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OBJECTIVE: A set of indicators has been reported to measure the quality of care for cirrhotic patients, and previously published studies report variable adherence rates to these indicators. This study aimed to assess the quality of care provided to cirrhotic outpatients before and after an educational intervention by determining its impact on adherence to quality indicators. METHODS: We conducted a quasi-experimental, cross-sectional study including 324 cirrhotic patients seen in 2017 and 2019 at a tertiary teaching hospital in Spain. Quality indicators were assessed in five domains: documentation of cirrhosis etiology, disease severity assessment, hepatocellular carcinoma (HCC) screening, variceal bleeding prophylaxis, and vaccination. After identifying areas for improvement, an educational intervention was implemented. A second evaluation was performed after the intervention to assess changes in adherence rates. RESULTS: Before the intervention, adherence rates were excellent (>90%) for indicators related to variceal bleeding prophylaxis and documentation of cirrhosis etiology, acceptable (60-80%) for HCC screening and disease severity assessment, and poor (<50%) for vaccinations. After the educational intervention, there was a statistically significant improvement in adherence rates for eight indicators related to HCC screening (70-90%), disease severity assessment (90%), variceal bleeding prophylaxis (>90%), and vaccinations (60-90%). CONCLUSION: Our study demonstrates a significant improvement in the quality of care provided to cirrhotic outpatients after an educational intervention. The findings highlight the importance of targeted educational interventions to enhance adherence to quality indicators in the management of cirrhosis.
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Cirrosis Hepática , Mejoramiento de la Calidad , Indicadores de Calidad de la Atención de Salud , Humanos , Cirrosis Hepática/complicaciones , Cirrosis Hepática/terapia , Femenino , Masculino , Estudios Transversales , Persona de Mediana Edad , Anciano , Neoplasias Hepáticas/terapia , Várices Esofágicas y Gástricas/etiología , Várices Esofágicas y Gástricas/terapia , Várices Esofágicas y Gástricas/prevención & control , Carcinoma Hepatocelular/terapia , Hemorragia Gastrointestinal/etiología , Hemorragia Gastrointestinal/prevención & control , España , Vacunación , Índice de Severidad de la Enfermedad , Atención Ambulatoria/normas , Adhesión a Directriz , Educación del Paciente como Asunto/normasRESUMEN
Recommended post-liver transplant (LT) prophylaxis in patients with hepatitis delta includes a nucleos(t)ide analogue (NA) and anti-hepatitis B immunoglobulin (HBIG) indefinitely. We analysed the use of HBIG in real-life clinical practice and its impact on HBV/HDV recurrence in 174 HDV-related LT patients from 10 Spanish liver transplant centres (1988-2018). Median post-LT follow-up was 7.8 (2.3-15.1) years and patient survival at 5 years was 90%. Most patients (97%) received HBIG in the immediate post-LT, but only 42% were on HBIG at the last control. Among those discontinuing HBIG, the median time on treatment was 18 (7-52) months. Post-LT HBsAg+ was detected in 16 (9%) patients and HBV-DNA in 12 (7%). Despite HBsAg positivity, HDV recurrence was reported only in three patients (1.7%), all of whom were not receiving NA and had discontinued HBIG. Our data suggest that a finite HBIG prophylaxis in HDV-LT is feasible, especially if high-barrier NAs are used.
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Trasplante de Hígado , Humanos , Antivirales/uso terapéutico , Antígenos de Superficie de la Hepatitis B , Resultado del Tratamiento , Cirrosis Hepática/complicaciones , Cirrosis Hepática/cirugía , Cirrosis Hepática/tratamiento farmacológico , Inmunoglobulinas/uso terapéutico , Recurrencia , Virus de la Hepatitis B/genéticaRESUMEN
Antibody-mediated rejection (AMR) after liver transplantation is uncommon but, when present, manifests as graft dysfunction. We report the case of a 54-year-old woman who developed portal hypertension with pleural effusion and ascites secondary to sinusoidal obstruction syndrome (SOS) due to acute AMR following an ABO-matched liver transplantation for autoimmune cirrhosis and hepatocellular carcinoma. Initial immunosuppression comprised basiliximab, decreasing prednisone, tacrolimus, and mycophenolate mofetil. After 1 month, she presented with the massive pleural effusion, slight ascites, and normal liver tests. After excluding common causes of pleural effusion, we performed a liver biopsy that showed atypical rejection with the involvement of large centrilobular veins partially occluded by marked endotheliitis and lax fibrosis suggestive of SOS. Direct immunofluorescence study of C4d showed diffuse endothelial sinusoidal staining, and de novo donor-specific anti-human leukocyte antigen antibodies were detected in his blood. Thus, we diagnosed AMR focused on centrilobular veins and initiated treatment with defibrotide, steroid pulses, and diuretics. However, this was ineffective, and the pleural effusion only resolved when plasmapheresis and intravenous immunoglobulin were started. This case shows that AMR can cause SOS with portal hypertension and present with a pleural effusion, and as such, it should be suspected after excluding other more common causes of effusion.
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Enfermedad Veno-Oclusiva Hepática , Neoplasias Hepáticas , Trasplante de Hígado , Anticuerpos , Femenino , Rechazo de Injerto/etiología , Enfermedad Veno-Oclusiva Hepática/etiología , Humanos , Trasplante de Hígado/efectos adversos , Persona de Mediana EdadRESUMEN
Introducción: El retrasplante hepático (ReTH) es una indicación de TH controvertida. Nuestro objetivo fue determinar la tasa de ReTH y las indicaciones, morbilidad, mortalidad posoperatoria y supervivencia actuarial del paciente retrasplantado en nuestra serie. Métodos: Estudio retrospectivo de una serie prospectiva de 1.645 pacientes trasplantados entre 1984 y 2018. Se analizan los resultados según el tipo de ReTH (precoz vs. tardío), periodo de estudio e indicaciones. Resultados: Hemos realizado 150 ReTH en 140 pacientes. La tasa de ReTH fue de 9%. El 30% (45) de los ReTH fueron precoces, siendo tardíos el otro 70% (105). Las causas más frecuentes fueron: colangitis isquémica (27%), trombosis de la arteria hepática (19%), fallo primario del injerto (15%) y recidiva de la cirrosis por virus de la hepatitis C (VHC) (15%). La duración de la cirugía (395 vs. 270 min; p = 0,001), tiempo de isquemia (435 vs. 390 min; p = 0,005) y necesidad transfusional (8 vs. 5 CH; p = 0,034) fue mayor en los casos de ReTH tardío, mientras que la mortalidad posoperatoria (10 vs. 20%; p = 0,01) fue mejor en los casos de ReTH tardío. La supervivencia actuarial a uno y cinco años fue de 71% y 58%, respectivamente, con una mejoría significativa en la última década (80% y 64%). Por otra parte, la supervivencia en los casos de ReTH por colangitis isquémica es superior que otras indicaciones (78 vs. 51%; p = 0,02). Conclusiones: El retrasplante es complejo y está asociado a una elevada morbimortalidad. Sin embargo, los resultados han mejorado en los últimos años por lo que su indicación está justificada. (AU)
Introduction: Liver retransplantation (LRT) is a controversial indication. Our aim was to evaluate the rate of LRT at our institution, and to analyze its indications and short- and long-term results. Methods: We conducted a retrospective study of a prospectively collected database, including 1645 LT from 1984 to 2018. Results have been analyzed depending on type of LRT (early vs late), study period and indications. Results: We performed 150 LRT in 140 patients. The LRT rate was 9%. Of these, 45 LRT were early (30%), and the other 70% were late LRT. The main indications were: ischemic cholangitis (27%), arterial thrombosis (19%), primary non-function (15%), and HCV recurrence (15%). Mean surgery duration (395 vs. 270 min; P = .001), cold ischemia time (435 vs. 390 min; P = .005) and transfused units required (8 vs. 5 RBC; P = .034) were higher in cases of late LRT. Postoperative mortality (10 vs. 20%; P = .01) was better in cases of late LRT. One- and 5-year actuarial survival rates were 71% and 58%, respectively, which were significantly better during the last decade (80% and 64%). Five-year actuarial survival for ischemic cholangitis is better than other indications, such as recurrence of HCV (78 vs. 51%; P = .02). Conclusions: Liver retransplantation is complex and associated with high morbidity and mortality. However, indications and long-term results have improved during recent years. Therefore, LRT is justified. (AU)
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Humanos , Masculino , Femenino , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Trasplante de Hígado/mortalidad , Reoperación/mortalidad , Hígado/cirugía , Estudios Retrospectivos , Colangitis , Tasa de SupervivenciaRESUMEN
BACKGROUND: Low adherence to chronic immunosuppression is associated with suboptimal transplantation outcomes. Mobile-health technology is a promising tool to monitor medication adherence, but data on patient engagement to these tools are lacking. METHODS: Prospective, observational, multicenter, 2-phase trial in kidney and liver transplant recipients, investigating the degree of engagement to TrackYourMed® (TYM), a novel m-Health technology with a QR code-scan app to track immunosuppression adherence and its association with drug monitoring. RESULTS: Out of 204 consecutive transplant patients, 90 patients were eligible to participate. 61 (68%) used TYM regularly, 21 (23%) never or barely used it, 5 (5.5%) were irregular users, and 3 (3.3%) were lost to follow-up. 6-month total correct intakes (CIN) ranged between 69%-76%, 12%-19% intakes were out-of-time (OUT), and 9%-12% were missed (MIS). Notably, a rate of intakes out of the scheduled time higher than 20% in the 6 days prior to blood immunosuppressant trough levels was associated with a higher intra-patient variability (17 IQR 13-21% vs. 29 IQR 23%-36%, p = .001), and with a higher dose-adjustment (p < .001). At 1 year, 53(59%) patients were still active users of TYM. CONCLUSIONS: Implementing m-Health technologies promoting immunosuppression adherence may be useful for a relevant number of transplant patients and help transplant physicians identifying erratic immunosuppression adherence.
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Trasplante de Riñón , Aplicaciones Móviles , Trasplante de Órganos , Telemedicina , Tecnología Biomédica , Humanos , Terapia de Inmunosupresión , Inmunosupresores , Cumplimiento de la Medicación , Proyectos Piloto , Estudios Prospectivos , TecnologíaRESUMEN
INTRODUCTION: Liver retransplantation (LRT) is a controversial indication. Our aim was to evaluate the rate of LRT at our institution, and to analyze its indications and short- and long-term results. METHODS: We conducted a retrospective study of a prospectively collected database, including 1645 LT from 1984 to 2018. Results have been analyzed depending on type of LRT (early vs late), study period and indications. RESULTS: We performed 150 LRT in 140 patients. The LRT rate was 9%. Of these, 45 LRT were early (30%), and the other 70% were late LRT. The main indications were: ischemic cholangitis (27%), arterial thrombosis (19%), primary non-function (15%), and HCV recurrence (15%). Mean surgery duration (395 vs. 270 min; P = .001), cold ischemia time (435 vs. 390 min; P = .005) and transfused units required (8 vs. 5 RBC; P = .034) were higher in cases of late LRT. Postoperative mortality (10 vs. 20%; P = .01) was better in cases of late LRT. One- and 5-year actuarial survival rates were 71% and 58%, respectively, which were significantly better during the last decade (80% and 64%). Five-year actuarial survival for ischemic cholangitis is better than other indications, such as recurrence of HCV (78 vs. 51%; P = .02). CONCLUSIONS: Liver retransplantation is complex and associated with high morbidity and mortality. However, indications and long-term results have improved during recent years. Therefore, LRT is justified.
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BACKGROUND AND AIM: Accurate information on the epidemiology of hepatitis C and B infection is mandatory to establish a national/regional plan. We aim to update the prevalence of hepatitis C and B infection in Catalonia using point-of-care tests to analyze the risk factors related and to implement a linkage-to-care circuit. METHODS: This is a community-based study. A random list of adult individuals was retrieved from censuses of primary care centers. Point-of-care tests for anti-hepatitis C virus (HCV) and HBV surface antigen (HBsAg) and a questionnaire for risk factor assessment were performed. Positive results were validated and a circuit for linkage-to-care was established. RESULTS: A total of 3328 individuals were included. The anti-HCV and HBsAg overall prevalence were lower than expected [1.02%, 95% confidence interval (CI) 0.65-1.39; and 0.52%, 95% CI 0.26-0.77, respectively]. Anti-HCV positive subjects were mostly (88%) autochthonous. The prevalence increased with age; only 12% were under age 40. The associated risk factors were drug use, blood transfusion, relative with HCV, and diabetes. Notably, the prevalence of active infection was only 0.49% (95% CI 0.23-0.74), 40% less than previously reported, reflecting the impact of direct acting antiviral therapy. Differently, HBsAg positive subjects were mostly foreign migrants (53%) with no other risk factors. Despite the implementation of a linkage-to-care circuit, one third of HBsAg positive subjects were lost. CONCLUSIONS: The prevalence of HCV infection was lower than previously reported, showing a strong impact of direct acting antiviral therapy in the last years. Because of hepatitis B universal vaccination, HBV infection in Catalonia is mainly associated with migrant population. Linkage-to-care in patients with hepatitis B was challenging and warrants additional efforts.
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Antivirales/administración & dosificación , Hepatitis B/diagnóstico , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Administración Oral , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Femenino , Hepatitis B/tratamiento farmacológico , Hepatitis B/epidemiología , Antígenos de Superficie de la Hepatitis B/sangre , Hepatitis C/tratamiento farmacológico , Anticuerpos contra la Hepatitis C/sangre , Humanos , Masculino , Persona de Mediana Edad , Pruebas en el Punto de Atención , Prevalencia , Factores de Riesgo , España/epidemiología , Encuestas y CuestionariosRESUMEN
BACKGROUND AND AIMS: Limited data are available on the effectiveness and tolerability of direct-acting antivirals (DAAs) therapies in the real world for HCV-infected patients with comorbidities. This study aimed to describe the effectiveness of OBV/PTV/r ± DSV (3D/2D regimen) with or without ribavirin (RBV) in HCV or HCV/HIV co-infected patients with GT1/GT4 and CKD (IIIb-V stages), including those under hemodialysis and peritoneal dialysis in routine clinical practice in Spain in 2015. MATERIAL AND METHODS: Non-interventional, retrospective, multicenter data collection study in 31 Spanish sites. Socio-demographic, clinical variables, study treatment characteristics, effectiveness and tolerability data were collected from medical records. RESULTS: Data from 135 patients with a mean age (SD) of 58.3 (11.4) years were analyzed: 92.6% GT1 (81.6% GT1b and 17.6% GT1a) and 7.4% GT4, 14 (10.4%) HIV/HCV co-infected, 19.0% with fibrosis F3 and 28.1% F4 by FibroScan®, 52.6% were previously treated with pegIFN and RBV. 11.1%, 14.8% and 74.1% of patients had CKD stage IIIb, IV and V respectively. 68.9% of patients were on hemodialysis; 8.9% on peritoneal dialysis and 38.5% had history of renal transplant. A total of 125 (96.2%) of 135 patients were treated with 3D, 10 (7.4%) with 2D and 30.4% received RBV. The overall intention-to-treat (ITT) sustained virologic response at week 12 (SVR12) was 92.6% (125/135) and the overall modified-ITT (mITT) SVR12 was 99.2% (125/126). The SVR12 rates (ITT) per sub-groups were: HCV mono-infected (91.7%), HCV/HIV co-infected (100%), GT1 (92.0%), GT4 (100%), CKD stage IIIb (86.7%), stage IV (95%) and stage V (93%). Among the 10 non-SVR there was only 1 virologic failure (0.7%); 4 patients had missing data due lost to follow up (3.0%) and 5 patients discontinued 3D/2D regimen (3.7%): 4 due to severe adverse events (including 3 deaths) and 1 patient´s decision. CONCLUSIONS: These results have shown that 3D/2D regimens are effective and tolerable in patients with advanced CKD including those in dialysis with GT 1 or 4 chronic HCV mono-infection and HIV/HCV coinfection in a real-life cohort. The overall SVR12 rates were 92.6% (ITT) and 99.2% (mITT) without clinically relevant changes in eGFR until 12 weeks post-treatment. These results are consistent with those reported in clinical trials.
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Antivirales/uso terapéutico , Coinfección/tratamiento farmacológico , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , VIH-1 , Hepatitis C Crónica/complicaciones , Hepatitis C Crónica/tratamiento farmacológico , Insuficiencia Renal Crónica/complicaciones , Insuficiencia Renal Crónica/terapia , 2-Naftilamina , Anciano , Anilidas/uso terapéutico , Antivirales/administración & dosificación , Antivirales/efectos adversos , Carbamatos/uso terapéutico , Ciclopropanos , Quimioterapia Combinada , Femenino , Genotipo , Hepacivirus/clasificación , Hepacivirus/genética , Hepatitis C Crónica/virología , Humanos , Lactamas Macrocíclicas , Compuestos Macrocíclicos/uso terapéutico , Masculino , Persona de Mediana Edad , Prolina/análogos & derivados , Diálisis Renal , Estudios Retrospectivos , Ribavirina/uso terapéutico , Ritonavir/uso terapéutico , España , Sulfonamidas/uso terapéutico , Respuesta Virológica Sostenida , Resultado del Tratamiento , Uracilo/análogos & derivados , Uracilo/uso terapéutico , ValinaRESUMEN
Several techniques have been proposed for liver transplantation with inadequate hepatic artery (HA) anastomosis. We aimed to analyze outcomes of arterial reconstruction with the splenic artery (SA). This was a prospective study of our experience with recipients who underwent arterial anastomosis on the SA compared with patients who underwent standard HA. We included 54 patients in the SA group and 1405 in the HA group. Patients in SA group were more frequently retransplantation (31% vs. 8%; P = 0.001), required more transfusion (11 ± 12 vs. 6 ± 9.9 PRC; P = 0.001), had longer surgeries (424 ± 95 vs. 394 ± 102 min; P = 0.03), and longer hospital stays (28 ± 29 vs. 20 ± 18 days; P = 0.002). There were no differences in vascular and biliary complications (15% and 7%; P = 0.18; and 32% and 23%; P = 0.32), primary dysfunction (11% and 9%; P = 0.74), reoperation (12% and 10%; P = 0.61), postoperative mortality (13% and 7%; P = 0.12) and 5 years survival (66% vs. 63%; P = 0.71). Following primary transplantation, there were no differences. The outcomes of arterial reconstruction using the recipients' SA in adult liver transplantation are comparable to those for standard HA reconstruction after a first transplant.
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Trasplante de Hígado/estadística & datos numéricos , Arteria Esplénica/cirugía , Adulto , Anastomosis Quirúrgica , Femenino , Estudios de Seguimiento , Humanos , Trasplante de Hígado/métodos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND Delaying initiation of tacrolimus after liver transplantation (LT) is a potential renal-sparing strategy. We assessed safety and efficacy of delayed initiation of prolonged-release tacrolimus (PR-T) in de novo LT. MATERIAL AND METHODS This was a single-center, single-arm, prospective, 12-month observational study of hepatitis C virus-negative orthotopic LT patients. Immunosuppression included PR-T (initially 0.1 or 0.2 mg/kg/day) initiated on Day 3 post LT, basiliximab (20 mg) on post-transplantation Day 0 and Day 4, and intraoperative corticosteroids (500 mg). Patients received maintenance corticosteroids and mycophenolate mofetil (MMF) according to center protocol. MMF dose was adjusted according to thrombocyte count. The primary endpoint was the estimated glomerular filtration rate (eGFR) measured using the Modification of Diet in Renal Disease 4-variable formula at 12 months. Secondary endpoints included biopsy-confirmed acute rejection (BCAR) and dialysis requirement. Adverse events were recorded. RESULTS Sixty-nine patients (mean age 55.0 years) were included. Most patients started MMF on Day 1 (60.9%) or Day 2 (10.1%), and PR-T on Day 3 (55.1%) or Day 4 (29.0%). Mean tacrolimus trough levels (ng/mL) were: Day 7, 9.5±6.3; Day 10, 9.4±5.4; Month 1, 8.0±3.1; Month 3, 7.8±3.7; Month 6, 8.0±4.1; and Month 12, 7.2±3.1. Mean 12-month eGFR was 77.2±24.5 mL/min/1.73 m2; 72.5% of patients had eGFR >60 mL/min/1.73 m² at 12 months; 89.9% had no eGFR measurements <40 mL/min/1.73 m² during the study. Renal insufficiency (any eGFR <60 mL/min/1.73 m²) was diagnosed in 27.5% of patients; one patient required dialysis. There were no BCAR episodes; the infection rate was 36.2%, and 3 patients died. Overall, 19 patients (27.5%) developed de novo diabetes mellitus, 18 patients (26.1%) had hypercholesterolemia, and 12 patients (17.4%) had hypertriglyceridemia. CONCLUSIONS Quadruple therapy with delayed administration of PR-T was well tolerated and efficacious, and was associated with acceptable renal function over 12 months.
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Inmunosupresores/uso terapéutico , Trasplante de Hígado , Tacrolimus/uso terapéutico , Corticoesteroides/uso terapéutico , Anciano , Preparaciones de Acción Retardada , Quimioterapia Combinada , Femenino , Supervivencia de Injerto , Humanos , Inmunosupresores/administración & dosificación , Inmunosupresores/efectos adversos , Masculino , Persona de Mediana Edad , Ácido Micofenólico/uso terapéutico , Estudios Prospectivos , Tacrolimus/administración & dosificación , Tacrolimus/efectos adversosRESUMEN
BACKGROUND & AIMS: The efficacy of direct-acting antivirals (DAAs) has dramatically changed the prognosis of patients with chronic hepatitis C. We aimed to evaluate the impact of DAA therapy on the composition of the liver transplant (LT) waiting list and the early post-transplant survival. METHODS: We evaluated all patients admitted to the waiting list for a primary LT between 1st January 2008 and 31st of December 2016 in Catalonia, Spain. Time span was divided into two periods according to the availability of different antiviral therapies: 2008-2013 (interferon-based therapies) and 2014-2016 (DAA). Changes in the indications of LT and the aetiology of liver disease, as well as post-LT patient survival, were evaluated according to the year of inclusion and transplantation, respectively. RESULTS: We included 1,483 patients. Admissions in the waiting list for hepatitis C virus (HCV)-related liver disease decreased significantly, from 47% in 2008-2013 to 35% in 2014-2016 (pâ¯<0.001), particularly because of a reduction in patients with decompensated cirrhosis. In contrast, NASH-related inclusions increased from 4% to 7% (pâ¯=â¯0.003). Three-year post-LT patient survival increased significantly in the second period in the whole cohort (82% vs. 91%, pâ¯=â¯0.002), because of better survival in anti-HCV positive patients (76% vs. 91%, pâ¯=â¯0.001), but not in anti-HCV negative patients (88% vs. 91% pâ¯=â¯0.359). Anti-HCV positive serology, the time period of 2008-2013 and higher donor age were independently associated with post-LT mortality in the whole cohort; while time period and donor age were independently associated with post-LT mortality in anti-HCV positive recipients. CONCLUSIONS: The high efficacy of DAAs is associated with significant changes in the composition of the LT waiting list and, more importantly, results in improved post-transplant survival. LAY SUMMARY: The efficacy of the new direct-acting antivirals is associated with a significant improvement in survival of patients undergoing liver transplantation because of hepatitis C virus-related liver disease. In addition, it has decreased the number of patients with hepatitis C that need a liver transplant.
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Antivirales/uso terapéutico , Rechazo de Injerto/tratamiento farmacológico , Supervivencia de Injerto/efectos de los fármacos , Hepacivirus/efectos de los fármacos , Hepatitis C Crónica/cirugía , Trasplante de Hígado , Listas de Espera , Femenino , Estudios de Seguimiento , Hepatitis C Crónica/virología , Humanos , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Receptores de TrasplantesRESUMEN
BACKGROUND AND AIMS: Hepatitis C (HCV) therapy with Sofosbuvir (SOF)/Simeprevir (SMV) in clinical trials and real-world clinical practice, showed high rates of sustained virological response (SVR) in non-cirrhotic genotype (GT)-1 and GT-4 patients. These results were slightly lower in cirrhotic patients. We investigated real-life effectiveness and safety of SOF/SMV with or without ribavirin (RBV) in a large cohort of cirrhotic patients. METHODS: This collaborative multicentre study included data from 968 patients with cirrhosis infected with HCV-GT1 or 4, treated with SOF/SMV±RBV in 30 centres across Spain between January-2014 and December-2015. Demographic, clinical, virological and safety data were analysed. RESULTS: Overall SVR was 92.3%; the majority of patients were treated with RBV (62%) for 12 weeks (92.4%). No significant differences in SVR were observed between genotypes (GT1a:94.3%; GT1b:91.7%; GT4:91.1%). Those patients with more advanced liver disease (Child B/C, MELD≥10) or portal hypertension (platelet count≤100×109 /L, transient elastography≥21 Kpa) showed significantly lower SVR rates (84.4%-91.9%) than patients with less advanced liver disease (93.8%-95.9%, P<.01 in all cases). In the multivariate analysis, the use of RBV, female gender, baseline albumin≥35 g/L, MELD<10 and lack of exposure to a triple therapy regimen were independent predictors of SVR (P<.05). Serious adverse events (SAEs) and SAE-associated discontinuation events occurred in 5.9% and 2.6%. CONCLUSIONS: In this large cohort of cirrhotic patients managed in the real-world setting in Spain, SOF/SMV±RBV yielded to excellent SVR rates, especially in patients with compensated liver cirrhosis. In addition, this combination showed to be safe, with low rates of SAEs and early discontinuations.
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Antivirales/uso terapéutico , Hepatitis C/tratamiento farmacológico , Sistema de Registros , Simeprevir/uso terapéutico , Sofosbuvir/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Quimioterapia Combinada , Femenino , Hepacivirus/genética , Hepatitis C/genética , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Adulto JovenRESUMEN
Direct-acting antiviral agents (DAAs) are highly effective and well tolerated in patients with chronic hepatitis C virus infection, including those with compensated cirrhosis. However, fewer data are available in patients with more advanced liver disease. Our retrospective, noninterventional, national, multicenter study in patients from the Spanish Hepa-C registry investigated the effectiveness and safety of interferon-free DAA regimens in patients with advanced liver disease, including those with decompensated cirrhosis, in routine practice (all currently approved regimens were registered). Patients transplanted during treatment or within 12 weeks of completing treatment were excluded. Among 843 patients with cirrhosis (Child-Turcotte-Pugh [CTP] class A, n = 564; CTP class B/C, n = 175), 90% achieved sustained virologic response 12 weeks after treatment (SVR12). Significant differences in SVR12 and relapse rates were observed between CTP class A and CTP class B/C patients (94% versus 78%, and 4% versus 14%, respectively; both P < 0.001). Serious adverse events (SAEs) were more common in CTP class B/C versus CTP class A patients (50% versus 12%, respectively; P < 0.001). Incident decompensation was the most common serious adverse event (7% overall). Death rate during the study period was 16/843 (2%), significantly higher among CTP class B/C versus CTP class A patients (6.4% versus 0.9%; P < 0.001). Baseline Model for End-Stage Liver Disease (MELD) score alone (cut-off 18) was the best predictor of survival. CONCLUSION: Patients with decompensated cirrhosis receiving DAAs present lower response rates and experience more SAEs. In this setting, a MELD score ≥18 may help clinicians to identify those patients with a higher risk of complications and to individualize treatment decisions. (Hepatology 2017;65:1810-1822).
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Antivirales/administración & dosificación , Enfermedad Hepática en Estado Terminal/tratamiento farmacológico , Hepatitis C Crónica/tratamiento farmacológico , Cirrosis Hepática/tratamiento farmacológico , Sistema de Registros , Adulto , Anciano , Anciano de 80 o más Años , Causas de Muerte , Estudios de Cohortes , Progresión de la Enfermedad , Enfermedad Hepática en Estado Terminal/mortalidad , Enfermedad Hepática en Estado Terminal/patología , Enfermedad Hepática en Estado Terminal/virología , Femenino , Hepacivirus/efectos de los fármacos , Hepacivirus/genética , Hepatitis C Crónica/mortalidad , Hepatitis C Crónica/fisiopatología , Humanos , Estimación de Kaplan-Meier , Cirrosis Hepática/mortalidad , Cirrosis Hepática/fisiopatología , Cirrosis Hepática/virología , Pruebas de Función Hepática , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Ribavirina/administración & dosificación , Medición de Riesgo , Índice de Severidad de la Enfermedad , Sofosbuvir/administración & dosificación , España , Análisis de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND & AIMS: The development of direct-acting antiviral agents (DAAs) is a major step forward in the treatment of hepatitis C (HCV). The aims of the study were to evaluate the efficacy and tolerability of DAAs in kidney transplant (KT) recipients. METHODS: Hepa-C is a Spanish registry of patients treated with DAAs in which clinical, virological and analytical data were prospectively included. We report on the data from 103 KT recipients who received DAAs. RESULTS: The most commonly used DAAs combinations were sofosbuvir/ledipasvir (n=59, 57%) and sofosbuvir+daclatasvir (n=18, 17%). Ribavirin was used in 41% of patients. Sustained viral response after 12weeks (SVR12) rate was 98%. Grade 2 or 3 anemia appeared in 14 (33%) of patients receiving ribavirin and in 9 (15%) without (p=0.03). There were three episodes of acute humoral graft rejection. No patient discontinued therapy due to adverse events. Importantly, 57 (55%) patients required immunosuppression dose adjustment. Overall, there were no statistically significant differences in the mean level of serum creatinine, eGFR and proteinuria before and after treatment. Nonetheless, seventeen (16%) patients experienced renal dysfunction (increase in serum creatinine >25%) during antiviral therapy, of whom 65% were cirrhotic in comparison with only 29% cirrhotic patients who did not develop significant renal dysfunction (p=0.004). CONCLUSIONS: Antiviral therapy with DAAs was highly efficacious and safe in KT recipients. Nevertheless, a non-negligible number of patients, most of them cirrhotic, developed mild allograft dysfunction and a significant proportion of patients required immunosuppression dose adjustment, warranting a close follow-up during therapy. LAY SUMMARY: Infection by hepatitis C virus is often found in kidney transplant patients and its presence increases mortality and graft failure. We investigated the efficacy and safety of the new direct-acting hepatitis C antivirals in this population, in which previous information is scarce. Our data shows that, as occurs in the non-transplant setting, new anti-HCV antivirals are highly efficacious kidney transplant patients. Overall, this therapy is also quite safe, although worsening of renal function is observed in 16% of patients warranting a close follow-up observation of graft function during antiviral therapy.
Asunto(s)
Antivirales/uso terapéutico , Hepatitis C Crónica/tratamiento farmacológico , Hepatitis C Crónica/cirugía , Trasplante de Riñón , Adulto , Anciano , Antivirales/administración & dosificación , Antivirales/efectos adversos , Quimioterapia Combinada , Femenino , Tasa de Filtración Glomerular , Hepatitis C Crónica/fisiopatología , Humanos , Terapia de Inmunosupresión , Interferones/administración & dosificación , Interferones/efectos adversos , Trasplante de Riñón/efectos adversos , Masculino , Persona de Mediana Edad , Sistema de Registros , Estudios Retrospectivos , España , Respuesta Virológica Sostenida , Resultado del TratamientoRESUMEN
No disponible
Asunto(s)
Humanos , Femenino , Adulto , Carcinoma Hepatocelular/patología , Síndrome de Budd-Chiari/complicaciones , Vena Cava Inferior/cirugía , AngiografíaAsunto(s)
Síndrome de Budd-Chiari/complicaciones , Carcinoma Hepatocelular/complicaciones , Neoplasias Hepáticas/complicaciones , Vena Cava Inferior , Adulto , Síndrome de Budd-Chiari/etiología , Síndrome de Budd-Chiari/terapia , Carcinoma Hepatocelular/cirugía , Femenino , Humanos , Neoplasias Hepáticas/cirugía , Vena Cava Inferior/patologíaRESUMEN
The role of contaminated preservation fluid in the development of infection after liver transplantation has not been fully elucidated. To assess the incidence and etiology of contaminated preservation fluid and determine its impact on the subsequent development of infection after liver transplantation, we prospectively studied 50 consecutive liver transplants, and cultured the following samples in each instance: preservation fluid (immediately before and at the end of the back-table procedure, and just before implantation), blood, and bile from the donor, and ascitic fluid from the recipient. When any culture was positive, blood cultures were obtained and targeted antimicrobial therapy was started. We found that the incidence of contaminated preservation fluid was 92% (46 of 50 cases of liver transplantation per year), but only 28% (14/50) were contaminated by recognized pathogens. Blood and bile cultures from the donor were positive in 28% and 6% respectively, whereas ascitic fluid was positive in 22%. The most frequently isolated microorganisms were coagulase-negative staphylococci. In nine cases, the microorganisms isolated from the preservation fluid concurred with those grown from the donor blood cultures, and in one case, the isolate matched with the one obtained from bile culture. No liver transplant recipient developed an infection due to the transmission of an organism isolated from the preservation fluid. Our findings indicate that contamination of the preservation fluid is frequent in liver transplantation, and it is mainly caused by saprophytic skin flora. Transmission of infection is low, particularly among those recipients given targeted antimicrobial treatment for organisms isolated in the preservation fluid.
Asunto(s)
Bacterias/aislamiento & purificación , Infecciones Bacterianas/epidemiología , Infecciones Bacterianas/etiología , Contaminación de Medicamentos , Trasplante de Hígado , Soluciones Preservantes de Órganos , Bacterias/clasificación , Humanos , Incidencia , Estudios Prospectivos , España/epidemiologíaRESUMEN
La escasez de órganos para trasplante ha hecho aumentar progresivamente la aceptación de donantes con criterios marginales, como la edad. MÉTODOS: Se ha realizado un análisis comparativo de la evolución postrasplante dependiendo de la edad de los donantes (grupo I: edad inferior a 70 años [n = 474] vs. grupo II: edad superior a 70 años [n = 105]), a lo largo de un periodo de 10 años. RESULTADOS: No había diferencias significativas entre ambos grupos en días de UCI, sexo, peso y requerimientos de fármacos vasoactivos. El grupo I presentó parada cardiaca de forma más frecuente (GI: 14 vs. GII: 3%; p = 0,005). No hubo diferencias en la disfunción primaria (GI: 6 vs. GII: 7,7%; p = 0,71), estancia en UCI (GI: 2,7 ± 2 vs. GII: 3,3 ± 3,8 días; p = 0,46) y hospitalaria (GI: 13,5 ± 10 vs. GII: 15,5 ± 11; p = 0,1), ni mortalidad hospitalaria (GI: 5,3 vs. GII: 5,8%; p = 0,66). Tras una mediana de seguimiento de 42 meses, tampoco se encontraron diferencias en la incidencia de complicaciones biliares (GI: 17 vs. GII: 20%; p = 0,40) ni vasculares (GI: 11 vs. GII: 9%; p = 0,69). La supervivencia actuarial a 5 años fue similar entre ambos grupos de estudio (GI: 70 vs. GII: 76%; p = 0,54). CONCLUSIONES: En nuestra experiencia, la utilización de injertos de donantes mayores de 70 años, si se evitan factores de riesgo adicionales (tiempo de isquemia, esteatosis, hipernatremia), no empeora los resultados del trasplante hepático a corto ni a largo plazo
Organ shortage has forced transplant teams to progressively expand the acceptance of marginal donors. METHODS: We performed a comparative analysis of the post-transplant evolution depending on donor age (group I: less than 70 years old (n = 474) vs. group II: 70 or more years old [n = 105]) over a 10 year period (2002-2011). RESULTS: Donors over 70 years old were similar to donors less than 70 years old in terms of ICU stay, gender, weight, laboratory results, and use of vasoactive drugs. However, the younger donor group presented with cardiac arrest more often (GI: 14 vs. GII: 3%, P=.005). There were no differences in initial poor function (GI: 6% vs. GII: 7,7%; P=.71), ICU stay (GI: 2.7 ± 2 vs. GII: 3.3 ± 3.8, P=.46), hospital stay (GI: 13.5 ± 10 vs. GII: 15.5 ± 11, P=.1), or hospital mortality (GI: 5.3 vs. GII: 5.8%, P=.66) between receptors of more or less than 70 year old grafts. After a median follow up of 32 months, no differences were found in the incidence of biliary tract complications (GI: 17 vs. GII: 20%, P=.4) or vascular complications (GI: 11 vs. GII: 9%, P=.69). The actuarial 5 year survival was similar for both study groups (GI: 70 vs. GII: 76%, P=.54). CONCLUSIONS: In our experience, the use of grafts from donors older than 70 years, when other risk factors are avoided (cold ischemia, steatosis, sodium levels), does not worsen the results of liver transplantation on the short or long term
Asunto(s)
Humanos , Trasplante de Hígado/métodos , Fallo Hepático/cirugía , Resultado del Tratamiento , Donantes de Tejidos/estadística & datos numéricos , 50293 , Supervivencia Tisular , Sobrevivientes/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiologíaRESUMEN
UNLABELLED: Organ shortage has forced transplant teams to progressively expand the acceptance of marginal donors. METHODS: We performed a comparative analysis of the post-transplant evolution depending on donor age (group I: less than 70 years old (n=474) vs. group II: 70 or more years old [n=105]) over a 10 year period (2002-2011). RESULTS: Donors over 70 years old were similar to donors less than 70 years old in terms of ICU stay, gender, weight, laboratory results, and use of vasoactive drugs. However, the younger donor group presented with cardiac arrest more often (GI: 14 vs. GII: 3%, P=.005). There were no differences in initial poor function (GI: 6% vs. GII: 7,7%; P=.71), ICU stay (GI: 2.7±2 vs. GII: 3.3±3.8, P=.46), hospital stay (GI: 13.5±10 vs. GII: 15.5±11, P=.1), or hospital mortality (GI: 5.3 vs. GII: 5.8%, P=.66) between receptors of more or less than 70 year old grafts. After a median follow up of 32 months, no differences were found in the incidence of biliary tract complications (GI: 17 vs. GII: 20%, P=.4) or vascular complications (GI: 11 vs. GII: 9%, P=.69). The actuarial 5 year survival was similar for both study groups (GI: 70 vs. GII: 76%, P=.54). CONCLUSIONS: In our experience, the use of grafts from donors older than 70 years, when other risk factors are avoided (cold ischemia, steatosis, sodium levels), does not worsen the results of liver transplantation on the short or long term.