Estudio de calidad de vida en pacientes asintomáticos con hepatitis C / No disponible

OBJETIVO Y MÉTODOS: estudio observacional, longitudinal, prospectivo en el que se evaluaron los cambios en la percepción de calidad de vida en pacientes asintomáticos con hepatitis C tratados con antivirales de acción directa. RESULTADOS: los cuestionarios SF-36 y EQ-5D-5L realizados sobre 86 pacientes tratados y 12 pacientes control demostraron mejoría de varios parámetros (función física, dolor corporal, salud general, vitalidad y función social), sobre todo cuando se compara la percepción antes del tratamiento y tras finalizar el seguimiento después de la curación. CONCLUSIÓN: estos datos apoyan la hipótesis de que el virus de la hepatitis C puede causar empeoramiento en la calidad de vida de los pacientes asintomáticos

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Pacientes con hepatitis C perdidos en el sistema: aspectos éticos-legales y resultados de su búsqueda / No disponible

INTRODUCCIÓN: se conoce la existencia de pacientes con hepatitis C perdidos en el sistema, pero se desconocen su prevalencia y características. Además, su identificación colisiona con la barrera de la protección de datos. MÉTODOS: se presentó un protocolo de identificación y contacto al Comité de Ética Asistencial. Se obtendrían las serologías anti-VHC+ de Microbiología entre 2010-18. Se analizaría su situación en la base de datos hospitalaria y regional. Se clasificarían: a) hepatitis C crónica, si última determinación de ARN-VHC+; b) hepatitis C curada, si última determinación de ARN-VHC- tras 12 semanas de tratamiento; c) hepatitis C posible, si anti-VHC+ sin determinación de ARN-VHC. Se considerarían perdidos aquellos con hepatitis C crónica o posible sin seguimiento en Digestivo o Medicina Interna. Se contactaría con ellos mediante correo postal y, posteriormente, por teléfono para ofrecerles tratamiento. RESULTADOS: el Comité de Ética consideró que el protocolo cumplía los principios bioéticos de autonomía, beneficencia, no maleficencia y justicia, y que el contacto era éticamente deseable. Sobre 4.816 serologías anti-VHC+ identificamos 677 pacientes perdidos (14,06 %; IC 95 %: 13,2-15,2): edad 54 años, 61 % hombres, 12 % extranjeros y 95 % monoinfectados. Se consumieron 1,3 minutos en el estudio de cada serología. Un 25 % de las perdidas habían sido solicitadas por Digestivo o Medicina Interna. De los 677 perdidos, 228 (33,7 %) tenían también ARN-VHC+ y 449 (66,3 %) solo tenían solicitada la serología. CONCLUSIÓN: un número importante de pacientes con hepatitis C se encuentran perdidos en el sistema. Su búsqueda y contacto es posible desde el punto de vista ético-legal

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Patients with hepatitis C lost to follow-up: ethical-legal aspects and search results.

INTRODUCTION: data on the prevalence and characteristics of hepatitis C patients lost to follow-up are lacking. In addition, the identification of this population clashes with data protection regulations. METHODS: the identification and contact protocol was submitted to the Health Care Ethics Committee. The protocol was based on anti-HCV serology test results for 2010-2018, which were obtained from the Microbiology Department. In addition, the situation of the patients in the hospital and regional database was analyzed, based on the following classification: a) chronic hepatitis C, if the last HCV RNA determination was positive; b) cured hepatitis C, if the last HCV RNA determination was negative after 12 weeks of treatment; and c) possible hepatitis C, if anti-HCV antibodies were positive with no result for HCV RNA. Lost patients were defined as those with chronic or possible hepatitis C and no follow-up in the Digestive Diseases or Internal Medicine Departments. The patients were contacted by postal mail and then by telephone, so that they could be offered treatment. RESULTS: the Ethics Committee considered that the protocol fulfilled the bioethical principles of autonomy, beneficence, non-maleficence and justice and that contact was ethically desirable. From 4,816 positive anti-HCV serology results, 677 patients were identified who were lost to follow-up (14.06 %; 95 % CI, 13.2-15.2). The mean age was 54 years, 61 % were male, 12 % were foreign born and 95 % were mono-infected. The study of each serology result took 1.3 minutes. One-quarter (25 %) of the losses corresponded to the Digestive Diseases and Internal Medicine Departments. Of the 677 losses, serology testing had only been ordered for 449 patients (66.3 %) and the remaining 228 (33.7 %) also had a positive HCV RNA result. CONCLUSION: a large number of patients with hepatitis C are lost to follow-up. Searching for and contacting these patients is legally and ethically viable.

Quality of life study in asymptomatic patients with hepatitis C.

OBJECTIVE AND METHODS: an observational, longitudinal, prospective study was performed to assess changes in perceived quality of life in asymptomatic patients with hepatitis C under treatment with direct-acting antivirals. Questionnaires SF-36 and EQ-5D-5L were administered to 86 treated patients and 12 controls. RESULTS: there were improvements in several parameters such as physical functioning, bodily pain, general health, vitality and social functioning, particularly when the perceptions were compared before treatment and after treatment completion and following recovery. CONCLUSION: these data support the hypothesis that the hepatitis C virus may worsen quality of life in asymptomatic patients.

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.

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

ANTECEDENTES: El diagnóstico de la infección por el virus de la hepatitis C en un solo paso (anticuerpos y carga viral en una misma muestra) disminuiría el tiempo de acceso al tratamiento. Se desconoce el proceso del diagnóstico de la hepatitis C en los hospitales españoles. OBJETIVO: Describir los recursos diagnósticos disponibles y el proceso del diagnóstico de la infección por virus de la hepatitis C en España. MÉTODOS: Encuesta dirigida a hospitales españoles, públicos o privados con acreditación docente, de 200 camas o más. RESULTADOS: De los 160 hospitales con criterios de inclusión, respondieron 90 (tasa de respuesta del 56,3%). Dos centros (2,2%) no disponen de ningún recurso diagnóstico, 15 (16,7%) solo pueden realizar determinación de anticuerpos (Ac), 9 (10%) de Ac y carga viral (CV), 47 (52,2%) de Ac, CV y genotipo, 2 (2,2%) de Ac, CV y antígeno core, y 15 (16,7%) de Ac, antígeno core, CV y genotipo. Ante un resultado de Ac positivo, 28 (31,1%) hospitales hacen diagnóstico virológico en la misma muestra. Cuando hay una infección activa, se utiliza alguna estrategia de comunicación en 62 (68,9%) hospitales. El 44,2% de los respondedores cree que las determinaciones para llegar a un diagnóstico definitivo se deben hacer con una muestra única de sangre. CONCLUSIONES: Aunque el 81% de los hospitales dispone de medios para realizar el diagnóstico de la infección por virus de la hepatitis C en un solo paso, únicamente lo hace el 31%. Menos de la mitad de los encuestados cree que el diagnóstico definitivo se debe hacer con una única muestra

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

Eficiencia de diversas estrategias para el diagnóstico de la hepatitis C en un solo paso / The efficiency of several one-step testing strategies for the diagnosis of hepatitis C

Antecedentes: la implementación de estrategias de diagnóstico de la hepatitis C en un solo paso contribuiría a disminuir el tiempo de acceso al tratamiento, evitando el progreso de la enfermedad y sus complicaciones y facilitando la eliminación de la enfermedad. Objetivo: evaluar la validez y la seguridad de las posibles estrategias del diagnóstico de la infección por virus de la hepatitis C (VHC) en un solo paso, así como sus costes y eficiencia. Métodos: estudio de evaluación económica de la eficiencia (coste/eficacia) mediante la construcción de árboles de decisión con análisis de sensibilidad determinista. La perspectiva del análisis es la del financiador (Sistema Nacional de Salud), que solo considera los costes directos. Se han considerado únicamente los costes diferenciales (costes de los test analíticos realizados). El ámbito del estudio es España. Se define la eficacia de una estrategia diagnóstica como el porcentaje de pacientes con infección activa por VHC con diagnóstico positivo y la eficiencia, como el coste de diagnosticar correctamente un paciente con infección activa. Resultados: todas las estrategias para el diagnóstico de VHC en un solo paso evaluadas presentan validez y seguridad aceptables como consecuencia de la elevada sensibilidad y especificidad que tienen los test utilizados. La estrategia más eficiente es Ac-Ag, seguida de Ac-Ag-CV y Ac-CV. La estrategia más eficiente es Ac-Ag debido a su menor coste por paciente testado, pero es menos eficaz que Ac-CV. Conclusión: los hallazgos de este estudio pueden contribuir a establecer las estrategias de diagnóstico más adecuadas en un solo paso teniendo en cuenta su eficacia y eficiencia

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

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.