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[This corrects the article DOI: 10.1371/journal.pone.0208112.].
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BACKGROUND AND AIM: Treatment of hepatitis C with direct-acting antiviral agents (DAA) has few side effects. Although pivotal studies suggested that DAA were safe in patients with psychiatric diseases who could not be treated with previous antiviral therapies, their effects on anxiety and depression have not yet been analysed in clinical practice. The aim of our study was to analyse anxiety and depression in the setting of DAA treatment in a clinical practice series. METHODS: All patients starting DAA treatment between November 1, 2014 and October 31, 2015 were eligible. Patients completed the Hospital Anxiety and Depression scale at different times during treatment. The results were plotted on line graphs and evaluated using a linear regression model with repeated measures. RESULTS: One hundred and forty-five patients were included (11% with major psychiatric disorders; 32% on psychiatric treatment). Sustained virologic response (SVR) was achieved in 97.3% of cases. Anxiety and depression measures did not differ between time points. No differences between patients on psychiatric treatment or with advanced fibrosis or cirrhosis were found at any time point analysed. CONCLUSION: DAA treatment had no impact on anxiety or depression during or after chronic hepatitis C infection treatment, even in high-risk patients with major psychiatric disorders.
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Antivirales/efectos adversos , Ansiedad/epidemiología , Depresión/epidemiología , Hepatitis C Crónica/tratamiento farmacológico , Trastornos Mentales/epidemiología , Anciano , Antivirales/administración & dosificación , Ansiedad/inducido químicamente , Ansiedad/diagnóstico , Comorbilidad , Depresión/inducido químicamente , Depresión/diagnóstico , Femenino , Hepacivirus/efectos de los fármacos , Hepacivirus/aislamiento & purificación , Hepatitis C Crónica/epidemiología , Hepatitis C Crónica/psicología , Hepatitis C Crónica/virología , Humanos , Masculino , Persona de Mediana Edad , Cuestionario de Salud del Paciente/estadística & datos numéricos , Estudios Prospectivos , Respuesta Virológica SostenidaRESUMEN
Omalizumab is marketed for chronic severe asthma patients who are allergic to perennial allergens. Our purpose was to investigate whether omalizumab is also effective in persistent severe asthma due to seasonal allergens. Thirty patients with oral corticosteroid-dependent asthma were treated with Omalizumab according to the dosing table. For each patient with asthma due to seasonal allergens, we recruited the next two consecutive patients with asthma due to perennial allergens. The dose of oral methyl prednisolone was tapered at a rate of 2 mg every two weeks after the start of treatment with omalizumab depending on tolerance. At each monthly visit, a forced spirometry and fractional exhaled nitric oxide (FeNO) measurement were performed and the accumulated monthly methyl prednisolone dose was calculated. At entry, there were no differences between groups in terms of gender, body mass index or obesity, year exacerbation rate, monthly dose of methyl-prednisolone (MP), FeNO and blood immunoglobuline E (IgE) MP, FeNO and IgE values, or spirometry (perennial: FVC: 76%; FEV1: 62%; seasonal: FVC: 79%; FEV1: 70%). The follow-up lasted 76 weeks. One patient in each group was considered a non-responder. Spirometry did not worsen in either group. There was a significant intragroup reduction in annual exacerbation rate and methyl prednisolone consumption but no differences were detected in the intergroup comparison. Omalizumab offered the same clinical benefits in the two cohorts regardless of whether the asthma was caused by a seasonal or a perennial allergen. These results strongly suggest that allergens are the trigger in chronic asthma but that it is the persistent exposure to IgE that causes the chronicity.
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Corticoesteroides/administración & dosificación , Alérgenos/inmunología , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Asma/inmunología , Omalizumab/uso terapéutico , Estaciones del Año , Administración Oral , Adulto , Anciano , Antiasmáticos/administración & dosificación , Antiasmáticos/efectos adversos , Asma/diagnóstico , Progresión de la Enfermedad , Eosinófilos , Espiración , Femenino , Humanos , Inmunoglobulina E/sangre , Inmunoglobulina E/inmunología , Recuento de Leucocitos , Masculino , Persona de Mediana Edad , Óxido Nítrico/metabolismo , Omalizumab/administración & dosificación , Omalizumab/efectos adversos , Pruebas de Función Respiratoria , Índice de Severidad de la Enfermedad , Pruebas Cutáneas , Resultado del TratamientoRESUMEN
UNLABELLED: Background. Despite the introduction of direct antiviral agents, pegylated interferon remains the mainstay of treatment for chronic hepatitis C. However, pegylated interferon is associated with a high rate of severe adverse events and decreased quality of life. Specific interventions can improve adherence and effectiveness. We aimed to determine whether implementing a multidisciplinary approach improved outcomes in the treatment of chronic hepatitis C. MATERIAL AND METHODS: We analyzed consecutive patients treated with pegylated interferon plus ribavirin between August 2001 and December 2011. We compared patients treated before and after the implementation of a multidisciplinary approach in 2007. We compared the baseline demographic and clinical characteristics and laboratory findings between groups, and used bivariate logistic regression models to detect factors involved in attaining a sustained virological response, calculating the odds ratios with their respective 95% confidence intervals. To evaluate the effect of the multidisciplinary team, we fitted a multivariate logistic regression model to compare the sustained virological response after adjusting for unbalanced variables and predictive factors. RESULTS: We included 514 patients [228 (44.4%) in the pre-intervention cohort]. Age, viral genotype, previous treatment, aspartate transaminase, ferritin, and triglyceride were prognostic factors of sustained virological response. After adjusting for prognostic factors, sustained virological response was higher in the multidisciplinary cohort (58 vs. 48%, p = 0.038). Despite higher psychiatric comorbidity and age in the multidisciplinary cohort, we observed a trend toward a lower rate of treatment abandonment in this group (2.2 vs. 4.9%, p = 0.107). CONCLUSION: Multidisciplinary management of chronic hepatitis C improves outcomes.
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Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Interferón-alfa/uso terapéutico , Grupo de Atención al Paciente , Polietilenglicoles/uso terapéutico , Adulto , Factores de Edad , Aspartato Aminotransferasas/sangre , Dermatólogos , Quimioterapia Combinada , Femenino , Ferritinas/sangre , Gastroenterólogos , Genotipo , Hepacivirus/genética , Hepatitis C Crónica/sangre , Humanos , Interferón alfa-2 , Modelos Logísticos , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Enfermeras y Enfermeros , Educación del Paciente como Asunto , Farmacéuticos , Pronóstico , Psiquiatría , Calidad de Vida , ARN Viral/sangre , Proteínas Recombinantes/uso terapéutico , Respuesta Virológica Sostenida , Resultado del Tratamiento , Triglicéridos/sangreRESUMEN
INTRODUCTION: Numerous clinical trials have demonstrated the efficacy of treatment with pegylated interferon and ribavirin but little is known about the results obtained in clinical practice. OBJECTIVE: To evaluate treatment response and factors influencing the treatment of chronic hepatitis C in clinical practice. MATERIAL AND METHODS: Between August 2001 and December 2005, we treated 219 patients with pegylated interferon (alpha 2a -fixed dose, or alpha 2b, according to weight) and ribavirin. Patients with genotype 1 or 4 received treatment with pegylated interferon alpha 2a (180 microg/week) and ribavirin (1000 mg/day if body weight was <75 kg or 1200 mg/day if body weight was >75 kg) or interferon alpha 2b (1.5 microg/kg/week) and ribavirin (10.6 mg/kg/day) for 48 weeks. Patients with genotype 2 or 3 were treated for 24 weeks with the same regimen of pegylated interferon alpha-2a or alpha-2b, but with 800 mg of ribavirin divided in two daily doses. Sustained viral response was defined as absence of HCV-RNA 6 months after the end of treatment. RESULTS: A total of 219 patients were included (69% men; mean age 44+/-10). As epidemiological antecedents, 22.4% of the treated patients had previously consumed drugs parenterally and 22.4% had received blood transfusions before 1992. Forty-seven percent of the patients with liver biopsy had fibrosis bridges or established liver cirrhosis. The genotype was distributed as follows: 69.8% genotype 1, 4.1% genotype 2, 17.8% genotype 3, and 8.2% genotype 4. Of the 219 patients, 76 (35%) were treated with pegylated interferon alpha 2a and 143 (65%) with interferon alpha 2b. Analysis of response by genotype revealed that sustained viral response was obtained in 46% genotype 1, 88.9% genotype 2, 78.9% genotype 3, and 33.3% genotype 4. Univariate analysis showed that the only variable influencing sustained viral response was genotype. CONCLUSION: Treatment with pegylated interferon and ribavirin in clinical practice shows a similar pattern of sustained viral response to that obtained in clinical research. The main variable correlated with sustained viral response continues to be viral genotype.
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Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Interferón-alfa/uso terapéutico , Polietilenglicoles/uso terapéutico , Ribavirina/uso terapéutico , Adulto , Femenino , Humanos , Interferón alfa-2 , Masculino , Proteínas Recombinantes , Factores de TiempoRESUMEN
INTRODUCCIÓN: Numerosos ensayos clínicos demuestran unaalta eficacia en el tratamiento con interferón pegilado y ribavirina;sin embargo, se conoce poco sobre los resultadosobtenidos en la práctica clínica.OBJETIVO: Evaluar en la práctica clínica la respuesta y losfactores que influyen en el tratamiento de la hepatitis crónicapor el virus C.MATERIAL Y MÉTODOS: Entre agosto de 2001 y diciembre de2005, se trató a 219 pacientes con interferón pegilado (alfa-2a en dosis fijas o alfa-2b según el peso) y ribavirina. Lospacientes que presentaban un genotipo 1 o 4 recibieron tratamientocon interferón pegilado alfa-2a (180 g/semana) yribavirina (1.000 mg/día si < 75 kg o 1.200 mg/día si > 75 kg)o interferón alfa-2b (1,5 g/kg/semana) y ribavirina (10,6mg/kg/día) durante 48 semanas. Los pacientes con genotipo2 y 3 fueron tratados durante 24 semanas con la misma pautade interferón pegilado alfa-2a o alfa-2b, pero con 800 mgde ribavirina al día repartida en dos dosis. La respuesta viralsostenida (RVS) se ha determinado como la negatividaddel ARN del virus de la hepatitis C a los 6 meses después definalizar el tratamiento.RESULTADOS: Se incluyeron 219 pacientes (un 69% varones,con una edad de 44 ± 10 años). Como antecedentes epidemiológicos,un 22,4% había consumido drogas por vía parenteraly un 22,4% había sido transfundido antes del año 1992.Un 47% de los pacientes con biopsia hepática tenía puentesde fibrosis o cirrosis hepática establecida. Los genotipos sedistribuyeron de la siguiente forma: 69,8% genotipo 1; 4,1%genotipo 2; 17,8% genotipo 3; 8,2% genotipo 4. Del total de219 pacientes, 76 (35%) fueron tratados con interferón pegiladoalfa-2a y 143 (65%) con interferón alfa-2b. Según el genotipo,la RVS se obtuvo en un 46% genotipo 1, un 88,9%genotipo 2, un 78,9% genotipo 3 y un 33,3% genotipo 4. Elanálisis univariado mostró que el genotipo es la única variableque influyó en la RVS. (..)(AU)
INTRODUCTION: Numerous clinical trials have demonstratedthe efficacy of treatment with pegylated interferon and ribavirinbut little is known about the results obtained in clinicalpractice.OBJECTIVE: To evaluate treatment response and factors influencingthe treatment of chronic hepatitis C in clinicalpractice.MATERIAL AND METHODS: Between August 2001 and December2005, we treated 219 patients with pegylated interferon(alpha 2a -fixed dose, or alpha 2b, according to weight) andribavirin. Patients with genotype 1 or 4 received treatmentwith pegylated interferon alpha 2a (180 g/week) and ribavirin(1000 mg/day if body weight was < 75 kg or 1200mg/day if body weight was > 75 kg) or interferon alpha 2b(1.5 g/kg/week) and ribavirin (10.6 mg/kg/day) for 48 weeks.Patients with genotype 2 or 3 were treated for 24 weekswith the same regimen of pegylated interferon alpha-2a oralpha-2b, but with 800 mg of ribavirin divided in two dailydoses. Sustained viral response was defined as absence ofHCV-RNA 6 months after the end of treatment (..) (AU)