Principles for implementing a population screening strategy for hepatitis C in Spain.

BACKGROUND: hepatitis C, besides health impairment, results in significant loss of productivity and diminished quality of life, and noticeably contributes to health expenditure increases. Because of all this, the Spanish Ministry of Health (Ministerio de Sanidad, Consumo y Bienestar Social - MSCBS) implemented in 2015 a strategic plan for managing hepatitis C (Plan Estratégico para el Abordaje de la Hepatitis C - PEAHC) within the National Health System. However, the PEAHC includes no screening plan. The MSCBS developed a framework document on population screening (Documento Marco sobre Cribado Poblacional) that defines the criteria a disease must meet in order to consider implementing a screening program. Specifically, it defines 4 criteria related to the health issue, 4 related to the screening test, and 3 criteria dealing with diagnosis confirmation and treatment. OBJECTIVE: to identify whether there is scientific evidence to support hepatitis C meeting the criteria to be considered a disease qualifying for a population screening strategy in Spain. METHODS: a literature search for scientific evidence concerning each required criterion for implementing a population screening plan for hepatitis C in Spain. RESULTS: sufficient scientific evidence was found to support hepatitis C meeting the criteria required by the MSCBS for the implementation of a population screening program. CONCLUSIONS: according to the available scientific evidence, hepatitis C in Spain meets the required criteria to qualify for consideration of population screening plan.

The efficiency of several one-step testing strategies for the diagnosis of hepatitis C.

BACKGROUND: implementing one-step strategies for hepatitis C diagnosis would help shorten the time to treatment access. Thus avoiding disease progression and complications, while facilitating hepatitis C virus (HCV) elimination. OBJECTIVE: to assess the validity and certainty of potential one-step strategies for the diagnosis of HCV infection and their associated cost and efficiency. METHODS: the study design is an economic appraisal of efficiency (cost/efficacy) using decision trees and deterministic sensitivity analysis. The analysis was performed from the payer perspective (Spanish National Health System), which exclusively considers the direct costs. Only the differential costs (diagnostic testing costs) were taken into account and the study was set in Spain. The efficacy of a diagnostic strategy was defined as the percentage of patients with an active HCV infection who received a positive diagnosis and the efficiency was defined as the cost per patient with a correctly diagnosed and active infection. RESULTS: the one-step strategies evaluated for the diagnosis of HCV had an acceptable validity and certainty due to the high sensitivity and specificity of the considered tests. The Ab-Ag strategy was the most efficient, followed by Ab-Ag-VL and Ab-VL. Ab-Ag was the most efficient due to the lower cost per patient tested, although the efficacy was lower than the Ab-VL efficacy. CONCLUSION: the study findings may help to establish more appropriate one-step diagnostic approaches whilst considering the efficacy and efficiency.

Diagnosis of hepatitis C virus infection in Spain: An opportunity to improve. / El diagnóstico de la infección por el virus de la hepatitis C en España: una oportunidad para mejorar.

BACKGROUND: Reflex testing of antibodies and viral load in the same sample for diagnosing hepatitis C virus infection speeds up access to treatment. However, how hepatitis C is diagnosed in Spanish hospitals is unknown. OBJECTIVE: To describe the available resources and procedures for the diagnosis of hepatitis C virus infection in Spain. METHODS: Survey sent to public and private Spanish hospitals with teaching accreditation with at least 200 beds. RESULTS: Of the 160 hospitals that met the inclusion criteria, 90 centres (response rate 56.3%) completed the survey. Two hospitals (2.2%) have no diagnostic resources, 15 (16.7%) can only test for anti-hepatitis C virus(Ab), 9 (10.0%) for Ab and viral load, 47 (52.2%) for Ab, viral load and genotype, 2 (2.2%) for Ab, viral load and core antigen, and 15 (16.7%) can perform Ab, core antigen, viral load and genotype tests. When an Ab test is positive, 28 (31.1%) hospitals perform reflex testing. When an active infection is diagnosed, some communication strategy is used in 62 (68.9%) hospitals. Approximately 44.2% of the respondents believe that all determinations needed to reach a definitive diagnosis should be done on a single blood sample. CONCLUSION: Although 81% of Spanish hospitals have the resources to perform reflex hepatitis C virus infection testing, it is only done in 31%, and less than a half of respondents believe that the definitive diagnosis should be performed on a single sample.