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3. Protective role of tacrolimus, deleterious role of age and comorbidities in liver transplant recipients with Covid-19: results from the ELITA/ELTR multi-center European study

Author

Belli LS, Fondevila C, Cortesi PA, Conti S, Karam V, Adam R, Coilly A, Ericzon BG, Loinaz C, Cuervas-Mons V, Zambelli M, Llado L, Diaz F, Invernizzi F, Patrono D, Faitot F, Bhooori S, Pirenne J, Perricone G, Magini G, Castells L, Detry O, Cruchaga PM, Colmenero J, Berrevoet F, Rodriguez G, Ysebaert D, Radenne S, Metselaar H, Morelli C, De Carlis L, Polak WG, Duvoux C, and ELITA-ELTR COVID-19 Registry

Subjects
Liver transplantation, COVID-19, Tacrolimus, Outcome
Abstract

BACKGROUND AND AIMS: Despite concerns that liver transplant (LT) recipients may be at increased risk of unfavorable outcomes from COVID-19 due the high prevalence of co-morbidities, immunosuppression and ageing, a detailed analysis of their effects in large studies is lacking. METHODS: Data from adult LT recipients with laboratory confirmed SARS-CoV2 infection were collected across Europe. All consecutive patients with symptoms were included in the analysis. RESULTS: Between March 1st and June 27th2020, data from 243 adult symptomatic cases from 36 centers and 9 countries were collected. Thirty-nine (16%) were managed as outpatients while 204 (84%) required hospitalization including admission to the ICU (39/204, 19.1%). Forty-nine (20.2%) patients died after a median of 13.5 (10-23) days, respiratory failure was the major cause. After multivariable Cox regression analysis, age >70 (HR, 4.16; 95% CI, 1.78-9.73) had a negative effect and tacrolimus (TAC) use (HR, 0.55; 95% CI, 0.31-0.99) had a positive independent effect on survival. The role of co-morbidities was strongly influenced by the dominant effect of age where comorbidities increased with the increasing age of the recipients. In a second model excluding age, both diabetes (HR, 1.95; 95% CI, 1.06-3.58) and chronic kidney disease (HR, 1.97; 95% CI, 1.05-3.67) emerged as associated with death CONCLUSIONS: Twenty-five per cent of patients requiring hospitalization for Covid-19 died, the risk being higher in patients older than 70 and with medical co-morbidities, such as impaired renal function and diabetes. Conversely, the use of TAC was associated with a better survival thus encouraging clinicians to keep TAC at the usual dose.

Published
2021

5. THE CASE-MIX IN LIVER TRANSPLANTATION. DIFFERENT PERCEPTIONS (TRANSPLANT SURGEONS AND TRANSPLANT HEPATOLOGISTS) AND DIFFERENT CONCORDANCE LEVELS WITHIN CENTERS

Author

Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, Cillo U, Calia, R, Avolio, A, Luciani, M, Franco, A, Lai, Q, Vivarelli, M, Benedetti, A, Lupo, L, Rendina, M, Colledan, M, Fagiuoli, S, Cescon, M, Morelli, C, Zamboni, F, Mameli, L, De Carlis, L, Belli, L, Rossi, G, Donato, F, Mazzaferro, V, Bhoori, S, Di Benedetto, F, De Maria, N, Santaniello, W, Di Costanzo, G, Gruttadauria, S, Volpes, R, De Simone, P, Carrai, P, Spada, M, Nobile, V, Agnes, S, Grieco, A, Spoletini, G, Ettorre, G, Giannelli, V, Tisone, G, Lenci, I, Rossi, M, Corradini, S, Romagnoli, R, Martini, S, Risaliti, A, Toniutto, P, Tedeschi, U, Carraro, A, Burra, P, Cillo, U, Calia R, Avolio A, Luciani M, Franco A, Lai Q, Vivarelli M, Benedetti A, Lupo L, Rendina M, Colledan M, Fagiuoli S, Cescon M, Morelli C, Zamboni F, Mameli L, De Carlis L, Belli LS, Rossi G, Donato F, Mazzaferro V, Bhoori S, Di Benedetto F, De Maria N, Santaniello W, Di Costanzo G, Gruttadauria S, Volpes R, De Simone P, Carrai P, Spada M, Nobile V, Agnes S, Grieco A, Spoletini G, Ettorre G, Giannelli V, Tisone G, Lenci I, Rossi M, Corradini SG, Romagnoli R, Martini S, Risaliti A, Toniutto P, Tedeschi U, Carraro A, Burra P, and Cillo U

Published
2019

6. Delisting HCV-infected liver transplant candidates who improved after viral eradication: Outcome 2 years after delisting

Author

Perricone, G, Duvoux, C, Berenguer, M, Cortesi, PA, Vinaixa, C, Facchetti, R, Mazzarelli, C, Rockenschaub, SR, Martini, S, Morelli, C, Monico, S, Volpes, R, Pageaux, GP, Fagiuoli, S, Belli, LS, and European Liver Intestine Transpla

Subjects
liver transplantation, delisting, cirrhosis, direct-acting antivirals
Abstract

Backgrounds & Aims Treating patients with decompensated cirrhosis with direct-acting antiviral (DAA) therapy while on the waiting list for liver transplantation results in substantial improvement of liver function allowing 1 in 4 patients to be removed from the waiting list or delisted, as reported in a previous study promoted by the European Liver and Intestine Transplant Association (ELITA). The aim of this study was to report on clinical outcomes of delisted patients, including mortality risk, hepatocellular carcinoma development and clinical decompensation requiring relisting. Methods Results One hundred and forty-two HCV-positive patients on the liver transplant waiting list for decompensated cirrhosis, negative for hepatocellular carcinoma, between February 2014 and June 2015 were treated with DAA therapy and were prospectively followed up. Forty-four patients (30.9%) were delisted following clinical improvement. This percentage was higher than in the original study because of a number of patients being delisted long after starting DAAs. The median Child-Pugh and MELD score of delisted patients was 5.5 and 9 respectively. Four patients were relisted, because of HCC diagnosis in 1 case and 3 patients developed ascites. One further patient died (2.4%) because of rapidly progressing hepatocellular carcinoma twenty-two months after delisting. Of the 70 patients who received a liver graft, 9 died (13%). Conclusions Antiviral therapy allows for a long-term improvement of liver function and the delisting of one-third of treated patients with risk of liver-related complications after delisting being very low.

Published
2018

7. Impatto dei farmaci anti virali ad azione diretta sulla cura dei pazienti con epatite C: un approccio di value-based medicine

Author

Conti S, Cortesi PA, Okolicsanyi S, Rota M, Ciaccio A, Gemma M, Scalone L, Cesana G, Cozzolino P, Fabris L, Colledan M, Fagiuoli S, Ideo G, Garcia-Tsao G, Belli LS, Munari LM, Mantovani LG, Strazzabosco M, Conti, S, Cortesi, P, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, and Strazzabosco, M

Subjects
MED/42 - IGIENE GENERALE E APPLICATA, MED/12 - GASTROENTEROLOGIA, epatite C, farmaci antivirali, value-based medicine, MED/01 - STATISTICA MEDICA
Published
2018

8. Impact of DAAs on liver transplantation: Major effects on the evolution of indications and results. An ELITA study based on the ELTR registry

Author

Belli, LS, Perricone, G, Adam, R, Cortesi, PA, Strazzabosco, M, Facchetti, R, Karam, V, Salizzoni, M, Andujar, RL, Fondevila, C, De Simone, P, Morelli, C, Fabregat-Prous, J, Samuel, D, Agarwaal, K, Gonzales, EM, Charco, R, Zieniewicz, K, De Carlis, L, Duvoux, C, and ELITA

Subjects
EtOH, Waiting list, HCV, HBV, NASH, digestive system diseases, Liver Transplantation
Abstract

Background & Aims: Direct-acting antivirals (DAAs) have dramatically improved the outcome of patients with hepatitis C virus (HCV) infection including those with decompensated cirrhosis (DC). We analyzed the evolution of indications and results of liver transplantation (LT) in the past 10 years in Europe, focusing on the changes induced by the advent of DAAs. Methods: This is a cohort study based on data from the European Liver Transplant Registry (ELTR). Data of adult LTs performed between January 2007 to June 2017 for HCV, hepatitis B virus (HBV), alcohol (EtOH) and non-alcoholic steatohepatitis (NASH) were analyzed. The period was divided into different eras: interferon (IFN/RBV; 2007-2010), protease inhibitor (PI; 2011-2013) and second generation DAA (DAA; 2014-June 2017). Results: Out of a total number of 60,527 LTs, 36,382 were performed in patients with HCV, HBV, EtOH and NASH. The percentage of LTs due to HCV-related liver disease varied significantly over time (p

Published
2018

9. Applicazione della value-based medicine nella valutazione della cura dei pazienti affetti da epatite

Author

Fornari, C, Cortesi, PA, Conti, S, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, LS, Munari, LM, Mantovani, LG, Strazzabosco, M, Fornari, C, Cortesi, P, Conti, S, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, and Strazzabosco, M

Subjects
Value- based medicine, epatite B, epatite C
Published
2018

11. Optimising the clinical strategy for autoimmune liver diseases: Principles of value-based medicine

Author

Carbone, M, Cristoferi, L, Cortesi, P, Rota, M, Ciaccio, A, Okolicsanyi, S, Gemma, M, Scalone, L, Cesana, G, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, Munari, LM, Carbone, M, Cristoferi, L, Cortesi, P, Rota, M, Ciaccio, A, Okolicsanyi, S, Gemma, M, Scalone, L, Cesana, G, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Cortesi, PA, Belli, LS, and Munari, LM

Abstract

Background: Autoimmune hepatitis, primary biliary cholangitis, and primary sclerosing cholangitis represent the three major autoimmune liver diseases (AILDs). Their management is highly specialized, requires a multidisciplinary approach and often relies on expensive, orphan drugs. Unfortunately, their treatment is often unsatisfactory, and the care pathway heterogeneous across different centers. Disease-specific clinical outcome indicators (COIs) able to evaluate the whole cycle of care are needed to assist both clinicians and administrators in improving quality and value of care. Aim of our study was to generate a set of COIs for the three AILDs. We then prospectively validated these indicators based on a series of consecutive patients recruited at three tertiary clinical centers in Lombardy, Italy. Methods: In phase I using a Delphi method and a RAND 9-point appropriateness scale a set of COIs was generated. In phase II the indicators were applied in a real-life dataset. Results: Two-hundred fourteen patients were enrolled and followed-up for a median time of 54. months and the above COIs were recorded using a web-based electronic medical record program. The COIs were easy to collect in the clinical practice environment and their values compared well with the available natural history studies. Conclusions: We have generated a comprehensive set of COIs which sequentially capture different clinical outcome of the three AILDs explored. These indicators represent a critical tool to implement a value-based approach to patients with these conditions, to monitor, compare and improve quality through benchmarking of clinical performance and to assess the significance of novel drugs and technologies. This article is part of a Special Issue entitled: Cholangiocytes in Health and Diseaseedited by Jesus Banales, Marco Marzioni, Nicholas LaRusso and Peter Jansen.

Published
2018

12. Impatto dei farmaci anti virali ad azione diretta sulla cura dei pazienti con epatite C: un approccio di value-based medicine

Author

Conti, S, Cortesi, P, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Conti S, Cortesi PA, Okolicsanyi S, Rota M, Ciaccio A, Gemma M, Scalone L, Cesana G, Cozzolino P, Fabris L, Colledan M, Fagiuoli S, Ideo G, Garcia-Tsao G, Belli LS, Munari LM, Mantovani LG, Strazzabosco M, Conti, S, Cortesi, P, Okolicsanyi, S, Rota, M, Ciaccio, A, Gemma, M, Scalone, L, Cesana, G, Cozzolino, P, Fabris, L, Colledan, M, Fagiuoli, S, Ideo, G, Garcia-Tsao, G, Belli, L, Munari, L, Mantovani, L, Strazzabosco, M, Conti S, Cortesi PA, Okolicsanyi S, Rota M, Ciaccio A, Gemma M, Scalone L, Cesana G, Cozzolino P, Fabris L, Colledan M, Fagiuoli S, Ideo G, Garcia-Tsao G, Belli LS, Munari LM, Mantovani LG, and Strazzabosco M

Published
2018

13. ELITA consensus statements on the use of DAAs in liver transplant candidates and recipients

Author

Belli, LS, Duvoux, C, Berenguer, M, Berg, T, Coilly, A, Colle, I, Fagiuoli, S, Khoo, S, Pageaux, GP, Puoti, M, Samuel, D, and Strazzabosco, M

Subjects
Hepatitis C, chronic, Antiviral agents, Liver transplantation, Waiting lists, Liver failure, Liver transplant recipient, Recurrent hepatitis C, Interferons, Guidelines, Liver transplant candidate
Abstract

The advent of safe and highly effective direct-acting antiviral agents (DAAs) has had huge implications for the hepatitis C virus (HCV) transplant field, and changed our management of both patients on the waiting list and those with HCV graft re-infection after liver transplantation (LT). When treating HCV infection before LT, HCV re-infection of the graft can be prevented in nearly all patients. In addition, some candidates show a remarkable clinical improvement and may be delisted. Alternatively, HCV infection can be treated post-LT either soon after the transplant, taking advantage of the removal of the infected native liver, or at the time of disease recurrence, as was carried out in the past. In either case, some DAAs have a limited use because of their drug to drug interactions with various immunosuppressants as well as the many other drugs liver transplant recipients are often prescribed. In addition, some DAAs should be avoided in case of severe renal failure, which is not an unusual complication after LT. The present document provides a series of consensus statements on the LT issues that have not been extensively addressed previously. These statements have been developed to support physicians and other stakeholders in charge of LT candidates and recipients when deciding to treat HCV, especially in difficult situations. (C) 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Published
2017

16. Difference in health related quality of life of chronic liver diseases and general population

Author

Cortesi, P, Conti, S, Scalone, L, Ciaccio, A, Okolicsanyi, S, Rota, M, Belli, L, Cesana, G, Strazzabosco, M, Mantovani, L, Cortesi, PA, Belli, LS, Mantovani, LG, Cortesi, P, Conti, S, Scalone, L, Ciaccio, A, Okolicsanyi, S, Rota, M, Belli, L, Cesana, G, Strazzabosco, M, Mantovani, L, Cortesi, PA, Belli, LS, and Mantovani, LG

Abstract

Objectives: The impact of chronic liver diseases (CLDs) on health-related quality of life (HRQoL) is relevant to understand the burden of these conditions and to inform decision-making processes. Exhaustive studies addressing simultaneously all major CLDs are still lacking, therefore we compared HRQoL of patients affected by major CLDs with that of the general population. Methods: We analyzed HRQoL data of Italian patients with major CLDs with those of a representative sample of the general Italian population. HRQoL data were collected using the EQ-5D-3L. In order to assess the association between each CLD and HRQoL, we performed multiple regression analyses, adjusting for possible confounders, using each domain of the EQ-5D descriptive system, the utility index and the visual analogue scale (VAS) as dependent variables. Results: Overall, data from 2,962 subjects with CLDs and from 6,800 individuals from the general population were analyzed. Advanced CLDs (decompensated cirrhosis and HCC) were associated with a significantly higher risk of reporting problems in physical domains(mobility, self-care and usual activity), autoimmune hepatitis in self-care, and hepatitis-C and NAFLD/NASH in anxiety/depression. Similar results were obtained with VAS and utility index: advanced CLDs were associated with a significant reduction in both indexes, while autoimmune hepatitis reduced only VAS score. Conclusions: HRQoL in early stage of CLDs is similar to the general population and it decreases with the progression to advanced stages. This study presents a real estimate of the impact of major CLDs on patients’ HRQoL, providing a key tool for decision-making in care delivery for CLDs. Key messages: Quality of life in early stage of chronic livers diseases is similar to the general population and lower in advanced stages. Our results providing a key tool for decision-making in care delivery

Published
2017

17. Practice guidelines for the treatment of hepatitis C: recommendations from an AISF/SIMIT/SIMAST Expert Opinion Meeting

Author

Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, Alfredo, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, Ls, Bruno, R, Bruno, S, Burra, Patrizia, Camma, C, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, Craxi, A, DE LUCA, A, DE MARTIN, E, DI MARCO, V, Fagiuoli, S, Ferrari, C, Gaeta, Gb, Galli, M, Grieco, A, Grossi, P, Licata, A, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, Mg, Santantonio, T, Smedile, A, Squadrito, G, Baroni, Gs, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, Mr, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, DI PERRI, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, Patrizia, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, Ubaldi, E, Santantanio, T, Alberti, A., Antonucci, Gf, Craxi, A., Prati D, Gasbarrini A, Mazzotta F, Sagnelli E, Carosi G, Abrescia N, Alberti A, Ambu S, Andreone P, Andriulli A, Angelico M, Antonucci GF, Ascione A, Belli LS, Bruno R, Bruno S, Burra P, Cammà, C, Caporaso N, Cariti G, Cillo U, Coppola N, Craxì, A, De Luca A, De Martin E, Di Marco, V, Fagiuoli S, Ferrari C, Gaeta GB, Galli M, Grieco A, Grossi P, Licata, A, Maida I, Mangia A, Marino N, Maserati R, Missale G, Mondelli M, Nasta P, Niro G, Persico M, Petrelli E, Picciotto A, Piscaglia F, Pollicino T, Prati D, Puoti C, Puoti M, Raimondo G, Rumi MG, Sagnelli E, Santantonio T, Smedile A, Squadrito G, Baroni GS, Taliani G, Tavio M, Toti M, Bonino F, Brunetto MR, Cacopardo B, Caremani M, Cauda R, Colombo M, Di Perri G, Donato F, Farci P, Fattovich G, Filice G, Ghinelli F, Guadagnino V, Lazzarin A, Levrero M, Licata G, Orani A, Paffetti A, Pastore G, Piccinino F, Pizzigallo E, Pontisso P, Portelli V, Rizzetto M, Rossi A, Stroffolini T, Ubaldi E., Italian Association for the Study of the Liver, Italian Society of Infectious, Tropical Disease, Italian Society for the Study of Sexually Transmitted Diseases: Prati D., Gasbarrini A., Mazzotta F., Sagnelli E., Carosi G., Abrescia N., Alberti A., Ambu S., Andreone P., Andriulli A., Angelico M., Antonucci G.F., Ascione A., Belli L.S., Bruno R., Bruno S., Burra P., Cammà C., Caporaso N., Cariti G., Cillo U., Coppola N., Craxì A., De Luca A., De Martin E., Di Marco V., Fagiuoli S., Ferrari C., Gaeta G.B., Galli M., Grieco A., Grossi P., Licata A., Maida I., Mangia A., Marino N., Maserati R., Missale G., Mondelli M., Nasta P., Niro G., Persico M., Petrelli E., Picciotto A., Piscaglia F., Pollicino T., Puoti C., Puoti M., Raimondo G., Rumi M.G., Santantonio T., Smedile A., Squadrito G., Baroni G.S., Taliani G., Tavio M., Toti M., Bonino F., Brunetto M.R., Cacopardo B., Caremani M., Cauda R., Colombo M., Di Perri G., Donato F., Farci P., Fattovich G., Filice G., Ghinelli F., Guadagnino V., Lazzarin A., Levrero M., Licata G., Orani A., Paffetti A., Pastore G., Piccinino F., Pizzigallo E., Pontisso P., Portelli V., Rizzetto M., Rossi A., Stroffolini T., Ubaldi E., Prati, D, Gasbarrini, A, Mazzotta, F, Sagnelli, E, Carosi, G, Abrescia, N, Alberti, A, Ambu, S, Andreone, P, Andriulli, A, Angelico, M, Antonucci, G, Ascione, A, Belli, L, Bruno, R, Bruno, S, Burra, P, Caporaso, N, Cariti, G, Cillo, U, Coppola, N, De Luca, A, De Martin, E, Fagiuoli, S, Ferrari, C, Gaeta, G, Galli, M, Grieco, A, Grossi, P, Maida, I, Mangia, A, Marino, N, Maserati, R, Missale, G, Mondelli, M, Nasta, P, Niro, G, Persico, M, Petrelli, E, Picciotto, A, Piscaglia, F, Pollicino, T, Puoti, C, Puoti, M, Raimondo, G, Rumi, M, Santantonio, T, Smedile, A, Squadrito, G, Baroni, G, Taliani, G, Tavio, M, Toti, M, Bonino, F, Brunetto, M, Cacopardo, B, Caremani, M, Cauda, R, Colombo, M, Di Perri, G, Donato, F, Farci, P, Fattovich, G, Filice, G, Ghinelli, F, Guadagnino, V, Lazzarin, A, Levrero, M, Licata, G, Orani, A, Paffetti, A, Pastore, G, Piccinino, F, Pizzigallo, E, Pontisso, P, Portelli, V, Rizzetto, M, Rossi, A, Stroffolini, T, and Ubaldi, E

Subjects
Liver Cirrhosis, ANTIVIRAL TREATMENT, Human immunodeficiency virus (HIV), HIV Infections, Hepacivirus, ANTIVIRAL THERAPY, PEGYLATED INTERFERON-ALPHA-2B, LIVER-TRANSPLANTATION, PEGINTERFERON ALPHA-2A, HIV-INFECTED PATIENTS, VIRUS-COINFECTED PATIENTS, RAPID VIROLOGICAL RESPONSE, Antiviral therapy, medicine.disease_cause, Gastroenterology, Polyethylene Glycols, HBV, guidelines, Acute hepatitis, Chronic hepatitis, Settore MED/12 - Gastroenterologia, liver transplantation, Hepatitis C, Recombinant Proteins, acute hepatitis, antiviral therapy, chronic hepatitis, cirrhosis, elderly patients, hbv, hcv, hdv, hiv, CLINICAL PRACTICE GUIDELINES, Cirrhosis, HCV, Drug Therapy, Combination, Antiviral therapy Acute hepatitis Chronic hepatitis,Cirrhosis, Elderly patients, HBV, HCV, HDV, HIV Liver transplantation, Elderly patient, Acute hepatiti, medicine.medical_specialty, Genotype, Alpha interferon, Interferon alpha-2, CHRONIC HEPATITIS C, Antiviral Agents, Hepatitis B, Chronic, Internal medicine, HDV, Drug Resistance, Viral, Ribavirin, medicine, Humans, Cirrhosi, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, HIV, Hepatitis C, Chronic, medicine.disease, Elderly patients, Family medicine, Expert opinion, Chronic hepatiti, business
Abstract

It is increasingly clear that a tailored therapeutic approach to patients with hepatitis C virus infection is needed. Success rates in difficult to treat and low-responsive hepatitis C virus patients are not completely satisfactory, and there is the need to optimise treatment duration and intensity in patients with the highest likelihood of response. In addition, the management of special patient categories originally excluded from phase III registration trials needs to be critically re-evaluated. This article reports the recommendations for the treatment of hepatitis C virus infection on an individual basis, drafted by experts of three scientific societies.

Published
2010

18. The impact of liver disease on the health-related quality of life

Author

Cortesi, PAOLO ANGELO, Rota, Matteo, Scalone, Luciana, Cozzolino, P, Cesana, Giancarlo, Mantovani, LORENZO GIOVANNI, Okolicsanyi, Stefano, Ciaccio, Antonio, Gemma, Marta, Fagiuoli, S, Valsecchi, MARIA GRAZIA, Belli, Ls, Strazzabosco, Mario, Cortesi, P, Rota, M, Scalone, L, Cozzolino, P, Cesana, G, Mantovani, L, Okolicsanyi, S, Ciaccio, A, Gemma, M, Fagiuoli, S, Valsecchi, M, Belli, L, and Strazzabosco, M

Subjects
health-related quality of life, VBMH study, MED/42 - IGIENE GENERALE E APPLICATA, MED/12 - GASTROENTEROLOGIA, liver disease, value-based medicine, MED/01 - STATISTICA MEDICA
Abstract

The impact of liver diseases (LDs) on health-related quality of life (HRQoL) is an important aspect to understand the burden of these conditions and to improve their management. A well characterized impact of the major LDs on HRQoL of the general population is still lacking. The aim of our study was to fill this gap. A dataset with HRQoL data of a representative sample of the general population of most populated Italian region was matched with the dataset from a multicenter study conducted in the same region and time period to generate and validate a set of health care outcomes indicators for the major LDs (hepatitis B (HBV), hepatitis C (HCV), compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/ NASH and patients listed for liver transplant (LTL)). Within both datasets, HRQoL data were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to be compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/ depression). It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL. Further, results from the EQ-5D health profile can be converted to utility index, useful to conduct economic evaluations. Multivariate logistic and linear regressions were then performed adjusting for possible confounders (age, sex, education and working status). A total of 6,800 nullhealthy subjectsnull and 3,105 subjects with LDs (625 HCV, 287 HBV, 614 CC, 531 DC, 647 HCC, 59 LTL, 229 NAFLD/NASH, 68 PBC, 55 PSC, and 49 AIH) were included in the analyses. Multivariate logistic analyses showed that DC, HCC, and LTL had significantly (p

Published
2014

19. Trattamento con Sofosbuvir e Ribavirina nei pazienti hcv-positivi listati per il trapianto di fegato: un analisi di costo-efficacia

Author

CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, Belli, LS, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, and Belli, L

Subjects
Costo-Efficacia, Epatite C, MED/42 - IGIENE GENERALE E APPLICATA, MED/12 - GASTROENTEROLOGIA, Pazienti listati trapianto, Sofosbuvir+Ribavirina, MED/01 - STATISTICA MEDICA
Abstract

INTRODUZIONE: Il virus dell'epatite C (HCV) è la principale indicazione per il trapianto di fegato, con una percentuale che varia dal 10% nei paesi dell'Europa settentrionale a quasi il 50% nei paesi dell’Europa meridionale. La prognosi dei pazienti affetti da HCV sottoposti a trapianto di fegato è gravemente limitata dall’alta probabilità di recidiva dell’HCV post-trapianto. L'unica opzione terapeutica disponibile attualmente per la recidiva da HCV è il trattamento con Peginterferone in combinazione con Ribavirina. Purtroppo, meno del 50% dei pazienti può effettivamente essere trattato con questi farmaci e il tasso di risposta tra i pazienti trattati è inferiore al 30%. Sofosbuvir in combinazione con ribavirina (SOF/RBV) è un nuovo trattamento senza interferone capace di sopprimere la viremia e prevenire la recidiva da HCV quando usato nei pazienti listati per il trapianto. L’obiettivo di questo studio è stato valutare la costo-efficacia del trattamento con SOF/RBV nei pazienti listati per il trapianto con diagnosi di cirrosi da HCV (HCV-cirrosi) o con diagnosi di epatocarcinoma da HCV (HCV-HCC). MATERIALI E METODI: Un modello analitico decisionale di semi-Markov è stato sviluppato per valutare la costo-efficacia del trattamento SOF/RBV nei pazienti listati per trapianto di fegato con HCV-cirrosi e in quelli con HCV-HCC. Il modello simula la progressione dei soggetti HCV-cirrosi o HCV-HCC dal momento del loro inserimento nella lista trapianti fino alla loro morte, considerando il rischio di recidiva da HCV post-trapianto. Con questo modello sono state confrontate due diverse strategie terapeutiche: 1) Trattamento con SOF/RBV fino a un massimo di 24 settimane o fino a trapianto se eseguito prima della 24° settimana dall’inizio del trattamento, 2) Nessun trattamento antivirale. Il modello ha stimato i costi relativi al trattamento con SOF/RBV, i costi associati a ciascun stato di salute, gli anni di vita (LYs), gli anni di vita aggiustati per la qualità (QALYs), ed il rapporto incrementale di costo-efficacia (ICER) espresso in € per QALY guadagnato. L'analisi è stata eseguita usando la prospettiva del Servizio Sanitario Nazionale Italiano, utilizzando i prezzi al 2014 espressi in Euro. L'orizzonte temporale della simulazione è stato la vita dei pazienti, con una durata per ciclo di simulazione di un mese. I costi e benefici clinici futuri sono stati attualizzati con un tasso di sconto del 3% annuo. L’intervento è stato considerato costo-efficace se l’ICER prodotto era inferiore alla soglia di € 60.000 per QALY guadagnato, che rappresenta la soglia della disponibilità a pagare per un nuovo trattamento all’interno del contesto Italiano. RISULTATI: Dalla simulazione fatta col modello, lo scenario che comprendeva il trattamento con SOF/RBV ha riportato una maggiore efficace ma anche un costo maggiore rispetto allo scenario che implicava nessun trattamento antivirale. Nei soggetti trattati con SOF/RBV, il modello ha riportato un incremento medio di LYs e QALYs per paziente di 4,32 e 2,41 nei soggetti HCV-cirrosi e 3,97 e 2,23 nei soggetti HCV-HCC. L’ICER stimato dal modello, confrontando il trattamento SOF/RBV con l’opzione nessun trattamento antivirale, è stato di € 30.518 per QALY guadagnato nei pazienti HCV-cirrosi e € 41.610 nei pazienti HCV-HCC. L'affidabilità dei risultati è stata confermata dall’analisi di sensibilità a una via e dalla curva di accettabilità del rapporto incrementale di costo-efficacia, la quale ha mostrato una probabilità del 97,5% che il trattamento SOF/RBV potesse essere costo-efficacie assumendo una soglia della disponibilità a pagare di € 60.000 per QALY guadagnato nello scenario HCV-cirrosi e dell’88,1% nello scenario HCV-HCC. Gli ICERs stimati sono stati particolarmente sensibili alle variazioni della durata del trattamento SOF/RBV; infatti, assumendo una durata di 12 settimane gli ICERs ottenuti sono stati € 19.317 per QALY guadagnato nello scenario HCV-cirrosi e € 29.540 in quello HCV-HCC. CONCLUSIONI: Lo studio ha dimostrato che un trattamento di 24 settimane con SOF/RBV nei pazienti con HCV-cirrosi o HCV-HCC in lista d'attesa per il trapianto di fegato è costo-efficace con un ICER di € 30.518 per QALY guadagnato nei primi e di € 41.610 nei secondi. Inoltre, questa potenziale costo-efficacia di SOF/RBV potrebbe ulteriormente aumentare se come mostrato dalle prime evidenze disponibili si potesse diminuire la durata del trattamento da 24 a 12 settimane. Questi risultati forniscono un’ulteriore e importante argomentazione a favore del potenziale uso del trattamento senza interferone nei pazienti HCV-positivi listati per il trapianto, tuttavia uno studio prospettico ben disegnato è necessario per confermare il valore dei parametri assunti nel modello e i risultati ottenuti. Infine bisogna considerare che nuove associazioni di antivirali ad azione diretta e senza interferone saranno a disposizione nei prossimi anni creando nuove sfide e opportunità anche nel contesto del trapianto di fegato.

Published
2014

20. A value-based approach to the management of patients with liver cirrhosis through the systematic measurement of clinical outcome and quality of life indicators

Author

OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, CORTESI, PAOLO ANGELO, ROTA, MATTEO, GEMMA, MARTA, Giani, P, SCALONE, LUCIANA, MANTOVANI, LORENZO GIOVANNI, Fagiuoli, S, VALSECCHI, MARIA GRAZIA, CESANA, GIANCARLO, Belli, LS, STRAZZABOSCO, MARIO, Okolicsanyi, S, Ciaccio, A, Cortesi, P, Rota, M, Gemma, M, Giani, P, Scalone, L, Mantovani, L, Fagiuoli, S, Valsecchi, M, Cesana, G, Belli, L, and Strazzabosco, M

Subjects
outcome indicators, liver cirrhosi, MED/12 - GASTROENTEROLOGIA, MED/42 - IGIENE GENERALE E APPLICATA, VBMH study, outcome indicator, liver cirrhosis, value-based medicine, MED/01 - STATISTICA MEDICA
Abstract

Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 73% of cases) was 96% for CPTA, 82% for CPT-B, 56% CPT-C, whereas it was 94% and 57% for MELD score respectively below or above 15. Furthermore, no significant changes in p-HRQoL between baseline and after 2 years follow-up were found in CC and CPT-A patients, while p-HRQoL progressively decreased in DC and CPT B-C patients. In conclusion, combined measurements of specific OIs and p-HRQoL scales provide the methodological bases to implement a value-based approach to the care of patients with LC. In fact, these outcomes combined with measurements of direct and indirect costs could guide future decision-making process and improve value of care in cirrhosis.

Published
2014

21. Sofosbuvir and ribavirinin in HCV-infected patients listed for liver transplantation: A cost-effectiveness analysis

Author

Cortesi, PAOLO ANGELO, Mantovani, LORENZO GIOVANNI, Ciaccio, Antonio, Rota, Matteo, Cesana, Giancarlo, Strazzabosco, Mario, Belli, Ls, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, and Belli, L

Subjects
hepatitis C patients listed for transplantation, MED/42 - IGIENE GENERALE E APPLICATA, MED/12 - GASTROENTEROLOGIA, cost-effectiveness analysis, cost-effectiveness analysi, sofosbuvir and ribavirin, MED/01 - STATISTICA MEDICA
Abstract

Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV cost-effectiveness was clearly sensitive to the duration of treatment; assuming 12 weeks SOF/RBV treatment duration, the ICER decreased to €19,317 in HCV-Cirrhosis and €29,540 in HCV-HCC. In conclusion, our study shows that treating patients with HCV-cirrhosis or HCV-HCC in the transplant waiting list with SOF/RBV is cost-effective and may become the new standard of care for these patients. However a well-defined prospective study is needed to confirm the value of the parameters assumed in the model and the results. Furthermore, associations of direct acting antivirals will soon appear into the horizon also in the transplant setting and bring new challenges and opportunities.

Published
2014

24. Sofosbuvir and ribavirinin in HCV-infected patients listed for liver transplantation: A cost-effectiveness analysis

Author

Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, Belli, LS, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, and Belli, LS

Abstract

Post-liver transplant recurrent hepatitis C virus (HCV) infection severely limits the prognosis of HCV-infected patients. Sofosbuvir in combination with ribavirin (SOF/RBV) is a novel interferon-free treatment able to suppress HCV viremia when applied to HCV patients listed for transplant, thereby preventing HCV recurrence. Aim of this study was to assess the cost-effectiveness of this regimens in patients listed for transplant for cirrhosis (HCV-cirrhosis) or for hepatocellular carcinoma in cirrhosis (HCV-HCC). A semi-Markov model was developed to assess the cost-effectiveness of pre-transplant SOF/RBV treatment in patients listed for HCV-cirrhosis and HCV-related HCC. The model simulates the progression of HCV-cirrhosis or HCV-HCC patients from the time of listing until death considering the risk of HCV recurrence post-transplant. The model compared 2 different strategies: 1) SOF/RBV up to a maximum of 24 weeks or until OLT if performed before the 24th week from the initiation of treatment, 2) No antiviral treatment. The model estimated the costs related to the treatment with SOF/RBV, the costs associated to each health state, the life-years (LYSs), the quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER) expressed as € per QALY gained. The analysis was performed from the Italian National Health System perspective with a lifetime time horizon and one-month Markov cycles. Future costs and clinical benefits, expressed as QALYs, were discounted at 3% per year. Results: in the base-case analysis the ICER for 24 weeks of SOF/RBVR was €30,518 per QALY gained in HCV-cirrhosis patients and €41,610 in HCV-HCC patients. The reliability of our results was confirmed by the one way sensitivity-analysis and by the cost-effectiveness acceptability curve that reported 97.5% probability of SOF/RBV to be cost-effective at a willingness to pay threshold of €60,000 in the HCV–cirrhosis scenario, and 88.1% in the HCV-HCC scenario. Further, SOF/RBV c

Published
2014

25. A value-based approach to the management of patients with liver cirrhosis through the systematic measurement of clinical outcome and quality of life indicators

Author

Okolicsanyi, S, Ciaccio, A, Cortesi, P, Rota, M, Gemma, M, Giani, P, Scalone, L, Mantovani, L, Fagiuoli, S, Valsecchi, M, Cesana, G, Belli, L, Strazzabosco, M, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, CORTESI, PAOLO ANGELO, ROTA, MATTEO, GEMMA, MARTA, SCALONE, LUCIANA, MANTOVANI, LORENZO GIOVANNI, VALSECCHI, MARIA GRAZIA, CESANA, GIANCARLO, Belli, LS, STRAZZABOSCO, MARIO, Okolicsanyi, S, Ciaccio, A, Cortesi, P, Rota, M, Gemma, M, Giani, P, Scalone, L, Mantovani, L, Fagiuoli, S, Valsecchi, M, Cesana, G, Belli, L, Strazzabosco, M, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, CORTESI, PAOLO ANGELO, ROTA, MATTEO, GEMMA, MARTA, SCALONE, LUCIANA, MANTOVANI, LORENZO GIOVANNI, VALSECCHI, MARIA GRAZIA, CESANA, GIANCARLO, Belli, LS, and STRAZZABOSCO, MARIO

Abstract

Development of complications in liver cirrhosis (LC) is associated with increased mortality, hospital admissions and costs. Management of LC complications in clinical practice is well established, but the real value and effectiveness of care provided are still difficult to assess. Measurement of outcome indicators (OIs) together with patients-health related quality of life (p-HRQoL) could assist both clinicians and administrators in the process of care, in order to ensure greater quality in patients with LC. Aim of our study was to validate specific OIs, coupled with p-HRQoL scales, and apply them in the clinical assessment of compensated (CC) and decompensated cirrhosis (DC) management. A panel of hepatologists identified a set of OIs using published evidence, a modified Delphi method and a standard 9-point RAND appropriateness scale. These OIs were part of a larger effort, included in a prospective multicenter observational study (Value Based Medicine in Hepatology Study), involving three European tertiary clinical centers. P-HRQoL collected using the EQ-5D questionnaire, generated an health profile, by means of five utility domains (mobility, self care, anxiety/ depression, usual activities and pain/discomfort), and a visual analogue scale (VAS), which measured overall p-HRQoL in a range from 0 to 100. During 18 months we enrolled 1772 patients with LC: 1015 CC and 757 DC; the median follow-up time was 2 years. Results: the OIs chosen by the panelist were meant to evaluate the efficacy of care of major complications of LC: variceal bleeding occurred with an annual incidence of 3,1%, with 1-year survival of 76% of patients, and hepatocellular carcinoma (HCC) developed in a rate of 3,5% per year, with 83% CC patients diagnosed at early stage HCC. The strongest OIs according to the experts were decompensation rate in CC, which was 6.6% per year in our study, and overall survival in DC patients. The 1-year survival after the first decompensation episode (ascites in 7

Published
2014

26. Trattamento con Sofosbuvir e Ribavirina nei pazienti hcv-positivi listati per il trapianto di fegato: un analisi di costo-efficacia

Author

Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, Belli, LS, Cortesi, P, Mantovani, L, Ciaccio, A, Rota, M, Cesana, G, Strazzabosco, M, Belli, L, CORTESI, PAOLO ANGELO, CIACCIO, ANTONIO, ROTA, MATTEO, CESANA, GIANCARLO, STRAZZABOSCO, MARIO, MANTOVANI, LORENZO GIOVANNI, and Belli, LS

Abstract

INTRODUZIONE: Il virus dell'epatite C (HCV) è la principale indicazione per il trapianto di fegato, con una percentuale che varia dal 10% nei paesi dell'Europa settentrionale a quasi il 50% nei paesi dell’Europa meridionale. La prognosi dei pazienti affetti da HCV sottoposti a trapianto di fegato è gravemente limitata dall’alta probabilità di recidiva dell’HCV post-trapianto. L'unica opzione terapeutica disponibile attualmente per la recidiva da HCV è il trattamento con Peginterferone in combinazione con Ribavirina. Purtroppo, meno del 50% dei pazienti può effettivamente essere trattato con questi farmaci e il tasso di risposta tra i pazienti trattati è inferiore al 30%. Sofosbuvir in combinazione con ribavirina (SOF/RBV) è un nuovo trattamento senza interferone capace di sopprimere la viremia e prevenire la recidiva da HCV quando usato nei pazienti listati per il trapianto. L’obiettivo di questo studio è stato valutare la costo-efficacia del trattamento con SOF/RBV nei pazienti listati per il trapianto con diagnosi di cirrosi da HCV (HCV-cirrosi) o con diagnosi di epatocarcinoma da HCV (HCV-HCC). MATERIALI E METODI: Un modello analitico decisionale di semi-Markov è stato sviluppato per valutare la costo-efficacia del trattamento SOF/RBV nei pazienti listati per trapianto di fegato con HCV-cirrosi e in quelli con HCV-HCC. Il modello simula la progressione dei soggetti HCV-cirrosi o HCV-HCC dal momento del loro inserimento nella lista trapianti fino alla loro morte, considerando il rischio di recidiva da HCV post-trapianto. Con questo modello sono state confrontate due diverse strategie terapeutiche: 1) Trattamento con SOF/RBV fino a un massimo di 24 settimane o fino a trapianto se eseguito prima della 24° settimana dall’inizio del trattamento, 2) Nessun trattamento antivirale. Il modello ha stimato i costi relativi al trattamento con SOF/RBV, i costi associati a ciascun stato di salute, gli anni di vita (LYs), gli anni di vita aggiustati per la qualità (QA

Published
2014

27. The impact of liver disease on the health-related quality of life

Author

Cortesi, P, Rota, M, Scalone, L, Cozzolino, P, Cesana, G, Mantovani, L, Okolicsanyi, S, Ciaccio, A, Gemma, M, Fagiuoli, S, Valsecchi, M, Belli, L, Strazzabosco, M, CORTESI, PAOLO ANGELO, ROTA, MATTEO, SCALONE, LUCIANA, CESANA, GIANCARLO, MANTOVANI, LORENZO GIOVANNI, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, GEMMA, MARTA, VALSECCHI, MARIA GRAZIA, Belli, LS, STRAZZABOSCO, MARIO, Cortesi, P, Rota, M, Scalone, L, Cozzolino, P, Cesana, G, Mantovani, L, Okolicsanyi, S, Ciaccio, A, Gemma, M, Fagiuoli, S, Valsecchi, M, Belli, L, Strazzabosco, M, CORTESI, PAOLO ANGELO, ROTA, MATTEO, SCALONE, LUCIANA, CESANA, GIANCARLO, MANTOVANI, LORENZO GIOVANNI, OKOLICSANYI, STEFANO, CIACCIO, ANTONIO, GEMMA, MARTA, VALSECCHI, MARIA GRAZIA, Belli, LS, and STRAZZABOSCO, MARIO

Abstract

The impact of liver diseases (LDs) on health-related quality of life (HRQoL) is an important aspect to understand the burden of these conditions and to improve their management. A well characterized impact of the major LDs on HRQoL of the general population is still lacking. The aim of our study was to fill this gap. A dataset with HRQoL data of a representative sample of the general population of most populated Italian region was matched with the dataset from a multicenter study conducted in the same region and time period to generate and validate a set of health care outcomes indicators for the major LDs (hepatitis B (HBV), hepatitis C (HCV), compensated cirrhosis (CC), decompensated cirrhosis (DC), hepatocellular carcinoma (HCC), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), NAFLD/ NASH and patients listed for liver transplant (LTL)). Within both datasets, HRQoL data were collected using the EQ-5D-3L, a generic instrument that enables HRQoL to be compared within and between clinical conditions and with the general population. It generates a health profile made up of 5 domains (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/ depression). It also consists of a visual analogue scale (EQ-5D VAS) which measures overall HRQoL. Further, results from the EQ-5D health profile can be converted to utility index, useful to conduct economic evaluations. Multivariate logistic and linear regressions were then performed adjusting for possible confounders (age, sex, education and working status). A total of 6,800 nullhealthy subjectsnull and 3,105 subjects with LDs (625 HCV, 287 HBV, 614 CC, 531 DC, 647 HCC, 59 LTL, 229 NAFLD/NASH, 68 PBC, 55 PSC, and 49 AIH) were included in the analyses. Multivariate logistic analyses showed that DC, HCC, and LTL had significantly (p<0.05) higher risk to have problems in mobility, self-care, and usual activities compared to nullhealthy subjectednull. AIH had significantly hig

Published
2014

28. GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY

Author

Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra P, Pompili M, Colledan M, Cillo U, Fagiuoli S, Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, and Burra, P

Subjects
Hepatology, Gastroenterology
Published
2009

29. The Benefit of Antiviral Therapy On Fibrosis Progression Due To Hcv Recurrence After Liver Transplantation (lt): An Italian Multicenter Study

Author

De Martin E, Senzolo M, Ponziani F, Vigano R, Belli LS, Pinzello G, Colledan M, Donato MF, Di Paolo D, Angelico M, Rendina M, Pompili M, Merli M, Villa E, Russo FP, Boninsegna S, Cillo U, Gasbarrini A, Toniutto P, Fagiuoli S, Burra P, De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, M, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Merli, M, Villa, E, Russo, F, Boninsegna, S, Cillo, U, Gasbarrini, A, Toniutto, P, Fagiuoli, S, and Burra, P

Subjects
Hepatology, Gastroenterology
Published
2009

31. GENOTYPE 2 AND 3 RECCURENT HEPATITIS C AFTER LIVER TRANSPLANTATION: EXCELLENT RESULTS WITH SUBOPTIMAL DOSES OF ANTIVIRAL THERAPY

Author

Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, Fagiuoli S, Vigano, R, Ponziani, F, Belli, L, Vangeli, M, Pinzello, G, Gasbarrini, A, Pasulo, L, De Martin, E, Burra, R, Pompili, M, Colledan, M, Cillo, U, Fagiuoli, S, Vigano R, Ponziani FR, Belli LS, Vangeli M, Pinzello G, Gasbarrini A, Pasulo L, De Martin E, Burra R, Pompili M, Colledan M, Cillo U, and Fagiuoli S

Published
2009

32. THE BENEFIT OF ANTIVIRAL THERAPY ON FIBROSIS PROGRESSION DUE TO HCV RECURRENCE AFTER LIVER TRANSPLANTATION (LT): AN ITALIAN MULTICENTER STUDY

Author

De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, M, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Merli, M, Villa, E, Russo, F, Boninsegna, S, Cillo, U, Gasbarrini, A, Toniutto, P, Fagiuoli, S, Burra, P, De Martin E, Senzolo M, Ponziani F, Vigano R, Belli LS, Pinzello G, Colledan M, Donato MF, Di Paolo D, Angelico M, Rendina M, Pompili M, Merli M, Villa E, Russo FP, Boninsegna S, Cillo U, Gasbarrini A, Toniutto P, Fagiuoli S, Burra P, De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, M, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Merli, M, Villa, E, Russo, F, Boninsegna, S, Cillo, U, Gasbarrini, A, Toniutto, P, Fagiuoli, S, Burra, P, De Martin E, Senzolo M, Ponziani F, Vigano R, Belli LS, Pinzello G, Colledan M, Donato MF, Di Paolo D, Angelico M, Rendina M, Pompili M, Merli M, Villa E, Russo FP, Boninsegna S, Cillo U, Gasbarrini A, Toniutto P, Fagiuoli S, and Burra P

Published
2009

33. Hepatocellular carcinoma: Comparison between liver transplantation, resective surgery, ethanol injection, and chemoembolization

Author

Colella, G, Bottelli, R, De Carlis, L, Sansalone, C, Rondinara, G, Alberti, A, Belli, L, Gelosa, F, Iamoni, G, Rampoldi, A, De Gasperi, A, Corti, A, Mazza, E, Aseni, P, Meroni, A, Slim, A, Finzi, M, Di Benedetto, F, Manochehri, F, Follini, M, Ideo, G, Forti, D, Sansalone, CV, Rondinara, GF, Belli, LS, Iamoni, GM, Slim, AO, Follini, ML, Colella, G, Bottelli, R, De Carlis, L, Sansalone, C, Rondinara, G, Alberti, A, Belli, L, Gelosa, F, Iamoni, G, Rampoldi, A, De Gasperi, A, Corti, A, Mazza, E, Aseni, P, Meroni, A, Slim, A, Finzi, M, Di Benedetto, F, Manochehri, F, Follini, M, Ideo, G, Forti, D, Sansalone, CV, Rondinara, GF, Belli, LS, Iamoni, GM, Slim, AO, and Follini, ML

Abstract

Between January 1989 and June 1997, 533 patients (423 male, 110 female, mean age 61 years, range 22-89 years) with hepatocellular carcinoma (HCC) were observed at our center. We report on 419 patients retrospectively compared for different treatments: liver transplantation (LT; 55 patients), resective surgery (RS; 41 patients), transarterial chemoembolization (TACE; 171 patients) and percutaneous ethanol injection (PEI; 152 patients). The 3- and 5-year actuarial survival rates were, respectively, 72% and 68% for LT, 64 and 44% for RS, 54 and 36% for PEI, and 32 and 22% for TACE. Survival curves were compared for sex, age, tumor characteristics, alphafetoprotein level, Child class, and etiology of cirrhosis. All patient-related characteristics examined (sex, age) are not significantly related to patient survival. Tumor-related variables and associated liver disease variables significantly conditioned survival in relation to different treatments. LT seems to be the treatment of choice for monofocal HCC less then 5 cm in diameter and in selected cases of plurifocal HCC. © Springer-Verlag 1998

Published
1998

34. Iliac artery graft interposition in liver transplantation: Our experience in 72 cases

Author

Sansalone, C, Colella, G, Rondinara, G, Rossetti, O, De Carlis, L, Belli, L, Meroni, A, Della Volpe, A, Trojsi, C, Sansalone, CV, Rondinara, GF, Belli, LS, Sansalone, C, Colella, G, Rondinara, G, Rossetti, O, De Carlis, L, Belli, L, Meroni, A, Della Volpe, A, Trojsi, C, Sansalone, CV, Rondinara, GF, and Belli, LS

Published
1994

40. The role of donor and recipient factors in initial renal graft non-function

Author

Belli, L, De Carlis, L, Del Favero, E, Civati, G, Brando, B, Romani, F, Aseni, P, Rondinara, G, Palmieri, B, Meroni, A, Belli, LS, Rondinara, GF, Palmieri, B., Belli, L, De Carlis, L, Del Favero, E, Civati, G, Brando, B, Romani, F, Aseni, P, Rondinara, G, Palmieri, B, Meroni, A, Belli, LS, Rondinara, GF, and Palmieri, B.

Abstract

Delayed renal graft function appears to be a complex multifactorial disease that has been related to the premortem condition of the donor total ischemia time (cold or warm), methods of preservation, and surgical harvesting procedure. Perioperative recipient management, recipient variables, and immunologically mediated early injuries have also been implicated. An increased interest in the detection of the possible causes of initial graft nonfunction (IGNF) was recently related to the usual practice of multiorgan procurement. Therefore, we retrospectively investigated the incidence of IGNF in our Department, analyzing the records of 90 consecutive renal donors and recipients with particular attention to the fate of the two harvested kidneys (twin kidney), and comparing the results from multiple organ donors (MOD) with those achieved from single organ donors (SOD)

Published
1988

42. Kidney and liver initial graft function under different procurement techniques

Author

Belli, L, De Carlis, L, Romani, F, Rondinara, G, Degna, C, Brando, B, Del Favero, E, Palmieri, B, Meroni, A, Frangi, M, Belli, LS, Rondinara, GF, Degna, CT, Belli, L, De Carlis, L, Romani, F, Rondinara, G, Degna, C, Brando, B, Del Favero, E, Palmieri, B, Meroni, A, Frangi, M, Belli, LS, Rondinara, GF, and Degna, CT

Published
1989

43. Hepatitis C virus recurrence after liver transplantation: a 10-year evaluation

Author

Roberto Di Donato, Mauro Bernardi, Marcello Vangeli, Antonio Daniele Pinna, Luciano De Carlis, Luca S. Belli, Stefania Lorenzini, Ranka Vukotic, Arrigo F G Cicero, Matteo Cescon, Arianna Martello Panno, Pietro Andreone, Gian Luca Grazi, Stefano Gitto, Aldo Airoldi, Lucia Brodosi, Gitto S, Belli LS, Vukotic R, Lorenzini S, Airoldi A, Cicero AF, Vangeli M, Brodosi L, Martello Panno A, Di Donato R, Cescon M, Grazi GL, De Carlis L, Pinna AD, Bernardi M, Andreone P., Gitto, S, Belli, L, Vukotic, R, Lorenzini, S, Airoldi, A, Cicero, A, Vangeli, M, Brodosi, L, Panno, A, Di Donato, R, Cescon, M, Grazi, G, De Carlis, L, Pinna, A, Bernardi, M, and Andreone, P

Subjects
Male, Time Factors, medicine.medical_treatment, Hepacivirus, Kaplan-Meier Estimate, Liver transplantation, Ten-year survival, Gastroenterology, Risk Factors, Recurrence, Retrospective Studie, Odds Ratio, Multivariate Analysi, General Medicine, Hepatitis C, Middle Aged, Exact test, Treatment Outcome, Italy, ANTIVIRAL TERAPHY, HEPATITIS C, SURVIVAL, Drug Therapy, Combination, Female, Viral hepatitis, LIVER TRANSPLANTATION, HEPATITIS C RECURRENCE, Human, Adult, medicine.medical_specialty, Logistic Model, Time Factor, Antiviral treatment, Hepatitis C virus recurrence, Antiviral Agents, NO, Hepatitis C, Liver transplantation, hepatitis C virus recurrence, Antiviral treatment, Ten-year survival, End Stage Liver Disease, Internal medicine, medicine, Humans, Retrospective Cohort Study, Survival rate, Survival analysis, Proportional Hazards Models, Retrospective Studies, Antiviral Agent, Chi-Square Distribution, Hepaciviru, Proportional hazards model, business.industry, Risk Factor, medicine.disease, Surgery, Transplantation, Logistic Models, Multivariate Analysis, Proportional Hazards Model, Virus Activation, business
Abstract

AIM: To evaluate the predictors of 10-year survival of patients with hepatitis C recurrence. /// METHODS: Data from 358 patients transplanted between 1989 and 2010 in two Italian transplant centers and with evidence of hepatitis C recurrence were analyzed. A χ 2, Fisher's exact test and Kruskal Wallis' test were used for categorical and continuous variables, respectively. Survival analysis was performed at 10 years after transplant using the Kaplan-Meier method, and a log-rank test was used to compare groups. A p level less than 0.05 was considered significant for all tests. Multivariate analysis of the predictive role of different variables on 10-year survival was performed by a stepwise Cox logistic regression./// RESULTS: The ten-year survival of the entire popu lation was 61.2%. Five groups of patients were identified according to the virological response or lack of a response to antiviral treatment and, among those who were not treated, according to the clinical status (mild hepatitis C recurrence, "too sick to be treated" and patients with comorbidities contraindicating the treatment). While the 10-year survival of treated and untreated patients was not different (59.1% vs 64.7%, p = 0.192), patients with a sustained virological response had a higher 10-year survival rate than both the "non-responders" (84.7% vs 39.8%, p < 0.0001) and too sick to be treated (84.7% vs 0%, p < 0.0001). Sustained virological responders had a survival rate comparable to patients untreated with mild recurrence (84.7% vs 89.3%). A sustained virological response and young donor age were independent predictors of 10-year survival./// CONCLUSION: Sustained virological response significantly increased long-term survival. Awaiting the interferon-free regimen global availability, antiviral treatment might be questionable in selected subjects with mild hepatitis C recurrence.

Published
2015

44. Prognostic scores for ursodeoxycholic acid-treated patients predict graft loss and mortality in recurrent primary biliary cholangitis after liver transplantation.

Author

Montano-Loza AJ, Lytvyak E, Hirschfield G, Hansen BE, Ebadi M, Berney T, Toso C, Magini G, Villamil A, Nevens F, Van den Ende N, Pares A, Ruiz P, Terrabuio D, Trivedi PJ, Abbas N, Donato MF, Yu L, Landis C, Dumortier J, Dyson JK, van der Meer AJ, de Veer R, Pedersen M, Mayo M, Manns MP, Taubert R, Kirchner T, Belli LS, Mazzarelli C, Stirnimann G, Floreani A, Cazzagon N, Russo FP, Burra P, Zigmound U, Houri I, Carbone M, Mulinacci G, Fagiuoli S, Pratt DS, Bonder A, Schiano TD, Haydel B, Lohse A, Schramm C, Rüther D, Casu S, Verhelst X, Beretta-Piccoli BT, Robles M, Mason AL, and Corpechot C

Subjects
Humans, Female, Male, Middle Aged, Prognosis, Graft Survival drug effects, Alkaline Phosphatase blood, Cholangitis diagnosis, Cholangitis etiology, Cholangitis drug therapy, Retrospective Studies, Follow-Up Studies, Liver Transplantation adverse effects, Ursodeoxycholic Acid therapeutic use, Recurrence, Cholagogues and Choleretics therapeutic use, Liver Cirrhosis, Biliary surgery, Liver Cirrhosis, Biliary mortality, Liver Cirrhosis, Biliary diagnosis
Abstract

Background & Aims: Recurrent primary biliary cholangitis (rPBC) develops in approximately 30% of patients and negatively impacts graft and overall patient survival after liver transplantation (LT). There is a lack of data regarding the response rate to ursodeoxycholic acid (UDCA) in rPBC. We evaluated a large, international, multi-center cohort to assess the performance of PBC scores in predicting the risk of graft and overall survival after LT in patients with rPBC., Methods: A total of 332 patients with rPBC after LT were evaluated from 28 centers across Europe, North and South America. The median age at the time of rPBC was 58.0 years [IQR 53.2-62.6], and 298 patients (90%) were female. The biochemical response was measured with serum levels of alkaline phosphatase (ALP) and bilirubin, and Paris-2, GLOBE and UK-PBC scores at 1 year after UDCA initiation., Results: During a median follow-up of 8.7 years [IQR 4.3-12.9] after rPBC diagnosis, 52 patients (16%) had graft loss and 103 (31%) died. After 1 year of UDCA initiation the histological stage at rPBC (hazard ratio [HR] 3.97, 95% CI 1.36-11.55, p = 0.01), use of prednisone (HR 3.18, 95% CI 1.04-9.73, p = 0.04), ALP xULN (HR 1.59, 95% CI 1.26-2.01, p <0.001), Paris-2 criteria (HR 4.14, 95% CI 1.57-10.92, p = 0.004), GLOBE score (HR 2.82, 95% CI 1.71-4.66, p <0.001), and the UK-PBC score (HR 1.06, 95% CI 1.03-1.09, p <0.001) were associated with graft survival in the multivariate analysis. Similar results were observed for overall survival., Conclusion: Patients with rPBC and disease activity, as indicated by standard PBC risk scores, have impaired outcomes, supporting efforts to treat recurrent disease in similar ways to pre-transplant PBC., Impact and Implications: One in three people who undergo liver transplantation for primary biliary cholangitis develop recurrent disease in their new liver. Patients with recurrent primary biliary cholangitis and incomplete response to ursodeoxycholic acid, according to conventional prognostic scores, have worse clinical outcomes, with higher risk of graft loss and mortality in similar ways to the disease before liver transplantation. Our results supportsupport efforts to treat recurrent disease in similar ways to pre-transplant primary biliary cholangitis., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)

Published
2024
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45. Transjugular intrahepatic portosystemic shunt in patients with splanchnic vein thrombosis: Prevalence and management of patent foramen ovale.

Author

Becchetti C, De Nicola S, Gallo C, Perricone G, Annoni G, Solcia M, Musca F, Alfonsi A, Morelli F, Barbosa F, Brambillasca PM, Rampoldi A, Airoldi A, and Belli LS

Subjects
Humans, Retrospective Studies, Female, Male, Middle Aged, Adult, Prevalence, Aged, Echocardiography, Splanchnic Circulation, Liver Cirrhosis complications, Liver Cirrhosis surgery, Treatment Outcome, Portasystemic Shunt, Transjugular Intrahepatic adverse effects, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnostic imaging, Hypertension, Portal surgery, Hypertension, Portal etiology, Hypertension, Portal complications, Venous Thrombosis etiology, Venous Thrombosis diagnostic imaging, Venous Thrombosis surgery, Portal Vein surgery
Abstract

Background and Aims: Transjugular intrahepatic portosystemic shunt (TIPS) is an established procedure for the treatment of several complications of portal hypertension (PH), including non-neoplastic portal vein thrombosis (PVT). Selection criteria for TIPS in PVT are not yet well established. Despite anecdotal, cases of thromboembolic events from paradoxical embolism due to the presence of patent foramen ovale (PFO) after TIPS placement have been reported in the literature. Therefore, we aimed at describing our experience in patients with non-neoplastic splanchnic vein thrombosis (SVT) who underwent TIPS following PFO screening., Methods: We conducted a single-centre retrospective study, including consecutive patients who underwent TIPS for the complications of cirrhotic and non-cirrhotic portal hypertension (NCPH) and having SVT., Results: Of 100 TIPS placed in patients with SVT, 85 patients were screened for PFO by bubble-contrast transthoracic echocardiography (TTE) with PFO being detected in 22 (26%) cases. PFO was more frequently detected in patients with non-cirrhotic portal hypertension (NCPH) (23% in the PFO group vs. 6% in those without PFO, p = .04) and cavernomatosis (46% in the PFO group vs. 19% in those without PFO, p = .008). Percutaneous closure was effectively performed in 11 (50%) after multidisciplinary evaluation of anatomical and clinical features. No major complications were observed following closure., Conclusions: PFO screening and treatment may be considered feasible for patients with SVT who undergo TIPS placement., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2024
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46. Statin therapy: improving survival in patients with hepatocellular carcinoma and portal hypertension is possible?

Author

Dispinzieri G, Becchetti C, Mazzarelli C, Airoldi A, Aprile F, Cesarini L, Cucco M, Perricone G, Stigliano R, Vangeli M, Viganò R, and Belli LS

Subjects
Humans, Hypertension, Portal drug therapy, Hypertension, Portal etiology, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular mortality, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Liver Neoplasms drug therapy
Abstract

Statins are generally known for their lipid-lowering properties and protection against cardiovascular events. However, growing evidence suggests that statins are a promising treatment for patients with chronic liver disease. Specifically, there is data supporting their role in reducing portal pressure and having a chemopreventive effect on hepatocellular carcinoma (HCC). Treatment options for HCC remain limited with portal hypertension (PH), thus statins could represent an inexpensive alternative, increasing survival of patients with HCC and PH. These drugs cannot be considered standard of care without a cardiac-metabolic indication to prescription in this patient group, although the potential beneficial effect should be indication for prompt use whenever considered appropriate. Our aim is to review the effects of statins on PH and on HCC, both in the pre-clinical and clinical setting in literature, discussing safety issues and limitations to the current body of evidence., Competing Interests: The authors declare that they have no conflict of interest, (© Acta Gastro-Enterologica Belgica.)

Published
2024
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47. Worldwide variations in COVID-19 vaccination policies and practices in liver transplant settings: results of a multi-society global survey.

Author

Di Maira T, Vinaixa C, Izzy M, Paolo Russo F, Kirchner VA, Rammohan A, Belli LS, Polak WG, Berg T, and Berenguer M

Abstract

Background: Despite the WHO's report of 24 available SARS-CoV-2 vaccines, limited data exist regarding vaccination policies for liver transplant (LT) patients. To address this, we conducted a global multi-society survey (EASL-ESOT-ELITA-ILTS) in LT centers., Methods: A digital questionnaire assessing vaccine policies, safety, efficacy, and center data was administered online to LT centers., Results: Out of 168 responding centers, 46.4%, 28%, 13.1%, 10.7%, and 1.8% were from European, American, Western Pacific, Southeast Asian, and Eastern Mediterranean Regions. Most LT centers prioritized COVID-19 vaccine access for LT patients (76%) and healthcare workers (86%), while other categories had lower priority (30%). One-third of responders recommended mRNA vaccine exclusively, while booster doses were widely recommended (81%). One-third conducted post-vaccine liver function tests post COVID-19 vaccine. Only 16% of centers modified immunosuppression, and mycophenolate discontinuation or modification was the main approach. Side effects were seen in 1 in 1,000 vaccinated patients, with thromboembolism, acute rejection, and allergic reaction being the most severe. mRNA showed fewer side effects (-3.1, p  = 0.002)., Conclusion: COVID-19 vaccines and booster doses were widely used among LT recipients and healthcare workers, without a specific vaccine preference. Preventative immunosuppression adjustment post-vaccination was uncommon. mRNA vaccines demonstrated a favorable safety profile in this population., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Di Maira, Vinaixa, Izzy, Paolo Russo, Kirchner, Rammohan, Belli, Polak, Berg and Berenguer.)

Published
2024
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48. Liver Transplantation for Primary Sclerosing Cholangitis (PSC) With or Without Inflammatory Bowel Disease (IBD)-A European Society of Organ Transplantation (ESOT) Consensus Statement.

Author

Carbone M, Della Penna A, Mazzarelli C, De Martin E, Villard C, Bergquist A, Line PD, Neuberger JM, Al-Shakhshir S, Trivedi PJ, Baumann U, Cristoferi L, Hov J, Fischler B, Hadzic NH, Debray D, D'Antiga L, Selzner N, Belli LS, and Nadalin S

Subjects
Humans, Risk Factors, Immunosuppressive Agents therapeutic use, Liver Transplantation, Cholangitis, Sclerosing complications, Cholangitis, Sclerosing surgery, Inflammatory Bowel Diseases complications, Inflammatory Bowel Diseases surgery
Abstract

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD) and a lead indication for liver transplantation (LT) in the western world. In this article, we present a Consensus Statement on LT practice, developed by a dedicated Guidelines' Taskforce of the European Society of Organ Transplantation (ESOT). The overarching goal is to provide practical guidance on commonly debated topics, including indications and timing of LT, management of bile duct stenosis in patients on the transplant waiting list, technical aspects of transplantation, immunosuppressive strategies post-transplant, timing and extension of intestinal resection and futility criteria for re-transplantation., Competing Interests: MC has received grant support unrelated to this study from Genetics spa, PSC Pediatric Foundation, AMAF, EpaC and AIRCS. He also received speakers/consultancy/advisory fees for GlaxoSmithKline, Dr. Falk Pharma, Cymabay, Advanz Pharma, Albireo, Ipsen, Mayoly Spindler, Perspectum, Echosens, Kowa, and Mirun. PT receives institutional support from Birmingham NIHR BRC. Unrelated to this study PT has received grant support from the Wellcome Trust, Innovate UK, the Medical Research Foundation, GlaxoSmithKline (GSK), Guts UK, PSC Support, LifeArc, NIHR, Intercept Pharma, Dr. Falk Pharma, Gilead Sciences, and Bristol Myers Squibb. He has also received speaker fees from Intercept and Dr. Falk, and advisory board/consultancy fees from Intercept, Cymabay, Pliant Pharma, Dr. Falk, Albireo, Ipsen and GlaxoSmithKine. HNH consultancies for Arrowhead, Takeda, GLG, Albireo, Alnylam and Mirum. LC received speakers fee from Advanz and Echosens. LD’A received consultancy fees from: Albireo, Mirum, Alexion, Astra Zeneca, Selecta, Vivet, Spark, Genespire, and Tome, in fields unrelated to the current topic. DD received consultancy fees from: Mirum, Vertex, Orphalan, Univar, Alexion, in fields unrelated to this study. UB received consultancy fees or grant support from: Mirum, Albireo, Alexion, Nestle and Vivet in fields unrelated to this study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Carbone, Della Penna, Mazzarelli, De Martin, Villard, Bergquist, Line, Neuberger, Al-Shakhshir, Trivedi, Baumann, Cristoferi, Hov, Fischler, Hadzic, Debray, D’Antiga, Selzner, Belli and Nadalin.)

Published
2023
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50. Similar survival but higher and delayed hepatocellular carcinoma recurrence in HIV-positive compared to negative cirrhotics undergoing liver transplantation.

Author

Rossotti R, Merli M, Mazzarelli C, De Carlis RM, Travi G, Vecchi M, Viganò R, Lauterio A, Raimondi A, Belli LS, De Carlis LG, and Puoti M

Subjects
Humans, Retrospective Studies, Antiviral Agents therapeutic use, Neoplasm Recurrence, Local pathology, Liver Cirrhosis complications, Liver Cirrhosis drug therapy, Carcinoma, Hepatocellular pathology, Liver Neoplasms pathology, Liver Transplantation, HIV Infections complications, HIV Infections drug therapy, End Stage Liver Disease, Hepatitis C drug therapy
Abstract

Background: Liver transplantation (LT) represents the best therapeutic option for hepatocellular carcinoma (HCC) and end-stage liver disease (ESLD). Although HIV infection does not seem to lower survival rates, HCV and HCC recurrence appear more harmful., Aims: To compare the overall survival after LT; evaluate the impact of anti-HCV direct-acting agents (DAA); assess the rate of HCC recurrence in HIV-positive and negative patients., Methods: Subjects with HCV/HBV infection who underwent LT for HCC or ESLD from 2012 to 2019 were retrospectively evaluated., Results: Study population included 299 individuals, 31 (10.4%) were HIV-positive. Overall mortality was similar (16.1% versus 19.0%, p = 0.695). HCC recurrence was observed in 6 HIV-positive (19.4%) and in 17 negative subjects (6.3%, p = 0.022). Time to relapse was 831 days in HIV-positive and 315 days in negative patients (p = 0.046). Cox model found a significant role for HIV in univariate analysis but, after adjusting for variables, extra-hepatic tumor was the only factor associated to recurrence (aHR 56.379, p < 0.001)., Conclusions: Post-LT survival improved after DAA availability and HIV has no impact on mortality. A higher and delayed rate of HCC recurrence was observed in co-infected individuals: surveillance protocols should be strengthened along time in this population., Competing Interests: Declaration of Competing Interest none of the Authors has conflicts of interests to declare., (Copyright © 2022. Published by Elsevier Ltd.)

Published
2023
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