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Article ; Online: Effectiveness and safety of once-daily tacrolimus formulations in de novo liver transplant recipients: The PRETHI study.

Bilbao, Itxarone / Gómez Bravo, Miguel Ángel / Otero, Alejandra / Lladó, Laura / Montero, José Luís / González Dieguez, Luisa / Graus, Javier / Pons Miñano, José Antonio

Clinical transplantation

2023 Volume 37, Issue 12, Page(s) e15105

Abstract: Data comparing long-term effectiveness and safety of once-daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR-Tac (Advagraf) for up to 12 ... ...

Abstract	Data comparing long-term effectiveness and safety of once-daily tacrolimus formulations in de novo liver transplantation are scarce. We compared the effectiveness, pharmacokinetic profile, and safety of LCPT (Envarsus) and PR-Tac (Advagraf) for up to 12 months post-transplant. Adult de novo liver transplant recipients who started IR-Tac (Prograf) and were converted to LCPT or PR-Tac 3-5 days post-transplant were included. Data from 163 patients were analyzed, 87 treated with LCPT and 76 with PR-Tac. The incidence of treatment failure was 30.5% in the LCPT group versus 23.0% in the PR-Tac group (p = .291). Biopsy-proven acute rejection (BPAR) was reported in 26.8% of patients in the LCPT group and 17.6% in the PR-Tac group (p = .166). Graft loss was experienced in one patient (1.2%) in the LCPT group and three patients (4.1%) in the PR-Tac group (p = .346). Death was registered in three patients (3.7%) in the LCPT group and three patients (4.1%) in the PR-Tac group (p > .999). Patients in the LCPT group showed 45.7% higher relative bioavailability (C
MeSH term(s)	Adult ; Humans ; Tacrolimus/therapeutic use ; Tacrolimus/pharmacokinetics ; Immunosuppressive Agents/therapeutic use ; Immunosuppressive Agents/pharmacokinetics ; Liver Transplantation ; Kidney Transplantation/adverse effects ; Drug Administration Schedule ; Prospective Studies ; Graft Rejection/drug therapy ; Graft Rejection/etiology ; Transplant Recipients
Chemical Substances	Tacrolimus (WM0HAQ4WNM) ; Immunosuppressive Agents
Language	English
Publishing date	2023-08-24
Publishing country	Denmark
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	639001-8
ISSN	1399-0012 ; 0902-0063
ISSN (online)	1399-0012
ISSN	0902-0063
DOI	10.1111/ctr.15105
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Article: Diabetes is not associated with an increased risk of hepatocellular carcinoma in patients with alcoholic or hepatitis C virus cirrhosis.

Rodríguez-Escaja, Carlos / Á Navascués, Carmen / González-Diéguez, Luisa / Cadahía, Valle / Varela, María / de Jorge, Miguel Ángel / Castaño-García, Andrés / Rodríguez, Manuel

Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva

2020 Volume 113, Issue 7, Page(s) 505–511

Abstract: Background and aims: diabetes has been reported as a risk factor for hepatocellular carcinoma (HCC) in population-based studies but there are controversial data in patients with cirrhosis. Metformin could have a protective role in HCC development. The ... ...

Abstract	Background and aims: diabetes has been reported as a risk factor for hepatocellular carcinoma (HCC) in population-based studies but there are controversial data in patients with cirrhosis. Metformin could have a protective role in HCC development. The aim of this study was to determine the influence of diabetes on the risk of developing HCC in patients with alcohol- and hepatitis C virus (HCV)-related cirrhosis. Methods: a cohort of 982 Caucasian patients were analyzed with alcoholic or HCV cirrhosis, included from 1992 to 2014 in a HCC surveillance program and prospectively followed. The influence of diabetes on the development of HCC was analyzed by Kaplan Meier analysis and adjusted with a Cox regression for relevant co-factors. Results: after a median follow-up of 49.5 (24.0-96.0) months, 156 patients (15.8 %) developed HCC. There were no differences in the cumulative incidences of HCC after 20 years between diabetic and non-diabetic patients in the global (53.5 % vs 45.4 %; p = 0.26), alcoholic (50.4 % vs 45.4 %; p = 0.21) or HCV (60 % vs 43.1 %; p = 0.57) cirrhosis series. Diabetes did not constitute a risk factor after adjusting for other potential co-factors, neither in the whole series (hazard ratio [HR]: 1.12, 95 % CI: 0.78-1.51; p = 0.26), alcoholic (HR: 1.160, 95 % CI: 0.74-1.82; p = 0.50) or HCV cirrhosis cohort (HR: 1.17, 95 % CI: 0.63-2.19; p = 0.60). These figures did not change after excluding patients treated with metformin. Conclusions: in Caucasian patients with alcoholic or HCV cirrhosis, diabetes is not a risk factor for developing HCC. This lack of an association does not seem to be a consequence of the protective effect of metformin.
MeSH term(s)	Carcinoma, Hepatocellular/epidemiology ; Carcinoma, Hepatocellular/etiology ; Diabetes Mellitus ; Hepacivirus ; Hepatitis C/complications ; Hepatitis C/epidemiology ; Humans ; Liver Cirrhosis/complications ; Liver Cirrhosis/epidemiology ; Liver Cirrhosis, Alcoholic/complications ; Liver Cirrhosis, Alcoholic/epidemiology ; Liver Neoplasms/epidemiology ; Liver Neoplasms/etiology ; Risk Factors
Language	English
Publishing date	2020-11-26
Publishing country	Spain
Document type	Journal Article
ZDB-ID	1070381-0
ISSN	1130-0108 ; 0212-7512
ISSN	1130-0108 ; 0212-7512
DOI	10.17235/reed.2020.6953/2020
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Article ; Online: Sinusoidal obstruction syndrome after liver transplantation: A multicenter observational study.

Caballero-Marcos, Aránzazu / Peligros, Isabel / Pérez-Rojas, Judith / Campos-Varela, Isabel / Colmenero, Jordi / Gómez-Bravo, Miguel Ángel / Justo, Iago / Otero, Alejandra / Molina-Pérez, Esther / González-Diéguez, Luisa / Baliellas, Carme / Romero-Cristobal, Mario / Aguilera, Victoria / Castells, Lluís / Díaz, Alba / Marín-Gómez, Luis Miguel / Loinaz, Carmelo / Bañares, Rafael / Salcedo, Magdalena

Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society

2022 Volume 28, Issue 7, Page(s) 1257–1261

MeSH term(s)	Hepatic Veno-Occlusive Disease/diagnosis ; Hepatic Veno-Occlusive Disease/etiology ; Humans ; Liver Transplantation/adverse effects
Language	English
Publishing date	2022-04-28
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study
ZDB-ID	2006866-9
ISSN	1527-6473 ; 1527-6465
ISSN (online)	1527-6473
ISSN	1527-6465
DOI	10.1002/lt.26452
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Article ; Online: Cytomegalovirus reactivation in liver transplant recipients due to hepatitis C cirrhosis is associated with higher cardiovascular risk - an observational, retrospective study.

Aguilera, Victoria / Di Maira, Tommaso / Conde, Isabel / Fornés-Ferrer, Victoria / Vinaixa, Carmen / Pallarés, Carmen / Carvalho-Gomes, Angela / Cubells, Almudena / García, María / Rubín, Ángel / Benlloch, Salvador / Gonzalez-Dieguez, Luisa / Molina, Jose Miguel / Puchades, Lorena / López-Labrador, F Xavier / Prieto, Martin / Berenguer, Marina

Transplant international : official journal of the European Society for Organ Transplantation

2018 Volume 31, Issue 6, Page(s) 649–657

Abstract: The association between cytomegalovirus (CMV) reactivation and cardiovascular risk has been reported in solid organ transplant populations; however, it has yet to be assessed in liver transplantation (LT). We aim to evaluate whether CMV reactivation is ... ...

Abstract	The association between cytomegalovirus (CMV) reactivation and cardiovascular risk has been reported in solid organ transplant populations; however, it has yet to be assessed in liver transplantation (LT). We aim to evaluate whether CMV reactivation is associated with cardiovascular events (CVE) in HCV-LT patients. LT patients (2010 and 2014) due to HCV cirrhosis were included. Clinically significant CMV (CS-CMV) was defined as viral load (VL) >5000 copies/ml, need of therapy or CMV disease. Baseline variables and endpoint measures (CVE, survival, severe recurrent hepatitis C, de novo tumors, and diabetes) were collected. One hundred and forty patients were included. At LT, a history of AHT was present in 23%, diabetes 22%, tobacco use 45%, obesity 20%, and renal impairment (eGFR < 60 ml/min) in 26.5%. CS-CMV reactivation occurred in 25% of patients. Twenty-six patients (18.5%) developed a CVE. Cox regression analysis revealed two factors significantly associated with CVE: Pre-LT DM [HR = 4.6 95% CI (1.6, 13), P = 0.004] and CS-CMV [HR = 4.7 95% CI (1.8, 12.5), P = 0.002]. CS-CMV was not independently associated with the remaining endpoints except for survival (P = 0.03). In our series, CS-CMV reactivation was associated with a greater risk of developing CVE, thus confirming data from other solid organ transplant populations and emphasizing the need for adequate CMV control.
MeSH term(s)	Aged ; Cardiovascular Diseases/complications ; Cardiovascular Diseases/virology ; Cytomegalovirus ; Cytomegalovirus Infections/complications ; Female ; Glomerular Filtration Rate ; Hepatitis C/complications ; Hepatitis C/surgery ; Humans ; Immunosuppression ; Liver Cirrhosis/complications ; Liver Cirrhosis/surgery ; Liver Cirrhosis/virology ; Liver Transplantation/adverse effects ; Male ; Middle Aged ; Proportional Hazards Models ; Retrospective Studies ; Risk Factors ; Tissue Donors ; Viral Load
Language	English
Publishing date	2018-03-26
Publishing country	England
Document type	Journal Article ; Observational Study
ZDB-ID	639435-8
ISSN	1432-2277 ; 0934-0874
ISSN (online)	1432-2277
ISSN	0934-0874
DOI	10.1111/tri.13145
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Article ; Online: Decreased Long-Term Severe Acute Respiratory Syndrome Coronavirus 2-Specific Humoral Immunity in Liver Transplantation Recipients 12 Months After Coronavirus Disease 2019.

Caballero-Marcos, Aránzazu / Citores, María Jesús / Alonso-Fernández, Roberto / Rodríguez-Perálvarez, Manuel / Valerio, Maricela / Graus Morales, Javier / Cuervas-Mons, Valentín / Cachero, Alba / Loinaz-Segurola, Carmelo / Iñarrairaegui, Mercedes / Castells, Lluís / Pascual, Sonia / Vinaixa-Aunés, Carmen / González-Grande, Rocío / Otero, Alejandra / Tomé, Santiago / Tejedor-Tejada, Javier / Fernández-Yunquera, Ainhoa / González-Diéguez, Luisa /

Nogueras-Lopez, Flor / Blanco-Fernández, Gerardo / Díaz-Fontenla, Fernando / Bustamante, Francisco Javier / Romero-Cristóbal, Mario / Martin-Mateos, Rosa / Arias-Milla, Ana / Calatayud, Laura / Marcacuzco-Quinto, Alberto A / Fernández-Alonso, Víctor / Gómez-Gavara, Concepción / Muñoz, Patricia / Bañares, Rafael / Pons, José Antonio / Salcedo, Magdalena

Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society

2022 Volume 28, Issue 6, Page(s) 1039–1050

Abstract: Long-term humoral immunity and its protective role in liver transplantation (LT) patients have not been elucidated. We performed a prospective multicenter study to assess the persistence of immunoglobulin G (IgG) antibodies in LT recipients 12 months ... ...

Abstract	Long-term humoral immunity and its protective role in liver transplantation (LT) patients have not been elucidated. We performed a prospective multicenter study to assess the persistence of immunoglobulin G (IgG) antibodies in LT recipients 12 months after coronavirus disease 2019 (COVID-19). A total of 65 LT recipients were matched with 65 nontransplanted patients by a propensity score including variables with recognized impact on COVID-19. LT recipients showed a lower prevalence of anti-nucleocapsid (27.7% versus 49.2%; P = 0.02) and anti-spike IgG antibodies (88.2% versus 100.0%; P = 0.02) at 12 months. Lower index values of anti-nucleocapsid IgG antibodies were also observed in transplantation patients 1 year after COVID-19 (median, 0.49 [interquartile range, 0.15-1.40] versus 1.36 [interquartile range, 0.53-2.91]; P < 0.001). Vaccinated LT recipients showed higher antibody levels compared with unvaccinated patients (P < 0.001); antibody levels reached after vaccination were comparable to those observed in nontransplanted individuals (P = 0.70). In LT patients, a longer interval since transplantation (odds ratio, 1.10; 95% confidence interval, 1.01-1.20) was independently associated with persistence of anti-nucleocapsid IgG antibodies 1 year after infection. In conclusion, compared with nontransplanted patients, LT recipients show a lower long-term persistence of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies. However, SARS-CoV-2 vaccination after COVID-19 in LT patients achieves a significant increase in antibody levels, comparable to that of nontransplanted patients.
MeSH term(s)	Antibodies, Viral/blood ; COVID-19/immunology ; COVID-19 Vaccines ; Humans ; Immunity, Humoral ; Immunoglobulin G/blood ; Liver Transplantation ; Prospective Studies ; SARS-CoV-2
Chemical Substances	Antibodies, Viral ; COVID-19 Vaccines ; Immunoglobulin G
Language	English
Publishing date	2022-01-17
Publishing country	United States
Document type	Journal Article ; Multicenter Study
ZDB-ID	2006866-9
ISSN	1527-6473 ; 1527-6465
ISSN (online)	1527-6473
ISSN	1527-6465
DOI	10.1002/lt.26389
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Article ; Online: Impact of Cytomegalovirus Infection on Severe Hepatitis C Recurrence in Patients Undergoing Liver Transplantation.

Caston, Juan Jose / Castells, Luis / Varo, Evaristo / Gomez, Miguel Angel / de la Mata, Manuel / Campos-Varela, Isabel / Lumbreras, Carlos / Gonzalez-Dieguez, Luisa / Fabregat, Joan / Herrero, Ignacio / Salcedo, Magdalena / Sanchez-Antolín, Gloria / Torre-Cisneros, Julian

Transplantation

2016 Volume 100, Issue 3, Page(s) 593–599

Abstract: Background: The influence of cytomegalovirus (CMV) on recurrent hepatitis C virus (HCV) in liver grafts is controversial. Our aim was to investigate the association between CMV infection and disease and severe HCV recurrence (composite variable of ... ...

Abstract	Background: The influence of cytomegalovirus (CMV) on recurrent hepatitis C virus (HCV) in liver grafts is controversial. Our aim was to investigate the association between CMV infection and disease and severe HCV recurrence (composite variable of presence of stage 3 to 4 fibrosis, need for retransplantation or death due to liver disease) in the first year after transplantation. Methods: An observational, prospective, multicenter study was performed. The CMV replication was monitored by determining CMV viral load weekly during hospitalization after transplantation, twice monthly in the first 3 months after discharge, and at each follow-up visit until month 12. Liver fibrosis was assessed histologically by liver biopsy or transient elastometry. Pretransplant, intraoperative, and posttransplant variables were recorded. Multiple logistic regression was performed to study the impact of CMV on severe HCV recurrence. Results: Ninety-eight patients were included. The CMV infection was detected in 48 patients (49%) in the first year posttransplant, of which 11 patients (22.9%) had CMV disease. Twenty-three patients (23.5%) had severe HCV recurrence. Of these, 17 (73.9%) developed stage 3 to 4 fibrosis, 4 (17.4%) died, and 2 (8.7%) underwent retransplantation. Only 7 of 12 (58.3%) seronegative recipients of a seropositive donor (positive donor/negative recipient [D+/R-]) received universal prophylaxis, and 10 of 12 (83.3%) D+/R- patients developed CMV replication. In the multivariate analysis, the presence of CMV D+/R- serodiscordance (odds ratio, 6.87; 95% confidence interval, 1.89-24.99; P = 0.003), and detection of a higher peak HCV viral load (odds ratio, 3.85; 95% confidence interval, 1.49-9.94; P = 0.005) were associated with severe HCV recurrence. Conclusions: Our results support an association between CMV D+/R- serodiscordance and severe HCV recurrence in patients undergoing liver transplantation for HCV liver disease.
MeSH term(s)	Adult ; Aged ; Antiviral Agents/therapeutic use ; Cytomegalovirus Infections/diagnosis ; Cytomegalovirus Infections/immunology ; Cytomegalovirus Infections/mortality ; Cytomegalovirus Infections/therapy ; Cytomegalovirus Infections/virology ; Female ; Hepacivirus/immunology ; Hepacivirus/pathogenicity ; Hepatitis C/diagnosis ; Hepatitis C/immunology ; Hepatitis C/mortality ; Hepatitis C/therapy ; Hepatitis C/virology ; Humans ; Immunocompromised Host ; Immunosuppressive Agents/adverse effects ; Kaplan-Meier Estimate ; Liver Cirrhosis/immunology ; Liver Cirrhosis/virology ; Liver Transplantation/adverse effects ; Liver Transplantation/mortality ; Logistic Models ; Male ; Middle Aged ; Multivariate Analysis ; Odds Ratio ; Opportunistic Infections/diagnosis ; Opportunistic Infections/immunology ; Opportunistic Infections/mortality ; Opportunistic Infections/therapy ; Opportunistic Infections/virology ; Prospective Studies ; Recurrence ; Reoperation ; Risk Factors ; Severity of Illness Index ; Spain ; Time Factors ; Treatment Outcome ; Viral Load ; Virus Activation
Chemical Substances	Antiviral Agents ; Immunosuppressive Agents
Language	English
Publishing date	2016-03
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	208424-7
ISSN	1534-6080 ; 0041-1337
ISSN (online)	1534-6080
ISSN	0041-1337
DOI	10.1097/TP.0000000000000912
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Article ; Online: Changes in humoral immune response after SARS-CoV-2 infection in liver transplant recipients compared to immunocompetent patients.

Caballero-Marcos, Aránzazu / Salcedo, Magdalena / Alonso-Fernández, Roberto / Rodríguez-Perálvarez, Manuel / Olmedo, María / Graus Morales, Javier / Cuervas-Mons, Valentín / Cachero, Alba / Loinaz-Segurola, Carmelo / Iñarrairaegui, Mercedes / Castells, Lluís / Pascual, Sonia / Vinaixa-Aunés, Carmen / González-Grande, Rocío / Otero, Alejandra / Tomé, Santiago / Tejedor-Tejada, Javier / Álamo-Martínez, José María / González-Diéguez, Luisa /

Nogueras-Lopez, Flor / Blanco-Fernández, Gerardo / Muñoz-Bartolo, Gema / Bustamante, Francisco Javier / Fábrega, Emilio / Romero-Cristóbal, Mario / Martin-Mateos, Rosa / Del Rio-Izquierdo, Julia / Arias-Milla, Ana / Calatayud, Laura / Marcacuzco-Quinto, Alberto A / Fernández-Alonso, Víctor / Gómez-Gavara, Concepción / Colmenero, Jordi / Muñoz, Patricia / Pons, José A

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons

2021 Volume 21, Issue 8, Page(s) 2876–2884

Abstract: The protective capacity and duration of humoral immunity after SARS-CoV-2 infection are not yet understood in solid organ transplant recipients. A prospective multicenter study was performed to evaluate the persistence of anti-nucleocapsid IgG antibodies ...

Abstract	The protective capacity and duration of humoral immunity after SARS-CoV-2 infection are not yet understood in solid organ transplant recipients. A prospective multicenter study was performed to evaluate the persistence of anti-nucleocapsid IgG antibodies in liver transplant recipients 6 months after coronavirus disease 2019 (COVID-19) resolution. A total of 71 liver transplant recipients were matched with 71 immunocompetent controls by a propensity score including variables with a well-known prognostic impact in COVID-19. Paired case-control serological data were also available in 62 liver transplant patients and 62 controls at month 3 after COVID-19. Liver transplant recipients showed a lower incidence of anti-nucleocapsid IgG antibodies at 3 months (77.4% vs. 100%, p < .001) and at 6 months (63.4% vs. 90.1%, p < .001). Lower levels of antibodies were also observed in liver transplant patients at 3 (p = .001) and 6 months (p < .001) after COVID-19. In transplant patients, female gender (OR = 13.49, 95% CI: 2.17-83.8), a longer interval since transplantation (OR = 1.19, 95% CI: 1.03-1.36), and therapy with renin-angiotensin-aldosterone system inhibitors (OR = 7.11, 95% CI: 1.47-34.50) were independently associated with persistence of antibodies beyond 6 months after COVID-19. Therefore, as compared with immunocompetent patients, liver transplant recipients show a lower prevalence of anti-SARS-CoV-2 antibodies and more pronounced antibody levels decline.
MeSH term(s)	COVID-19 ; Female ; Humans ; Immunity, Humoral ; Liver Transplantation ; Prospective Studies ; SARS-CoV-2 ; Transplant Recipients
Language	English
Publishing date	2021-04-27
Publishing country	United States
Document type	Journal Article ; Multicenter Study
ZDB-ID	2060594-8
ISSN	1600-6143 ; 1600-6135
ISSN (online)	1600-6143
ISSN	1600-6135
DOI	10.1111/ajt.16599
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Article ; Online: Human immunodeficiency virus-infected liver transplant recipients with incidental hepatocellular carcinoma: A prospective multicenter nationwide cohort study.

Agüero, Fernando / Forner, Alejandro / Valdivieso, Andrés / Blanes, Marino / Barcena, Rafael / Manzardo, Christian / Rafecas, Antoni / Castells, Lluis / Abradelo, Manuel / Barrera-Baena, Pilar / González-Diéguez, Luisa / Salcedo, Magdalena / Serrano, Trinidad / Jiménez-Pérez, Miguel / Herrero, José Ignacio / Gastaca, Mikel / Aguilera, Victoria / Fabregat, Juan / Del Campo, Santos /

Bilbao, Itxarone / Romero, Carlos Jiménez / Moreno, Asunción / Rimola, Antoni / Miro, José M

Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society

2017 Volume 23, Issue 5, Page(s) 645–651

Abstract: There is a lack of data on incidental hepatocellular carcinoma (iHCC) in the setting of liver transplantation (LT) in human immunodeficiency virus (HIV)-infected patients. This study aims to describe the frequency, histopathological characteristics, and ... ...

Abstract	There is a lack of data on incidental hepatocellular carcinoma (iHCC) in the setting of liver transplantation (LT) in human immunodeficiency virus (HIV)-infected patients. This study aims to describe the frequency, histopathological characteristics, and outcomes of HIV+ LT recipients with iHCC from a Spanish multicenter cohort in comparison with a matched cohort of LT patients without HIV infection. A total of 15 (6%) out of 271 patients with HIV infection who received LT in Spain from 2002 to 2012 and 38 (5%) out of the 811 HIV- counterparts presented iHCC in liver explants (P = 0.58). Patients with iHCC constitute the present study population. All patients also had hepatitis C virus (HCV)-related cirrhosis. There were no significant differences in histopathological features of iHCC between the 2 groups. Most patients showed a small number and size of tumoral nodules, and few patients had satellite nodules, microvascular invasion, or poorly differentiated tumors. After a median follow-up of 49 months, no patient developed hepatocellular carcinoma (HCC) recurrence after LT. HIV+ LT recipients tended to have lower survival than their HIV- counterparts at 1 (73% versus 92%), 3 (67% versus 84%), and 5 years (50% versus 80%; P = 0.06). There was also a trend to a higher frequency of HCV recurrence as a cause of death in the former (33% versus 10%; P = 0.097). In conclusion, among LT recipients for HCV-related cirrhosis, the incidence and histopathological features of iHCC in HIV+ and HIV- patients were similar. However, post-LT survival was lower in HIV+ patients probably because of a more aggressive HCV recurrence. Liver Transplantation 23 645-651 2017 AASLD.
Language	English
Publishing date	2017-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	2006866-9
ISSN	1527-6473 ; 1527-6465
ISSN (online)	1527-6473
ISSN	1527-6465
DOI	10.1002/lt.24741
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Article ; Online: Clinical outcomes of patients undergoing antiviral therapy while awaiting liver transplantation.

Pascasio, Juan Manuel / Vinaixa, Carmen / Ferrer, María Teresa / Colmenero, Jordi / Rubin, Angel / Castells, Lluis / Manzano, María Luisa / Lorente, Sara / Testillano, Milagros / Xiol, Xavier / Molina, Esther / González-Diéguez, Luisa / Otón, Elena / Pascual, Sonia / Santos, Begoña / Herrero, José Ignacio / Salcedo, Magdalena / Montero, José Luis / Sánchez-Antolín, Gloria /

Narváez, Isidoro / Nogueras, Flor / Giráldez, Álvaro / Prieto, Martín / Forns, Xavier / Londoño, María-Carlota

Journal of hepatology

2017 Volume 67, Issue 6, Page(s) 1168–1176

Abstract: Background & aims: Antiviral therapy for the treatment of hepatitis C (HCV) infection has proved to be safe and efficacious in patients with cirrhosis awaiting liver transplantation (LT). However, the information regarding the clinical impact of viral ... ...

Abstract	Background & aims: Antiviral therapy for the treatment of hepatitis C (HCV) infection has proved to be safe and efficacious in patients with cirrhosis awaiting liver transplantation (LT). However, the information regarding the clinical impact of viral eradication in patients on the waiting list is still limited. The aim of the study was to investigate the probability of delisting in patients who underwent antiviral therapy, and the clinical outcomes of these delisted patients. Methods: Observational, multicenter and retrospective analysis was carried out on prospectively collected data from patients positive for HCV, treated with an interferon-free regimen, while awaiting LT in 18 hospitals in Spain. Results: In total, 238 patients were enrolled in the study. The indication for LT was decompensated cirrhosis (with or without hepatocellular carcinoma [HCC]) in 171 (72%) patients, and HCC in 67 (28%) patients. Sustained virologic response (SVR) rate was significantly higher in patients with compensated cirrhosis and HCC (92% vs. 83% in patients with decompensated cirrhosis with or without HCC, p=0.042). Among 122 patients with decompensated cirrhosis without HCC, 29 (24%) were delisted due to improvement. No patient with baseline MELD score >20 was delisted. After delisting (median follow-up of 88weeks), three patients had clinical decompensations and three had de novo HCC. Only two of the patients with HCC had to be re-admitted onto the waiting list. The remaining 23 patients remained stable, with no indication for LT. Conclusions: Antiviral therapy is safe and efficacious in patients awaiting LT. A quarter of patients with decompensated cirrhosis can be delisted asa result of clinical improvement, which appears to be remain stable in most patients. Thus, delisting is a safe strategy that could spare organs and benefit other patients with a more urgent need. Lay summary: Antiviral therapy in patients awaiting liver transplantation is safe and efficacious. Viral eradication allows removal from the waiting list of a quarter of treated patients. Delisting because of clinical improvement is a safe strategy that can spare organs for patients in urgent need.
MeSH term(s)	Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use ; Female ; Hepatitis C/drug therapy ; Humans ; Liver Cirrhosis/surgery ; Liver Transplantation ; Male ; Middle Aged ; Retrospective Studies ; Waiting Lists
Chemical Substances	Antiviral Agents
Language	English
Publishing date	2017-08-24
Publishing country	Netherlands
Document type	Journal Article ; Multicenter Study ; Observational Study ; Research Support, Non-U.S. Gov't
ZDB-ID	605953-3
ISSN	1600-0641 ; 0168-8278
ISSN (online)	1600-0641
ISSN	0168-8278
DOI	10.1016/j.jhep.2017.08.008
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Article ; Online: Altered Underlying Renal Tubular Function in Patients With Chronic Hepatitis B Receiving Nucleos(t)ide Analogs in a Real-World Setting: The MENTE Study.

Journal of clinical gastroenterology

2016 Volume 50, Issue 9, Page(s) 779–789

Abstract: Background: Cases of renal tubular dysfunction have been reported in patients with hepatitis B and in patients with human immunodeficiency virus who are undergoing tenofovir treatment. However, little is known about the impact on tubular function in ... ...

Abstract	Background: Cases of renal tubular dysfunction have been reported in patients with hepatitis B and in patients with human immunodeficiency virus who are undergoing tenofovir treatment. However, little is known about the impact on tubular function in patients with chronic hepatitis B (CHB) under long-term use of entecavir (ETV) and tenofovir disoproxil fumarate (TDF). We evaluated markers of renal tubular function and bone turnover in patients with CHB treated with ETV or TDF. Patients and methods: A multicenter, cross-sectional study was performed on markers of renal tubular function and bone turnover in hepatitis B virus-monoinfected patients on long-term treatment with Entecavir or Tenofovir (the MENTE study). The analyzed parameters were: retinol-binding protein/creatinine, neutrophil gelatinase-associated lipocalin/creatinine, excretion of phosphates, uric acid excretion, glomerular filtrate, protein/creatinine, albumin/creatinine, serum creatinine, phosphate, CTX, P1NP, vitamin D, and parathormone. Results: A total of 280 patients (ETV: 89, TDF: 69, control: 122) were included in this study. The TDF group was associated with altered levels of retinol-binding protein (RBP)/creatinine (TDF 25% vs. 7% ETV and control; P<0.001). Protein/creatinine, uric acid excretion, P1NP1, and parathormone were higher in the TDF group. The proportion of patients with serum phosphate <2.5 mg/dL was higher in both the ETV and the TDF groups compared with the control. The multivariate analysis showed that the use of TDF was independently associated with a higher risk of altered excretion of RBP/creatinine (4.4; interquartile range: 1.4 to 14; P=0.013). Conclusions: We found an independent association between TDF use and altered RBP excretion. This finding indicates subclinical tubular damage. Because tubular dysfunction can precede the decline of renal function, close monitoring of RBP levels in patients with CHB on nucleos(t)ide analog treatment must be performed for early detection of TDF-related renal toxicity. In this study, these differences in tubular function were not associated with concomitant changes in markers of bone turnover.
MeSH term(s)	Adolescent ; Adult ; Aged ; Antiviral Agents/administration & dosage ; Antiviral Agents/therapeutic use ; Creatinine/urine ; Cross-Sectional Studies ; Disease Progression ; Female ; Glomerular Filtration Rate ; Guanine/adverse effects ; Guanine/analogs & derivatives ; Guanine/therapeutic use ; Hepatitis B, Chronic/drug therapy ; Hepatitis B, Chronic/urine ; Humans ; Kidney Tubules, Proximal/physiopathology ; Male ; Middle Aged ; Nucleosides/adverse effects ; Nucleosides/therapeutic use ; Nucleotides/adverse effects ; Nucleotides/therapeutic use ; Retinol-Binding Proteins/urine ; Retrospective Studies ; Spain ; Tenofovir/adverse effects ; Tenofovir/therapeutic use ; Young Adult
Chemical Substances	Antiviral Agents ; Nucleosides ; Nucleotides ; Retinol-Binding Proteins ; entecavir (5968Y6H45M) ; Guanine (5Z93L87A1R) ; Tenofovir (99YXE507IL) ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2016-05-30
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
ZDB-ID	448460-5
ISSN	1539-2031 ; 0192-0790
ISSN (online)	1539-2031
ISSN	0192-0790
DOI	10.1097/MCG.0000000000000569
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