ABSTRACT
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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Subject(s)
Humans , Male , Female , Middle Aged , Aged , Hepatitis C/psychology , Quality of Life/psychology , Asymptomatic Infections/psychology , Hepatitis C/drug therapy , Antiviral Agents/therapeutic use , Case-Control Studies , Socioeconomic Factors , Surveys and Questionnaires , Longitudinal Studies , Prospective Studies , Drug Therapy, Combination , Sofosbuvir/administration & dosage , Ribavirin/administration & dosageABSTRACT
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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Subject(s)
Humans , Male , Female , Middle Aged , Aged , Hepatitis C/diagnosis , Hepatitis C/epidemiology , RNA, Viral/blood , Computer Security/ethics , Clinical Record , Medical Records , Confidentiality/ethics , Spain/epidemiology , IncidenceABSTRACT
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.
Subject(s)
Hepatitis C, Chronic , Hepatitis C , Hepacivirus/genetics , Hepatitis C/diagnosis , Hepatitis C/epidemiology , Hepatitis C Antibodies , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/epidemiology , Humans , Male , Middle Aged , PrevalenceABSTRACT
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.
Subject(s)
Hepatitis C, Chronic , Quality of Life , Antiviral Agents/therapeutic use , Hepacivirus , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Humans , Prospective Studies , Surveys and QuestionnairesABSTRACT
AIM: To study the hepatitis B virus (HBV) and hepatitis D virus (HDV) replication interferences in patients with chronic hepatitis delta infected with different HBV genotypes. METHODS: We conducted a transversal study including 68 chronic hepatitis delta (CHD) (37 HIV-positive) patients and a control group of 49 chronic hepatitis B (CHB) (22 HIV-positive) patients. In addition, a dynamic follow-up was performed in 16 CHD patients. In all the samples, the surface antigen of hepatitis B (HBsAg) serum titers were analyzed with the Monolisa HBsAg Ultra system (Bio-Rad), using as quantification standard a serial dilution curve of an international HBsAg standard. Serum HBV-DNA titers were analyzed using the Roche Cobas TaqMan (Roche, Barcelona, Spain), and the serum HDV-RNA using an in-house real-time qRT-PCR method, with TaqMan probes. HBV genotype was determined with the line immunoassay LiPA HBV genotyping system (Innogenetics, Ghent, Belgium). In those patients negative for LiPA assay, a nested PCR method of complete HBsAg coding region, followed by sequence analysis was applied. RESULTS: No differences in the HBV-DNA levels were found in CHB patients infected with different HBV genotypes. However, in CHD patients the HBV-DNA levels were lower in those infected with HBV-A than in those with HBV-D, both in HIV negative [median (IQR): 1.25 (1.00-1.35) vs 2.95 (2.07-3.93) log10 (copies/mL), P = 0.013] and HIV positive patients [2.63 (1.24-2.69) vs 7.25 (4.61-7.55) log10 (copies/mL), P < 0.001]. This was confirmed in the dynamic study of the HBV/HDV patients. These differences induce an under-estimation of HBV-A incidence in patients with CHD analyzed with LiPA assay. Finally, the HBsAg titers reflected no significant differences in CHD patients infected with HBV-A or D. CONCLUSION: Viral replication interference between HBV and HDV is HBV-genotype dependent, and more evident in patients infected with HBV-genotype A, than with HBV-D or E.
