Interferon-free treatment with DAAs provides excellent chances for HCV elimination [19]. The WHO estimates the elimination of viral hepatitis by 2030; among the target populations that needed screening, linkage-to-care and treatment programs, there were also individuals originating from a country with an HCV prevalence of > 2% [7].
The migrants, although a high-risk population for HCV infection and, as young people, are an important source of infection from sexual intercourse, are a difficult-to-reach and-to-treat population, especially if undocumented or refugees from low-income countries, such as the population enrolled in the present study. Migrants lack access to optimal healthcare services due to different types of barriers, such as patient-physician communication, language problems, legal and bureaucratic barriers, beliefs in traditional medicine, ethnic disparities and inadequacies arising from socio-economic problems including a lack of family support [20]. On arrival at reception areas, infectious diseases are not a health priority for migrants. Moreover, migrants do not always have adequate knowledge of HCV infection, its evolution and treatment [21] and therefore remain undiagnosed and untreated [22].
With the present model we enrolled about 3,500 migrants from areas endemic for hepatitis virus infections. After an educational phase on the route of transmission, natural history and treatment availability for HCV infection, nearly 98% of subjects agreed to be evaluated and screened for hepatitis virus infections, about 90% of the HCV-RNA-positive patients were linked to care at one of the infectious disease units and started DAA treatment, and all but one obtained a sustained virological response. Thus, the program achieved outstanding success, probably because it was performed directly where the migrants were, that is, in humanitarian organizations, with free access even for migrants who did not have valid identification documents. These humanitarian organizations meet the basic needs of migrants (hot meals, and medical and legal assistance), and thus allowed us to enroll and link to care a difficult-to-manage population. In fact, one of the main problems of migrants was the lack of valid documents and these associations helped them, through legal tutelage, to get these valid documents, which allowed them to leave their anonymity condition and to become part of the community, only in this way could they hope to find work, improve their socio-economic condition and approach our national health service. For all these reasons the migrants willingly attended these associations and the rate of acceptance of the different phases of the program, from HCV screening to follow-up during and after DAA regimens, was very high.
Another key-point of the present program was the role of cultural mediators, who helped us gain the trust of the migrants and to overcome the bureaucratic, cultural and social problems in allowing HCV screening and managing infection in HCV subjects.
Specifically, our program consisted of four different phases. First, a phase of information and education on sexually transmitted infectious diseases and a subsequent phase of HCV screening. Informing migrants that there are sexually and parenterally transmitted infectious diseases widespread in their countries of origin made them aware that they could have contracted one of these infectious diseases. All this was demonstrated by the high percentage of subjects who agreed to be screened (about 98%). Most of them were unaware of the existence of infectious diseases potentially at risk to their health and did not know that there were treatments that would have avoided serious problems for their health. Furthermore, screening was free of charge and anonymous, and this was an additional incentive to make it easier for them to accept.
Interestingly, only 30% of anti-HCV-positive subjects were HCV-RNA-positive in the present study.
These data can be explained by the fact that they come from a population-based study, and not from analysis performed in liver units. Thus, the data of the present study may be useful to clarify the prevalence of HCV in the general population of migrants and a warning for the Italian Healthcare Authorities to develop suitable cost-effective screening policies in this setting.
There are no standardized screening programs for infectious diseases in migrants worldwide: for example, in the US, the immigration medical examination does not include tests for viral hepatitis [23]; testing for viral hepatitis is not mandated also in Canada, even in patients originating from countries with high prevalence [24]; in the EU region, instead, the immigration medical screening policies are country-specific [25]. Even in Italy there is no screening program organized by the Italian national health system but there are initiatives by individual clinical research groups that deal with the screening of migrants. In these experiences the prevalence of anti-HCV-positive-migrants varied from 0.9–20% [10, 11, 15].
In the third and fourth phases, the HCV-RNA-positive patients were linked to care at one of the Infectious Disease units participating in the study and were treated with sofosbuvir plus velpatasvir for 12 weeks. We obtained a linkage-to-care percentage of almost 90% and an SVR at an intention to treat analysis of about 98%.
In line with our results, Prestileo et al investigating 2,639 migrants arrived in Sicily, Southern Italy, showed 24 (0.9%) anti-HCV-positive; of these 24, 18 subjects were HCV RNA positive and 11 (61%) received DAA therapy, 10 (90%) of them completed therapy and achieved sustained virological response, and one patient was lost to follow-up after 4 weeks of therapy [11].
Undiagnosed and untreated cases of viral hepatitis among migrants are important points that favor the growing morbidity and mortality. It is known that without treatment, approximately 20% of people with chronic HCV infection progress to liver cirrhosis, which can lead to end-stage liver disease and the development of HCC [26], with important implications for the host country's healthcare system.
Moreover, despite the availability of effective therapies, DAA based regimens were only moderately cost-effective and as a result less than 30% of people with HCV had been screened and less 5% of all HCV cases had been treated in the EU/EEA in 2015. Migrants had additional barriers in linkage to care and treatment due to several health system barriers [8].
Few studies have been published at present on the care and DAA-treatment outcome of HCV-positive migrants due to the scanty possibility of screening, late submission to a clinical center authorized for the free administration of drugs and poor adherence to treatment and follow-up. For example, in the Canadian Network Undertaking against Hepatitis C (CANUHC), including 725 HCV-infected patients assessed for DAA treatment (18.5% were born outside the country) among migrants and native subjects, there was a similar proportion of subjects initiating DAA therapy (56.7% vs 49.9%) and SVR rates (89.4% vs. 92.5%) [27]. In another study conducted in Spain on 175 immigrant patients treated with DAAs, an SVR was obtained in 156 (89.1%) [28]. Yasseen. et al [29], using laboratory and health administrative records, described HCV cascades of care in a large population-based cohort in Ontario, Canada (1997–2014): this population study included 23,759 screened migrants, from these 14,802 (62%) were anti-HCV-positive, 11,290 (76%) were tested for HCV-RNA, 6,731 (60%) were HCV-RNA-positive, 6,493 (96%) were genotyped, 2,319 (36%) started treatment, 986 (55%) obtained viral clearance.