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17 results on '"Miglioresi L"'

1. Toward Zero Hepatitis C Virus-Related Mortality as a Prerequisite for the Release of Resources in a Center for Follow-up of Liver Transplant.

Author

Valente G, Miglioresi L, Sgueglia T, Rinaldi L, and Piai G

Subjects
Female, Follow-Up Studies, Hepacivirus, Hepatitis C, Chronic mortality, Humans, Male, Retrospective Studies, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Liver Transplantation mortality, Sustained Virologic Response
Abstract

Taking charge of a liver transplanted (LT) patient implies not only to follow up the transplanted organ (eg, immunosuppression and cancer risk) but also to deal with the prevailing patient's active problems. The recurrence of hepatitis C on the graft has historically been one of the main active problems to be addressed, leading to 30% to 40% mortality per se in these patients and has involved many resources in the hepatological centers responsible for the follow-up. We verified how much the availability of the new drugs with direct-acting antiviral agents (DAAs) against hepatitis C virus (HCV) has impacted the mortality within the assisted population, changing its characteristics and addressing new clinical issues in the LT-patients. We performed a retrospective comparison between 230 LT patients followed up during pre-DAA era (group 1, with 88 HCV RNA-positive) and 244 patients observed from 2014 onward when DAAs became available (group 2, with 79 HCV RNA-positive). Fifty-two antiviral therapies were performed in group 1 with 18 sustained virologic response (SVR) (35%) and 53 treatments, of which 37 were retreatments, in group 2 with 51 SVR (96%), P = .0001. Deaths for HCV-related causes were 19 of 33 (57%) in group 1 and 7 of 24 (24%) in group 2, P = .01. The Kaplan-Meier showed a dramatic reduction in excess mortality in HCV-LT patients after the availability of DAAs. These results suggest that HCV is no longer the main active problem of follow-up in liver transplants, therefore the resources can be relocated to take care of other clinical aspects., (Copyright © 2019. Published by Elsevier Inc.)

Published
2019
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2. Incidence and risk factors of early HCC occurrence in HCV patients treated with direct acting antivirals: a prospective multicentre study.

Author

Rinaldi L, Perrella A, Guarino M, De Luca M, Piai G, Coppola N, Pafundi PC, Ciardiello F, Fasano M, Martinelli E, Valente G, Nevola R, Monari C, Miglioresi L, Guerrera B, Berretta M, Sasso FC, Morisco F, Izzi A, and Adinolfi LE

Subjects
Aged, Female, Humans, Incidence, Liver Cirrhosis complications, Logistic Models, Male, Middle Aged, Multivariate Analysis, Prospective Studies, Risk Factors, Sustained Virologic Response, Antiviral Agents therapeutic use, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular virology, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Liver Neoplasms epidemiology, Liver Neoplasms virology
Abstract

Background: An unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals., Methods: According to the Italian ministerial guidelines for direct-acting-antivirals treatment, 1022 consecutive HCV patients treated with direct-acting-antivirals were enrolled. Patients either with active HCC at imaging or history of previous treated HCC, HBV or HIV co-infection, or liver transplant recipients were excluded. The SVR, defined as the persistent absence of detectable serum HCV-RNA 12 weeks after the end of treatment (SVR12), was assessed for all enrolled patients. Abdominal ultrasound was performed before starting antiviral therapy, and repeated every 6 months. HCC was diagnosed according to the international guidelines. Patients showing either nodular patterns suggestive of HCC or with uncertain dynamic vascular behaviour were excluded from a further follow-up., Results: Nine hundred and eighty-five patients completed the 48 weeks follow-up after the end of treatment. A Sofosbuvir-based regimen was administered in the 74.9% of patients, among whom, the 71.6% underwent a simultaneous Ribavirin administration. A sustained virological response at 12 weeks off treatment was documented in 966 patients (98.2%). During the post treatment follow-up HCC was detected in 35 patients, with a cumulative incidence rate of the 3.55%. At multivariate analysis, four variables resulted independently associated with HCC development, both in a cirrhosis based and a class B Child based model, respectively: cirrhosis/class B Child, therapeutic schedule including Sofosbuvir without Ribavirin, liver stiffness values, male gender and presence of diabetes. A multivariate analysis performed on Child A cirrhotic patients, showed that Sofosbuvir based therapeutic treatment without Ribavirin had a HCC occurrence 5.7 higher than Ribavirin-based schedules with or without Sofosbuvir (p < 0.0001, OR: 5.686, 95% CI 2.455-13.169)., Conclusions: Our data suggest that early HCC occurrence appears more frequently related to Sofosbuvir-based therapy without Ribavirin which, indeed, seems to play a protective role on HCC onset. Therefore, a careful follow-up should be mandatory, especially in those regimens including Sofosbuvir without Ribavirin.

Published
2019
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3. Eradication of Hepatitis C After Liver Transplantion: Consequences for the Organization of the Transplant Patient's Follow-up.

Author

Piai G, Miglioresi L, and Valente G

Subjects
Follow-Up Studies, Hepacivirus, Humans, Recurrence, Antiviral Agents therapeutic use, Hepatitis C drug therapy, Liver Transplantation adverse effects
Abstract

The recurrence of the hepatitis C virus (HCV) in the liver graft has been so far the main cause of morbidity and mortality in post-transplantation patients. The treatment has significantly committed the resources of transplant hepatologists despite the poor results obtained with the past standard treatment with the use of interferon plus ribavirin. The new direct-acting antivirals (DAAs) are safe and effective even in the transplant setting, and our purpose was to check whether the eradication of HCV can make predominant other clinical problems that require different skills from those classic to hepatology. Prevalence of different items, such as metabolic syndrome, chronic renal insufficiency, and post-transplantation neoplasms, analyzed in the pre-DAA and post-DAA periods within a homogeneous population of all-cause and HCV transplant patients referred to our local hepatology service resulted in an increase in the post-DAA period after the substantial eradication of HCV. The suggestion that the main active issue has become extrahepatic sets the stage for the diversification of resources to be committed in the follow-up of liver transplantation., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Published
2017
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4. Long-term maintenance of sustained virological response in liver transplant recipients treated for recurrent hepatitis C.

Author

Ponziani FR, Viganò R, Iemmolo RM, Donato MF, Rendina M, Toniutto P, Pasulo L, Morelli MC, Burra P, Miglioresi L, Merli M, Di Paolo D, Fagiuoli S, Gasbarrini A, Pompili M, Belli L, Gerunda GE, Marino M, Montalti R, Di Benedetto F, De Ruvo N, Rigamonti C, Colombo M, Rossi G, Di Leo A, Lupo L, Memeo V, Bringiotti R, Zappimbulso M, Bitetto D, Vero V, Colpani M, Fornasiere E, Pinna AD, Morelli MC, Bertuzzo V, De Martin E, Senzolo M, Ettorre GM, Visco-Comandini U, Antonucci G, Angelico M, Tisone G, Giannelli V, and Giusto M

Subjects
Drug Therapy, Combination, Female, Follow-Up Studies, Genotype, Graft Survival, Hepatitis C, Chronic blood, Hepatitis C, Chronic mortality, Humans, Interferon-alpha therapeutic use, Interferons, Interleukins genetics, Maintenance Chemotherapy methods, Male, Middle Aged, Polyethylene Glycols therapeutic use, Recombinant Proteins therapeutic use, Recurrence, Retrospective Studies, Ribavirin therapeutic use, Survival Rate, Time Factors, Antiviral Agents therapeutic use, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Liver Transplantation mortality, RNA, Viral blood
Abstract

Background: The recurrence of hepatitis C viral infection is common after liver transplant, and achieving a sustained virological response to antiviral treatment is desirable for reducing the risk of graft loss and improving patients' survival., Aim: To investigate the long-term maintenance of sustained virological response in liver transplant recipients with hepatitis C recurrence., Methods: 436 Liver transplant recipients (74.1% genotype 1) who underwent combined antiviral therapy for hepatitis C recurrence were retrospectively evaluated., Results: The overall sustained virological response rate was 40% (173/436 patients), and the mean follow-up after liver transplantation was 11±3.5 years (range, 5-24). Patients with a sustained virological response demonstrated a 5-year survival rate of 97% and a 10-year survival rate of 93%; all but 6 (3%) patients remained hepatitis C virus RNA-negative during follow-up. Genotype non-1 (p=0.007), treatment duration >80% of the scheduled period (p=0.027), and early virological response (p=0.002), were associated with the maintenance of sustained virological response as indicated by univariate analysis. Early virological response was the only independent predictor of sustained virological response maintenance (p=0.008)., Conclusions: Sustained virological response achieved after combined antiviral treatment is maintained in liver transplant patients with recurrent hepatitis C and is associated with an excellent 5-year survival., (Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Published
2014
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5. Treatment of genotype-1 hepatitis C recurrence after liver transplant improves survival in both sustained responders and relapsers.

Author

Ponziani FR, Milani A, Gasbarrini A, Zaccaria R, Viganò R, Iemmolo RM, Donato MF, Rendina M, Toniutto P, Pasulo L, Cescon M, Burra P, Miglioresi L, Merli M, Paolo DD, Fagiuoli S, and Pompili M

Subjects
Cohort Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Graft Rejection, Graft Survival, Hepatitis C, Chronic mortality, Hepatitis C, Chronic pathology, Humans, Interferon-alpha administration & dosage, Italy, Kaplan-Meier Estimate, Liver Transplantation adverse effects, Liver Transplantation methods, Male, Middle Aged, Multivariate Analysis, Polyethylene Glycols administration & dosage, Predictive Value of Tests, Recombinant Proteins administration & dosage, Recurrence, Regression Analysis, Retreatment, Retrospective Studies, Ribavirin administration & dosage, Risk Assessment, Survival Analysis, Treatment Outcome, Antiviral Agents administration & dosage, Genotype, Hepatitis C, Chronic genetics, Hepatitis C, Chronic surgery, Liver Transplantation mortality
Abstract

The aim of this study was to evaluate the factors affecting the response to treatment and how it could affect survival in a large series of genotype-1 HCV-transplanted patients. Three-hundred and twenty six genotype-1 HCV patients were enrolled. One hundred and ninety-six patients (60.1%) were nonresponders and 130 (39.9%) showed negative HCV-RNA at the end of treatment. Eighty-four of them (25.8%) achieved sustained virological response, while 46 (14.1%) showed viral relapse. Five-year cumulative survival was significantly worse in nonresponders (76.4%) compared with sustained viral response (93.2) or relapsers (94.9%). Sustained responders and relapsers were therefore considered as a single 'response group' in further analysis. Pretreatment variables significantly associated with virological response at multivariate regression analysis were the absence of ineffective pretransplant antiviral therapy, the recurrence of HCV-hepatitis more than 1 year after transplant, an histological grading ≥4 at pretreatment liver biopsy, a pretreatment HCV-RNA level <1.2 × 10(6 ) IU/ml, and the absence of diabetes. As expected, also on-treatment variables (rapid and early virological response) were significantly associated to the response to antiviral treatment. In conclusion, this study shows that postliver transplant antiviral treatment results in beneficial effect on survival not only in sustained responders but also in relapsers., (© 2012 The Authors Transplant International © 2012 European Society for Organ Transplantation. Published by Blackwell Publishing Ltd.)

Published
2013
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6. HCV genotype 1a shows a better virological response to antiviral therapy than HCV genotype 1b.

Author

Pellicelli AM, Romano M, Stroffolini T, Mazzoni E, Mecenate F, Monarca R, Picardi A, Bonaventura ME, Mastropietro C, Vignally P, Andreoli A, Marignani M, D'Ambrosio C, Miglioresi L, Nosotti L, Mitidieri O, Gentilucci UV, Puoti C, Barbaro G, Barlattani A, Furlan C, and Barbarini G

Subjects
Adult, Alanine Transaminase blood, Biopsy, Drug Therapy, Combination, Female, Genotype, Hepatitis C, Chronic pathology, Humans, Interferon alpha-2, Liver Cirrhosis drug therapy, Liver Cirrhosis pathology, Liver Cirrhosis virology, Male, Middle Aged, RNA, Viral blood, Recombinant Proteins therapeutic use, Ribavirin therapeutic use, Treatment Outcome, Antiviral Agents therapeutic use, Hepacivirus drug effects, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Interferon-alpha therapeutic use, Polyethylene Glycols therapeutic use
Abstract

Background: The impact of viral subtype on the rate of sustained virological response (SVR) to antiviral therapy in patients chronically infected with hepatitis C genotype 1 subtype 1a and 1b has not been extensively investigated. The aim of this study is to determine whether the HCV genotype 1 subtypes 1a and 1b respond differently to treatment with PEGylated interferon (PEG-IFN) plus ribavirin., Methods: For 48 weeks, 388 "naïve"genotype 1 patients were treated weekly with PEG-IFN α-2a or PEG-INF α-2b combined with daily ribavirin (1000-1200 mg/day). The numbers of patients in whom HCV-RNA was undetectable were compared after 4 (rapid virological response, RVR), 12 (early virological response, EVR), and 48 (end treatment virological response, ETR) weeks of treatment as well as 24 weeks after the last treatment (sustained virological response, SVR)., Results: The rate of SVR was higher in subtype 1a patients than subtype 1b patients (55% vs. 43%; p < 0.02). Multiple logistic regression analysis showed that infection with genotype 1a (odds ratio(OR) : 1.8; 95% confidence interval (CI): 1.4 to 4.1), age < 50 years (OR:7.0; 95% CI 1.1 to 21.2), alanine aminotransferase level (ALT)<100 IU/ml (OR:2.1; 95% CI: 1.3 to3.5), HCV-RNA < 5.6 log10 IU/ml (OR: 3.2; 95% CI: 2.7 to 6.9) and fibrosis score < S3 (OR: 3.8; 95% CI:3.2 to 7.4), were all independent predictors of SVR., Conclusion: Dual antiviral therapy is more effective against HCV subtype 1a than against subtype 1b and this difference is independent of other factors that may favour viral clearance., Trial Registration: ClinicalTrials.gov Identifier: NCT01342003.

Published
2012
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7. Treatment of recurrent genotype 4 hepatitis C after liver transplantation: early virological response is predictive of sustained virological response. An AISF RECOLT-C group study.

Author

Ponziani FR, Milani A, Gasbarrini A, Zaccaria R, Viganò R, Donato MF, Morelli MC, Miglioresi L, Pasulo L, Rendina M, Paolo DD, Marino M, Toniutto P, Fagiuoli S, and Pompili M

Subjects
Adult, Cohort Studies, Drug Therapy, Combination, Female, Humans, Interferon-alpha therapeutic use, Italy, Male, Middle Aged, Polyethylene Glycols therapeutic use, Recombinant Proteins therapeutic use, Recurrence, Retrospective Studies, Ribavirin therapeutic use, Treatment Outcome, Antiviral Agents therapeutic use, Genotype, Hepacivirus genetics, Hepatitis B, Chronic epidemiology, Hepatitis B, Chronic therapy, Liver Transplantation
Abstract

Introduction: Hepatitis C virus genotype 4 is predominant in the Middle East and Northern Africa, even if it has recently spread to Southern Europe. Data about the treatment of post-liver transplantation (LT) genotype 4 hepatitis C recurrence are scarce. We report a retrospective analysis of post-LT genotype 4 hepatitis C treatment in 9 Italian transplant centres, focusing on the overall survival rates and treatment outcome., Results: Among 452 recipients, we identified 17 HCV genotype 4 patients (16 males, 1 female) transplanted between 1998 and 2007. All patients received combined antiviral treatment with conventional doses of interferon (recombinant or pegylated) and ribavirin after histological diagnosis of hepatitis C recurrence. The observed overall survival after LT was 100% at 1 year and 83.3% at 5 years. More than 1/3 (35.3%) of patients achieved a sustained virological response (SVR) and 40% (data available in 15 subjects) an early virological response (EVR), which was significantly associated with the achievement of SVR (overall accuracy: 85.7%; predictive values of EVR absence/presence 80/88.8%; chi-square p < 0.05)., Conclusion: In conclusion, in post-LT genotype 4 hepatitis C treatment, SVR rates are similar to genotype 1. Patients who don't show an EVR are not likely to achieve a SVR.

Published
2012

8. Treatment of hepatitis C recurrence is less successful in female than in male liver transplant recipients.

Author

Giannelli V, Giusto M, Farcomeni A, Ponziani FR, Pompili M, Viganò R, Iemmolo RM, Donato MF, Rendina M, Toniutto P, Pasulo L, Morelli MC, De Martin E, Miglioresi L, Di Paolo D, Fagiuoli S, and Merli M

Subjects
Adult, Aged, Female, Hepacivirus genetics, Humans, Male, Middle Aged, Patient Compliance, RNA, Viral blood, Recurrence, Retrospective Studies, Sex Factors, Treatment Outcome, Viral Load, Antiviral Agents therapeutic use, Hepatitis C, Chronic virology, Interferon-alpha therapeutic use, Liver Transplantation, Polyethylene Glycols therapeutic use, Ribavirin therapeutic use
Abstract

It has been recently suggested that the risk of graft loss after liver transplantation (LT) may increase in female HCV patients. The aim of the study was to examine gender differences in HCV therapy tolerance and outcome in LT patients treated for HCV recurrence. A retrospective study was conducted on liver recipients with HCV recurrence, who were given antiviral therapy from 2001 to 2009 in 12 transplant centers in Italy. Sustained virological response (SVR), adherence-to-therapy, and side effects were evaluated. A multivariate logistic regression model was used after adjusting for possible confounders. The data regarding 342 treated patients were analyzed. SVR was reported in 38.8% of patients. At baseline, male and female did not differ in HCV viral load, histology, or rate of diabetes. SVR was lower in females than in males (29.5% vs. 42.1%; P=0.03). Adherence-to-therapy was also lower in females than in males 43.4% vs. 23.8%; P=0.001); anemia was the main reason for lower adherence. In a multivariate analysis in patients Genotype1, female gender (P<0.04), early virological response (P<0.0001), and adherence to therapy (P<0.0001) were independent predictors for SVR. In conclusion, female gender represents an independent negative prognostic factor for the outcome of HCV antiviral therapy after LT., (© 2012 The Authors. Transplant International © 2012 European Society for Organ Transplantation.)

Published
2012
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9. The controversial role of lamivudine prophylaxis in occult HBV carriers treated with chemo-immune therapy.

Author

D'Andrea M, Nosotti L, Pimpinelli F, Dessanti ML, Paviglianiti A, Miglioresi L, Morrone A, and Petti MC

Subjects
Chemoprevention, Drug-Related Side Effects and Adverse Reactions, Hepatitis B Antibodies blood, Hepatitis B Core Antigens immunology, Humans, Lymphoma drug therapy, Retrospective Studies, Antiviral Agents therapeutic use, Carrier State drug therapy, Hepatitis B drug therapy, Lamivudine therapeutic use
Published
2009
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10. Leucopenia is a side effect of combination therapy for hepatitis C infection.

Author

Russo F, Bacosi M, Miglioresi L, and Ricci GL

Subjects
Adult, Antiviral Agents administration & dosage, Drug Therapy, Combination, Female, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Leukocyte Count drug effects, Male, Recombinant Proteins, Ribavirin administration & dosage, Antiviral Agents adverse effects, Hepatitis C, Chronic drug therapy, Interferon-alpha adverse effects, Leukopenia chemically induced, Ribavirin adverse effects
Published
2000
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11. Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

Author

Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio Maria, Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxì, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini Silberstein, Francesca, Mariani, R., Iapadre, N., Grimaldi, A., Cozzolongo, R., Andreone, P., Verucchi, G., Menzaghi, B., Quirino, T., Pisani, V., Torti, MARIA CHIARA, Vecchiet, J., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L. A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, Miriam, Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Magni, C. F., Mancon, A., Monico, S., Niero, F., Russo, M. L., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Gaeta, G. B., Lembo, V., Sangiovanni, V., Di Marco, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Aragri, M., Baiocchi, L., Barbaliscia, S., Biliotti, Elisa, Biolato, M., Carioti, L., Ceccherini Silberstein, F., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Maio, V. C., Di Paolo, D., Furlan, Caterina, Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lenci, I., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, Donatella, Pellicelli, A., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M. C., Spaziante, M., Svicher, V., Tisone, G., Vespasiani Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M. S., Falconi, L., Di Giammartino, D., Di Maio, V., Cento, V., Lenci, I., Aragri, M., Rossi, P., Barbaliscia, S., Melis, M., Verucchi, G., Magni, C., Teti, E., Bertoli, A., Antonucci, F., Bellocchi, M., Micheli, V., Masetti, C., Landonio, S., Francioso, S., Santopaolo, F., Pellicelli, A., Calvaruso, V., Gianserra, L., Siciliano, M., Romagnoli, D., Cozzolongo, R., Grieco, A., Vecchiet, J., Morisco, F., Merli, M., Brancaccio, G., Di Biagio, A., Loggi, E., Mastroianni, C., Pace Palitti, V., Tarquini, P., Puoti, M., Taliani, G., Sarmati, L., Picciotto, A., Vullo, V., Caporaso, N., Paoloni, M., Pasquazzi, C., Rizzardini, G., Parruti, G., Craxã¬, A., Babudieri, S., Andreoni, M., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Iapadre, N., Grimaldi, A., Andreone, P., Menzaghi, B., Quirino, T., Pisani, V., Torti, C., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Mancon, A., Monico, S., Niero, F., Russo, M., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Gaeta, G., Lembo, V., Sangiovanni, V., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Paolo, D., Furlan, C., Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, D., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Tisone, G., Vespasiani-Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M., Falconi, L., Di Giammartino, D., Di Maio, V, Cento, V, Lenci, I, Aragri, M, Rossi, P, Barbaliscia, S, Melis, M, Verucchi, G, Magni, C, Teti, E, Bertoli, A, Antonucci, F, Bellocchi, M, Micheli, V, Masetti, C, Landonio, S, Francioso, S, Santopaolo, F, Pellicelli, A, Calvaruso, V, Gianserra, L, Siciliano, M, Romagnoli, D, Cozzolongo, R, Grieco, A, Morisco, F, Merli, M, Brancaccio, G, Di Biagio, A, Loggi, E, Mastroianni, C, Pace Palitti, V, Tarquini, P, Puoti, M, Taliani, G, Sarmati, L, Picciotto, A, Vullo, V, Caporaso, N, Paoloni, M, Pasquazzi, C, Rizzardini, G, Parruti, G, Craxì, A, Babudieri, S, Andreoni, M, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Velia C. Di Maio, Valeria Cento, Ilaria Lenci, Marianna Aragri, Piera Rossi, Silvia Barbaliscia, Michela Meli, Gabriella Verucchi, Carlo F. Magni, Elisabetta Teti, Ada Bertoli, Francesco Paolo Antonucci, Maria C. Bellocchi, Valeria Micheli, Chiara Masetti, Simona Landonio, Simona Francioso, Francesco Santopaolo, Adriano M. Pellicelli, Vincenza Calvaruso, Laura Gianserra, Massimo Siciliano, Dante Romagnoli, Raffaele Cozzolongo, Antonio Grieco, Jacopo Vecchiet, Filomena Morisco, Manuela Merli, Giuseppina Brancaccio, Antonio Di Biagio, Elisabetta Loggi, Claudio M. Mastroianni, Valeria Pace Palitti, Pierluigi Tarquini, Massimo Puoti, Gloria Taliani, Loredana Sarmati, Antonino Picciotto, Vincenzo Vullo, Nicola Caporaso, Maurizio Paoloni, Caterina Pasquazzi, Giuliano Rizzardini, Giustino Parruti, Antonio Craxì, Sergio Babudieri, Massimo Andreoni, Mario Angelico, Carlo F. Perno, Francesca Ceccherini-Silberstein, for the HCV Italian Resistance Network Study Group: [.., P. Andreone, E. Loggi, G. Verucchi, ], Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio M., Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxã¬, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini-Silberstein, Francesca, Nicolini, L. A., Magni, C. F., Russo, M. L., Gaeta, G. B., Di Marco, V., Di Maio, V. C., Sorbo, M. C., Mura, M. S., Di Maio, Velia C, Magni, Carlo F, Bellocchi, Maria C, Pellicelli, Adriano M, Mastroianni, Claudio M, Craxì, Antonio, Perno, Carlo F, and Ceccherini Silberstein, Francesca

Subjects
Male, 0301 basic medicine, hepatitis C virus, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Drug Resistance, resistance-associated substitutions, Viral Nonstructural Proteins, VARIANTS, NS5A, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, INFECTION, antiviral therapy, Medicine, hepatitis C viru, Viral, Treatment Failure, Chronic, direct-acting antivirals, resistance test, hepatology, biology, GENOTYPE 1, virus diseases, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Hepatitis C, Italy, Combination, Interferon, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Author Keywords:antiviral therapy, RIBAVIRIN, Sequence Analysis, Human, medicine.drug, medicine.medical_specialty, Daclatasvir, Genotype, Hepatitis C virus, Antiviral Agents, LONG-TERM PERSISTENCE, DACLATASVIR, 03 medical and health sciences, Drug Therapy, Aged, Drug Resistance, Viral, Hepatitis C, Chronic, Humans, Interferons, Mutation, Ribavirin, Sequence Analysis, DNA, Hepatology, TREATMENT-NAIVE, Internal medicine, Antiviral Agent, resistance-associated substitution, direct-acting antiviral, Hepaciviru, resistance test KeyWords Plus:HEPATITIS-C VIRUS, business.industry, Viral Nonstructural Protein, DNA, biology.organism_classification, Clinical trial, 030104 developmental biology, SOFOSBUVIR, chemistry, Sequence Analysi, Immunology, business
Abstract

Background & Aims: Despite the excellent efficacy of direct-acting antivirals (DAA) reported in clinical trials, virological failures can occur, often associated with the development of resistance-associated substitutions (RASs). This study aimed to characterize the presence of clinically relevant RASs to all classes in real-life DAA failures. Methods: Of the 200 virological failures that were analyzed in 197 DAA-treated patients, 89 with pegylated-interferon+ribavirin (PegIFN+RBV) and 111 without (HCV-1a/1b/1g/2/3/4=58/83/1/6/24/25; 56.8% treatment experienced; 65.5% cirrhotic) were observed. Sanger sequencing of NS3/NS5A/NS5B was performed by home-made protocols, at failure (N= 200) and whenever possible at baseline (N= 70). Results: The majority of the virological failures were relapsers (57.0%), 22.5% breakthroughs, 20.5% non-responders. RAS prevalence varied according to IFN/RBV use, DAA class, failure type and HCV genotype/subtype. It was 73.0% in IFN group vs 49.5% in IFN free, with the highest prevalence of NS5A-RASs (96.1%), compared to NS3-RASs (75.9% with IFN, 70.5% without) and NS5B-RASs (66.6% with IFN, 20.4% without, in sofosbuvir failures). In the IFN-free group, RASs were higher in breakthrough/non-responders than in relapsers (90.5% vs 40.0%, P= 2 DAA classes showed multiclass resistance, including 11/11 NS3+NS5A failures. Furthermore, 20.0% of patients had baseline-RASs, which were always confirmed at failure. Conclusions: In our failure setting, RAS prevalence was remarkably high in all genes, with a partial exception for NS5B, whose limited resistance is still higher than previously reported. This multiclass resistance advocates for HCV resistance testing at failure, in all three genes for the best second-line therapeutic tailoring.

Published
2017

12. Treatment of hepatitis C recurrence is less successful in female than in male liver transplant recipients

Author

Giannelli, V, Giusto, M, Farcomeni, A, Ponziani, F, Pompili, M, Viganò, R, Iemmolo, R, Donato, M, Rendina, M, Toniutto, P, Pasulo, L, Morelli, M, De Martin, E, Miglioresi, L, DI PAOLO, D, Fagiuoli, S, Merli, M, Belli, L, Gerunda, G, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Fornasiere, E, Di Leo, A, Castellaneta, N, Lupo, L, Nemeo, V, Bringiotti, R, Zappimbulso, M, Vero, V, Colpani, M, Cescon, M, Bertuzzo, V, Pinna, A, Visco Comandini, U, Antonucci, G, Ettorre, G, Burra, P, Senzolo, M, Ginanni, C, Mennini, G, Rossi, M, Angelico, M, Tisone, G, Gasbarrini, A, Giannelli, V, Giusto, M, Farcomeni, A, Ponziani, F, Pompili, M, Viganò, R, Iemmolo, R, Donato, M, Rendina, M, Toniutto, P, Pasulo, L, Morelli, M, De Martin, E, Miglioresi, L, Di Paolo, D, Fagiuoli, S, Merli, M, Giannelli, Valerio, Giusto, Michela, Farcomeni, Alessio, Ponziani, Francesca R, Pompili, Maurizio, Viganò, Raffaella, Iemmolo, Rosa Maria, Donato, Maria F, Rendina, Maria, Toniutto, Pierluigi, Pasulo, Luisa, Morelli, Maria Cristina, De Martin, Eleonora, Miglioresi, Lucia, Di Paolo, Daniele, Fagiuoli, Stefano, Merli, Manuela, Montalti, Roberto, Giannelli V., Giusto M., Farcomeni A., Ponziani F.R., Pompili M., Viganò R., Iemmolo R.M., Donato M.F., Rendina M., Toniutto P., Pasulo L., Morelli M.C., De Martin E., Miglioresi L., Di Paolo D., Fagiuoli S., Merli M., Belli L., Gerunda G.E., Montalti R., Di Benedetto F., De Ruvo N., Rigamonti C., Colombo M., Rossi G., Fornasiere E., Di Leo A., Castellaneta N.M., Lupo L., Nemeo V., Bringiotti R., Zappimbulso M., Vero V., Colpani M., Cescon M., Bertuzzo V., Pinna A.D., Visco-Comandini U., Antonucci G., Ettorre G.M., Burra P., Senzolo M., Ginanni C.S., Mennini G., Rossi M., Angelico M., Tisone G., and Gasbarrini A.

Subjects
Adult, Male, antiviral treatment, Sex Factor, Hepacivirus, Polyethylene Glycol, Antiviral Agents, Settore MED/01 - Statistica Medica, Polyethylene Glycols, Sex Factors, INTERFERON THERAPY, Retrospective Studie, Recurrence, Ribavirin, gender, Humans, adherence, HCV, liver transplant, hepatitis c, Aged, Retrospective Studies, Antiviral Agent, Settore MED/12 - Gastroenterologia, Hepaciviru, liver transplantation, Settore MED/09 - MEDICINA INTERNA, HCV recurrence, liver transplantation, virus diseases, HEPATITIS C VIRUS, Interferon-alpha, Hepatitis C, Chronic, Middle Aged, Viral Load, hcv, hepatitis c virus, digestive system diseases, Liver Transplantation, Treatment Outcome, Patient Compliance, RNA, Viral, Female, HCV recurrence, Human
Abstract

It has been recently suggested that the risk of graft loss after liver transplantation (LT) may increase in female HCV patients. The aim of the study was to examine gender differences in HCV therapy tolerance and outcome in LT patients treated for HCV recurrence. A retrospective study was conducted on liver recipients with HCV recurrence, who were given antiviral therapy from 2001 to 2009 in 12 transplant centers in Italy. Sustained virological response (SVR), adherence-to-therapy, and side effects were evaluated. A multivariate logistic regression model was used after adjusting for possible confounders. The data regarding 342 treated patients were analyzed. SVR was reported in 38.8% of patients. At baseline, male and female did not differ in HCV viral load, histology, or rate of diabetes. SVR was lower in females than in males (29.5% vs. 42.1%; P=0.03). Adherence-to-therapy was also lower in females than in males 43.4% vs. 23.8%; P=0.001); anemia was the main reason for lower adherence. In a multivariate analysis in patients Genotype1, female gender (P

Published
2012

13. Long-term maintenance of sustained virological response in liver transplant recipients treated for recurrent hepatitis C

Author

Ponziani, Fr, Viganò, R, Iemmolo, Rm, Donato, Mf, Rendina, M, Toniutto, P, Pasulo, L, Morelli, Mc, Burra, Patrizia, Miglioresi, L, Merli, M, Di Paolo, D, Fagiuoli, S, Gasbarrini, A, Pompili, M, Belli, L, Gerunda, Ge, Marino, M, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Di Leo, A, Lupo, L, Memeo, V, Bringiotti, R, Zappimbulso, M, Bitetto, D, Vero, V, Colpani, M, Fornasiere, E, Pinna, Ad, Bertuzzo, V, DE MARTIN, Eleonora, Senzolo, M, Ettorre, Gm, Visco Comandini, U, Antonucci, G, Angelico, M, Tisone, G, Giannelli, V, Giusto, M, Group, AISF RECOLT C., Ponziani, Francesca Romana, Viganò, Raffaella, Iemmolo, Rosa Maria, Donato, Maria Francesca, Rendina, Maria, Toniutto, Pierluigi, Pasulo, Luisa, Morelli, Maria Cristina, Burra, Patrizia, Miglioresi, Lucia, Merli, Manuela, Di Paolo, Daniele, Fagiuoli, Stefano, Gasbarrini, Antonio, Pompili, Maurizio, Belli, L, Gerunda, G E, Marino, M, Montalti, R, Di Benedetto, F, De Ruvo, N, Rigamonti, C, Colombo, M, Rossi, G, Di Leo, A, Lupo, L, Memeo, V, Bringiotti, R, Zappimbulso, M, Bitetto, D, Vero, V, Colpani, M, Fornasiere, E, Pinna, A D, Morelli, M C, Bertuzzo, V, De Martin, E, Senzolo, M, Ettorre, G M, Visco-Comandini, U, Antonucci, G, Angelico, M, Tisone, G, Giannelli, V, Giusto, M, Ponziani, F, Fagiuoli, S, Gasbarrini, A, Pompili, M, Francesca Romana Ponziani, Raffaella Viganò, Rosa Maria Iemmolo, Maria Francesca Donato, Maria Rendina, Pierluigi Toniutto, Luisa Pasulo, Maria Cristina Morelli, Patrizia Burra, Lucia Miglioresi, Manuela Merli, Daniele Di Paolo, Stefano Fagiuoli, Antonio Gasbarrini, Maurizio Pompili, L. Belli, G.E. Gerunda, M. Marino, R. Montalti, F. Di Benedetto, N. De Ruvo, C. Rigamonti, M. Colombo, G. Rossi, A. Di Leo, L. Lupo, V. Memeo, R. Bringiotti, M. Zappimbulso, D. Bitetto, V. Vero, M. Colpani, E. Fornasiere, A.D. Pinna, M.C. Morelli, V. Bertuzzo, E. De Martin, M. Senzolo, G.M. Ettorre, U. Visco-Comandini, G. Antonucci, M. Angelico, G. Tisone, V. Giannelli, and M. Giusto

Subjects
Male, Sustained viral response, Time Factors, medicine.medical_treatment, Hepacivirus, Liver transplantation, medicine.disease_cause, Gastroenterology, Polyethylene Glycol, Polyethylene Glycols, Virological response, HCV antiviral treatment, Recurrence, Retrospective Studie, antiviral therapy, Viral, Recurrent hepatitis, Chronic, hepatitis c, Univariate analysis, Graft Survival, Hepatitis C recurrence, Long term maintenance, Hepatitis C, Middle Aged, Recombinant Protein, Recombinant Proteins, Survival Rate, Combination, RNA, Viral, Drug Therapy, Combination, Female, Human, medicine.medical_specialty, Genotype, Time Factor, Hepatitis C virus, Settore MED/12 - GASTROENTEROLOGIA, Antiviral Agents, liver transplantation, hepatitis c recurrence, sustained viral response, hcv antiviral treatment, Follow-Up Studie, Maintenance Chemotherapy, Drug Therapy, Internal medicine, Ribavirin, medicine, Follow-Up Studies, Hepatitis C, Chronic, Humans, Interferon-alpha, Interleukins, Retrospective Studies, Liver Transplantation, Survival rate, Antiviral Agent, Hepaciviru, Hepatology, business.industry, Interleukin, medicine.disease, Immunology, HCV, virological response, liver transplant, RNA, Interferons, business
Abstract

Background The recurrence of hepatitis C viral infection is common after liver transplant, and achieving a sustained virological response to antiviral treatment is desirable for reducing the risk of graft loss and improving patients’ survival. Aim To investigate the long-term maintenance of sustained virological response in liver transplant recipients with hepatitis C recurrence. Methods 436 Liver transplant recipients (74.1% genotype 1) who underwent combined antiviral therapy for hepatitis C recurrence were retrospectively evaluated. Results The overall sustained virological response rate was 40% (173/436 patients), and the mean follow-up after liver transplantation was 11 ± 3.5 years (range, 5–24). Patients with a sustained virological response demonstrated a 5-year survival rate of 97% and a 10-year survival rate of 93%; all but 6 (3%) patients remained hepatitis C virus RNA-negative during follow-up. Genotype non-1 (p = 0.007), treatment duration >80% of the scheduled period (p = 0.027), and early virological response (p = 0.002), were associated with the maintenance of sustained virological response as indicated by univariate analysis. Early virological response was the only independent predictor of sustained virological response maintenance (p = 0.008). Conclusions Sustained virological response achieved after combined antiviral treatment is maintained in liver transplant patients with recurrent hepatitis C and is associated with an excellent 5-year survival.

Published
2014

14. Toward Zero Hepatitis C Virus-Related Mortality as a Prerequisite for the Release of Resources in a Center for Follow-up of Liver Transplant

Author

Luca Rinaldi, Tommaso Sgueglia, Giovanna Valente, Guido Piai, Lucia Miglioresi, Valente, G., Miglioresi, L., Sgueglia, T., Rinaldi, L., and Piai, G.

Subjects
Male, medicine.medical_specialty, Sustained Virologic Response, medicine.medical_treatment, Hepacivirus, Hepatitis C virus, Population, medicine.disease_cause, Antiviral Agents, Follow-Up Studie, Retrospective Studie, Internal medicine, Humans, Medicine, education, Retrospective Studies, Antiviral Agent, Excess mortality, Transplantation, education.field_of_study, Hepaciviru, biology, business.industry, Immunosuppression, Retrospective cohort study, Hepatitis C, Hepatitis C, Chronic, medicine.disease, biology.organism_classification, Liver Transplantation, Virologic response, Female, Surgery, business, Follow-Up Studies, Human
Abstract

Taking charge of a liver transplanted (LT) patient implies not only to follow up the transplanted organ (eg, immunosuppression and cancer risk) but also to deal with the prevailing patient’s active problems. The recurrence of hepatitis C on the graft has historically been one of the main active problems to be addressed, leading to 30% to 40% mortality per se in these patients and has involved many resources in the hepatological centers responsible for the follow-up. We verified how much the availability of the new drugs with direct-acting antiviral agents (DAAs) against hepatitis C virus (HCV) has impacted the mortality within the assisted population, changing its characteristics and addressing new clinical issues in the LT-patients. We performed a retrospective comparison between 230 LT patients followed up during pre-DAA era (group 1, with 88 HCV RNA-positive) and 244 patients observed from 2014 onward when DAAs became available (group 2, with 79 HCV RNA-positive). Fifty-two antiviral therapies were performed in group 1 with 18 sustained virologic response (SVR) (35%) and 53 treatments, of which 37 were retreatments, in group 2 with 51 SVR (96%), P = .0001. Deaths for HCV-related causes were 19 of 33 (57%) in group 1 and 7 of 24 (24%) in group 2, P = .01. The Kaplan-Meier showed a dramatic reduction in excess mortality in HCV-LT patients after the availability of DAAs. These results suggest that HCV is no longer the main active problem of follow-up in liver transplants, therefore the resources can be relocated to take care of other clinical aspects.

Published
2019

15. Incidence and risk factors of early HCC occurrence in HCV patients treated with direct acting antivirals: a prospective multicentre study

Author

Maria Guarino, Nicola Coppola, Luigi Elio Adinolfi, Guido Piai, Massimo De Luca, Antonio Izzi, Morena Fasano, Luca Rinaldi, Fortunato Ciardiello, Ferdinando Carlo Sasso, Riccardo Nevola, Filomena Morisco, Giovanna Valente, Alessandro Perrella, Caterina Monari, Pia Clara Pafundi, Lucia Miglioresi, Erika Martinelli, Barbara Guerrera, Massimiliano Berretta, Rinaldi, Luca, Perrella, Alessandro, Guarino, Maria, De Luca, Massimo, Piai, Guido, Coppola, Nicola, Pafundi, Pia Clara, Ciardiello, Fortunato, Fasano, Morena, Martinelli, Erika, Valente, Giovanna, Nevola, Riccardo, Monari, Caterina, Miglioresi, Lucia, Guerrera, Barbara, Berretta, Massimiliano, Sasso, Ferdinando Carlo, Morisco, Filomena, Izzi, Antonio, Adinolfi, Luigi Elio, Rinaldi, L., Perrella, A., Guarino, M., De Luca, M., Piai, G., Coppola, N., Pafundi, P. C., Ciardiello, F., Fasano, M., Martinelli, E., Valente, G., Nevola, R., Monari, C., Miglioresi, L., Guerrera, B., Berretta, M., Sasso, F. C., Morisco, F., Izzi, A., and Adinolfi, L. E.

Subjects
Liver Cirrhosis, Male, 0301 basic medicine, Cirrhosis, Sustained Virologic Response, Sofosbuvir, lcsh:Medicine, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Medicine, Cumulative incidence, Prospective Studies, HCC, Incidence, Incidence (epidemiology), HCV cirrhosis, Liver Neoplasms, General Medicine, Middle Aged, 030220 oncology & carcinogenesis, Female, Immune-surveillance, Off Treatment, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Antiviral Agents, General Biochemistry, Genetics and Molecular Biology, Direct acting antivirals, 03 medical and health sciences, Diabetes mellitus, Internal medicine, Humans, Aged, business.industry, Research, Ribavirin, lcsh:R, Hepatitis C, Chronic, medicine.disease, digestive system diseases, Regimen, HCV cirrhosi, Logistic Models, 030104 developmental biology, chemistry, Multivariate Analysis, Direct acting antiviral, business
Abstract

Background An unexpected increased HCC recurrence and occurrence rate among HCV patients treated with direct acting antivirals combination has been reported. Aim of the study was the evaluation of early HCC occurrence rate and its risk factors in a HCV infected population, treated with direct-acting-antivirals. Methods According to the Italian ministerial guidelines for direct-acting-antivirals treatment, 1022 consecutive HCV patients treated with direct-acting-antivirals were enrolled. Patients either with active HCC at imaging or history of previous treated HCC, HBV or HIV co-infection, or liver transplant recipients were excluded. The SVR, defined as the persistent absence of detectable serum HCV-RNA 12 weeks after the end of treatment (SVR12), was assessed for all enrolled patients. Abdominal ultrasound was performed before starting antiviral therapy, and repeated every 6 months. HCC was diagnosed according to the international guidelines. Patients showing either nodular patterns suggestive of HCC or with uncertain dynamic vascular behaviour were excluded from a further follow-up. Results Nine hundred and eighty-five patients completed the 48 weeks follow-up after the end of treatment. A Sofosbuvir-based regimen was administered in the 74.9% of patients, among whom, the 71.6% underwent a simultaneous Ribavirin administration. A sustained virological response at 12 weeks off treatment was documented in 966 patients (98.2%). During the post treatment follow-up HCC was detected in 35 patients, with a cumulative incidence rate of the 3.55%. At multivariate analysis, four variables resulted independently associated with HCC development, both in a cirrhosis based and a class B Child based model, respectively: cirrhosis/class B Child, therapeutic schedule including Sofosbuvir without Ribavirin, liver stiffness values, male gender and presence of diabetes. A multivariate analysis performed on Child A cirrhotic patients, showed that Sofosbuvir based therapeutic treatment without Ribavirin had a HCC occurrence 5.7 higher than Ribavirin-based schedules with or without Sofosbuvir (p

Published
2019

16. Treatment of recurrent genotype 4 hepatitis C after liver transplantation: early virological response is predictive of sustained virological response. An AISF RECOLT-C group study

Author

Luisa Pasulo, Stefano Fagiuoli, L. Miglioresi, Maria Rendina, Maria Marino, Pierluigi Toniutto, Maria Cristina Morelli, Raffaella Viganò, A. Milani, Maria Francesca Donato, Antonio Gasbarrini, Francesca Romana Ponziani, Maurizio Pompili, Raffaella Zaccaria, Daniele Di Paolo, Ponziani, F, Milani, A, Gasbarrini, A, Zaccaria, R, Viganò, R, Donato, M, Morelli, M, Miglioresi, L, Pasulo, L, Rendina, M, Paolo, D, Marino, M, Toniutto, P, Fagiuoli, S, and Pompili, M

Subjects
Adult, Male, medicine.medical_specialty, Genotype, medicine.medical_treatment, Specialties of internal medicine, Hepacivirus, Liver transplantation, Antiviral Agents, Gastroenterology, Polyethylene Glycols, Cohort Studies, Virological response, chemistry.chemical_compound, Hepatitis B, Chronic, Recurrence, Interferon, Internal medicine, Ribavirin, medicine, Humans, Retrospective Studies, Hepatology, Group study, business.industry, Settore MED/09 - MEDICINA INTERNA, Interferon-alpha, Genotype 4, General Medicine, Hepatitis C, Middle Aged, medicine.disease, Recombinant Proteins, Transplantation, Treatment Outcome, Italy, chemistry, RC581-951, Immunology, HCV treatment, Drug Therapy, Combination, Female, business, EVR, medicine.drug, HCV recurrence
Abstract

Introduction. Hepatitis C virus genotype 4 is predominant in the Middle East and Northern Africa, even if it has recently spread to Southern Europe. Data about the treatment of post-liver transplantation (LT) genotype 4 hepatitis C recurrence are scarce. We report a retrospective analysis of post-LT genotype 4 hepatitis C treatment in 9 Italian transplant centres, focusing on the overall survival rates and treatment outcome. Results. Among 452 recipients, we identified 17 HCV genotype 4 patients (16 males, 1 female) transplanted between 1998 and 2007. All patients received combined antiviral treatment with conventional doses of interferon (recombinant or pegylated) and ribavirin after histological diagnosis of hepatitis C recurrence. The observed overall survival after LT was 100% at 1 year and 83.3% at 5 years. More than 1/3 (35.3%) of patients achieved a sustained virological response (SVR) and 40% (data available in 15 subjects) an early virological response (EVR), which was significantly associated with the achievement of SVR (overall accuracy: 85.7%; predictive values of EVR absence/presence 80/88.8%; chi-square p < 0.05). Conclusion. In conclusion, in post-LT genotype 4 hepatitis C treatment, SVR rates are similar to genotype 1. Patients who don't show an EVR are not likely to achieve a SVR.

Published
2012

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