研究动态
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直接作用抗病毒药物对移民丙型肝炎病毒感染的检测与治疗模型的有效性:意大利的一项前瞻性干预研究。

Effectiveness of test-and-treat model with direct-acting antiviral for hepatitis C virus infection in migrants: a prospective interventional study in Italy.

发表日期:2024 May 28
作者: Nicola Coppola, Loredana Alessio, Stefania De Pascalis, Margherita Macera, Giovanni Di Caprio, Vincenzo Messina, Lorenzo Onorato, Carmine Minichini, Maria Stanzione, Gianfranca Stornaiuolo, Mario Starace, Caterina Monari, Federica Calò, Caterina Sagnelli, Mariantonietta Pisaturo
来源: MEDICINE & SCIENCE IN SPORTS & EXERCISE

摘要:

移民(主要是无证移民和低收入难民)感染丙型肝炎病毒(HCV)的风险很高,但又是难以接触和治疗的人群。该研究的目的是评估使用直接抗病毒药物治疗丙型肝炎病毒感染的测试和治疗模型对来自意大利南部的低收入移民的有效性。一项基于四项研究的前瞻性、多中心、合作研究阶段计划(教育咨询、筛查、护理和治疗联系)是在意大利南部设计的;该研究于 2018 年 6 月开始,因意大利爆发 SARS-CoV2 感染而于 2020 年 2 月停止,并于 2021 年 2 月恢复至 2021 年 11 月。在对通过血液或性匿名 HCV 筛查传播的传染病进行教育咨询后,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。 HCV-RNA 阳性受试者被转至传染病 (ID) 三级单位之一,并接受为期 12 周的索磷布韦-维帕他韦疗程,并在直接抗病毒药物 (DAA) 治疗结束后观察 12 周对于描述性分析,分类变量报告为绝对数和相对频率。如果正态分布,则连续变量总结为平均值和标准差 (SD);如果不是正态分布,则总结为中位数和四分位数范围 (IQR)。我们对分类变量使用 Pearson 卡方检验或 Fisher 精确检验,对连续变量使用 Student t 检验或 Mann-Whitney 检验。 P值 < 0.05被认为具有统计学显着性。采用SPSS 21.0进行分析。在研究期间观察的3501名移民中,有3417人(97.6%)同意接受筛查; 185 人 (4.7%) 为抗 HCV 阳性,其中 53 人 (28.6%) 为 HCV-RNA 阳性。在这 53 名受试者中,48 名 (90.5%) 被转至 ID 科并开始 DAA 治疗。 HCV-RNA 阳性受试者年龄较大 [中位数 36 岁 (IQR: 32-21) vs 27.19 (IQR: 30.5-19.25); P = 0.001],与血清阴性参与者相比,男性较少[35 (66.03 %) vs 119 (90.1%),P < 0.0001]。他们更频繁地来自东欧 (70.8%) 在意大利停留的时间更长 [在意大利停留的月数,平均值 ± 标准差:51.02 ± 52.84 vs 25.7 ± 42.65,P = 0.001],并且受教育年限较长 [受教育年数,平均值±SD:9.61±2.81 vs 7.10±4,P = 0.0001]。 HCV-RNA 阳性受试者较少将穿孔、纹身和部落疤痕报告为危险因素 (23.6%)。在这 48 名开始 DAA 的 HCV RNA 阳性受试者中,47 名(97.9%)显示出持续的病毒学应答,1 名在 DAA 治疗后随访中退出。没有受试者出现任何不良事件。这种 HCV 筛查和与护理挂钩的模式似乎可以有效消除难以接触和治疗的人群(例如无证移民和低收入难民)的 HCV 感染。文化调解者参与研究使得移民和医生之间更好的互动成为可能,这一点从大量的受试者中就可以看出。从公共卫生和医疗保健的角度来看,消除移民中的丙肝病毒将产生长期的积极影响,因为它可以减少可能出现肝硬化和肝细胞癌等丙肝病毒相关并发症的人数,并减少丙肝病毒在居住地区的传播。这些国家和意大利一样,HCV 感染的流行程度通常较低。© 2024。作者。
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.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.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.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.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.© 2024. The Author(s).