Screening guide for Hepatitis C Virus infection in Spain

Since the Plan Estratégico para el Abordaje de la Hepatitis C [Strategic Plan for Tackling Hepatitis C] (PEAHC) of the Spanish Health Service (SNS) was approved in 2015, the joint response to hepatitis C in Spain has made great progress. From 2015 to mid-2020, more than 135,000 people had access to direct-acting antiviral therapies. That same period saw advances in knowledge of the epidemiology of the active infection as well as heightened awareness and community participation in infection prevention.

To provide continuity to the PEAHC, the Spanish Ministry of Health just published the Guía de cribado de la infección por el VHC [Screening Guide for Hepatitis C Virus (HCV) Infection] (https://www.mscbs.gob.es/ciudadanos/enfLesiones/enfTransmisibles/sida/docs/GUIA_DE_CRIBADO_DE_LA_INFECCION_POR_EL_VHC_2020.pdf), which includes advice on screening for hepatitis C virus and linking diagnosed people to follow-up care and treatment.

This guide is the result of a joint effort coordinated by the Secretaría del Plan Nacional sobre el sida [Secretariat of the Spanish Plan on acquired immunodeficiency syndrome (AIDS)], in collaboration with the Screening Programmes Unit of the Spanish Ministry of Health's Directorate General of Public Health and with the participation of representatives from different spheres: the Plan nacional sobre drogas [Spanish Plan on Drugs]; Centro Nacional de Epidemiología [Spanish Epidemiology Centre]; epidemiology departments and screening programmes in the different autonomous regions of Spain; prison health; the PEAHC scientific advisory board; scientific organisations (Asociación Española para el Estudio del Hígado [Spanish Association for the Study of the Liver] [AEEH], Alianza para la Eliminación de las Hepatitis Víricas en España [Alliance for the Elimination of Viral Hepatitis in Spain] [AEHVE], Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica-Grupo de Estudio de las Hepatitis Víricas [Spanish Association for Infectious Diseases and Clinical Microbiology-Study Group for Viral Hepatitis] [SEIMC-GEHEP], Grupo de Estudio de Sida [Study Group for AIDS] [GeSIDA], Sociedad Española Interdisciplinaria del SIDA [Interdisciplinary Spanish Association for AIDS] [SEISIDA], Sociedad Española de Medicina de Familia y Comunitaria [Spanish Association for Family and Community Medicine] [SEMFyC], Sociedad Española de Médicos Generales y de Familia [Spanish Association for General Practitioners and Family Physicians] [SEMG] and Sociedad Española de Médicos de Atención Primaria [Spanish Association for Primary Care Physicians] [SEMERGEN]); and patient associations and non-governmental organisations (NGOs) (Plataforma de Afectados por Hepatitis C Madrid [Platform for Individuals Affected by Hepatitis C] [PLAFHC], PLAFHC Madrid, Coordinadora estatal de VIH y sida [State Coordinator for Human Immunodeficiency Virus (HIV) and AIDS] [CESIDA], Apoyo Positivo [Positive Support], Federación Nacional de Enfermos y Trasplantados Hepáticos [Spanish Federation of Liver Patients and Transplant Recipients] [FNETH] and Grupo de Trabajo sobre Tratamientos del VIH [Working Group on HIV Treatments] [gTt-HIV]). The document is recognised by the Ponencia de cribado poblacional [Population Screening Report], the World Health Organization (WHO) Regional Office for Europe and expert personnel from the Barcelona Institute for Global Health.

As with all early detection activities, HCV may be detected as part of population-based screening programmes or through opportunistic case-finding, which is non-systematic at the request of the person concerned, or in taking advantage of a person making contact with the healthcare system for other reasons. Population screening programmes are essential care and prevention programmes in public health, and health authorities are responsible for establishing policies in this regard. Such programmes involve comprehensive identification of the entire population and implementation of mechanisms to locate candidates for screening by letters, telephone calls and other proactive methods. One example of such a programme is breast cancer screening. Population screening programmes must be guided by the principles set forth in the Spanish General Public Health Law: equity, relevance, precaution, evaluation, transparency, comprehensiveness and safety.

A number of different criteria were taken into account when deciding on the best HCV screening strategy and the recommendations for suitable implementation contained in this guide. A seroprevalence study found Spain to be a country with a low prevalence of HCV, with 0.22% of the general population having active infection. However, despite the efforts made, 29.4% (22,478) of those people had not been diagnosed, and around a fifth of those diagnosed were not being monitored and had not started treatment. The guide reviews the prevalence in populations with different risk factors for exposure, all of which have higher rates than the general population.

In addition to the epidemiological situation, the following were also taken into account: the history of risk factors in more than 80% of people with active HCV infection, the priority of overcoming the barriers to accessing diagnosis for the most affected populations, insufficient evidence on the efficacy and cost-effectiveness of screening the general population, and the feasibility of screening by risk factors for exposure, as it is already included in the portfolio of services.

Based on the evidence considered, HCV screening is indicated in people with risk factors for exposure to transmission of HCV, such as injected and/or inhaled drug use, unprotected sex, coinfection with HIV and/or hepatitis B virus (HBV), procedures for health-related or cosmetic purposes performed without the proper safety precautions, time spent in prison, or origin from a country with a medium to high prevalence of HCV infection. Screening for HCV infection is not recommended in asymptomatic people with no risk factors for exposure.

This indication will be reviewed based on the results of the report requested from the Red Española de Agencias de Evaluación de Tecnologías Sanitarias Y Prestaciones del Sistema Nacional de Salud [Spanish Network of Agencies for Assessment of Health Technologies and Services] of the SNS concerning the evidence on clinical efficacy and cost-effectiveness of population-based screening and opportunistic screening with various assumptions, including that of birth cohorts.

At this point, efforts must be made to improve access to diagnosis and linking to follow-up care and treatment. In these realms, gastroenterology and hepatology departments have been, and continue to be, key players. The guide makes several proposals on this subject, including continuing advocacy of one-step diagnosis, which in recent years has achieved widespread implementation thanks to the impetus of healthcare professionals in hepatology, microbiology and infectious diseases. The guide also recommends adaptation of care for vulnerable people. For example, it includes several initiatives on multidisciplinary care at centres for people with drug addiction, in which a complete diagnosis and supply of treatment would be done at these centres. Other experiences describe community interventions for the promotion of screening in the migrant population from countries with high prevalence, collaboration with primary care to improve detection among people with risk factors for exposure and a search for people in health registries who have a diagnosis of HCV but no record of subsequent monitoring and treatment. This recommendation falls under the current legislative framework.

We would like to thank the journal Gastroenterología y Hepatología [Gastroenterology and Hepatology] and Revista Española de las Enfermedades Digestivas [Spanish Journal of Gastrointestinal Diseases] for this editorial space to present the Screening Guide for HCV Infection. We encourage all professionals to read the guide and spread the word, and to be part of the necessarily multidisciplinary, coordinated and equitable response to hepatitis C in Spain.