 3417 (97.6%) agreed to be screened; 185 (4.7%) were anti-HCV-positive and, of these, 53 (28.6%) were HCV-RNA-positive. Of these 53 subjects, 48 (90.5%) were referred to an ID unit and started DAA treatment. The HCV-RNA-positive-subjects were older [median 36 years (IQR: 32-21) vs 27.19 (IQR: 30.5-19.25); P = 0.001], and less frequently males [35 (66.03 %) vs 119 (90.1%), P < 0 .0001] than seronegative participants. They more frequently came from Eastern Europe (70.8%) stayed longer in Italy [months of stay in Italy, mean ± SD: 51.02 ± 52.84 vs 25.7 ± 42.65, P = 0.001], and had more years of schooling [years of schooling, mean ± SD: 9.61±2.81 vs 7.10 ± 4, P = 0.0001]. HCV-RNA-positive-subjects less frequently reported piercing, tattoos and tribal scars as risk factors (23.6%). Of these 48 HCV RNA positive subjects who started DAA, 47 (97.9%) showed a sustained virological response and one dropped-out in follow-up after DAA treatment. No subject had any adverse event.
CONCLUSIONS: This model of HCV screening and linkage to care seems effective to eliminate HCV infectionin a difficult-to-reach and to-treat population, such as undocumented migrants and low-income refugees. The participation of cultural mediators in the study made possible a better interaction between migrants and physicians, as is evident from the large number of subjects enrolled. Eliminating HCV among migrants will have a long-term positive impact from a public health and healthcare perspective by reducing the number of individuals who potentially develop HCV-related complications such as liver cirrhosis and hepatocellular carcinoma and reducing the circulation of HCV in the regions that host them which often, as in the case of Italy, are low endemic for HCV infection.