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1. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, Andrealli, A, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F. A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F. M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A. B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G. B., Rendina M., Bringiotti R., Castellaneta N. M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., and Andrealli A.

Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay

Published
2021

2. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Renal Transplant Patients: Preliminary Results From NEVERWOUND Study.: Abstract# D2430

Author

Carmellini, M., Ruggieri, G., Sforza, D., Veroux, M., Secchi, A., Todeschini, P., De Rosa, P., Sghirlanzoni, M., Fior, F., Setti, G., Iappelli, M., Silvestre, C., Taruscia, D., Minetti, E., Spagnoletti, G., Gesualdo, L., Izzo, C., Pisani, F., Piredda, G., Berloco, P., Dal Canton, A., Cappelli, G., Guarisco, R., and Caputo, F.

Published
2014

3. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, Salerno, F, Caraceni P., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F. G., Levantesi F., Airoldi A., Boccia S., Svegliati-Baroni G., Fagiuoli S., Romanelli R. G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Tortora A., De Marco R., Angelico M., Cacciola I., Elia G., Federico A., Massironi S., Guarisco R., Galioto A., Ballardini G., Rendina M., Nardelli S., Piano S., Elia C., Prestianni L., Cappa F. M., Cesarini L., Simone L., Pasquale C., Cavallin M., Andrealli A., Fidone F., Ruggeri M., Roncadori A., Baldassarre M., Tufoni M., Zaccherini G., Bernardi M., Domenicali M., Giannone F. A., Merli M., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G. M., Maiorca D., Rizzotto A., Lanzi A., Neri E., Visani A., Mastroianni A., Alberti A. B., Mazzarelli C., Vangeli M., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Laffi G., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Gasbarrini A., Leo P., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Negri E., Dallio M., Loguercio C., Conte D., Celli N., Bringiotti R., Castellaneta N. M., and Salerno F.

Abstract

Background: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794. Findings: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events. Interpretation: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding: Italian Medicine Agency.

Published
2018

4. Impact of new DAA therapy on real clinical practice: a multicenter region-wide cohort study

Author

Lanini, Simone, Scognamiglio, Paola, Mecozzi, Alessandra, Lombardozzi, Lorella, Vullo, Vincenzo, Angelico, Mario, Gasbarrini, Antonio, Taliani, Gloria, Attili, Adolfo Francesco, Perno, Carlo Federico, De Santis, Adriano, Puro, Vincenzo, Cerqua, Fabio, D'Offizi, Gianpiero, Pellicelli, Adriano, Armignacco, Orlando, Mennini, Francesco Saverio, Siciliano, Massimo, Girardi, Enrico, Panella, Vincenzo, Ippolito, Giuseppe, Sarrecchia, C., Di Paolo, M. D., Francioso, S., Brega, A., Lenci, I., Sarmati, L., Pompili, Maurizio, Grieco, Antonio, Tamburrini, Enrica, Apaccini, R., Miele, Luca, D'Ettorre, G., Mezzaroma, I., Furlan, C., Accapezzato, D., Paoletti, F., Merili, M., Corradini, S., Sereno, S., Fimiani, C., Mastropietro, C., Labbadia, G., Gentile, Giuseppe, Pasquazzi, C., Marignani, M., Guarisco, R., Puoti, C., Spilabotti, L., Montalbano, M., Boumis, E., Visco-Comandini, U., Zaccarelli, M., Ammassari, A., Lionetti, R., Murachelli, S., Loiacono, L., Antinori, Armando, Noto, P., Palmieri, F., Cicalini, S., Cerilli, S., Sampaolesi, A., Vincenzi, L., Bellagamba, R., Galati, V., Abdeddaim, A., Iacomi, F., Iannicelli, G., Mastroianni, Chiara, Lichtner, M., Ridola, L., Coluzzi, T., Mercurio, V., Del Borgo, C., Fondacaro, L., Cerasari, G., Guarascio, P., D'Ambrosio, C., Starnini, G., Caterini, A., Villani, Emanuele Rocco, Sarracino, L., Casinelli, K., Moretti, A., Vespasiani, U., Galati, G., Cecere, R., Bonaventura, M., and Scudieri, M.

Subjects
Male, Cirrhosis, Investigational, chronic hepatitis c, clinical study, direct acting antiviral, hepatitis c virus, liver cirrhosis, liver damage, mixed effect model, multicenter cohort study, new therapy, treatment efficacy, Logistic regression, Chronic hepatitis C, Cohort Studies, 0302 clinical medicine, Clinical study, Direct acting antiviral, Hepatitis C virus, Liver cirrhosis, Liver damage, Mixed effect model, Multicenter cohort study, New therapy, Treatment efficacy, Adult, Aged, Aged, 80 and over, Antiviral Agents, Drug Therapy, Combination, Drugs, Investigational, Female, Follow-Up Studies, Hepatitis C, Chronic, Humans, Liver Cirrhosis, Middle Aged, Therapies, Investigational, 80 and over, 030212 general & internal medicine, Stage (cooking), Chronic, Confounding, Drugs, Hepatitis C, Infectious Diseases, Cohort, Combination, Settore SECS-P/03 - Scienza delle Finanze, 030211 gastroenterology & hepatology, Cohort study, Research Article, medicine.medical_specialty, Side effect, Hepatitis C virus, Chronic hepatitis C, Liver cirrhosis, Direct acting antiviral, Multicenter cohort study, Mixed effect model, Liver damage, Treatment efficacy, Clinical study, New therapy, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, lcsh:RC109-216, business.industry, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Clinical trial, Therapies, business
Abstract

Background Management of chronic hepatitis C (CHC) has significantly accelerated in the last few years. Currently, second generation direct acting antivirals (DAAs) promise clearance of infection in most of patients. Here we present the results of the first analysis carried out on data of Lazio clinical network for DAAs. Methods The study was designed as a multicenter cohort: a) to assess the evolution of treatment during the first 24 months of the activity of the Clinical Network; b) to report overall efficacy of treatments; c) to analyze potential factors associated with lack of virological response at 12 weeks after therapy (SVR12); d) to evaluate the variation of ALT at baseline and 12 weeks after therapy in those who achieved SVR12 in comparison to those who did not. Analyses of efficacy were carried out with multilevel mixed effect logistic regression model. ALT temporal variation was assessed by mixed effect model mixed models with random intercept at patient’s level and random slope at the level of the time; i.e. either before or after therapy. Results Between 30 December 2014 and 31 December 2016 5279 patients started a DAA treatment; of those, 5127 (in 14 clinical centers) had completed the 12-week follow-up. Overall proportion of SVR12 was 93.41% (N = 4780) with no heterogeneity between the 14 clinical centers. Interruption as the consequence of severe side effect was very low (only 23 patients). Unadjusted analysis indicates that proportion of SVR12 significantly changes according to patient’s baseline characteristics, however after adjusting for potential confounders only adherence to current guidelines, stage of liver diseases, gender, transplant and HIV status were independently associated with the response to therapy. Analysis of ALT temporal variation showed that ALT level normalized in most, but not, all patients who achieved SVR12. Conclusion Our study confirmed the extraordinary efficacy of DAAs outside clinical trials. The advantage of DAAs was particularly significant for those patients who were previously considered as difficult-to-treat and did not have treatment options before DAAs era. Intervention based on network of select centers and prioritization of patients according to diseases severity was successful. Further studies are needed to establish whether clearance of HCV after DAAs therapy can arrest or even revert liver fibrosis in non-cirrhotic patients and/or improve life quality and expectancy in those who achieve SVR12 with cirrhosis.

Published
2018
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5. Immediate Introduction of Everolimus Does Not Affect Wound Healing and Delayed Graft Function in Renal Transplant Patients: Preliminary Results From NEVERWOUND Study

Author

Carmellini, M., Ruggieri, G., Sforza, D., Veroux, M., Secchi, A., Todeschini, P., Rosa, P., Sghirlanzoni, M., Fior, F., Setti, G., Iappelli, M., Silvestre, C., Taruscia, D., Minetti, E., Spagnoletti, G., Gesualdo, L., Izzo, C., Pisani, F., Piredda, G., Berloco, P., Dal Canton, A., Gianni Cappelli, Guarisco, R., and Caputo, F.

6. On-treatment serum albumin level can guide long-term treatment in patients with cirrhosis and uncomplicated ascites

Author

Alessandro Federico, M. Colpani, Paolo Caraceni, Marco Domenicali, Manuel Tufoni, L. Simone, A Alberti, Giovanni Raimondo, A. Risso, Antonietta Sticca, Salvatore Piano, Anna Visani, Francesco Salerno, Giacomo Laffi, Piera Rossi, Paolo Angeli, F. Fidone, Pierluigi Toniutto, Vincenza Calvaruso, Silvia Nardelli, Aldo Airoldi, Sara Massironi, Stefania Gioia, A. Roncadori, Marco Marzioni, Nicola Caporaso, N.M. Castellaneta, Stefano Fagiuoli, Francesco Giuseppe Foschi, Raffaele Cozzolongo, Maria Rendina, Irene Cacciola, Oliviero Riggio, Sergio Neri, Raffaella Viganò, Ferdinando Giannone, Chiara Mazzarelli, Maria Marsico, Giovanni Parrella, Riccardo Guarisco, Chiara Elia, F. Levantesi, M. Cavallin, Alida Andrealli, A. Pecchioli, Loredana Prestianni, Rosanna De Marco, T Gabbani, Elga Neri, S. Boccia, Arianna Lanzi, Giacomo Zaccherini, Marcello Dallio, Giovanni Perricone, Giorgio Ballardini Natascia Celli, Francesco Auriemma, Federica Mirici Cappa, Agnese Antognoli, Annalisa Tortora, Gianfranco Elia, R. Bringiotti, Francesco De Leonardis, Marcello Vangeli, Agostino Rizzotto, Dario Conte, Manuela Merli, Francesca Capretti, Mauro Bernardi, Chiara Pasquale, Pietro Leo, D. Maiorca, M. Zappimbulso, Filomena Morisco, Vincenzo Sangiovanni, Maurizio Baldassarre, Lucia Cesarini, Gianluca Svegliati-Baroni, Maria Guarino, Carmelina Loguercio, Alessandra Galioto, Antonio Mastroianni, Giorgio Maria Saracco, Antonio Gasbarrini, G. Magini, Alba Kostandini, Carlo Alessandria, Josè Petruzzi, Vito Di Marco, Silvano Fasolato, Elisa Negri, Fabio Pugliese, Mario Angelico, Daniela Campion, Caraceni P., Tufoni M., Zaccherini G., Riggio O., Angeli P., Alessandria C., Neri S., Foschi F.G., Levantesi F., Airoldi A., Simone L., Svegliati-Baroni G., Fagiuoli S., Laffi G., Cozzolongo R., Di Marco V., Sangiovanni V., Morisco F., Toniutto P., Gasbarrini A., De Marco R., Piano S., Nardelli S., Elia C., Roncadori A., Baldassarre M., Bernardi M., Domenicali M., Giannone F.A., Antognoli A., Merli M., Pasquale C., Gioia S., Fasolato S., Sticca A., Campion D., Risso A., Saracco G.M., Prestianni L., Fidone F., Maiorca D., Rizzotto A., Cappa F.M., Lanzi A., Neri E., Visani A., Mastroianni A., Perricone G., Alberti A.B., Cesarini L., Mazzarelli C., Vangeli M., Vigano R., Marzioni M., Capretti F., Kostandini A., Magini G., Colpani M., Gabbani T., Marsico M., Zappimbulso M., Petruzzi J., Calvaruso V., Parrella G., Caporaso N., Auriemma F., Guarino M., Pugliese F., Tortora A., Leo P., Angelico M., De Leonardis F., Pecchioli A., Rossi P., Raimondo G., Cacciola I., Elia G., Negri E., Dallio M., Loguercio C., Federico A., Conte D., Massironi S., Natascia Celli G.B., Rendina M., Bringiotti R., Castellaneta N.M., Salerno F., Boccia S., Guarisco R., Galioto A., Cavallin M., Andrealli A., Caraceni, P., Tufoni, M., Zaccherini, G., Riggio, O., Angeli, P., Alessandria, C., Neri, S., Foschi, F. G., Levantesi, F., Airoldi, A., Simone, L., Svegliati-Baroni, G., Fagiuoli, S., Laffi, G., Cozzolongo, R., Di Marco, V., Sangiovanni, V., Morisco, F., Toniutto, P., Gasbarrini, A., De Marco, R., Piano, S., Nardelli, S., Elia, C., Roncadori, A., Baldassarre, M., Bernardi, M., Domenicali, M., Giannone, F. A., Antognoli, A., Merli, M., Pasquale, C., Gioia, S., Fasolato, S., Sticca, A., Campion, D., Risso, A., Saracco, G. M., Prestianni, L., Fidone, F., Maiorca, D., Rizzotto, A., Cappa, F. M., Lanzi, A., Neri, E., Visani, A., Mastroianni, A., Perricone, G., Alberti, A. B., Cesarini, L., Mazzarelli, C., Vangeli, M., Vigano, R., Marzioni, M., Capretti, F., Kostandini, A., Magini, G., Colpani, M., Gabbani, T., Marsico, M., Zappimbulso, M., Petruzzi, J., Calvaruso, V., Parrella, G., Caporaso, N., Auriemma, F., Guarino, M., Pugliese, F., Tortora, A., Leo, P., Angelico, M., De Leonardis, F., Pecchioli, A., Rossi, P., Raimondo, G., Cacciola, I., Elia, G., Negri, E., Dallio, M., Loguercio, C., Federico, A., Conte, D., Massironi, S., Natascia Celli, G. B., Rendina, M., Bringiotti, R., Castellaneta, N. M., Salerno, F., Boccia, S., Guarisco, R., Galioto, A., Cavallin, M., Andrealli, A., Caraceni, P, Tufoni, M, Zaccherini, G, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Simone, L, Svegliati-Baroni, G, Fagiuoli, S, Laffi, G, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Gasbarrini, A, De Marco, R, Piano, S, Nardelli, S, Elia, C, Roncadori, A, Baldassarre, M, Bernardi, M, Domenicali, M, Giannone, F, Antognoli, A, Merli, M, Pasquale, C, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Prestianni, L, Fidone, F, Maiorca, D, Rizzotto, A, Cappa, F, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Perricone, G, Alberti, A, Cesarini, L, Mazzarelli, C, Vangeli, M, Vigano, R, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Tortora, A, Leo, P, Angelico, M, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Cacciola, I, Elia, G, Negri, E, Dallio, M, Loguercio, C, Federico, A, Conte, D, Massironi, S, Natascia Celli, G, Rendina, M, Bringiotti, R, Castellaneta, N, Salerno, F, Boccia, S, Guarisco, R, Galioto, A, Cavallin, M, and Andrealli, A

Subjects
Male, 0301 basic medicine, Cirrhosis, ascites, complications, liver cirrhosis, serum albumin, survival, Serum albumin, Survival, Logistic regression, Gastroenterology, Biomarkers, Pharmacological, Ascites, Complications, 0302 clinical medicine, Medicine, biology, Middle Aged, Intention to Treat Analysis, Treatment Outcome, Ascite, Female, 030211 gastroenterology & hepatology, Drug Monitoring, medicine.symptom, medicine.medical_specialty, Settore MED/12 - GASTROENTEROLOGIA, Serum Albumin, Human, 03 medical and health sciences, Serum albumin level, Predictive Value of Tests, Internal medicine, Post-hoc analysis, Humans, In patient, Biological Products, Cirrhosi, Hepatology, business.industry, Albumin, medicine.disease, Long-Term Care, Survival Analysis, 030104 developmental biology, biology.protein, business, Complication
Abstract

Background & Aims: The ANSWER study reported that long-term albumin administration in patients with cirrhosis and uncomplicated ascites improves survival. During treatment, serum albumin increased within a month and remained stable thereafter. In this post hoc analysis, we aimed to determine whether on-treatment serum albumin levels could guide therapy. Methods: Logistic regression was used to assess the association between baseline serum albumin and mortality, as well as to determine on-treatment factors associated with mortality and to predict the achievement of a given on-treatment serum albumin level. Survival was assessed by Kaplan-Meier estimates and second-order polynomial regression. Patients whose on-treatment serum albumin remained below normal were compared with a subset of patients from the control arm matched by principal score. Results: Baseline serum albumin was closely associated with 18-month mortality in untreated patients; albumin treatment almost effaced this relationship. On-treatment serum albumin and MELD-Na at month 1 were the sole independent variables associated with mortality. Second-order polynomial regression revealed that survival improved in parallel with increased 1-month on-treatment serum albumin. Kaplan-Meier estimations showed that any value of 1-month on-treatment serum albumin (0.1 g/dl intervals) in the range 2.5–4.5 g/dl discriminated patient survival. In the normal range of serum albumin, the best discriminant value was 4.0 g/dl. Compared to untreated patients, survival even improved in patients whose on-treatment serum albumin remained below normal. Conclusion: Baseline serum albumin per se should not guide the decision to start albumin therapy. Conversely, 1-month on-treatment serum albumin levels are strongly associated with outcomes and could guide the use of albumin – 4.0 g/dl being the target threshold. However, even patients whose serum albumin remains below normal benefit from long-term albumin administration. Lay summary: The ANSWER study has shown that long-term albumin administration improves survival and prevents the occurrence of major complications in patients with cirrhosis and ascites. This study shows that the achievement of these beneficial effects is related to a significant increase in serum albumin concentration. Even though the best results follow the achievement of a serum albumin concentration of 4 g/dl, a survival benefit is also achieved in patients who fail to normalise serum albumin.

Published
2020

7. Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial

Author

Caraceni, Paolo, Riggio, Oliviero, Angeli, Paolo, Alessandria, Carlo, Neri, Sergio, Foschi, Francesco G, Levantesi, Fabio, Airoldi, Aldo, Boccia, Sergio, Svegliati-Baroni, Gianluca, Fagiuoli, Stefano, Romanelli, Roberto G, Cozzolongo, Raffaele, Di Marco, Vito, Sangiovanni, Vincenzo, Morisco, Filomena, Toniutto, Pierluigi, Tortora, Annalisa, De Marco, Rosanna, Angelico, Mario, Cacciola, Irene, Elia, Gianfranco, Federico, Alessandro, Massironi, Sara, Guarisco, Riccardo, Galioto, Alessandra, Ballardini, Giorgio, Rendina, Maria, Nardelli, Silvia, Piano, Salvatore, Elia, Chiara, Prestianni, Loredana, Cappa, Federica Mirici, Cesarini, Lucia, Simone, Loredana, Pasquale, Chiara, Cavallin, Marta, Andrealli, Alida, Fidone, Federica, Ruggeri, Matteo, Roncadori, Andrea, Baldassarre, Maurizio, Tufoni, Manuel, Zaccherini, Giacomo, Bernardi, Mauro, Domenicali, Marco, Giannone, Ferdinando A, Merli, Manuela, Gioia, Stefania, Fasolato, Silvano, Sticca, Antonietta, Campion, Daniela, Risso, Alessandro, Saracco, Giorgio M, Maiorca, Daniela, Rizzotto, Agostino, Lanzi, Arianna, Neri, Elga, Visani, Anna, Mastroianni, Antonio, Alberti, Alberto B, Mazzarelli, Chiara, Vangeli, Marcello, Marzioni, Marco, Capretti, Francesca, Kostandini, Alba, Magini, Giulia, Colpani, Maria, Laffi, Giacomo, Gabbani, Tommaso, Marsico, Maria, Zappimbulso, Marianna, Petruzzi, Josè, Calvaruso, Vincenza, Parrella, Giovanni, Caporaso, Nicola, Auriemma, Francesco, Guarino, Maria, Pugliese, Fabio, Gasbarrini, Antonio, Leo, Pietro, De Leonardis, Francesco, Pecchioli, Alessandra, Rossi, Piera, Raimondo, Giovanni, Negri, Elisa, Dallio, Marcello, Loguercio, Carmelina, Conte, Dario, Celli, Natascia, Bringiotti, Roberto, Castellaneta, Nicola M, Salerno, Francesco, ANSWER Study Investigators, Caraceni, Paolo, Riggio, Oliviero, Angeli, Paolo, Alessandria, Carlo, Neri, Sergio, Foschi, Francesco G, Levantesi, Fabio, Airoldi, Aldo, Boccia, Sergio, Svegliati-Baroni, Gianluca, Fagiuoli, Stefano, Romanelli, Roberto G, Cozzolongo, Raffaele, Di Marco, Vito, Sangiovanni, Vincenzo, Morisco, Filomena, Toniutto, Pierluigi, Tortora, Annalisa, De Marco, Rosanna, Angelico, Mario, Cacciola, Irene, Elia, Gianfranco, Federico, Alessandro, Massironi, Sara, Guarisco, Riccardo, Galioto, Alessandra, Ballardini, Giorgio, Rendina, Maria, Nardelli, Silvia, Piano, Salvatore, Elia, Chiara, Prestianni, Loredana, Cappa, Federica Mirici, Cesarini, Lucia, Simone, Loredana, Pasquale, Chiara, Cavallin, Marta, Andrealli, Alida, Fidone, Federica, Ruggeri, Matteo, Roncadori, Andrea, Baldassarre, Maurizio, Tufoni, Manuel, Zaccherini, Giacomo, Bernardi, Mauro, Domenicali, Marco, Giannone, Ferdinando A, Merli, Manuela, Gioia, Stefania, Fasolato, Silvano, Sticca, Antonietta, Campion, Daniela, Risso, Alessandro, Saracco, Giorgio M, Maiorca, Daniela, Rizzotto, Agostino, Lanzi, Arianna, Neri, Elga, Visani, Anna, Mastroianni, Antonio, Alberti, Alberto B, Mazzarelli, Chiara, Vangeli, Marcello, Marzioni, Marco, Capretti, Francesca, Kostandini, Alba, Magini, Giulia, Colpani, Maria, Laffi, Giacomo, Gabbani, Tommaso, Marsico, Maria, Zappimbulso, Marianna, Petruzzi, Josè, Calvaruso, Vincenza, Parrella, Giovanni, Caporaso, Nicola, Auriemma, Francesco, Guarino, Maria, Pugliese, Fabio, Gasbarrini, Antonio, Leo, Pietro, De Leonardis, Francesco, Pecchioli, Alessandra, Rossi, Piera, Raimondo, Giovanni, Negri, Elisa, Dallio, Marcello, Loguercio, Carmelina, Conte, Dario, Celli, Natascia, Bringiotti, Roberto, Castellaneta, Nicola M, Salerno, Francesco, Caraceni P1, Riggio O2, Angeli P3, Alessandria C4, Neri S5, Foschi FG6, Levantesi F7, Airoldi A8, Boccia S9, Svegliati-Baroni G10, Fagiuoli S11, Romanelli RG12, Cozzolongo R13, Di Marco Vito, Sangiovanni V15, Morisco F16, Toniutto P17, Tortora A18, De Marco R19, Angelico M20, Cacciola I21, Elia G22, Federico A23, Massironi S24, Guarisco R25, Galioto A26, Ballardini G27, Rendina M28, Nardelli S2, Piano S3, Elia C4, Prestianni L5, Cappa FM6, Cesarini L8, Simone L9, Pasquale C2, Cavallin M3, Andrealli A4, Fidone F5, Ruggeri M29, Roncadori A30, Baldassarre M1, Tufoni M1, Zaccherini G1, Bernardi M31, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso Vincenza, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni P, Riggio O, Angeli P, Alessandria C, Neri S, Foschi FG, Levantesi F, Airoldi A, Boccia S, Svegliati-Baroni G, Fagiuoli S, Romanelli RG, Cozzolongo R, Di Marco V, Sangiovanni V, Morisco F, Toniutto P, Tortora A, De Marco R, Angelico M, Cacciola I, Elia G, Federico A, Massironi S, Guarisco R, Galioto A, Ballardini G, Rendina M, Nardelli S, Piano S, Elia C, Prestianni L, Cappa FM, Cesarini L, Simone L, Pasquale C, Cavallin M, Andrealli A, Fidone F, Ruggeri M, Roncadori A, Baldassarre M, Tufoni M, Zaccherini G, Bernardi M, Domenicali M, Giannone FA, Merli M, Gioia S, Fasolato S, Sticca A, Campion D, Risso A, Saracco GM, Maiorca D, Rizzotto A, Lanzi A, Neri E, Visani A, Mastroianni A, Alberti AB, Mazzarelli C, Vangeli M, Marzioni M, Capretti F, Kostandini A, Magini G, Colpani M, Laffi G, Gabbani T, Marsico M, Zappimbulso M, Petruzzi J, Calvaruso V, Parrella G, Caporaso N, Auriemma F, Guarino M, Pugliese F, Gasbarrini A, Leo P, De Leonardis F, Pecchioli A, Rossi P, Raimondo G, Negri E, Dallio M, Loguercio C, Conte D, Celli N, Bringiotti R, Castellaneta NM, Salerno F., Caraceni, P, Riggio, O, Angeli, P, Alessandria, C, Neri, S, Foschi, F, Levantesi, F, Airoldi, A, Boccia, S, Svegliati-Baroni, G, Fagiuoli, S, Romanelli, R, Cozzolongo, R, Di Marco, V, Sangiovanni, V, Morisco, F, Toniutto, P, Tortora, A, De Marco, R, Angelico, M, Cacciola, I, Elia, G, Federico, A, Massironi, S, Guarisco, R, Galioto, A, Ballardini, G, Rendina, M, Nardelli, S, Piano, S, Elia, C, Prestianni, L, Cappa, F, Cesarini, L, Simone, L, Pasquale, C, Cavallin, M, Andrealli, A, Fidone, F, Ruggeri, M, Roncadori, A, Baldassarre, M, Tufoni, M, Zaccherini, G, Bernardi, M, Domenicali, M, Giannone, F, Merli, M, Gioia, S, Fasolato, S, Sticca, A, Campion, D, Risso, A, Saracco, G, Maiorca, D, Rizzotto, A, Lanzi, A, Neri, E, Visani, A, Mastroianni, A, Alberti, A, Mazzarelli, C, Vangeli, M, Marzioni, M, Capretti, F, Kostandini, A, Magini, G, Colpani, M, Laffi, G, Gabbani, T, Marsico, M, Zappimbulso, M, Petruzzi, J, Calvaruso, V, Parrella, G, Caporaso, N, Auriemma, F, Guarino, M, Pugliese, F, Gasbarrini, A, Leo, P, De Leonardis, F, Pecchioli, A, Rossi, P, Raimondo, G, Negri, E, Dallio, M, Loguercio, C, Conte, D, Celli, N, Bringiotti, R, Castellaneta, N, and Salerno, F

Subjects
Liver Cirrhosis, Male, Time Factors, Cirrhosis, Kaplan-Meier Estimate, law.invention, ascites, 0302 clinical medicine, Hepatorenal syndrome, Randomized controlled trial, Furosemide, law, Ascites, Clinical endpoint, Paracentesis, Diuretics, albumin, decompensated cirrhosi, Mineralocorticoid Receptor Antagonists, Settore MED/12 - Gastroenterologia, Medicine (all), Hazard ratio, General Medicine, Middle Aged, Survival Rate, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Quality-Adjusted Life Years, medicine.symptom, Hyponatremia, medicine.medical_specialty, 03 medical and health sciences, Albumins, Internal medicine, medicine, Humans, Survival rate, albumin, Aged, business.industry, cirrhosis, medicine.disease, Clinical trial, albumin, cirrhosis, ascites, liver decompensation, Quality of Life, Hyperkalemia, business, Esophagus Varices, Portal Hypertension, Varicosis
Abstract

Background Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. Methods We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008–000625–19, and ClinicalTrials.gov, number NCT01288794. Findings From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40–0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3–4 non-liver related adverse events. Interpretation In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. Funding Italian Medicine Agency. Copyright © 2018 Elsevier Ltd. All rights reserved.

Published
2018

8. Hepatic venous pressure gradient does not correlate with the presence and the severity of portal hypertensive gastropathy in patients with liver cirrhosis.

Author

Bellis L, Nicodemo S, Galossi A, Guarisco R, Spilabotti L, Durola L, Dell'Unto O, and Puoti C

Subjects
Aged, Data Interpretation, Statistical, Esophageal and Gastric Varices epidemiology, Esophageal and Gastric Varices etiology, Female, Humans, Hypertension, Portal complications, Liver Cirrhosis complications, Male, Middle Aged, Portal Pressure physiology, Prevalence, Venous Pressure physiology, Esophageal and Gastric Varices physiopathology, Hepatic Veins physiology, Hypertension, Portal physiopathology, Liver Cirrhosis physiopathology, Stomach Diseases etiology
Abstract

Background and Aims: To evaluate whether the hepatic venous pressure gradient (HVPG) differs between cirrhotic patients with severe portal hypertensive gastropathy (PHG) and those with mild or absent PHG., Methods: 59 cirrhotic patients with portal hypertension underwent hepatic vein catheterisation. 44 patients (76%) had PHG (16 mild and 28 severe)., Setting: tertiary care setting (Liver Unit, Internal Medicine)., Results: HVPG values did not differ between the patients without PHG (21.6 +/- 10.1 mmHg) and those with PHG (18.6 +/- 9.1 mmHg), nor between those with mild (19.3 +/- 4.3 mmHg) or severe PHG (17.7 +/- 4.6 mmHg; p = 0.26). The overall prevalence of PHG and the proportion of patients with severe PHG did not differ regarding the Child Pugh classification. The etiology of the cirrhosis did not influence the HVPG. No correlations were found between HVPG values and Child Pugh score, age, platelet count, prothrombin time, bilirubin levels and ALT values. The HVPG did not differ between patients with small, medium or large esophageal varices, nor between subjects with or without gastric varices., Conclusions: Our data show that PHG does not correlate with the degree of portal pressure, and that the prevalence and the severity of this condition are not influenced by the severity of underlying liver disease or by the size of varices.

Published
2007

9. Extrahepatic manifestations of chronic HCV infection.

Author

Galossi A, Guarisco R, Bellis L, and Puoti C

Subjects
Humans, Hepatitis C, Chronic complications
Abstract

Several extrahepatic manifestations have been reported in the natural history of hepatitis C virus infection (HCV). Up to 40-74% of patients infected with HCV might develop at least one extrahepatic manifestation during the course of their disease. Mixed Cryoglobulinemia (MC) is the most known and studied syndrome associated with HCV infection. It is a systemic vasculitis that may involve the skin, kidney and nervous system. A frequent reported association is that between HCV infection and non-Hodgkin lymphoma. The cryoglobulinemia may be the intermediary disorder, in fact some persistent forms of cyoglobulinemia can switch over to a more aggressive haematologic disorder. As compared to cutaneous vasculitis described in MC, HCV infection has been associated with dermatological disorders such as porphyria cutanea tarda and lichen planus. Thyroid disease (usually hypothyroidism) is commonly seen in people with HCV. Up to 25% have thyroid antibodies. Several studies described a correlation between HCV and lympho-cytic sialoadenitis, similar to sialoadenitis associated with idiopathic Sjögren syndrome, but we can define as "pseudo- Sjögren syndrome" the one associated with HCV infection, because it shows several differences in the idiopathic form. In the course of chronic HCV infection, a common obser-vation are rheumatological symptoms such as polyarthritis. The clinical pattern of joint involvement in the course of HCV infection varies from a rheumatoid arthritis-like form (very rare), to a non erosive oligoarthritis involving the large-sized and middle joints.

Published
2007

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