Author: "Zignego AL." / Publication Year Range: Last 10 years - Searchworks@Jio Institute Digital Library Search Results

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135 results on '"Zignego AL."'

1. COVID-19 VACCINATION RATE AND SAFETY PROFILE IN PATIENTS AFFECTED BY MIXED CRYOGLOBULINEMIC VASCULITIS

Author: Vacchi, C, Testoni, S, Visentini, M, Zani, R, Lauletta, G, Gragnani, L, Filippini, Da, Mazzaro, C, Fraticelli, P, Quartuccio, L, Padoan, R, Castelnovo, L, Zignego, Al, Ferri, C, Hoxha, A, Salvarani, C, Monti, G, Galli, M, and Sebastiani, M
Published: 2022

2. Effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients: Results of the Italian cohort of a post-marketing observational study

Author: Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, Mr, Chessa, L, Ciancio, A, Craxì, A, Gaeta, Gb, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, As, Zignego, Al, MARS Study Group, Aghemo A., Alberti A., Andreone P., Angelico M., Brunetto M.R., Chessa L., Ciancio A., Craxi A., Gaeta G.B., Galli M., Gasbarrini A., Giorgini A., Grilli E., Lampertico P., Lichtner M., Milella M., Morisco F., Persico M., Pirisi M., Puoti M., Raimondo G., Romano A., Russello M., Sangiovanni V., Schiavini M., Serviddio G., Villa E., Vinci M., De Michina A., Gallinaro V., Gualberti G., Roscini A.S., Zignego A.L., Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, M, Chessa, L, Ciancio, A, Craxi, A, Gaeta, G, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, A, Zignego, A, Aghemo, A., Alberti, A., Andreone, P., Angelico, M., Brunetto, M. R., Chessa, L., Ciancio, A., Craxi, A., Gaeta, G. B., Galli, M., Gasbarrini, A., Giorgini, A., Grilli, E., Lampertico, P., Lichtner, M., Milella, M., Morisco, F., Persico, M., Pirisi, M., Puoti, M., Raimondo, G., Romano, A., Russello, M., Sangiovanni, V., Schiavini, M., Serviddio, G., Villa, E., Vinci, M., De Michina, A., Gallinaro, V., Gualberti, G., Roscini, A. S., and Zignego, A. L.
Subjects: Male, Adult, medicine.medical_specialty, Pyrrolidines, Quinoxaline, Sustained Virologic Response, Settore MED/12 - GASTROENTEROLOGIA, Population, Antiviral Agents, elderly, Benzimidazole, GLE/PIB, Quinoxalines, Internal medicine, Drug Combination, Clinical endpoint, medicine, Product Surveillance, Postmarketing, Humans, Prospective Studies, education, Adverse effect, Aged, Antiviral Agent, Sulfonamides, education.field_of_study, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, PWUD, Glecaprevir, Middle Aged, HCV, Hepatitis C, Chronic, Pibrentasvir, Discontinuation, Drug Combinations, Italy, Cohort, Quality of Life, Benzimidazoles, Female, Observational study, business
Abstract: Background and Aims The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naive and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.
Published: 2021

3. Pilot screening of HBV and HCV prevalence in at risk po-pulations due to geographical origin and conditions of socio-economic distress

Author: Lorini, S., primary, Gragnani, L., additional, Marri, S., additional, Madia, F., additional, Monti, M., additional, Stasi, C., additional, Petraccia, L., additional, Bamoshmoosh, M., additional, and Zignego, AL., additional
Published: 2021
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4. Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Author: Kondili, La, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, Al, Brunetto, Mr, Raimondo, G, Taliani, G, Iannone, A, Russo, Fp, Santantonio, Ta, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, Em, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, Mg, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, Mg, Montilla, S, Razavi, H, Melazzini, M, Vella, S, Craxì, A, PITER Collaborating, Group., Kondili LA, Robbins S, Blach S, Gamkrelidze I, Zignego AL, Brunetto MR, Raimondo G, Taliani G, Iannone A, Russo FP, Santantonio TA, Zuin M, Chessa L, Blanc P, Puoti M, Vinci M, Erne EM, Strazzabosco M, Massari M, Lampertico P, Rumi MG, Federico A, Orlandini A, Ciancio A, Borgia G, Andreone P, Caporaso N, Persico M, Ieluzzi D, Madonia S, Gori A, Gasbarrini A, Coppola C, Brancaccio G, Andriulli A, Quaranta MG, Montilla S, Razavi H, Melazzini M, Vella S, Craxì Antonio, Kondili, Loreta A., Robbins, Sarah, Blach, Sarah, Gamkrelidze, Ivane, Zignego, Anna L., Brunetto, Maurizia R., Raimondo, Giovanni, Taliani, Gloria, Iannone, Andrea, Russo, Francesco P., Santantonio, Teresa A., Zuin, Massimo, Chessa, Luchino, Blanc, Pierluigi, Puoti, Massimo, Vinci, Maria, Erne, Elke M., Strazzabosco, Mario, Massari, Marco, Lampertico, Pietro, Rumi, Maria G., Federico, Alessandro, Orlandini, Alessandra, Ciancio, Alessia, Borgia, Guglielmo, Andreone, Pietro, Caporaso, Nicola, Persico, Marcello, Ieluzzi, Donatella, Madonia, Salvatore, Gori, Andrea, Gasbarrini, Antonio, Coppola, Carmine, Brancaccio, Giuseppina, Andriulli, Angelo, Quaranta, Maria G., Montilla, Simona, Razavi, Homie, Melazzini, Mario, Vella, Stefano, Craxì, Antonio, Kondili, L. A., Robbins, S., Blach, S., Gamkrelidze, I., Zignego, A. L., Brunetto, M. R., Raimondo, G., Taliani, G., Iannone, A., Russo, F. P., Santantonio, T. A., Zuin, M., Chessa, L., Blanc, P., Puoti, M., Vinci, M., Erne, E. M., Strazzabosco, M., Massari, M., Lampertico, P., Rumi, M. G., Federico, A., Orlandini, A., Ciancio, A., Borgia, G., Andreone, P., Caporaso, N., Persico, M., Ieluzzi, D., Madonia, S., Gori, A., Gasbarrini, A., Coppola, C., Brancaccio, G., Andriulli, A., Quaranta, M. G., Montilla, S., Razavi, H., Melazzini, M., Vella, S., Craxi, A., Kondili, L, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, A, Brunetto, M, Raimondo, G, Taliani, G, Iannone, A, Russo, F, Santantonio, T, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, E, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, M, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, M, Montilla, S, Razavi, H, Melazzini, M, Vella, S, and Craxi, A
Subjects: HCV, WHO, chronic infection, linkage to care, Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Sustained Virologic Response, Viral Hepatitis, Settore MED/12 - GASTROENTEROLOGIA, World Health Organization, Antiviral Agents, NO, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Pharmacotherapy, Cost of Illness, Cause of Death, Health care, medicine, Humans, 030212 general & internal medicine, Viremia, chronic infection, HCV, linkage to care, WHO, Disease Eradication, Mortality, Intensive care medicine, Cause of death, Hepatology, business.industry, Public health, Carcinoma, Liver Neoplasms, Hepatocellular, Hepatitis C, medicine.disease, Markov Chains, Italy, 030211 gastroenterology & hepatology, business, Viral hepatitis
Abstract: Background & Aims Advances in direct‐acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked‐to‐care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030. Methods Using a modelling approach grounded in Italian real‐life data of diagnosed and treated patients, different linkage‐to‐care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals. Results Under the 40% linked‐to‐care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948‐1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0‐F3 cases. Under the 60% linked‐to‐care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958‐1978 birth cohorts could capture 55% of F0‐F3 individuals. Under the 80% linked‐to‐care scenario, screening limited in 1968‐1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals. Conclusion In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.
Published: 2018

5. AISF position paper on HCV in immunocompromised patients

Author: Angelucci, E, Astegiano, M, Baratelli, C, Biancone, L, Bironzo, P, Brancaccio, G, Brunetto, M, Bruno, R, Burra, P, Cabras, M, l Caraceni, P, Chialà, C, Clemente, M, Colli, A, Daniele, B, De Gasperi, E, Di Marco, V, Ditto, M, Fagiuoli, S, Ferri, C, Gaeta, G, Grossi, P, Imperatrice, B, Lampertico, P, Macaluso, F, Madonia, S, Marignani, M, Mazzarelli, C, Mella, A, Missale, G, Parisi, S, Pasulo, L, Puoti, M, Rendina, M, Ribaldone, D, Rossi, G, Toniutto, P, Tucci, A, Vajro, P, Viganò, M, Volpes, R, Zignego, A, Giannini, E, Miele, L, Russo, F, Petta, S, Bonora, S, Brignardello, E, Busca, A, Cariti, G, Cavallo, F, Conforti, M, Coscia, M, Craxì, A, Curci, D, Cusinato, S, Di Maio, M, Valle, R, Fusaro, E, Giacardi, A, Giaccone, L, Lagget, M, Libertucci, D, Minutolo, R, Montrucchio, G, Orlando, A, Orsucci, L, Pasquina, C, Pera, A, Peroni, C, Pirisi, M, Racca, P, Riccardini, F, Rizzetto, M, Salizzoni, M, Salomone, M, Saracco, G, Scaglione, L, Torre, G, Tozzi, R, Vitolo, U, Verme, G, Brunetto, MR, Cabras, MG, Clemente, MG, Ditto, MC, Gaeta, GB, Grossi, PA, Macaluso, FS, Zignego, AL, Giannini, EG, Russo, FP, Valle, RD, Peroni, CL, Saracco, GM, Angelucci, E, Astegiano, M, Baratelli, C, Biancone, L, Bironzo, P, Brancaccio, G, Brunetto, M, Bruno, R, Burra, P, Cabras, M, l Caraceni, P, Chialà, C, Clemente, M, Colli, A, Daniele, B, De Gasperi, E, Di Marco, V, Ditto, M, Fagiuoli, S, Ferri, C, Gaeta, G, Grossi, P, Imperatrice, B, Lampertico, P, Macaluso, F, Madonia, S, Marignani, M, Mazzarelli, C, Mella, A, Missale, G, Parisi, S, Pasulo, L, Puoti, M, Rendina, M, Ribaldone, D, Rossi, G, Toniutto, P, Tucci, A, Vajro, P, Viganò, M, Volpes, R, Zignego, A, Giannini, E, Miele, L, Russo, F, Petta, S, Bonora, S, Brignardello, E, Busca, A, Cariti, G, Cavallo, F, Conforti, M, Coscia, M, Craxì, A, Curci, D, Cusinato, S, Di Maio, M, Valle, R, Fusaro, E, Giacardi, A, Giaccone, L, Lagget, M, Libertucci, D, Minutolo, R, Montrucchio, G, Orlando, A, Orsucci, L, Pasquina, C, Pera, A, Peroni, C, Pirisi, M, Racca, P, Riccardini, F, Rizzetto, M, Salizzoni, M, Salomone, M, Saracco, G, Scaglione, L, Torre, G, Tozzi, R, Vitolo, U, Verme, G, Brunetto, MR, Cabras, MG, Clemente, MG, Ditto, MC, Gaeta, GB, Grossi, PA, Macaluso, FS, Zignego, AL, Giannini, EG, Russo, FP, Valle, RD, Peroni, CL, and Saracco, GM
Abstract: This report summarizes the clinical features and the indications for treating HCV infection in immunocompromised and transplanted patients in the Direct Acting Antiviral drugs era.
Published: 2019

6. AISF position paper on liver transplantation and pregnancy: Women in Hepatology Group, Italian Association for the Study of the Liver (AISF)

Author: Burra, P, Rodríguez-Castro, K, Guarino, M, Morisco, F, Villa, E, Mazzella, G, Women in Hepatology Group, Italian Association for the Study of the Liver (AISF) (Alisi, A, Balsano, C, Bernabucci, V, Berzigotti, A, Brunetto, M, Bugianesi, E, Calvaruso, V, Cariani, E, Coco, B, Colle, I, Critelli, R, De Martin, E, Del Buono, M, Fabregat, I, Faillaci, F, Fattovich, G, Floreani, A, Garcia-Tsao, G, Housset, C, Karampatou, A, Lei, B, Mangia, A, Martinez-Chantar, Ml, Milosa, F, Nasta, P, Ozben, T, Pollicino, T, Ponti, Ml, Pontisso, P, Reeves, H, Rendina, M, Rodríguez-Castro, Ki, Sagnelli, C, Sebastiani, Giulia, Smedile, A, Taliani, G, Vandelli, C, Vanni, E, Vukotic, R, Zignego, Al), Alisi A, Balsano C, Bernabucci V, Berzigotti A, Brunetto M, Bugianesi E, Burra P, Calvaruso V, Cariani E, Coco B, Colle I, Critelli R, De Martin E, Del Buono M, Fabregat I, Faillaci F, Fattovich G, Floreani A, Garcia-Tsao G, Housset C, Karampatou A, Lei B, Mangia A, Martinez-Chantar ML, Milosa F, Morisco F, Nasta P, Ozben T, Pollicino T, Ponti ML, Pontisso P, Reeves H, Rendina M, Rodríguez-Castro KI, Sagnelli C, Sebastiani G, Smedile A, Taliani G, Vandelli C, Vanni E, Villa E, Vukotic R, Zignego AL, Burra P, Rodríguez-Castro K, Guarino M, Morisco F, Villa E, Mazzella G., Alisi, A, Balsano, C, Bernabucci, V, Berzigotti, A, Brunetto, M, Bugianesi, E, Burra, P, Calvaruso, V, Cariani, E, Coco, B, Colle, I, Critelli, R, De Martin, E, Del Buono, M, Fabregat, I, Faillaci, F, Fattovich, G, Floreani, A, Garcia-Tsao, G, Housset, C, Karampatou, A, Lei, B, Mangia, A, Martinez-Chantar, Ml, Milosa, F, Morisco, F, Nasta, P, Ozben, T, Pollicino, T, Ponti, Ml, Pontisso, P, Reeves, H, Rendina, M, Rodríguez-Castro, Ki, Sagnelli, C, Sebastiani, G, Smedile, A, Taliani, G, Vandelli, C, Vanni, E, Vukotic, R, Zignego, Al, Rodríguez-Castro, K, Guarino, M, Villa, E, Mazzella, G., Garcia Tsao, G, Martinez Chantar, Ml, Morisco, Filomena, Rodríguez Castro, Ki, Rodríguez Castro, K, Guarino, Maria, Alisi, Anna, Balsano, Clara, Bernabucci, Veronica, Berzigotti, Annalisa, Brunetto, Maurizia, Bugianesi, Elisabetta, Burra, Patrizia, Calvaruso, Vincenza, Cariani, Elisabetta, Coco, Barbara, Colle, Isabelle, Critelli, Rosina, De Martin, Eleonora, Del Buono, Mariagrazia, Fabregat, Isabel, Faillaci, Francesca, Fattovich, Giovanna, Floreani, Annarosa, Garcia-tsao, Guadalupe, Housset, Chantal, Karampatou, Aimilia, Lei, Barbara, Mangia, Alessandra, Martinez-chantar, Maria Luz, Milosa, Fabiola, Nasta, Paola, Ozben, Tomri, Pollicino, Teresa, Ponti, Maria Laura, Pontisso, Patrizia, Reeves, Helen, Rendina, Maria, Rodrãguez-castro, Kryssia Isabel, Sagnelli, Caterina, Sebastiani, Giada, Smedile, Antonella, Taliani, Gloria, Vandelli, Carmen, Vanni, Ester, Villa, Erica, Vukotic, Ranka, Zignego, Anna Linda, Rodrãguez-castro, Kryssia, and Mazzella, Giuseppe
Subjects: Risk Assessment, Fertility, Immunosuppression, Liver transplantation, Pregnancy, Immunosuppressive Agent, Medical, Hepatology, Gastroenterology, Humans, Obstetric Labor Complication, Societies, Medical, Postpartum Period, Pregnancy Outcome, Contraception, Female, Italy, Obstetric Labor Complications, Practice Guidelines as Topic, Pregnancy Complications, Immunosuppressive Agents, Liver Transplantation, Pregnancy Complication, surgical procedures, operative, Societies, Human
Abstract: After the first successful pregnancy in a liver transplant recipient in 1978, much evidence has accumulated on the course, outcomes and management strategies of pregnancy following liver transplantation. Generally, liver transplantation restores sexual function and fertility as early as a few months after transplant. Considering that one third of all liver transplant recipients are women, that approximately one-third of them are of reproductive age (18-49 years), and that 15% of female liver transplant recipients are paediatric patients who have a >70% probability of reaching reproductive age, the issue of pregnancy after liver transplantation is rather relevant, and obstetricians, paediatricians, and transplant hepatologists ever more frequently encounter such patients. Pregnancy outcomes for both the mother and infant in liver transplant recipients are generally good, but there is an increased incidence of preterm delivery, hypertension/preeclampsia, foetal growth restriction, and gestational diabetes, which, by definition, render pregnancy in liver transplant recipients a high-risk one. In contrast, the risk of congenital anomalies and the live birth rate are comparable to those of the general population. Currently there are still no robust guidelines on the management of pregnancies after liver transplantation. The aim of this position paper is to review the available evidence on pregnancy in liver transplant recipients and to provide national Italian recommendations for clinicians caring for these patients. (C) 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
Published: 2016

7. PITER collaborating group. Forecasting Hepatitis C liver disease burden on real life data. Does the hidden iceberg matter to reach the elimination goals?

Author: Kondili, La, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, Al, Brunetto, Mr, Raimondo, G, Taliani, G, Iannone, A, Russo, Fp, Santantonio, Ta, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, Em, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, Mg, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, Mg, Montilla, S, Razavi, H, Melazzini, M, Vella, S, and Craxì, A
Published: 2018

8. Non-Invasive B-Cell Clonality Markers May Help in the Rational Approach to HCV Svr Cryoglobulinemic Patients with Persisting Manifestations

Author: Lorini, S, Gragnani, L, Santarlasci, V, Monti, M, Basile, U, Petraccia, L, Madia, F, Marri, S, Martini, L, Carradori, E, Xheka, A, Caini, P, Pellicelli, Am, Cosmi, L, Annunziato, F, and Zignego, Al
Published: 2018

9. IgG cryoglobulinemia

Author: Gulli, F, Basile, U, Gragnani, L, Napodano, C, Pocino, K, Miele, L, Santini, Sa, Zignego, Al, Gasbarrini, A, and Rapaccini, Gl
Subjects: Male, Hepatitis C Virus, Settore MED/12 - GASTROENTEROLOGIA, IgG3, Cryoglobulin, IgG3, Hepatitis C Virus, Cryoglobulin, Peripheral Nervous System Diseases, Middle Aged, Hepatitis C, Cryoglobulinemia, Blood-Brain Barrier, Rheumatoid Factor, Immunoglobulin G, inglese, Humans, Female, Aged
Abstract: Mixed Cryoglobulinemia is the most well-known Hepatitis C Virus (HCV)-associated extrahepatic manifestation. MC is both an autoimmune and B-lymphoproliferative disorder. Cryoglobulins (CGs) are classified into three groups according to immunoglobulin (Ig) composition: type I is composed of one isotype or Ig class. Type II and type III mixed CGs are immune complexes composed of polyclonal IgGs acting as autoantigens and mono, polyclonal or oligoclonal IgM with rheumatoid factor activity. IgG1 and IgG3 are the predominant subclasses involved. This study shows the simultaneous presence of IgG-RF and IgG3, supporting the hypothesis of an involvement of this subclass in the initiation of early stages of CGs.We describe a case series of six HCV-positive patients, all of whom had peripheral neuropathy and transient ischemic attacks, presenting cryoprecipitates formed by IgG3 and IgG1. Cryoprecipitate IgG subclass research was carried out by immunofixation electrophoresis by using antisera against IgG1, IgG2, IgG3, and IgG4.Our six patients presented with an immunochemical pattern characterized by the mere presence of IgG1 and IgG3 subclasses with probable RF activity and one of these six patients exhibited monoclonal IgG3 in his cerebrospinal fluid.We can hypothesize that the IgG passage through the blood-brain barrier could have contributed to the cause of TIAs, through a mechanism involving the precipitation of circulating immune complexes formed by the two subclasses in the intrathecal vessels.
Published: 2018

10. International therapeutic guidelines for patients with HCV-related extrahepatic disorders. A multidisciplinary expert statement

Author: Zignego, Al, Ramos-Casals, M, Ferri, C, Saadoun, D, Arcaini, L, Roccatello, D, Antonelli, A, Desbois, Ac, Comarmond, C, Gragnani, L, Casato, M, Lamprecht, P, Mangia, A, Tzioufas, Ag, Younossi, Zm, Cacoub, P, and De Santis, A.
Subjects: medicine.medical_specialty, Health Planning Guidelines, SF-36, Non-etiological therapy, Hepatitis C virus, Immunology, Hepacivirus, medicine.disease_cause, Antiviral Agents, 03 medical and health sciences, 0302 clinical medicine, Multidisciplinary approach, medicine, Humans, Immunology and Allergy, Anti-HCV therapy, Intensive care medicine, Cryoglobulinemic vasculitis, Extrahepatic manifestations of HCV, Hepatitis C virus (HCV), business.industry, virus diseases, medicine.disease, Hepatitis C, digestive system diseases, Lymphoma, 030220 oncology & carcinogenesis, Etiology, 030211 gastroenterology & hepatology, business
Abstract: Hepatitis C virus (HCV) is both hepatotrophic and lymphotropic virus that causes liver as well extrahepatic manifestations including cryoglobulinemic vasculitis, the most frequent and studied condition, lymphoma, and neurologic, cardiovascular, endocrine-metabolic or renal diseases. HCV-extrahepatic manifestations (HCV-EHMs) may severely affect the overall prognosis, while viral eradication significantly reduces non-liver related deaths. Different clinical manifestations may coexist in the same patient. Due to the variety of HCV clinical manifestations, a multidisciplinary approach along with appropriate therapeutic strategies are required. In the era of interferon-free anti-HCV treatments, international recommendations for the therapeutic management of HCV-EHMs are needed. This implies the need to define the best criteria to use antivirals and/or other therapeutic approaches. The present recommendations, based on qualified expert experience and specific literature, will focus on etiological (antiviral) therapies and/or traditional pathogenetic treatments that still maintain their therapeutic utility.
Published: 2017

11. Modeling cost-effectiveness and health gains of a âuniversalâ versus âprioritizedâ hepatitis C virus treatment policy in a real-life cohort

Author: Kondili, La, Romano, F, Rolli, Fr, Ruggeri, M, Rosato, S, Brunetto, Mr, Zignego, Al, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, Ta, Blanc, P, Gaeta, Gb, Gasbarrini, A, Chessa, L, Erne, Em, Villa, E, Ieluzzi, D, Russo, Fp, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, Mg, Quaranta, Mg, Cicchetti, A, Craxì, A, Vella, S, PITER Collaborating Group, Kondili, Loreta A., Romano, Federica, Rolli, Francesca Romana, Ruggeri, Matteo, Rosato, Stefano, Brunetto, Maurizia Rossana, Zignego, Anna Linda, Ciancio, Alessia, Di Leo, Alfredo, Raimondo, Giovanni, Ferrari, Carlo, Taliani, Gloria, Borgia, Guglielmo, Santantonio, Teresa Antonia, Blanc, Pierluigi, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Chessa, Luchino, Erne, Elke Maria, Villa, Erica, Ieluzzi, Donatella, Russo, Francesco Paolo, Andreone, Pietro, Vinci, Maria, Coppola, Carmine, Chemello, Liliana, Madonia, Salvatore, Verucchi, Gabriella, Persico, Marcello, Zuin, Massimo, Puoti, Massimo, Alberti, Alfredo, Nardone, Gerardo, Massari, Marco, Montalto, Giuseppe, Foti, Giuseppe, Rumi, Maria Grazia, Quaranta, Maria Giovanna, Cicchetti, Americo, Craxì, Antonio, Vella, Stefano, Kondili, L, Romano, F, Rolli, F, Ruggeri, M, Rosato, S, Brunetto, M, Zignego, A, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, T, Blanc, P, Gaeta, G, Gasbarrini, A, Chessa, L, Erne, E, Villa, E, Ieluzzi, D, Russo, F, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, M, Quaranta, M, Cicchetti, A, Craxì, A, Vella, S, Kondili LA1, Romano F2, Rolli FR2, Ruggeri M2, Rosato S1, Brunetto MR3, Zignego AL4, Ciancio A5, Di Leo A6, Raimondo G7, Ferrari C8, Taliani G9, Borgia G10, Santantonio TA11, Blanc P12, Gaeta GB13, Gasbarrini A2, Chessa L14, Erne EM15, Villa E16, Ieluzzi D17, Russo FP15, Andreone P18, Vinci M19, Coppola C20, Chemello L15, Madonia S21, Verucchi G18, Persico M22, Zuin M23, Puoti M19, Alberti A15, Nardone G13, Massari M24, Montalto G25, Foti G26, Rumi MG23, Quaranta MG1, Cicchetti A2, Craxì Antonio, Vella S1, and PITER Collaborating Group.
Subjects: hepatitis C virus, Pediatrics, Cost effectiveness, Viral Hepatitis, Adult, Aged, Aged, 80 and over, Antiviral Agents, Cohort Studies, Cost-Benefit Analysis, Health Policy, Hepatitis C, Humans, Middle Aged, Young Adult, Models, Economic, Hepatology, Direct-acting antiviral, Liver disease, 0302 clinical medicine, Models, Health care, antiviral therapy, 80 and over, incremental cost-effectiveness ratio, health care economics and organizations, HCV cost -effectiveness, Direct-acting antiviral, hepatocellular carcinoma, hepatitis C virus, incremental cost-effectiveness ratio, interferon, quality-adjusted life-years, sustained virological response, willingness to pay, Cost–benefit analysis, 030503 health policy & services, quality-adjusted life-years, hepatocellular carcinoma, interferon, HCV, cost-effectiveness, real-life cohort, Cohort, 030211 gastroenterology & hepatology, Original Article, sustained virological response, 0305 other medical science, Cohort study, Human, medicine.medical_specialty, Economic, NO, 03 medical and health sciences, medicine, Cost-Benefit Analysi, Health policy, Antiviral Agent, business.industry, Original Articles, medicine.disease, Surgery, Cohort Studie, business, willingness to pay
Abstract: We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virusâinfected patients: policy 1, âuniversal,â treat all patients, regardless of fibrosis stage; policy 2, treat only âprioritizedâ patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virusâinfected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policiesâ cost-effectiveness. The patientsâ age and fibrosis stage, assumed DAA treatment cost of â¬15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of â¬30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was â¬8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was â¬19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 postâsustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (â¬15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. Conclusion: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814â1825).
Published: 2017

12. Modeling cost-effectiveness and health gains of a “universal” versus “prioritized” hepatitis C virus treatment policy in a real-life cohort

Author: Kondili, L, Romano, F, Rolli, F, Ruggeri, M, Rosato, S, Brunetto, M, Zignego, A, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, T, Blanc, P, Gaeta, G, Gasbarrini, A, Chessa, L, Erne, E, Villa, E, Ieluzzi, D, Russo, F, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, M, Quaranta, M, Cicchetti, A, Craxì, A, Vella, S, Kondili, LA, Rolli, FR, Brunetto, MR, Zignego, AL, Santantonio, TA, Gaeta, GB, Erne, EM, Russo, FP, Rumi, MG, Quaranta, MG, Kondili, L, Romano, F, Rolli, F, Ruggeri, M, Rosato, S, Brunetto, M, Zignego, A, Ciancio, A, Di Leo, A, Raimondo, G, Ferrari, C, Taliani, G, Borgia, G, Santantonio, T, Blanc, P, Gaeta, G, Gasbarrini, A, Chessa, L, Erne, E, Villa, E, Ieluzzi, D, Russo, F, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Puoti, M, Alberti, A, Nardone, G, Massari, M, Montalto, G, Foti, G, Rumi, M, Quaranta, M, Cicchetti, A, Craxì, A, Vella, S, Kondili, LA, Rolli, FR, Brunetto, MR, Zignego, AL, Santantonio, TA, Gaeta, GB, Erne, EM, Russo, FP, Rumi, MG, and Quaranta, MG
Abstract: We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus–infected patients: policy 1, “universal,” treat all patients, regardless of fibrosis stage; policy 2, treat only “prioritized” patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus–infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies’ cost-effectiveness. The patients’ age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post–sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. Conclusion: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases wh
Published: 2017

13. Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study

Author: Petta, S, Marzioni, M, Russo, P, Aghemo, A, Alberti, A, Ascione, A, Antinori, A, Bruno, R, Bruno, S, Chirianni, A, Gaeta, G, Giannini, E, Merli, M, Messina, V, Montilla, S, Perno, C, Puoti, M, Raimondo, G, Rendina, M, Silberstein, F, Villa, E, Zignego, A, Pani, L, Craxì, A, Fagiuoli, S, Gaeta, GB, Giannini, EG, Perno, CF, Silberstein, FC, Zignego, AL, FAGIUOLI, STEFANO, Petta, S, Marzioni, M, Russo, P, Aghemo, A, Alberti, A, Ascione, A, Antinori, A, Bruno, R, Bruno, S, Chirianni, A, Gaeta, G, Giannini, E, Merli, M, Messina, V, Montilla, S, Perno, C, Puoti, M, Raimondo, G, Rendina, M, Silberstein, F, Villa, E, Zignego, A, Pani, L, Craxì, A, Fagiuoli, S, Gaeta, GB, Giannini, EG, Perno, CF, Silberstein, FC, Zignego, AL, and FAGIUOLI, STEFANO
Abstract: Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. Findings 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4·76 [95% CI 1·83–12·3]; p=0·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring in 36 (5%) p
Published: 2017

14. A serum metabolomic analysis of HCV-infected patients successfully treated with IFN-free DAA regimens

Author: Ceccotti, G, Meoni, G, Tenori, L, Gragnani, L, Fognani, E, Gianni, E, Luchinat, C, and Zignego, Al
Subjects: nuclear magnetic resonance, HCV, metabolomics
Published: 2016

15. Impact of Safety-Related Dose Reductions or Discontinuations on Sustained Virologic Response in HCV-Infected Patients: Results from the GUARD-C Cohort

Author: GUARD C, Study Group, Hassanein, T, Bakalos, G, Ahlers, S, Shiffman, Ml, Tallarico, L, Reddy, Kr, Orlandini, A, Ferenci, P, Derbala, M, Coppola, C, Foster, Gr, Basho, J, Shabanaj, G, Harxhi, A, Debzi, N, Afredj, N, Guessab, N, Mahindad, N, Mahiou, H, Aissaoui, M, Al Qameesh, J, Al Ghandoor, Z, Assene, C, Bastens, B, Brixko, C, Cool, M, De Galocsy, C, Delwaide, J, George, C, Laukens, P, Lefebvre, V, Mulkay, Jp, Nevens, F, Servais, B, Van Vlierberghe, H, Horsmans, Y, Henrion, J, Sprengers, D, Michielsen, P, Bourgeois, S, Lasser, L, Langlet, P, Robaeys, G, Martinet, Jp, Warzee, P, Hoste, P, Reynaert, H, Juriens, I, Decaestecker, J, Van Der Meersch, F, Janssens, F, Ahmetagic, S, Verhaz, A, Bevanda, M, Calkic, L, Ibrahimpasic, N, Mesihovic, R, Mello, Ce, Ruiz, Fj, Martins Junior, E, Ferraz, Ml, Silva, G, Mendes, C, Lyra, A, Silva, Mh, Gomide, G, Fernandes, Jc, Pereira, P, Correa, Mc, Teixeira, R, Yousry, A, Hanno, A, Gabr, M, Omar, A, Esmat, G, Karatapanis, S, Nikolopoulou, V, Giannoulis, G, Manolakopoulos, S, Elefsiniotis, I, Drakoulis, C, Dimitroulopoulos, D, Kanatakis, S, Ketikoglou, I, Mimidis, K, Evgenidis, N, Akriviades, E, Vafiadi Zoubouli, I, Tsianos, E, Mela, M, Orfanou, E, Mousoulis, G, Karagiannis, I, Manesis, E, Varga, M, Nemesánszky, E, Fried, K, Schuller, J, Szalay, F, Lengyel, G, Tornai, I, Banyai, T, Lesch, M, Nagy, I, Gervain, J, Tusnadi, A, Schneider, F, Szentgyörgyi, L, Hunyady, B, Vincze, A, Tolvaj, G, Varkonyi, I, Makkai, E, Enyedi, J, Racz, I, Hausinger, P, Váczi, Z, Patai, Á, Ozsvár, Z, Lakner, L, Ribiczey, P, Bhalla, A, Somani, S, Luaia, R, Rao, P, Philip, M, Lawate, P, Nagral, A, Sood, A, Parikh, S, Merat, S, Nassiri Toosi, M, Alavian, Sm, Zali, Mr, Daryani, Ne, Drenaggi, D, Attili, Af, Bandiera, F, Bassi, P, Bellati, G, Bellantani, S, Brunetto, MAURIZIA ROSSANA, Bruno, S, Castelli, F, Castellacci, R, Cattelan, Am, Colombo, M, Craxi, A, D'Angelo, S, Colombo, S, Demelia, L, Di Perri, G, Di Giacomo, A, Ferrari, C, Francisci, D, Casinelli, K, Ganga, R, Costa, C, Mangia, A, Russo, Fp, Matarazzo, F, Mazzella, G, Mazzeo, M, Memoli, M, Montalbano, M, Montalto, G, Pieri, A, Passariello, N, Picciotto, A, Pietrangelo, A, Pirisi, M, Quirino, T, Raimondo, G, Rapaccini, Gl, Rizzardini, G, Rizzetto, M, Russello, M, Sabusco, G, Santantonio, T, Soardo, G, Amedea, A, Verucchi, G, Vinelli, F, Zignego, Al, Zuin, M, Ascione, A, Vinci, M, Pigozzi, Mg, Tundo, P, Saracco, Gm, Amoroso, P, Andreoni, M, Colletta, C, Erne, E, Megna, As, Biglino, A, Chiriaco, P, Foti, G, Spinzi, G, D'Amico, E, Paik, Sw, Ahn, Sh, Lee, Yn, Kim, Y, Yang, J, Han, Sy, Varghese, R, Al Gharabally, A, Askar, H, Sharara, A, Yaghi, C, Rached, Aa, Houmani, Z, Zaarour, F, Dohaibi, A, Ivanovski, L, Joksimovic, N, Abbas, Z, Memon, S, Mohsin, A, Masood, S, Hashmi, Z, Halota, W, Deron, Z, Mazur, W, Flisiak, R, Lipczynski, A, Musialik, J, Piekarska, A, Augustyniak, K, Baka Cwierz, B, Simon, K, Gietka, A, Berak, H, Sieklucki, J, Radowska, D, Szlauer, B, Piekos, T, Olszok, I, Jablkowski, M, Orszulak, G, Warakomska, I, Aleixo, Mj, Valente, C, Macedo, G, Sarmento Castro, R, Roxo, F, Faria, T, Mansinho, K, Velez, J, Ramos, Jp, Guerreiro, H, Alberto, S, Monteverde, C, Serejo, F, Peixe, P, Malhado, J, Curescu, M, Streinu Cercel, A, Caruntu, F, Livia, H, Preotescu, L, Arama, V, Ancuta, I, Gheorghe, L, Stanciu, C, Trifan, A, Acalovschi, M, Andreica, V, Pascu, O, Lencu, M, Sporea, I, Olteanu, D, Ionita Radu, F, Fierbinteanu Braticevici, C, Motoc, A, Silaghi, R, Musat, M, Coman, F, Stan, M, Cijevschi, C, Miftode, E, Delic, D, Jesic, R, Nozic, D, Svorcan, P, Fabri, M, Konstantinovic, L, Pelemis, M, Jankovic, G, Todorovic, Z, Nagorni, A, Kupcova, V, Skladany, L, Szantova, M, Krkoska, D, Jarcuska, P, Schreter, I, Oltman, M, Bocakova, J, Bunganic, I, Holoman, J, Giguere, A, Abdou, A. M., Basic (bio-) Medical Sciences, Gastroenterology, Laboratory of Molecullar and Cellular Therapy, Liver Cell Biology, Michielsen, Peter, GUARD-C Study Group, Graham R. Foster, Carmine Coppola, Moutaz Derbala, Peter Ferenci, Alessandra Orlandini, K. Rajender Reddy, Ludovico Tallarico, Mitchell L. Shiffman, Silke Ahler, Georgios Bakalo, Tarek Hassanein, GUARD-C Study Group: [.., Davide Drenaggi, Adolfo Francesco Attili, Franco Bandiera, Paolo Bassi, Giorgio Bellati, Stefano Bellantani, Maurizia Brunetto, Savino Bruno, Francesco Castelli, Roberto Castellacci, Anna Maria Cattelan, Massimo Colombo, Antonio Craxi, Salvatore D'angelo, Silvia Colombo, Luigi Demelia, Giovanni Di Perri, Antonio Di Giacomo, Carlo Ferrari, Daniela Francisci, Katia Casinelli, Roberto Ganga, Chiara Costa, Alessandra Mangia, Francesco Paolo Russo, Filippo Matarazzo, Giuseppe Mazzella, Maurizio Mazzeo, Massimo Memoli, Marzia Montalbano, Giuseppe Montalto, Alessandro Pieri, Nicola Passariello, Antonio Picciotto, Antonello Pietrangelo, Mario Pirisi, Tiziana Quirino, Giovanni Raimondo, Gian Ludovico Rapaccini, Giuliano Rizzardini, Mario Rizzetto, Maurizio Russello, Giuseppe Sabusco, Teresa Santantonio, Giorgio Soardo, Alessandri Amedea, Gabriella Verucchi, Francesco Vinelli, Anna Linda Zignego, Massimo Zuin, Antonio Ascione, Maria Vinci, Maria Graziella Pigozzi, Paolo Tundo, Giorgio Maria Saracco, Pietro Amoroso, Massimo Andreoni, Cosimo Colletta, Elke Erne, Angelo Salomone Megna, Alberto Biglino, Piergiorgio Chiriaco, Giuseppe Foti, Giancarlo Spinzi, Emilio D'amico, …], Foster G.R., Coppola C., Derbala M., Ferenci P., Orlandini A., Reddy K.R., Tallarico L., Shiffman M.L., Ahlers S., Bakalos G., Hassanein T., Basho J., Shabanaj G., Harxhi A., Debzi N., Afredj N., Guessab N., Mahindad N., Mahiou H., Aissaoui M., Al Qameesh J., Al Ghandoor Z., Assene C., Bastens B., Brixko C., Cool M., De Galocsy C., Delwaide J., George C., Laukens P., Lefebvre V., Mulkay J.-P., Nevens F., Servais B., Van Vlierberghe H., Horsmans Y., Henrion J., Sprengers D., Michielsen P., Bourgeois S., Lasser L., Langlet P., Robaeys G., Martinet J.-P., Warzee P., Hoste P., Reynaert H., Juriens I., Decaestecker J., Van Der Meersch F., Janssens F., Ahmetagic S., Verhaz A., Bevanda M., Calkic L., Ibrahimpasic N., Mesihovic R., Mello C.E., Ruiz F.J., Junior E.M., Ferraz M.L., Silva G., Mendes C., Lyra A., Silva M.H., Gomide G., Fernandes J.C., Pereira P., Correa M.C., Teixeira R., Yousry A., Hanno A., Gabr M., Omar A., Esmat G., Karatapanis S., Nikolopoulou V., Giannoulis G., Manolakopoulos S., Elefsiniotis I., Drakoulis C., Dimitroulopoulos D., Kanatakis S., Ketikoglou I., Mimidis K., Evgenidis N., Akriviades E., Vafiadi-Zoubouli I., Tsianos E., Mela M., Orfanou E., Mousoulis G., Karagiannis I., Manesis E., Varga M., Nemesanszky E., Fried K., Schuller J., Szalay F., Lengyel G., Tornai I., Banyai T., Lesch M., Nagy I., Gervain J., Tusnadi A., Schneider F., Szentgyorgyi L., Hunyady B., Vincze A., Tolvaj G., Varkonyi I., Makkai E., Enyedi J., Racz I., Hausinger P., Vaczi Z., Patai A., Ozsvar Z., Lakner L., Ribiczey P., Bhalla A., Somani S., Luaia R., Rao P., Philip M., Lawate P., Nagral A., Sood A., Parikh S., Merat S., Nassiri-Toosi M., Alavian S.-M., Zali M.R., Daryani N.E., Drenaggi D., Attili A.F., Bandiera F., Bassi P., Bellati G., Bellantani S., Brunetto M., Bruno S., Castelli F., Castellacci R., Cattelan A.M., Colombo M., Craxi A., D'angelo S., Colombo S., Demelia L., Di Perri G., Di Giacomo A., Ferrari C., Francisci D., Casinelli K., Ganga R., Costa C., Mangia A., Russo F.P., Matarazzo F., Mazzella G., Mazzeo M., Memoli M., Montalbano M., Montalto G., Pieri A., Passariello N., Picciotto A., Pietrangelo A., Pirisi M., Quirino T., Raimondo G., Rapaccini G.L., Rizzardini G., Rizzetto M., Russello M., Sabusco G., Santantonio T., Soardo G., Amedea A., Verucchi G., Vinelli F., Zignego A.L., Zuin M., Ascione A., Vinci M., Pigozzi M.G., Tundo P., Saracco G.M., Amoroso P., Andreoni M., Colletta C., Erne E., Megna A.S., Biglino A., Chiriaco P., Foti G., Spinzi G., D'amico E., Paik S.W., Ahn S.-H., Lee Y.N., Kim Y., Yang J., Han S.Y., Varghese R., Al Gharabally A., Askar H., Sharara A., Yaghi C., Abou Rached A., Houmani Z., Zaarour F., Dohaibi A., Ivanovski L., Joksimovic N., Abbas Z., Memon S., Mohsin A., Masood S., Hashmi Z., Halota W., Deron Z., Mazur W., Flisiak R., Lipczynski A., Musialik J., Piekarska A., Augustyniak K., Baka-Cwierz B., Simon K., Gietka A., Berak H., Sieklucki J., Radowska D., Szlauer B., Piekos T., Olszok I., Jablkowski M., Orszulak G., Warakomska I., Aleixo M.J., Valente C., Macedo G., Sarmento-Castro R., Roxo F., Faria T., Mansinho K., Velez J., Ramos J.P., Guerreiro H., Alberto S., Monteverde C., Serejo F., Peixe P., Malhado J., Curescu M., Streinu-Cercel A., Caruntu F., Livia H., Preotescu L., Arama V., Ancuta I., Gheorghe L., Stanciu C., Trifan A., Acalovschi M., Andreica V., Pascu O., Lencu M., Sporea I., Olteanu D., Ionita-Radu F., Fierbinteanu-Braticevici C., Motoc A., Silaghi R., Musat M., Coman F., Stan M., Cijevschi C., Miftode E., Delic D., Jesic R., Nozic D., Svorcan P., Fabri M., Konstantinovic L., Pelemis M., Jankovic G., Todorovic Z., Nagorni A., Kupcova V., Skladany L., Szantova M., Krkoska D., Jarcuska P., Schreter I., Oltman M., Bocakova J., Bunganic I., Holoman J., Giguere A., Abdou A.M.S., UCL - SSS/IREC-Institut de recherche expérimentale et clinique, UCL - SSS/IREC/GAEN-Pôle d'Hépato-gastro-entérologie, and UCL - (SLuc) Service de gastro-entérologie
Subjects: Genetics and Molecular Biology (all), Male, Chronic Hepatitis, Hepacivirus, Ribavirin/adverse effects, Asthenia/chemically induced, Polyethylene Glycol, Biochemistry, Polyethylene Glycols, Body Mass Index, Chronic Liver Disease, 0302 clinical medicine, Neutropenia/chemically induced, Interferon-alpha/adverse effects, Medicine, Chronic, lcsh:Science, Liver Diseases, virus diseases, Antiviral Agents/adverse effects, Cohort, Science & Technology - Other Topics, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cohort study, Human, medicine.medical_specialty, Alpha interferon, Gastroenterology and Hepatology, Antiviral Agents, Microbiology, Dose-Response Relationship, 03 medical and health sciences, Pharmacotherapy, Hepatitis C, Chronic/drug therapy, Dose Prediction Methods, Drug Therapy, Anemia/chemically induced, Humans, Hemoglobin, Aged, Medicine and health sciences, Biochemistry, Genetics and Molecular Biology (all), Hepaciviru, Science & Technology, Dose-Response Relationship, Drug, Flaviviruses, lcsh:R, Organisms, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, chemistry, Agricultural and Biological Sciences (all), Withholding Treatment, Asthenia, Immunology, Proportional Hazards Model, lcsh:Q, Human medicine, RNA viruses, Physiology, lcsh:Medicine, Peginterferon-alfa, Polyethylene Glycols/adverse effects, Adult, Anemia, Cohort Studies, Female, Hepatitis C, Chronic, Host-Pathogen Interactions, Interferon-alpha, Middle Aged, Neutropenia, Outcome Assessment (Health Care), Proportional Hazards Models, RNA, Viral, Recombinant Proteins, Ribavirin, Medicine (all), chemistry.chemical_compound, Outcome Assessment, Health Care, Medicine and Health Sciences, 030212 general & internal medicine, Viral, Pathology and laboratory medicine, Multidisciplinary, biology, Hepatitis C virus, Pharmaceutics, Hepatitis C, Hematology, Recombinant Protein, Outcome Assessment (Health Care)/methods, Medical microbiology, Host-Pathogen Interaction, Multidisciplinary Sciences, Physiological Parameters, Research Design, Combination, Viruses, Drug, Pathogens, Host-Pathogen Interactions/drug effects, Research Article, Clinical Research Design, Research and Analysis Methods, Internal medicine, Recombinant Proteins/adverse effects, RNA, Viral/blood, Antiviral Agent, business.industry, Body Weight, Hepacivirus/drug effects, Viral pathogens, biology.organism_classification, Hepatitis viruses, Microbial pathogens, RNA, Adverse Events, Cohort Studie, business
Abstract: Background: Despite the introduction of direct-acting antiviral agents for chronic hepatitis C virus (HCV) infection, peginterferon alfa/ribavirin remains relevant in many resource-constrained settings. The non-randomized GUARD-C cohort investigated baseline predictors of safety-related dose reductions or discontinuations (sr-RD) and their impact on sustained virologic response (SVR) in patients receiving peginterferon alfa/ribavirin in routine practice. Methods: A total of 3181 HCV-mono-infected treatment-naive patients were assigned to 24 or 48 weeks of peginterferon alfa/ribavirin by their physician. Patients were categorized by time-to-first sr-RD (Week 4/12). Detailed analyses of the impact of sr-RD on SVR24 (HCV RNA
Published: 2015

16. Cryoglobulinemic Vasculitis and Primary sjögren's Syndrome are Independent Risk Factors for Lymphoma in a Large Worldwide Population of Patients with Positive Serum Cryoglobulins

Author: Quartuccio, L, Corazza, L, Ramos Casals, M, Retamozo, S, Ragab, Gm, Ferraccioli, G, Gremese, E, Tzioufas, A, Voulgarelis, M, Vassilopoulos, D, Koutsianas, C, Scarpato, S, Salvarani, Carlo, Guillevin, L, Terrier, B, Cacoub, P, Saccardo, F, Gabrielli, A, Fraticelli, P, Tomsic, M, Tavoni, A, Nishimoto, N, Filippini, D, Scaini, P, Zignego, Al, Ferri, Clodoveo, Sansonno, D, Monti, G, Pietrogrande, M, Galli, M, Bombardieri, S, and Vita, S. De
Published: 2015

17. MIR-17/92 EXPRESSION PATTERN: A MOLECULAR SIGNATURE OF HCV-RELATED MIXED CRYOGLOBULINEMIA

Author: Piluso, A, Gragnani, L, Genovesi, A, Monti, M, Urraro, T, and Zignego, Al
Published: 2015

18. Virological and Clinical Response in Patients with HCV-Related Mixed Cryoglobulinemia Treated with Interferon-Free Regimens: Preliminary Results of a Prospective Pilot Study

Author: Gragnani, L, Piluso, A, Urraro, T, Fabbrizzi, A, Fognani, E, Petraccia, L, Monti, M, and Zignego, Al.
Published: 2015

19. HCV-related liver and lymphoproliferative diseases: association with polymorphisms of IL28B and TLR2

Author: De Re, V, De Zorzi, M, Caggiari, L, Lauletta, G, Tornesello, ML, Fognani, E, Miorin, M, Racanelli, V, Quartuccio, L, Gragnani, L, Russi, S, Pavone, F, Ghersetti, M, Costa, EG, Casarin, P, Bomben, R, Mazzaro, C, Basaglia, G, Berretta, M, Vaccher, E, Izzo, F, Buonaguro, FM, De Vita, S, Zignego, AL, De Paoli, P, Dolcetti, R, De Re, V, De Zorzi, M, Caggiari, L, Lauletta, G, Tornesello, ML, Fognani, E, Miorin, M, Racanelli, V, Quartuccio, L, Gragnani, L, Russi, S, Pavone, F, Ghersetti, M, Costa, EG, Casarin, P, Bomben, R, Mazzaro, C, Basaglia, G, Berretta, M, Vaccher, E, Izzo, F, Buonaguro, FM, De Vita, S, Zignego, AL, De Paoli, P, and Dolcetti, R
Abstract: To explore the relationship between innate immunity and hepatitis C Virus (HCV) in determining the risk of cirrhosis (CIR), hepatocellular carcinoma (HCC), mixed cryoglobulinemia syndrome (MCS) and non-Hodgkin lymphoma (NHL), we investigated the impact of the toll-like receptor-2 (TLR2) and interleukin-28B (IL28B) genetic variants. TLR2 -174 del variant was associated with TLR2 expression and with specific downstream molecules that drive the expression of different interleukins; rs12979860 Il28B was important in response to interferon-treatment and in spontaneous clearance of HCV. The risk for liver and lymphoproliferative diseases in HCV progression was clarified by stratifying 862 HCV-positive patients into groups based on liver (CIR, HCC) and lymphoproliferative HCV-related diseases (MCS, NHL) and compared with chronic HCV (CHC) infection. Analysis of TLR2-IL28B haplotypes showed an association of wild type haplotype with the lymphoproliferative diseases (OR 1.77, p = 0.029) and a slight increase in HCV viral load (HR 1.38, p = 0.054). Wild type haplotype (TLR2 ins/ins- IL28B C/C) was also found associated with older age in patients with an hepatic diseases (in CIR and in HCC p = 0.038 and p = 0.020, respectively) supporting an effect of innate immunity in the liver disease progression. TLR2 and IL28B polymorphisms in combination showed a role in the control of HCV viral load and different HCV disease progression.
Published: 2016

20. A randomized, controlled study of peginterferon lambda-1a/ribavirin ± daclatasvir for hepatitis C virus genotype 2 or 3

Author: Foster, GR, Chayama, K, Chuang, W-L, Fainboim, H, Farkkila, M, Gadano, A, Gaeta, GB, Hezode, C, Inada, Y, Heo, J, Kumada, H, Lu, S-N, Marcellin, P, Moreno, C, Roberts, SK, Strasser, SI, Thompson, AJ, Toyota, J, Paik, SW, Vierling, JM, Zignego, AL, Cohen, D, McPhee, F, Wind-Rotolo, M, Srinivasan, S, Hruska, M, Myler, H, Portsmouth, SD, Foster, GR, Chayama, K, Chuang, W-L, Fainboim, H, Farkkila, M, Gadano, A, Gaeta, GB, Hezode, C, Inada, Y, Heo, J, Kumada, H, Lu, S-N, Marcellin, P, Moreno, C, Roberts, SK, Strasser, SI, Thompson, AJ, Toyota, J, Paik, SW, Vierling, JM, Zignego, AL, Cohen, D, McPhee, F, Wind-Rotolo, M, Srinivasan, S, Hruska, M, Myler, H, and Portsmouth, SD
Abstract: BACKGROUND AND PURPOSE: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. METHODS: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). RESULTS: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. CONCLUSION: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.
Published: 2016

21. Economic Consequences of Investing in Anti-HCV Antiviral Treatment from the Italian NHS Perspective: A Real-World-Based Analysis of PITER Data

Author: Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L. A., Vella, S., Quaranta, M. G., Rosato, S., Tosti, M. E., Weimer, L. E., Ferrigno, L., D’Angelo, F., Falzano, L., Benedetti, A., Schiadà, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Di Leo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, Peter, Rimenti, G., Rossini, A., Contessi, G. B., Castelli, Fulvio, Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, Lucia, Quintieri, F., De Siena, Martina, Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall’Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., DelundefinedPin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, Francesca, Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., DiundefinedBiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, Chiara, Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D’ArminioundefinedMonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, Margherita, D’Ambrosio, R., Degasperi, E., Vinci, Maria Rosaria, Villa, E., Bernabucci, V., Bristot, Luca, Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, Alex, Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D’Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, Enrico, Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, Maria Chiara, Montalto, G., Licata, A., Capitano, A. R., Craxì, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, Paolo, Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, Antonio, Siciliano, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D’Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, Roberto, Cingolani, Antonella, Lamonica, S., D’Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, Antonio, D’Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, Patrizia, Dell’Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, Monia, Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, A, Viti, R, Kondili, L, Rosato, S, Vella, S, Mennini, F, Quaranta, M, Tosti, M, Weimer, L, Ferrigno, L, D'Angelo, F, Falzano, L, Benedetti, A, Schiada, L, Cucco, M, Giacometti, A, Brescini, L, Castelletti, S, Drenaggi, D, Mazzaro, C, Angarano, G, Milella, M, Dileo, A, Rendina, M, Contaldo, A, Iannone, A, La Fortezza, F, Rizzi, M, Cologni, G, Bolondi, L, Benevento, F, Serio, I, Andreone, P, Caraceni, P, Guarneri, V, Margotti, M, Simonetti, G, Mazzella, G, Verucchi, G, Donati, V, Mian, P, Rimenti, G, Rossini, A, Contessi, G, Castelli, F, Zaltron, S, Spinetti, A, Odolini, S, Leandro, G, Cozzolongo, R, Zappimbulso, M, Russello, M, Benigno, R, Coco, C, Torti, C, Costa, C, Greco, G, Mazzitelli, M, Pisani, V, Cosco, L, Quintieri, F, Desiena, M, Giancotti, F, Vecchiet, J, Falasca, K, Mastroianni, A, Apuzzo, G, Chidichimo, L, Foschi, F, Dall'Aglio, A, Libanore, M, Segala, D, Sighinolfi, L, Bartolozzi, D, Salomoni, E, Blanc, P, Baragli, F, Delpin, B, Mariabelli, E, Mazzotta, F, Poggi, A, Zignego, A, Monti, M, Madia, F, Xheka, A, Cela, E, Santantonio, T, Bruno, S, Viscoli, C, Alessandrini, A, Curti, C, Dibiagio, A, Nicolini, L, Balletto, E, Mastroianni, C, Blerta, K, Prati, D, Raffaele, L, Andreoletti, M, Perboni, G, Costa, P, Manzini, L, Raimondo, G, Filomia, R, Lazzarin, A, Morsica, G, Salpietro, S, Puoti, M, Baiguera, C, Vassalli, S, Rumi, M, Labanca, S, Zuin, M, Giorgini, A, Orellana, D, D'Arminiomonforte, A, Debona, A, Solaro, S, Fargion, S, Valenti, L, Periti, G, Pelusi, S, Galli, M, Calvi, E, Milazzo, L, Peri, A, Lampertico, P, Borghi, M, D'Ambrosio, R, Degasperi, E, Vinci, M, Villa, E, Bernabucci, V, Bristot, L, Pereira, F, Chessa, L, Pasetto, M, Loi, M, Gori, A, Beretta, I, Pastore, V, Soria, A, Strazzabosco, M, Ciaccio, A, Gemma, M, Borgia, G, Foggia, A, Zappulo, E, Gentile, I, Buonomo, A, Abrescia, N, Maddaloni, A, Caporaso, N, Morisco, F, Camera, S, Donnarumma, L, Coppola, C, Amoruso, D, Staiano, L, Saturnino, M, Coppola, N, Martini, S, Monari, C, Federico, A, Dallio, M, Loguercio, C, Gaeta, G, Brancaccio, G, Nardone, G, Sgamato, C, D'Adamo, G, Alberti, A, Gonzo, M, Piovesan, S, Chemello, L, Buggio, A, Cavalletto, L, Barbaro, F, Castelli, E, Floreani, A, Cazzagon, N, Franceschet, I, Russo, F, Zanetto, A, Franceschet, E, Madonia, S, Cannizzaro, M, Montalto, G, Licata, A, Capitano, A, Craxi, A, Petta, S, Calvaruso, V, Rini, F, Ferrari, C, Negri, E, Orlandini, A, Pesci, M, Bruno, R, Lombardi, A, Zuccaro, V, Gulminetti, R, Asti, A, Villaraggia, M, Mondelli, M, Ludovisi, S, Baldelli, F, Di Candilo, F, Parruti, G, Di Stefano, P, Sozio, F, Gizzi, M, Brunetto, M, Colombatto, P, Coco, B, Surace, L, Foti, G, Pellicano, S, Fornaciari, G, Schianchi, S, Vignoli, P, Massari, M, Corsini, R, Garlassi, E, Ballardini, G, Andreoni, M, Cerva, C, Angelico, M, Gasbarrini, A, Siciliano, M, De Siena, M, Nosotti, L, Taliani, G, Biliotti, E, Santori, M, Spaziante, M, Tamburini, F, Vullo, V, D'Ettorre, G, Cavallari, E, Gebremeskel, T, Pavone, P, Cauda, R, Cingolani, A, Lamonica, S, D'Offizi, G, Lionetti, R, Visco Comandini, U, Grieco, A, D'Aversa, F, Picardi, A, De Vincentis, A, Galati, G, Gallo, P, Dell'Unto, C, Aghemo, A, Gatti Comini, A, Persico, M, Masarone, M, Anselmo, M, De Leo, P, Marturano, M, Brunelli, E, Ridolfi, F, Schimizzi, A, Ayoubi Khajekini, M, Framarin, L, Di Perri, G, Cariti, G, Boglione, L, Cardellino, C, Marinaro, L, Saracco, G, Ciancio, A, Toniutto, P, Alterini, G, Capra, F, Ieluzzi, D, Kondili LA, Vella S, Quaranta MG, Rosato S, Tosti ME, Weimer LE, Ferrigno L, D'Angelo F, Falzano L, Benedetti A, Schiadà L, Cucco M, Giacometti A, Brescini L, Castelletti S, Drenaggi D, Mazzaro C, Angarano G, Milella M, Di Leo A, Rendina M, Contaldo A, Iannone A, La Fortezza F, Rizzi M, Cologni G, Bolondi L, Benevento F, Serio I, Andreone P, Caraceni P, Guarneri V, Margotti M, Simonetti G, Mazzella G, Verucchi G, Donati V, Mian P, Rimenti G, Rossini A, Contessi GB, Castelli F, Zaltron S, Spinetti A, Odolini S, Leandro G, Cozzolongo R, Zappimbulso M, Russello M, Benigno R, Coco C, Torti C, Costa C, Greco G, Mazzitelli M, Pisani V, Cosco L, Quintieri F, De Siena M, Giancotti F, Vecchiet J, Falasca K, Mastroianni A, Apuzzo G, Chidichimo L, Foschi FG, Dall'Aglio AC, Libanore M, Segala D, Sighinolfi L, Bartolozzi D, Salomoni E, Blanc P, Baragli F, Del Pin B, Mariabelli E, Mazzotta F, Poggi A, Zignego AL, Monti M, Madia F, Xheka A, Cela EM, Santantonio TA, Bruno SR, Viscoli C, Alessandrini AI, Curti C, Di Biagio A, Nicolini LA, Balletto E, Mastroianni C, Blerta K, Prati D, Raffaele L, Andreoletti M, Perboni G, Costa P, Manzini L, Raimondo G, Filomia R, Lazzarin A, Morsica G, Salpietro S, Puoti M, Baiguera C, Vassalli S, Rumi MG, Labanca S, Zuin M, Giorgini A, Orellana D, D'Arminio Monforte A, Debona A, Solaro S, Fargion S, Valenti L, Periti G, Pelusi S, Galli M, Calvi E, Milazzo L, Peri A, Lampertico P, Borghi M, D'Ambrosio R, Degasperi E, Vinci M, Villa E, Bernabucci V, Bristot L, Pereira F, Chessa L, Pasetto MC, Loi M, Gori A, Beretta I, Pastore V, Soria A, Strazzabosco M, Ciaccio A, Gemma M, Borgia G, Foggia A, Zappulo E, Gentile I, Buonomo AR, Abrescia N, Maddaloni A, Caporaso N, Morisco F, Camera S, Donnarumma L, Coppola C, Amoruso DC, Staiano L, Saturnino MR, Coppola N, Martini S, Monari C, Federico A, Dallio M, Loguercio C, Gaeta GB, Brancaccio G, Nardone G, Sgamato C, D'Adamo G, Alberti A, Gonzo M, Piovesan S, Chemello L, Buggio A, Cavalletto L, Barbaro F, Castelli E, Floreani A, Cazzagon N, Franceschet I, Russo FP, Zanetto A, Franceschet E, Madonia S, Cannizzaro M, Montalto G, Licata A, Capitano AR, Craxì A, Petta S, Calvaruso V, Rini F, Ferrari C, Negri E, Orlandini A, Pesci M, Bruno R, Lombardi A, Zuccaro V, Gulminetti R, Asti A, Villaraggia M, Mondelli M, Ludovisi S, Baldelli F, Di Candilo F, Parruti G, Di Stefano P, Sozio F, Gizzi MC, Brunetto MR, Colombatto P, Coco B, Surace L, Foti G, Pellicano S, Fornaciari G, Schianchi S, Vignoli P, Massari M, Corsini R, Garlassi E, Ballardini G, Andreoni M, Cerva C, Angelico M, Gasbarrini A, Siciliano M, De Siena M, Nosotti L, Taliani G, Biliotti E, Santori M, Spaziante M, Tamburini F, Vullo V, D'Ettorre G, Cavallari EN, Gebremeskel TS, Pavone P, Cauda R, Cingolani A, Lamonica S, D'Offizi G, Lionetti R, Visco Comandini U, Grieco A, D'Aversa F, Picardi A, De Vincentis A, Galati G, Gallo P, Dell'Unto C, Aghemo A, Gatti Comini A, Persico M, Masarone M, Anselmo M, De Leo P, Marturano M, Brunelli E, Ridolfi F, Schimizzi AM, Ayoubi Khajekini M, Framarin L, Di Perri G, Cariti G, Boglione L, Cardellino C, Marinaro L, Saracco GM, Ciancio A, Toniutto P, Alterini G, Capra F, Ieluzzi D., Marcellusi, A., Viti, R., Kondili, L. A., Rosato, S., Vella, S., Mennini, F. S., Quaranta, M. G., Tosti, M. E., Weimer, L. E., Ferrigno, L., D'Angelo, F., Falzano, L., Benedetti, A., Schiada, L., Cucco, M., Giacometti, A., Brescini, L., Castelletti, S., Drenaggi, D., Mazzaro, C., Angarano, G., Milella, M., Dileo, A., Rendina, M., Contaldo, A., Iannone, A., La Fortezza, F., Rizzi, M., Cologni, G., Bolondi, L., Benevento, F., Serio, I., Andreone, P., Caraceni, P., Guarneri, V., Margotti, M., Simonetti, G., Mazzella, G., Verucchi, G., Donati, V., Mian, P., Rimenti, G., Rossini, A., Contessi, G. B., Castelli, F., Zaltron, S., Spinetti, A., Odolini, S., Leandro, G., Cozzolongo, R., Zappimbulso, M., Russello, M., Benigno, R., Coco, C., Torti, C., Costa, C., Greco, G., Mazzitelli, M., Pisani, V., Cosco, L., Quintieri, F., Desiena, M., Giancotti, F., Vecchiet, J., Falasca, K., Mastroianni, A., Apuzzo, G., Chidichimo, L., Foschi, F. G., Dall'Aglio, A. C., Libanore, M., Segala, D., Sighinolfi, L., Bartolozzi, D., Salomoni, E., Blanc, P., Baragli, F., Delpin, B., Mariabelli, E., Mazzotta, F., Poggi, A., Zignego, A. L., Monti, M., Madia, F., Xheka, A., Cela, E. M., Santantonio, T. A., Bruno, S. R., Viscoli, C., Alessandrini, A. I., Curti, C., Dibiagio, A., Nicolini, L. A., Balletto, E., Mastroianni, C., Blerta, K., Prati, D., Raffaele, L., Andreoletti, M., Perboni, G., Costa, P., Manzini, L., Raimondo, G., Filomia, R., Lazzarin, A., Morsica, G., Salpietro, S., Puoti, M., Baiguera, C., Vassalli, S., Rumi, M. G., Labanca, S., Zuin, M., Giorgini, A., Orellana, D., D'Arminiomonforte, A., Debona, A., Solaro, S., Fargion, S., Valenti, L., Periti, G., Pelusi, S., Galli, M., Calvi, E., Milazzo, L., Peri, A., Lampertico, P., Borghi, M., D'Ambrosio, R., Degasperi, E., Vinci, M., Villa, E., Bernabucci, V., Bristot, L., Pereira, F., Chessa, L., Pasetto, M. C., Loi, M., Gori, A., Beretta, I., Pastore, V., Soria, A., Strazzabosco, M., Ciaccio, A., Gemma, M., Borgia, G., Foggia, A., Zappulo, E., Gentile, I., Buonomo, A. R., Abrescia, N., Maddaloni, A., Caporaso, N., Morisco, F., Camera, S., Donnarumma, L., Coppola, C., Amoruso, D. C., Staiano, L., Saturnino, M. R., Coppola, N., Martini, S., Monari, C., Federico, A., Dallio, M., Loguercio, C., Gaeta, G. B., Brancaccio, G., Nardone, G., Sgamato, C., D'Adamo, G., Alberti, A., Gonzo, M., Piovesan, S., Chemello, L., Buggio, A., Cavalletto, L., Barbaro, F., Castelli, E., Floreani, A., Cazzagon, N., Franceschet, I., Russo, F. P., Zanetto, A., Franceschet, E., Madonia, S., Cannizzaro, M., Montalto, G., Licata, A., Capitano, A. R., Craxi, A., Petta, S., Calvaruso, V., Rini, F., Ferrari, C., Negri, E., Orlandini, A., Pesci, M., Bruno, R., Lombardi, A., Zuccaro, V., Gulminetti, R., Asti, A., Villaraggia, M., Mondelli, M., Ludovisi, S., Baldelli, F., Di Candilo, F., Parruti, G., Di Stefano, P., Sozio, F., Gizzi, M. C., Brunetto, M. R., Colombatto, P., Coco, B., Surace, L., Foti, G., Pellicano, S., Fornaciari, G., Schianchi, S., Vignoli, P., Massari, M., Corsini, R., Garlassi, E., Ballardini, G., Andreoni, M., Cerva, C., Angelico, M., Gasbarrini, A., Siciliano, M., De Siena, M., Nosotti, L., Taliani, G., Biliotti, E., Santori, M., Spaziante, M., Tamburini, F., Vullo, V., D'Ettorre, G., Cavallari, E. N., Gebremeskel, T. S., Pavone, P., Cauda, R., Cingolani, A., Lamonica, S., D'Offizi, G., Lionetti, R., Visco Comandini, U., Grieco, A., D'Aversa, F., Picardi, A., De Vincentis, A., Galati, G., Gallo, P., Dell'Unto, C., Aghemo, A., Gatti Comini, A., Persico, M., Masarone, M., Anselmo, M., De Leo, P., Marturano, M., Brunelli, E., Ridolfi, F., Schimizzi, A. M., Ayoubi Khajekini, M., Framarin, L., Di Perri, G., Cariti, G., Boglione, L., Cardellino, C., Marinaro, L., Saracco, G. M., Ciancio, A., Toniutto, P., Alterini, G., Capra, F., Ieluzzi, D., Marcellusi, Andrea, Viti, Raffaella, Kondili, Loreta A., Rosato, Stefano, Vella, Stefano, Mennini, Francesco Saverio, Kondili, L.A., Quaranta, M.G., Tosti, M.E., Weimer, L.E., D’Angelo, F., Schiadà, L., Di&nbsp, Leo, A., Contessi, G.B., De&nbsp, Siena, M., Foschi, F.G., Dall’Aglio, A.C., Del&nbsp, Pin, B., Zignego, A.L., Cela, E.M., Santantonio, T.A., Bruno, S.R., Alessandrini, A.I., Biagio, A., Nicolini, L.A., Rumi, M.G., D’Arminio&nbsp, Monforte, A., D’Ambrosio, R., Pasetto, M.C., Buonomo, A.R., Amoruso, D.C., Saturnino, M.R., Gaeta, G.B., D’Adamo, G., Russo, F.P., Capitano, A.R., Craxì, A., Gizzi, M.C., Brunetto, M.R., D’Ettorre, G., Cavallari, E.N., Gebremeskel, T.S., D’Offizi, G., D’Aversa, F., Dell’Unto, C., Schimizzi, A.M., Saracco, G.M., Cosco, Alfredo, Dall’Aglio, A. C., Salomoni, Valentina, Nicolini, Elvira, Calvi, Marta, Soria, Giovanni, D'Adamo, Danilo, ALONSO ALBERTI, MARIA PALOMA CARMEN, Orlandini, Giovanni, DE ASTIS, Fabio, Sozio, Concetta, Terzini, Angelico, DE SIENA, ANDREA URIEL, Taliani, Sabrina, Spaziante, Agata, Lamonica, Emilia, and Capra, Carlo
Subjects: Liver Cirrhosis, Pediatrics, Time Factors, Settore MED/09 - Medicina Interna, National Health Programs, ERADICATION, OUTBREAK, antiviral treatment, anti HCV, economic consequences, Hepacivirus, LIVER FIBROSIS, Severity of Illness Index, Health Services Accessibility, COST-EFFECTIVENESS, Indirect costs, 0302 clinical medicine, Epidemiology, virus infection, 030212 general & internal medicine, health care economics and organizations, cost effectiveness, 030503 health policy & services, Health Policy, Health services research, health, Hepatitis C, Markov Chains, chronic hepatitis C, virus infection, fibrosis progression, cost effectiveness, liver fibrosis, Italy, Pharmacology, Public Health, Environmental and Occupational Health, Cohort, Settore SECS-P/03 - Scienza delle Finanze, Disease Progression, Public Health, 0305 other medical science, Viral hepatitis, Anti-HCV antiviral treatment, CHRONIC HEPATITIS-C, medicine.medical_specialty, Genotype, Settore MED/12 - GASTROENTEROLOGIA, VIRUS-INFECTION, Antiviral Agents, NO, 03 medical and health sciences, Cost Savings, Humans, medicine, MANAGEMENT, chronic hepatitis C, INDUCED DISEASES, METAANALYSIS, Health economics, business.industry, Public health, Environmental and Occupational Health, medicine.disease, FIBROSIS PROGRESSION, business
Abstract: OBJECTIVE:\ud We estimated the cost consequence of Italian National Health System (NHS) investment in direct-acting antiviral (DAA) therapy according to hepatitis C virus (HCV) treatment access policies in Italy.\ud \ud METHODS:\ud A multistate, 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and genotype distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. The treatment efficacy, disease progression probabilities and direct costs in each health state were obtained from the literature. The break-even point in time (BPT) was defined as the period of time required for the cumulative costs saved to recover the Italian NHS investment in DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.\ud \ud RESULTS:\ud The disease stages of 2657 patients who consecutively underwent DAA therapy from January 2015 to December 2017 at 30 PITER clinical centres were standardized for 1000 patients. The investment in DAAs was considered to equal €25 million, €15 million, and €9 million in 2015, 2016, and 2017, respectively. For patients treated in 2015, the BPT was not achieved, because of the disease severity of the treated patients and high DAA prices. For 2016 and 2017, the estimated BPTs were 6.6 and 6.2 years, respectively. The total cost savings after 20 years were €50.13 and €55.50 million for 1000 patients treated in 2016 and 2017, respectively.\ud \ud CONCLUSIONS:\ud This study may be a useful tool for public decision makers to understand how HCV clinical and epidemiological profiles influence the economic burden of HCV.
Published: 2019

22. Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN)

Author: Roberto, Minutolo, Alessio, Aghemo, Antonio, Chirianni, Fabrizio, Fabrizi, Loreto, Gesualdo, Edoardo, G Giannini, Paolo, Maggi, Vincenzo, Montinaro, Ernesto, Paoletti, Marcello, Persico, Francesco, Perticone, Salvatore, Petta, Massimo, Puoti, Giovanni, Raimondo, Maria, Rendina, Zignego, Anna Linda, Italian Society of Nephrology (SIN), the Italian Association for the Study of the Liver (AISF), the Italian Society of Infectious and Tropical Disease (SIMIT), the Italian Society of Internal Medicine (SIMI), Minutolo, R, Aghemo, A, Chirianni, A, Fabrizi, F, Gesualdo, L, Giannini, Eg, Maggi, P, Montinaro, V, Paoletti, E, Persico, Marcello, Perticone, F, Petta, S, Puoti, M, Raimondo, G, Rendina, Maria, Zignego, Al, Giannini, E, Persico, M, Rendina, M, Zignego, A, Minutolo R., Aghemo A., Chirianni A., Fabrizi F., Gesualdo L., Giannini E.G., Maggi P., Montinaro V., Paoletti E., Persico M., Perticone F., Petta S., Puoti M., Raimondo G., Rendina M., Zignego A.L., Minutolo, Roberto, Aghemo, Alessio, Chirianni, Antonio, Fabrizi, Fabrizio, Gesualdo, Loreto, Giannini, Edoardo G., Maggi, Paolo, Montinaro, Vincenzo, Paoletti, Ernesto, Perticone, Francesco, Petta, Salvatore, Puoti, Massimo, Raimondo, Giovanni, and Zignego, Anna Linda
Subjects: 0301 basic medicine, Nephrology, Direct-acting antiviral agent, medicine.medical_treatment, 030232 urology & nephrology, Disease, Hepacivirus, urologic and male genital diseases, Severity of Illness Index, Liver disease, 0302 clinical medicine, Risk Factors, Chronic kidney disease, Prevalence, Renal Insufficiency, 030212 general & internal medicine, Chronic, Cooperative Behavior, Direct-acting antiviral agents, HCV in renal transplantation, HCV infection, Antiviral Agents, Expert Testimony, Hepatitis C, Humans, Infectious Disease Medicine, Internal Medicine, Italy, Kidney Transplantation, Renal Insufficiency, Chronic, Societies, Disease Management, Societies, Medical, Kidney transplantation, education.field_of_study, Evidence-Based Medicine, Gastroenterology, General Medicine, Infectious Diseases, Treatment Outcome, Hepatology, Emergency Medicine, 030211 gastroenterology & hepatology, Hemodialysis, Human, Microbiology (medical), medicine.medical_specialty, Consensus, 030106 microbiology, Population, Consensu, Risk Assessment, 03 medical and health sciences, Renal Dialysis, Internal medicine, medicine, education, Antiviral Agent, Hepaciviru, business.industry, Risk Factor, Hepatitis C, Chronic, medicine.disease, Transplantation, business, Chronic kidney disease, Direct-acting antiviral agents, HCV in renal transplantation, HCV infection, Nephrology, Kidney disease
Abstract: Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.
Published: 2018

23. Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network

Author: Maria Grazia Rumi, Teresa Santantonio, Vincenza Calvaruso, D.C. Amoruso, Giovanni Raimondo, Salvatore Petta, Maria Cristina Pasetto, Romina Corsini, Alfredo Di Leo, Anna Linda Zignego, Barbara Coco, Francesco Paolo Russo, Giovanni Battista Gaeta, Maurizia Rossana Brunetto, Giuseppina Brancaccio, Veronica Bernabucci, Alberto Zanetto, Filomena Morisco, Mario Masarone, Pietro Andreone, Pierluigi Blanc, D. Ieluzzi, Salvatore Madonia, Adele Giammario, Marzia Margotti, Edoardo G. Giannini, M. Cannizzaro, Emanuela Zappulo, Gloria Taliani, Monica Monti, Roberto Filomia, Marco Massari, Guglielmo Borgia, Andrea Iannone, Massimo Siciliano, Erica Villa, Marcello Persico, Stefano Vella, Stefano Rosato, Maria Giovanna Quaranta, L. E. Weimer, Carmine Coppola, Liliana Chemello, Loreta A. Kondili, Barbara Del Pin, Loredana Falzano, Luchino Chessa, L. Donnarumma, Luisa Cavalletto, Elisa Biliotti, Antonio Gasbarrini, Kondili, Loreta A., Gaeta, Giovanni Battista, Brunetto, Maurizia Rossana, Di Leo, Alfredo, Iannone, Andrea, Santantonio, Teresa Antonia, Giammario, Adele, Raimondo, Giovanni, Filomia, Roberto, Coppola, Carmine, Amoruso, Daniela Caterina, Blanc, Pierluigi, Del Pin, Barbara, Chemello, Liliana, Cavalletto, Luisa, Morisco, Filomena, Donnarumma, Laura, Rumi, Maria Grazia, Gasbarrini, Antonio, Siciliano, Massimo, Massari, Marco, Corsini, Romina, Coco, Barbara, Madonia, Salvatore, Cannizzaro, Marco, Zignego, Anna Linda, Monti, Monica, Russo, Francesco Paolo, Zanetto, Alberto, Persico, Marcello, Masarone, Mario, Villa, Erica, Bernabucci, Veronica, Taliani, Gloria, Biliotti, Elisa, Chessa, Luchino, Pasetto, Maria Cristina, Andreone, Pietro, Margotti, Marzia, Brancaccio, Giuseppina, Ieluzzi, Donatella, Borgia, Guglielmo, Zappulo, Emanuela, Calvaruso, Vincenza, Petta, Salvatore, Falzano, Loredana, Quaranta, Maria Giovanna, Weimer, Liliana Elena, Rosato, Stefano, Vella, Stefano, Giannini, Edoardo Giovanni, Kondili LA, Gaeta GB, Brunetto MR, Di Leo A, Iannone A, Santantonio TA, Giammario A, Raimondo G, Filomia R, Coppola C, Amoruso DC, Blanc P, Del Pin B, Chemello L, Cavalletto L, Morisco F, Donnarumma L, Rumi MG, Gasbarrini A, Siciliano M, Massari M, Corsini R, Coco B, Madonia S, Cannizzaro M, Zignego AL, Monti M, Russo FP, Zanetto A, Persico M, Masarone M, Villa E, Bernabucci V, Taliani G, Biliotti E, Chessa L, Pasetto MC, Andreone P, Margotti M, Brancaccio G, Ieluzzi D, Borgia G, Zappulo E, Calvaruso V, Petta S, Falzano L, Quaranta MG, Weimer LE, Rosato S, Vella S, Giannini EG., Kondili, L., Gaeta, G., Brunetto, M., Di Leo, A., Iannone, A., Santantonio, T., Giammario, A., Raimondo, G., Filomia, R., Coppola, C., Amoruso, D., Blanc, P., Del Pin, B., Chemello, L., Cavalletto, L., Morisco, F., Donnarumma, L., Rumi, M., Gasbarrini, A., Siciliano, M., Massari, M., Corsini, R., Coco, B., Madonia, S., Cannizzaro, M., Zignego, A., Monti, M., Russo, F., Zanetto, A., Persico, M., Masarone, M., Villa, E., Bernabucci, V., Taliani, G., Biliotti, E., Chessa, L., Pasetto, M., Andreone, P., Margotti, M., Brancaccio, G., Ieluzzi, D., Borgia, G., Zappulo, E., Calvaruso, V., Petta, S., Falzano, L., Quaranta, M., Weimer, L., Rosato, S., Vella, S., and Giannini, E.
Subjects: Simeprevir, Male, Genetics and Molecular Biology (all), Hepacivirus, Pediatrics, Gastroenterology, Biochemistry, 0302 clinical medicine, Animal Cells, 80 and over, Bile, Medicine, Public and Occupational Health, Prospective Studies, lcsh:Science, Aged, 80 and over, Adult, Aged, Antiviral Agents, Drug Therapy, Combination, Female, Hepatitis C, Humans, Incidence, Liver Diseases, Middle Aged, Biochemistry, Genetics and Molecular Biology (all), Agricultural and Biological Sciences (all), Liver Disease, Child Health, Blood, Cirrhosis, Physical Sciences, Regression Analysis, 030211 gastroenterology & hepatology, Cellular Types, Statistics (Mathematics), Human, medicine.medical_specialty, Gastroenterology and Hepatology, Microbiology, 03 medical and health sciences, Drug Therapy, Statistical Methods, Blood Cells, Flaviviruses, lcsh:R, Organisms, Biology and Life Sciences, medicine.disease, Regimen, Prospective Studie, 030104 developmental biology, chemistry, lcsh:Q, Mathematics, Developmental Biology, RNA viruses, 0301 basic medicine, DAA, HCV, resistance, Sofosbuvir, Physiology, lcsh:Medicine, Liver disease, chemistry.chemical_compound, Mathematical and Statistical Techniques, Medicine and Health Sciences, Pathology and laboratory medicine, Multidisciplinary, Hepatitis C virus, Medical microbiology, Body Fluids, Viruses, Combination, Anatomy, Pathogens, Research Article, medicine.drug, Platelets, Ledipasvir, Daclatasvir, Settore MED/12 - GASTROENTEROLOGIA, HCV, liver diseases, Cirrhosis, DAA failure, Research and Analysis Methods, Internal medicine, Antiviral Agent, business.industry, Viral pathogens, Bilirubin, Cell Biology, Fibrosis, Hepatitis viruses, Microbial pathogens, Surgery, Liver function, business
Abstract: Background: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. Aim: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. Methods: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. Results: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin levels >1.5mg/dl, platelet count
Published: 2017

24. GENDER DIFFERENCES IN HCV CHRONIC LIVER DISEASE: A REAL LIFE EVALUATION IN PITER (PIATTAFORMA ITALIANA PER LO STUDIO DELLA TERAPIA DELLE EPATITI VIRALI) COHORT STUDY

Author: M. Puoti, G.B. Gaeta, T. Santantonio, Francesco Paolo Russo, Silvia Fargion, M. Siciliano, M. Di Gregorio, Salvatore Madonia, Pierluigi Toniutto, D. Ieluzzi, Loredana Falzano, Giuseppe Montalto, Luchino Chessa, Giuseppe Foti, Adriano Lazzarin, Gianpiero D'Offizi, Carmine Coppola, Gloria Taliani, Claudio Viscoli, Massimo Zuin, Maria Rendina, Antonio Craxì, Al Zignego, Giovanni Raimondo, V. De Maria, E.M. Erne, Mario Strazzabosco, Adele Giammario, M. Colombo, P. Andreone, Claudio Maria Mastroianni, Alessandro Federico, G. Angarano, Andrea Giacometti, Maria Cristina Vinci, Antonio Benedetti, Carlo Ferrari, Erica Villa, Floriano Rosina, Marcello Persico, G. Nardone, Marco Massari, M. Rumi, Liliana Chemello, Gabriella Verucchi, Ivan Gentile, M.G. Quaranta, Loreta A. Kondili, Guglielmo Borgia, M. Andreoni, Stefano Vella, Antonio Gasbarrini, Maurizia Rossana Brunetto, Pierluigi Blanc, Alessia Ciancio, Alfredo Alberti, Carlo Torti, A. Di Leo, Nicola Caporaso, Kondili, L, Quaranta, Mg, Falzano, L, Di Gregorio, M, Brunetto, M, Zignego, Al, Ciancio, A, Di Leo, A, Rendina, M, Raimondo, G, Ferrari, C, Craxi, A, Taliani, G, Borgia, Guglielmo, Gentile, Ivan, Santantonio, Ta, Giammario, A, Blanc, P, Gaeta, Gb, Gasbarrini, A, Siciliano, M, Chessa, L, Erne, Em, Ieluzzi, D, Russo, Fp, Andreone, P, Vinci, M, Coppola, C, Chemello, L, Madonia, S, Verucchi, G, Persico, M, Zuin, M, Alberti, A, Puoti, M, Nardone, G, De Maria, V, Massari, M, Montalto, G, Foti, G, Rumi, Mg, Giacometti, A, Benedetti, A, D'Offizi, G, Strazzabosco, M, Fargion, S, Angarano, G, Federico, A, Caporaso, Nicola, Mastroianni, C, Toniutto, P, Colombo, M, Lazzarin, A, Torti, C, Andreoni, M, Rosina, F, Viscoli, C, Vella, S, and Villa, E.
Subjects: 030203 arthritis & rheumatology, medicine.medical_specialty, Hepatology, business.industry, Chronic liver disease, medicine.disease, Surgery, 03 medical and health sciences, 0302 clinical medicine, Life evaluation, Internal medicine, medicine, 030211 gastroenterology & hepatology, business, Studio, Cohort study
Published: 2016

25. Retreatment regimen of rituximab monotherapy given at the relapse of severe HCV-related cryoglobulinemic vasculitis: Long-term follow up data of a randomized controlled multicentre study

Author: Salvatore Scarpato, F. Zuliani, Paolo Fraticelli, Francesco Saccardo, T. Urraro, L. Corazza, Clodoveo Ferri, Cesare Mazzaro, Oreste Perrella, Anna Linda Zignego, Massimo Galli, Stefano Bombardieri, Patrizia Scaini, Costanza Sbreglia, Salvatore De Vita, Marco Sebastiani, Marco Lenzi, Dario Roccatello, Luca Quartuccio, Giuseppe Monti, Armando Gabrielli, Antonio Tavoni, Roberta Zani, M. Pietrogrande, Simone Baldovino, Piero Pioltelli, Davide Filippini, Quartuccio, L, Zuliani, F, Corazza, L, Scaini, P, Zani, R, Lenzi, M, Tavoni, A, Sebastiani, M, Baldovino, S, Urraro, T, Saccardo, F, Sbreglia, C, Mazzaro, C, Pioltelli, P, Fraticelli, P, Filippini, D, Gabrielli, A, Perrella, O, Scarpato, S, Roccatello, D, Zignego, Al, Ferri, C, Bombardieri, S, Pietrogrande, M, Monti, G, Galli, M, and De Vita, S
Subjects: Vasculitis, medicine.medical_specialty, Vasculiti, Immunology, education, Hepatiti, Hepatitis, Follow-Up Studie, Hypogammaglobulinemia, Agammaglobulinemia, Recurrence, Internal medicine, Immunology and Allergy, Medicine, Humans, Cryoglobulinemic vasculitis, business.industry, Cryoglobulinemia, Rituximab, Antirheumatic Agents, Follow-Up Studies, Hepatitis C, Chronic, Italy, Treatment Outcome, Antirheumatic Agent, medicine.disease, humanities, Surgery, Regimen, Peripheral neuropathy, business, medicine.drug, Human
Abstract: Objective To evaluate the efficacy and safety in the long term of a retreatment regimen with Rituximab (RTX) alone administered at clinical relapse in cryoglobulinemic vasculitis (CV). Methods Thirty patients with severe HCV-related CV, previously enrolled in the multicentre Italian trial on RTX in the treatment of CV, were retrospectively evaluated after the end of the trial. All of them were managed with RTX alone at clinical relapse, if any. Disease activity at the last available follow up was defined as complete remission (absence of active disease), partial remission (response > 50% of at least one manifestation among glomerulonephritis, peripheral neuropathy or skin ulcers) or active disease. Results The mean follow up after the first RTX cycle was 72.6 (20.4) months. After the end of the trial, 21/30 (70%) patients showed an active follow up [81.7 (10.9) months)], 3/30 (10%) lost follow up and 6/30 (20%) died. 12/21 (57.1%) patients were in complete disease remission, 5/21 (23.8%) showed a partial response and 4/21 (19%) had an active disease. 17/30 (56.7%) patients needed retreatment for relapse with a mean time to retreatment of 22.3 (12.1) months. Treatment survival of this regimen was 7.6 (0.3) years. Recurrent non-severe infections occurred in 3/30, with chronic hypogammaglobulinemia in 2/3 patients. Conclusions A long-term regimen of retreatment with RTX alone given at clinical relapse seems to be effective and safe in CV, with a low rate of infections and severe hypogammaglobulinemia.
Published: 2015

26. Hepatitis C epidemiology and treatment outcomes in Italy: Impact of the DAA era and the COVID-19 pandemic.

Author: Tramonti Fantozzi MP, Ceccarelli L, Petri D, De Vita E, Agostini A, Colombatto P, Stasi C, Rossetti B, Brunetto M, Surace L, Salvati A, Calì A, Tacconi D, Bianco C, Redi D, Fabbiani M, Panza F, Luchi S, Modica S, Moneta S, Iacopini S, Nencioni C, Chigiotti S, Ottaviano G, Zignego AL, Blanc P, Pierotti P, Mariabelli E, Berni R, Silvestri C, and Tavoschi L
Subjects: Humans, Male, Italy epidemiology, Female, Middle Aged, Retrospective Studies, Aged, Treatment Outcome, SARS-CoV-2, Adult, Hepacivirus drug effects, Hepacivirus genetics, Risk Factors, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic epidemiology, Hepatitis C epidemiology, Hepatitis C drug therapy, Antiviral Agents therapeutic use, COVID-19 epidemiology
Abstract: HCV infection poses a global health threat, with significant morbidity and mortality. This study examines HCV trends in a large Italian region from 2015 to 2022, considering demographic changes, evolving clinical profiles, treatment regimens and outcomes, including the impact of the COVID-19 pandemic. This multicentre retrospective study analysed demographics, clinical histories and risk factors in 6882 HCV patients. The study spanned before and after the direct-acting antiviral (DAA) era, and the COVID-19 period, focusing on treatment outcomes (SVR12, non-SVR12 and patients lost to follow-up). Statistical methods included ANOVA, multinomial logistic regression, Kruskal-Wallis test and chi-square analysis, and were conducted adhering to the intention-to-treat (ITT) principle. The cohort, mainly Italian males (average age 58.88), showed Genotype 1 dominance (56.6%) and a high SVR12 rate (97.5%). The pandemic increased follow-up losses, yet SVR12 rates remained stable, influenced by factors like age, gender, cirrhosis and comorbidities. Despite COVID-19 challenges, the region sustained high SVR12 rates in HCV care, emphasising the importance of sustained efforts in HCV care. Continuous screening and targeted interventions in high-risk populations are crucial for achieving WHO elimination targets. The study highlights the resilience of HCV care during the pandemic and provides insights for future public health strategies., (© 2024 The Author(s). Journal of Viral Hepatitis published by John Wiley & Sons Ltd.)
Published: 2024
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27. A holistic evaluation of patients with chronic Hepatitis D virus (HDV) infection enrolled in the Italian PITER-B and delta cohort.

Author: Kondili LA, Brancaccio G, Tosti ME, Coco B, Quaranta MG, Messina V, Ciancio A, Morisco F, Cossiga V, Claar E, Rosato V, Ciarallo M, Cacciola I, Ponziani FR, Cerrito L, Coppola R, Longobardi F, Biliotti E, Rianda A, Barbaro F, Coppola N, Stanzione M, Barchiesi F, Fagiuoli S, Viganò M, Massari M, Russo FP, Ferrarese A, Laccabue D, Di Marco V, Blanc P, Marrone A, Morsica G, Federico A, Ieluzzi D, Rocco A, Foschi FG, Soria A, Maida I, Chessa L, Milella M, Rosselli Del Turco E, Madonia S, Chemello L, Gentile I, Toniutto P, Bassetti M, Surace L, Baiocchi L, Pellicelli A, De Santis A, Puoti M, Degasperi E, Niro GA, Zignego AL, Craxi A, Raimondo G, Santantonio TA, Brunetto MR, and Gaeta GB
Subjects: Humans, Female, Male, Italy epidemiology, Adult, Middle Aged, Cross-Sectional Studies, Cohort Studies, Liver Cirrhosis epidemiology, Liver Cirrhosis virology, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular virology, Comorbidity, Aged, Hepatitis B Surface Antigens blood, Liver Neoplasms epidemiology, Liver Neoplasms virology, Interferons therapeutic use, Antiviral Agents therapeutic use, Hepatitis D, Chronic epidemiology, Hepatitis Delta Virus immunology, Hepatitis Delta Virus genetics
Abstract: Background and Aims: We aimed to characterize the epidemiologic and comorbidities profiles of patients with chronic Hepatitis D (CHD) followed in clinical practice in Italy and explored their interferon (IFN) eligibility., Methods: This was a cross-sectional study of the PITER cohort consisting of consecutive HBsAg-positive patients from 59 centers over the period 2019-2023. Multivariable analysis was performed by logistic regression model., Results: Of 5492 HBsAg-positive enrolled patients, 4152 (75.6%) were screened for HDV, 422 (10.2%) were anti-HDV positive. Compared with HBsAg mono-infected, anti-HDV positive patients were more often younger, non-Italians, with a history of drug use, had elevated alanine transaminase (ALT), cirrhosis, or hepatocellular carcinoma (HCC). Compared with Italians, anti-HDV positive non-Italians were younger (42.2% age ≤ 40 years vs. 2.1%; P < 0.001), more often females (males 43.0% vs. 68.6%; P < 0.001) with less frequent cirrhosis and HCC. HDV-RNA was detected in 63.2% of anti-HDV-positive patients, who were more likely to have elevated ALT, cirrhosis, and HCC. Extrahepatic comorbidities were present in 47.4% of anti-HDV positive patients and could affect the eligibility of IFN-containing therapies in at least 53.0% of patients in care., Conclusions: CHD affects young, foreign-born patients and older Italians, of whom two-thirds had cirrhosis or HCC. Comorbidities were frequent in both Italians and non-Italians and impacted eligibility for IFN., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2024
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28. EASL position paper on clinical follow-up after HCV cure.

Author: Reiberger T, Lens S, Cabibbo G, Nahon P, Zignego AL, Deterding K, Elsharkawy AM, and Forns X
Subjects: Humans, Liver Neoplasms etiology, Liver Neoplasms virology, Liver Neoplasms therapy, Sustained Virologic Response, Liver Cirrhosis virology, Hepacivirus drug effects, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic virology, Hepatitis C, Chronic complications, Carcinoma, Hepatocellular etiology, Carcinoma, Hepatocellular virology, Carcinoma, Hepatocellular therapy
Abstract: Following the advent of direct-acting antivirals (DAAs), hepatitis C virus (HCV) infection can be cured in almost all infected patients. This has led to a number of clinical questions regarding the optimal management of the millions of patients cured of HCV. This position statement provides specific guidance on the appropriate follow-up after a sustained virological response in patients without advanced fibrosis, those with compensated advanced chronic liver disease, and those with decompensated cirrhosis. Guidance on hepatocellular carcinoma risk assessment and the management of extrahepatic manifestations of HCV is also provided. Finally, guidance is provided on the monitoring and treatment of reinfection in at-risk patients. The recommendations are based on the best available evidence and are intended to help healthcare professionals involved in the management of patients after treatment for HCV., (Copyright © 2024 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)
Published: 2024
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29. Reduction of the Risk of Hepatocellular Carcinoma over Time Using Direct-Acting Antivirals: A Propensity Score Analysis of a Real-Life Cohort (PITER HCV).

Author: Quaranta MG, Cavalletto L, Russo FP, Calvaruso V, Ferrigno L, Zanetto A, Mattioli B, D'Ambrosio R, Panetta V, Brancaccio G, Raimondo G, Brunetto MR, Zignego AL, Coppola C, Iannone A, Biliotti E, Rosselli Del Turco E, Massari M, Licata A, Barbaro F, Persico M, Morisco F, Pompili M, Cerini F, Puoti M, Santantonio T, Craxì A, Kondili LA, Chemello L, and On Behalf Of Piter Collaborating Investigators
Subjects: Humans, Male, Female, Middle Aged, Aged, Incidence, Liver Cirrhosis virology, Liver Cirrhosis epidemiology, Prospective Studies, Italy epidemiology, Risk Factors, Cohort Studies, Adult, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular virology, Antiviral Agents therapeutic use, Liver Neoplasms epidemiology, Liver Neoplasms etiology, Liver Neoplasms prevention & control, Liver Neoplasms virology, Propensity Score, Sustained Virologic Response, Hepacivirus drug effects, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic complications
Abstract: The treatment of hepatitis C virus (HCV) with direct-acting antivirals (DAA) leads to high sustained virological response (SVR) rates, but hepatocellular carcinoma (HCC) risk persists in people with advanced liver disease even after SVR. We weighted the HCC risk in people with cirrhosis achieving HCV eradication through DAA treatment and compared it with untreated participants in the multicenter prospective Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. Propensity matching with inverse probability weighting was used to compare DAA-treated and untreated HCV-infected participants with liver cirrhosis. Kaplan-Meier analysis and competing risk regression analysis were performed. Within the first 36 months, 30 de novo HCC cases occurred in the untreated group ( n = 307), with a weighted incidence rate of 0.34% (95%CI: 0.23-0.52%), compared to 63 cases among SVR patients ( n = 1111), with an incidence rate of 0.20% (95%CI: 0.16-0.26%). The 12-, 24-, and 36-month HCC weighted cumulative incidence rates were 6.7%, 8.4%, and 10.0% in untreated cases and 2.3%, 4.5%, and 7.0% in the SVR group. Considering death or liver transplantation as competing events, the untreated group showed a 64% higher risk of HCC incidence compared to SVR patients (SubHR 1.64, 95%CI: 1.02-2.62). Other variables independently associated with the HCC occurrence were male sex, increasing age, current alcohol use, HCV genotype 3, platelet count ≤ 120,000/µL, and albumin ≤ 3.5 g/dL. In real-life practice, the high efficacy of DAA in achieving SVR is translated into high effectiveness in reducing the HCC incidence risk.
Published: 2024
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30. Predicting de-novo portal vein thrombosis after HCV eradication: A long-term competing risk analysis in the ongoing PITER cohort.

Author: Kondili LA, Zanetto A, Quaranta MG, Ferrigno L, Panetta V, Calvaruso V, Zignego AL, Brunetto MR, Raimondo G, Biliotti E, Ieluzzi D, Iannone A, Madonia S, Chemello L, Cavalletto L, Coppola C, Morisco F, Barbaro F, Licata A, Federico A, Cerini F, Persico M, Pompili M, Ciancio A, Piscaglia F, Chessa L, Giacometti A, Invernizzi P, Brancaccio G, Benedetti A, Baiocchi L, Gentile I, Coppola N, Nardone G, Craxì A, and Russo FP
Subjects: Humans, Antiviral Agents therapeutic use, Portal Vein, Liver Cirrhosis diagnosis, Liver Cirrhosis epidemiology, Liver Cirrhosis complications, Risk Assessment, Albumins therapeutic use, Bilirubin, Esophageal and Gastric Varices complications, Hepatitis C, Chronic complications, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Venous Thrombosis diagnosis, Venous Thrombosis epidemiology, Venous Thrombosis etiology
Abstract: Background & Aims: Sustained virological response (SVR) by direct-acting antivirals (DAAs) may reverse the hypercoagulable state of HCV cirrhosis and the portal vein thrombosis (PVT) risk. We evaluated the incidence and predictive factors of de novo, non-tumoral PVT in patients with cirrhosis after HCV eradication., Methods: Patients with HCV-related cirrhosis, consecutively enrolled in the multi-center ongoing PITER cohort, who achieved the SVR using DAAs, were prospectively evaluated. Kaplan-Meier and competing risk regression analyses were performed., Results: During a median time of 38.3 months (IQR: 25.1-48.7 months) after the end of treatment (EOT), among 1609 SVR patients, 32 (2.0%) developed de novo PVT. A platelet count ≤120,000/μL, albumin levels ≤3.5 mg/dL, bilirubin >1.1 mg/dL, a previous liver decompensation, ALBI, Baveno, FIB-4, and RESIST scores were significantly different (p < 0.001), among patients who developed PVT versus those who did not. Considering death and liver transplantation as competing risk events, esophageal varices (subHR: 10.40; CI 95% 4.33-24.99) and pre-treatment ALBI grade ≥2 (subHR: 4.32; CI 95% 1.36-13.74) were independent predictors of PVT. After HCV eradication, a significant variation in PLT count, albumin, and bilirubin (p < 0.001) versus pre-treatment values was observed in patients who did not develop PVT, whereas no significant differences were observed in those who developed PVT (p > 0.05). After the EOT, esophageal varices and ALBI grade ≥2, remained associated with de novo PVT (subHR: 9.32; CI 95% 3.16-27.53 and subHR: 5.50; CI 95% 1.67-18.13, respectively)., Conclusions: In patients with HCV-related cirrhosis, a more advanced liver disease and significant portal hypertension are independently associated with the de novo PVT risk after SVR., (© 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)
Published: 2024
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31. Impact of COVID-19 and vaccination campaign on 1,755 systemic sclerosis patients during first three years of pandemic. Possible risks for individuals with impaired immunoreactivity to vaccine, ongoing immunomodulating treatments, and disease-related lung involvement during the next pandemic phase.

Author: Ferri C, Raimondo V, Giuggioli D, Gragnani L, Lorini S, Dagna L, Bosello SL, Foti R, Riccieri V, Guiducci S, Cuomo G, Tavoni A, De Angelis R, Cacciapaglia F, Zanatta E, Cozzi F, Murdaca G, Cavazzana I, Romeo N, Codullo V, Pellegrini R, Varcasia G, De Santis M, Selmi C, Abignano G, Caminiti M, L'Andolina M, Olivo D, Lubrano E, Spinella A, Lumetti F, De Luca G, Ruscitti P, Urraro T, Visentini M, Bellando-Randone S, Visalli E, Testa D, Sciascia G, Masini F, Pellegrino G, Saccon F, Balestri E, Elia G, Ferrari SM, Tonutti A, Dall'Ara F, Pagano Mariano G, Pettiti G, Zanframundo G, Brittelli R, Aiello V, Dal Bosco Y, Foti R, Di Cola I, Scorpiniti D, Fusaro E, Ferrari T, Gigliotti P, Campochiaro C, Francioso F, Iandoli C, Caira V, Zignego AL, D'Angelo S, Franceschini F, Matucci-Cerinic M, Giacomelli R, Doria A, Santini SA, Fallahi P, Iannone F, and Antonelli A
Abstract: Introduction: The impact of COVID-19 pandemic represents a serious challenge for 'frail' patients' populations with inflammatory autoimmune systemic diseases such as systemic sclerosis (SSc). We investigated the prevalence and severity of COVID-19, as well the effects of COVID-19 vaccination campaign in a large series of SSc patients followed for the entire period (first 38 months) of pandemic., Patients and Method: This prospective survey study included 1755 unselected SSc patients (186 M, 1,569F; mean age 58.7 ± 13.4SD years, mean disease duration 8.8 ± 7.3SD years) recruited in part by telephone survey at 37 referral centers from February 2020 to April 2023. The following parameters were carefully evaluated: i. demographic, clinical, serological, and therapeutical features; ii. prevalence and severity of COVID-19; and iii. safety, immunogenicity, and efficacy of COVID-19 vaccines., Results: The prevalence of COVID-19 recorded during the whole pandemic was significantly higher compared to Italian general population (47.3 % vs 43.3 %, p < 0.000), as well the COVID-19-related mortality (1.91 % vs 0.72 %, p < 0.001). As regards the putative prognostic factors of worse outcome, COVID-19 positive patients with SSc-related interstitial lung involvement showed significantly higher percentage of COVID-19-related hospitalization compared to those without (5.85 % vs 1.73 %; p < 0.0001), as well as of mortality rate (2.01 % vs 0.4 %; p = 0.002). Over half of patients (56.3 %) received the first two plus one booster dose of vaccine; while a fourth dose was administered to 35.6 %, and only few of them (1.99 %) had five or more doses of vaccine. Of note, an impaired seroconversion was recorded in 25.6 % of individuals after the first 2 doses of vaccine, and in 8.4 % of patients also after the booster dose. Furthermore, the absence of T-cell immunoreactivity was observed in 3/7 patients tested by QuantiFERON® SARSCoV-2 Starter Set (Qiagen). The efficacy of vaccines, evaluated by comparing the COVID-19-related death rate recorded during pre- and post-vaccination pandemic periods, revealed a quite stable outcome in SSc patients ( death rate from 2.54 % to 1.76 %; p = ns), despite the significant drop of mortality observed in the Italian general population (from 2.95 % to 0.29 %; p < 0.0001)., Conclusions: An increased COVID-19 prevalence and mortality rate was recorded in SSc patients; moreover, the efficacy of vaccines in term of improved outcomes was less evident in SSc compared to Italian general population. This discrepancy might be explained by concomitant adverse prognostic factors: increased rate of non-responders to vaccine in SSc series, low percentage of individuals with four or more doses of vaccine, ongoing immunomodulating treatments, disease-related interstitial lung disease, and/or reduced preventive measures in the second half of pandemic. A careful monitoring of response to COVID-19 vaccines together with adequate preventive/therapeutical strategies are highly recommendable in the near course of pandemic in this frail patients' population., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Alessandro Antonelli reports financial support was provided by Italian 10.13039/100009647Ministry of Health, Ricerca Finalizzata (RF-2021-12374986) Destinatario istituzionale: Regione Toscana. Unità Operative:U.O.1: Azienda Ospedaliero-Universitaria Pisana; U.O.2: Azienda Ospedaliero-Universitaria Aldo Moro Bari; U.O.3: Azienda Ospedaliero-Universitaria Modena, CUP Master: D55E22000670001., (© 2023 Published by Elsevier B.V.)
Published: 2023
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32. Persistence of monoclonal B-cell expansion and intraclonal diversification despite virus eradication in patients affected by hepatitis C virus-associated lymphoproliferative disorders.

Author: Mazzaro C, Visentini M, Gragnani L, Vit F, Tissino E, Pozzo F, Papotti R, Casato M, Zignego AL, Bittolo T, Zucchetto A, Degan M, Bomben R, and Gattei V
Abstract: We investigated 23 hepatitis C virus (HCV)-infected patients with overt lymphoproliferative diseases (15 cases) or monoclonal B lymphocytosis (8 cases) treated with direct agent antiviral (DAAs) per clinical practice. DAA therapy yielded undetectable HCV-RNA, the complete response of cryoglobulinemia vasculitis and related signs, whilst the presence of B-cell clones (evaluated by flow cytometry, IGHV, and BCL2-IGH rearrangements), detected in 19/23 cases at baseline, was maintained (17/19). Similarly, IGHV intraclonal diversification, supporting an antigen-driven selection mechanism, was identified in B-cell clones at baseline and end of follow-up. DAA therapy alone, despite HCV eradication and good immunological responses, was less effective on the pathological B-cell clones., (© 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.)
Published: 2023
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33. Evaluation of Plasma miR-17-5p, miR-24-3p and miRNA-223-3p Profile of Hepatitis C Virus-Infected Patients after Treatment with Direct-Acting Antivirals.

Author: Öksüz Z, Gragnani L, Lorini S, Temel GÖ, Serin MS, and Zignego AL
Abstract: The expression of miR-223-3p, miR-17-5p, and miR-24-3p was evaluated in hepatitis C virus (HCV) patient serum samples, collected before DAA treatment and after a sustained virological response (SVR). Fifty HCV patients were stratified based on their liver damage stages into three different subgroups (21 with chronic hepatitis-CH, 15 with cirrhosis, and 14 with hepatocellular carcinoma-HCC). Considering the entire HCV population, the miRNA expression levels were significantly downregulated after the SVR compared to pre-treatment ones ( p < 0.05). Stratifying the patients based on liver damage, the post-SVR values of the three miRNAs were significantly downregulated compared to the pre-treatment levels for both cirrhosis and HCC patients. No significant differences emerged from the analysis of the CH group. To our knowledge, this is the first study to detail the behavior of miR-223-3p, miR-17-5p, and miR-24-3p levels in patients with HCV-related CH, cirrhosis, and HCC after DAA therapy. Our findings show that HCV-infected patients have different miRNA profiles before and after treatment with DAAs, strongly suggesting that miRNAs may be involved in the pathogenesis of HCV-related damage. In this respect, the correlation observed among the three studied miRNAs could imply that they share common pathways by which they contribute the progression of HCV-induced chronic liver damage.
Published: 2023
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34. Serological and Molecular Characterization of Hepatitis C Virus-Related Cryoglobulinemic Vasculitis in Patients without Cryoprecipitate.

Author: Napodano C, Ciasca G, Chiusolo P, Pocino K, Gragnani L, Stefanile A, Gulli F, Lorini S, Minnella G, Fosso F, Di Santo R, Romanò S, Basile V, De Stefano V, Rapaccini GL, Zignego AL, Di Stasio E, Marino M, and Basile U
Subjects: Humans, Male, Female, Rheumatoid Factor blood, Immunoglobulins blood, Vasculitis diagnosis, Vasculitis immunology, Vasculitis virology, Cryoglobulinemia diagnosis, Cryoglobulinemia virology, Cryoglobulins analysis, Hepatitis C, Chronic blood, Hepatitis C, Chronic complications
Abstract: Prolonged B cells stimulation due to the Hepatitis C virus (HCV) can result in autoimmunity, stigmatized by rising levels of cryoglobulins (CGs), the rheumatoid factor (RF), and free light chains (FLC) of immunoglobulins (Ig) associated with a range of symptoms, from their absence to severe cryoglobulinemic vasculitis and lymphoma. Here, we aimed to identify an immunological signature for the earliest stages of vasculitis when cryoprecipitate is still not detectable. We firstly analyzed the IgG subclasses, FLC, and RF in 120 HCV-RNA-positive patients divided into four groups according to the type of cryoprecipitate and symptoms: 30 asymptomatic without cryoprecipitate (No Cryo), 30 with vasculitis symptoms but without CGs that we supposed were circulating but still not detectable (Circulating), 30 type II and 30 type III mixed cryoglobulinemia (Cryo II and Cryo III, respectively). Our results revealed that patients with supposed circulating CGs displayed a pattern of serological parameters that closely resembled Cryo II and Cryo III, with a stronger similarity to Cryo II. Accordingly, we analyzed the groups of Circulating and Cryo II for their immunoglobulin heavy chain (IgH) and T-cell receptor (TCR) gene rearrangements, finding a similar mixed distribution of monoclonal, oligoclonal, and polyclonal responses compared to a control group of ten HCV-RNA-negative patients recovered from infection, who displayed a 100% polyclonal response. Our results strengthened the hypothesis that circulating CGs are the origin of symptoms in HCV-RNA-positive patients without cryoprecipitate and demonstrated that an analysis of clonal IGH and TCR rearrangements is the best option for the early diagnosis of extrahepatic complications.
Published: 2023
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35. Profiling the risk of hepatocellular carcinoma after long-term HCV eradication in patients with liver cirrhosis in the PITER cohort.

Author: Kondili LA, Quaranta MG, Cavalletto L, Calvaruso V, Ferrigno L, D'Ambrosio R, Simonelli I, Brancaccio G, Raimondo G, Brunetto MR, Zignego AL, Coppola C, Iannone A, Biliotti E, Verucchi G, Massari M, Licata A, Barbaro F, Persico M, Russo FP, Morisco F, Pompili M, Viganò M, Puoti M, Santantonio T, Villa E, Craxì A, and Chemello L
Subjects: Humans, Antiviral Agents therapeutic use, Risk Factors, Liver Cirrhosis epidemiology, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular etiology, Carcinoma, Hepatocellular diagnosis, Liver Neoplasms epidemiology, Liver Neoplasms etiology, Liver Neoplasms diagnosis, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy
Abstract: Background and Aims: Severe liver disease markers assessed before HCV eradication are acknowledged to usually improve after the SVR. We prospectively evaluated, in the PITER cohort, the long-term HCC risk profile based on predictors monitored after HCV eradication by direct-acting antivirals in patients with cirrhosis., Methods: HCC occurrence was evaluated by Kaplan-Meier analysis. Cox regression analysis identified the post-treatment variables associated with de-novo HCC; their predictive power was presented in a nomogram., Results: After the end of therapy (median follow-up:28.47 months), among 2064 SVR patients, 119 (5.8%) developed de-novo HCC. The HCC incidence was 1.90%, 4.21%, 6.47% at 12-, 24- and 36-months from end-of-therapy, respectively (incidence rate 2.45/100 person-years). Age, genotype 3, diabetes, platelets (PLT)≤120,000/µl and albumin ≤3.5g/dl levels were identified as pre-treatment HCC independent predictors. Adjusting for age, the post-treatment PLT≤120,000/µl (AdjHR 1.92; 95%CI:1.06-3.45) and albumin≤3.5g/dl (AdjHR 4.38; 95%CI 2.48-7.75) values were independently associated with HCC occurrence. Two different risk profiles were identified by combining long-term post-therapy evaluation of PLT ≤ vs. >120,000/µl and albumin ≤ vs. >3.5g/dl showing a significant different HCC incidence rate of 1.35 vs. 3.77/100 p-y, respectively., Conclusions: The nomogram score based on age, PLT and albumin levels after SVR showed an accurate prediction capability and may support the customizing management for early HCC detection., Competing Interests: Conflict of interest None declared., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2023
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36. COVID-19 and Mixed Cryoglobulinemia Syndrome: Long-Term Survey Study on the Prevalence and Outcome, Vaccine Safety, and Immunogenicity.

Author: Gragnani L, Visentini M, Lorini S, Santini SA, Lauletta G, Mazzaro C, Urraro T, Quartuccio L, Cacciapaglia F, Ruscitti P, Tavoni A, Marri S, Cusano G, Petraccia L, Naclerio C, Treppo E, Del Frate G, Di Cola I, Raimondo V, Scorpiniti D, Monti M, Puccetti L, Elia G, Fallahi P, Basili S, Scarpato S, Iannone F, Casato M, Antonelli A, Zignego AL, and Ferri C
Subjects: Aged, Aged, 80 and over, Humans, Middle Aged, Antibodies, Viral, Immunologic Factors, Prevalence, Vaccination adverse effects, Vaccines, COVID-19 complications, COVID-19 epidemiology, COVID-19 Vaccines adverse effects, Cryoglobulinemia diagnosis, Cryoglobulinemia epidemiology
Abstract: Purpose: Mixed cryoglobulinemia syndrome (MCs) is a rare immunoproliferative systemic disorder with cutaneous and multiple organ involvement. Our multicenter survey study aimed to investigate the prevalence and outcome of COVID-19 and the safety and immunogenicity of COVID-19 vaccines in a large MCs series., Methods: The survey included 430 unselected MCs patients (130 M, 300 F; mean age 70 ± 10.96 years) consecutively collected at 11 Italian referral centers. Disease classification, clinico-serological assessment, COVID-19 tests, and vaccination immunogenicity were carried out according to current methodologies., Results: A significantly higher prevalence of COVID-19 was found in MCs patients compared to Italian general population (11.9% vs 8.0%, p < 0.005), and the use of immunomodulators was associated to a higher risk to get infected (p = 0.0166). Moreover, higher mortality rate was recorded in MCs with COVID-19 compared to those without (p < 0.01). Patients' older age (≥ 60 years) correlated with worse COVID-19 outcomes. The 87% of patients underwent vaccination and 50% a booster dose. Of note, vaccine-related disease flares/worsening were significantly less frequent than those associated to COVID-19 (p = 0.0012). Impaired vaccination immunogenicity was observed in MCs patients compared to controls either after the first vaccination (p = 0.0039) and also after the booster dose (p = 0.05). Finally, some immunomodulators, namely, rituximab and glucocorticoids, hampered the vaccine-induced immunogenicity (p = 0.029)., Conclusions: The present survey revealed an increased prevalence and morbidity of COVID-19 in MCs patients, as well an impaired immunogenicity even after booster vaccination with high rate of no response. Therefore, MCs can be included among frail populations at high risk of infection and severe COVID-19 manifestations, suggesting the need of a close monitoring and specific preventive/therapeutical measures during the ongoing pandemic., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Published: 2023
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37. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination.

Author: Brancaccio G, Coco B, Nardi A, Quaranta MG, Tosti ME, Ferrigno L, Cacciola I, Messina V, Chessa L, Morisco F, Milella M, Barbaro F, Ciancio A, Russo FP, Coppola N, Blanc P, Claar E, Verucchi G, Puoti M, Zignego AL, Chemello L, Madonia S, Fagiuoli S, Marzano A, Ferrari C, Lampertico P, Di Marco V, Craxì A, Santantonio TA, Raimondo G, Brunetto MR, Gaeta GB, and Kondili LA
Subjects: Humans, Female, Hepatitis B e Antigens, Cross-Sectional Studies, Italy epidemiology, Liver Cirrhosis complications, Hepatitis B Surface Antigens, Hepatitis Delta Virus, Hepatitis B virus, Hepatitis B, Chronic epidemiology, Hepatitis B, Chronic complications, Hepatitis B epidemiology
Abstract: Objectives: The study measures trends in the profile of patients with chronic hepatitis B virus linked to care in Italy., Methods: A cross-sectional, multicenter, observational cohort (PITER cohort) of consecutive patients with hepatitis B surface antigen (HBsAg) over the period 2019-2021 from 46 centers was evaluated. The reference was the MASTER cohort collected over the years 2012-2015. Standard statistical methods were used., Results: The PITER cohort enrolled 4583 patients, of whom 21.8% were non-Italian natives. Compared with those in MASTER, the patients were older and more often female. The prevalence of hepatitis B e antigen (HBeAg) declined (7.2% vs 12.3; P <0.0001) and that of anti-hepatitis D virus (HDV) remained stable (9.3% vs 8.3%). In both cohorts, about 25% of the patients had cirrhosis, and those in the PITER cohort were older. HBeAg-positive was 5.0% vs 12.6% (P <0.0001) and anti-HDV positive 24.8% vs 17.5% (P <0.0017). In the logistic model, the variables associated with cirrhosis were anti-HDV-positive (odds ratio = 10.08; confidence interval 7.63-13.43), age, sex, and body mass index; the likelihood of cirrhosis was reduced by 40% in the PITER cohort. Among non-Italians, 12.3% were HBeAg-positive (vs 23.4% in the MASTER cohort; P <0.0001), and 12.3% were anti-HDV-positive (vs 11.1%). Overall, the adherence to the European Association for the Study of the Liver recommendations for antiviral treatment increased over time., Conclusion: Chronic hepatitis B virus infection appears to be in the process of becoming under control in Italy; however, HDV infection is still a health concern in patients with cirrhosis and in migrants., Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)
Published: 2023
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38. COVID-19 vaccination rate and safety profile in a multicentre Italian population affected by mixed cryoglobulinaemic vasculitis.

Author: Vacchi C, Testoni S, Visentini M, Zani R, Lauletta G, Gragnani L, Filippini D, Mazzaro C, Fraticelli P, Quartuccio L, Padoan R, Castelnovo L, Zignego AL, Ferri C, Scarpato S, Casato M, Hoxha A, Salvarani C, Monti G, Galli M, and Sebastiani M
Subjects: Humans, Glucocorticoids, Italy epidemiology, Rituximab, SARS-CoV-2, Vaccination adverse effects, COVID-19 complications, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Cryoglobulinemia, Giant Cell Arteritis, Granulomatosis with Polyangiitis, Polyarteritis Nodosa
Abstract: Objectives: Mixed cryoglobulinaemic vasculitis (MCV) is an immune-complex-mediated systemic vasculitis characterised by heterogeneous clinical manifestations mainly involving lymphatic system, skin, kidney and peripheral nervous system. Although MCV patients have been included in priority programs for vaccination against SARS-CoV-2 in Italy, limited information is available for these patients. The aims of this multicentre Italian study were to investigate SARS-CoV-2 vaccination rate in MCV patients and its safety profile., Methods: All MCV patients referring to participating centres were assessed with an interview-based survey about vaccination, reasons for not getting vaccinated, adverse events (AE), and disease flares within a month after vaccination., Results: A total of 416 patients were included in the study. Among participants, 7.7% did not get vaccinated, mainly for fear related to vaccine side-effects (50%) or medical decision (18.8%). They were more frequently treated with chronic glucocorticoids or rituximab (p=0.049 and p=0.043, respectively). Mild and self-limiting AE were recorded in 31.7% of cases, while post-vaccination vasculitis flares were observed in 5.3% of subjects. Disease relapses were mainly observed in patients with peripheral neuropathy or skin vasculitis (40% and 25%, respectively)., Conclusions: Vaccination against SARS-CoV-2 has been performed in a high percentage of MCV patients with encouraging safety profile. Vasculitis flares rate was in line with that observed for other autoimmune diseases, despite patients with purpura or peripheral neuropathy seem to be at risk for symptoms' exacerbation. Patients' hesitancy, rituximab and glucocorticoids treatment were the main reasons for delaying vaccination.
Published: 2023
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39. Management of mixed cryoglobulinemia with rituximab: evidence and consensus-based recommendations from the Italian Study Group of Cryoglobulinemia (GISC).

Author: Quartuccio L, Bortoluzzi A, Scirè CA, Marangoni A, Del Frate G, Treppo E, Castelnovo L, Saccardo F, Zani R, Candela M, Fraticelli P, Mazzaro C, Renoldi P, Scaini P, Filippini DA, Visentini M, Scarpato S, Giuggioli D, Mascia MT, Sebastiani M, Zignego AL, Lauletta G, Fiorilli M, Casato M, Ferri C, Pietrogrande M, Pioltelli PE, De Vita S, Monti G, and Galli M
Subjects: Humans, Rituximab therapeutic use, Consensus, Hepacivirus, Cryoglobulinemia drug therapy, Cryoglobulinemia complications, Hepatitis C complications, Hepatitis C drug therapy, Vasculitis drug therapy, Vasculitis complications
Abstract: Cryoglobulinemic vasculitis (CV) or mixed cryoglobulinemic syndrome (MCS) is a systemic small-vessel vasculitis characterized by the proliferation of B-cell clones producing pathogenic immune complexes, called cryoglobulins. It is often secondary to hepatitis C virus (HCV), autoimmune diseases, and hematological malignancies. CV usually has a mild benign clinical course, but severe organ damage and life-threatening manifestations can occur. Recently, evidence in favor of rituximab (RTX), an anti-CD 20 monoclonal antibody, is emerging in CV: nevertheless, questions upon the safety of this therapeutic approach, especially in HCV patients, are still being issued and universally accepted recommendations that can help physicians in MCS treatment are lacking. A Consensus Committee provided a prioritized list of research questions to perform a systematic literature review (SLR). A search was made in Medline, Embase, and Cochrane library, updated to August 2021. Of 1227 article abstracts evaluated, 27 studies were included in the SLR, of which one SLR, 4 RCTs, and 22 observational studies. Seventeen recommendations for the management of mixed cryoglobulinemia with rituximab from the Italian Study Group of Cryoglobulinemia (GISC) were developed to give a valuable tool to the physician approaching RTX treatment in CV., (© 2022. The Author(s).)
Published: 2023
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40. Correction to: Management of mixed cryoglobulinemia with rituximab: evidence and consensus-based recommendations from the Italian Study Group of Cryoglobulinemia (GISC).

Author: Quartuccio L, Bortoluzzi A, Scirè CA, Marangoni A, Del Frate G, Treppo E, Castelnovo L, Saccardo F, Zani R, Candela M, Fraticelli P, Mazzaro C, Renoldi P, Scaini P, Filippini DA, Visentini M, Scarpato S, Giuggioli D, Mascia MT, Sebastiani M, Zignego AL, Lauletta G, Fiorilli M, Casato M, Ferri C, Pietrogrande M, Pioltelli PE, De Vita S, Monti G, and Galli M
Published: 2023
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41. Direct-Acting Antivirals as Primary Treatment for Hepatitis C Virus-Associated Indolent Non-Hodgkin Lymphomas: The BArT Study of the Fondazione Italiana Linfomi.

Author: Merli M, Rattotti S, Spina M, Re F, Motta M, Piazza F, Orsucci L, Ferreri AJM, Perbellini O, Dodero A, Vallisa D, Pulsoni A, Santoro A, Sacchi P, Zuccaro V, Chimienti E, Russo F, Visco C, Zignego AL, Marcheselli L, Passamonti F, Luminari S, Paulli M, Bruno R, and Arcaini L
Subjects: Humans, Aged, Hepacivirus genetics, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Lymphoma, Non-Hodgkin drug therapy, Lymphoma
Abstract: Purpose: We prospectively treated patients with hepatitis C virus (HCV)-associated indolent lymphomas with genotype-appropriate direct-acting antivirals (DAAs) with the aim to evaluate virologic and hematologic outcomes. No prospective studies in this setting have been published so far., Methods: FIL_BArT is a prospective, multicenter, phase II trial that evaluated genotype-appropriate DAAs in untreated HCV-positive patients with indolent lymphomas without criteria for immediate conventional antilymphoma treatment. The primary objective was sustained virologic response, whereas the main secondary objectives were overall response rate of lymphoma and progression-free survival., Results: Forty patients were enrolled, including 27 with marginal zone lymphoma. Median age was 68 years. Extranodal sites were involved in 14 cases (35%). Main genotypes were 1 in 16 patients and 2 in 21 patients. All patients received genotype-guided DAAs: 17 ledipasvir/sofosbuvir, eight sofosbuvir plus ribavirin, and 15 sofosbuvir/velpatasvir. All patients achieved sustained virologic response (100%). DAAs were well tolerated, with only two grade 3-4 adverse events. Overall response rate of lymphoma was 45%, including eight patients (20%) achieving complete response and 10 (25%) partial response, whereas 16 exhibited stable disease and six progressed. With a median follow-up of 37 months, two patients died (3-year overall survival 93%; 95% CI, 74 to 98) and three additional patients progressed, with a 3-year progression-free survival of 76% (95% CI, 57 to 87)., Conclusion: HCV eradication by DAAs was achieved in 100% of HCV-positive patients with indolent lymphomas not requiring immediate conventional treatment and resulted in non-negligible rate of lymphoma responses. Treatment with DAAs should be considered as the first-line therapy in this setting.
Published: 2022
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42. B-cell activating factor (BAFF), BAFF promoter and BAFF receptor allelic variants in hepatitis C virus related Cryoglobulinemic Vasculitis and Non-Hodgkin's Lymphoma.

Author: Gragnani L, Lorini S, Marri S, Rattotti S, Madia F, Zibellini S, Monti M, Basile U, Di Stasio E, Libra M, Arcaini L, and Zignego AL
Subjects: Alleles, Hepacivirus, Humans, Interleukin-4, B-Cell Activating Factor genetics, B-Cell Activation Factor Receptor genetics, Cryoglobulinemia genetics, Hepatitis C complications, Hepatitis C genetics, Lymphoma, Non-Hodgkin complications, Lymphoma, Non-Hodgkin genetics, Vasculitis complications, Vasculitis genetics
Abstract: Cryoglobulinemic Vasculitis (CV) is an autoimmune/lymphoproliferative disorder associated with HCV infection that in 5%-10% of cases evolves into a B cell Non-Hodgkin's Lymphoma (NHL). B-cell activating factor (BAFF) is a key regulator in B-cell development and survival. Particular genetic variants are responsible for BAFF signaling impairment in autoimmune and neoplastic diseases. We evaluated BAFF and BAFF-receptor (BAFF-R) polymorphisms in order to determine if they predispose to HCV-related CV and NHL. The analysis was performed on 416 HCV-chronically infected patients: 136 HCV without signs/symptoms of lymphoproliferations/autoimmunity (HCV), 166 HCV with CV (HCV-CV) and 114 HCV with NHL (HCV-NHL). Rs9514828 SNP on BAFF promoter, rs61756766 on BAFF-R and rs12428930 on the BAFF gene were evaluated by Real-Time PCR. Concerning rs9514828, the frequency of C/T genotype was significantly higher in HCV-CV than in HCV. The difference in the distribution of the T/T mutant genotype in HCV-CV compared to HCV was significant as well as the distribution of C/T and T/T genotype in HCV-NHL versus HCV. T minor allele was more frequent in HCV-NHL and HCV-CV than in HCV. The distribution of C/T + T/T (for the dominant model of penetrance C/T + T/T vs. C/C) was significantly higher in HCV-CV and HCV-NHL than in HCV. Genotyping of rs61756766 on BAFF-R coding gene, revealed C/T heterozygosis at a frequency of 11% in HCV-NHL versus 3% in HCV. The T minor allele frequency was higher in HCV-NHL than in HCV. No differences emerged by genotyping rs12428930 SNP on BAFF coding gene. Our results reinforce the hypothesis that BAFF/BAFF-R genetic pattern has a role in the pathogenesis of HCV-related lymphoproliferations. BAFF/BAFF-R variants could identify a risk haplotype for HCV related CV and NHL and a BAFF/BAFF-R genetic profile assessment could potentially contribute to tailoring anti-BAFF therapy by identifying patients with BAFF alterations in which the treatment could be more beneficial., (© 2022 The Authors. Hematological Oncology published by John Wiley & Sons Ltd.)
Published: 2022
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43. Reply.

Author: Zignego AL, Gragnani L, and Kondili LA
Published: 2022
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44. A prospective study of direct-acting antiviral effectiveness and relapse risk in HCV cryoglobulinemic vasculitis by the Italian PITER cohort.

Author: Kondili LA, Monti M, Quaranta MG, Gragnani L, Panetta V, Brancaccio G, Mazzaro C, Persico M, Masarone M, Gentile I, Andreone P, Madonia S, Biliotti E, Filomia R, Puoti M, Fracanzani AL, Laccabue D, Ieluzzi D, Coppola C, Rumi MG, Benedetti A, Verucchi G, Coco B, Chemello L, Iannone A, Ciancio A, Russo FP, Barbaro F, Morisco F, Chessa L, Massari M, Blanc P, and Zignego AL
Subjects: Antiviral Agents therapeutic use, Hepacivirus, Humans, Prospective Studies, Recurrence, Sustained Virologic Response, Clinical Deterioration, Cryoglobulinemia drug therapy, Cryoglobulinemia etiology, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis drug therapy
Abstract: Background and Aims: Mixed cryoglobulinemia is the most common HCV extrahepatic manifestation. We aimed to prospectively evaluate the cryoglobulinemic vasculitis (CV) clinical profile after a sustained virologic response (SVR) over a medium-term to long-term period., Approach and Results: Direct-acting antiviral-treated cryoglobulinemic patients, consecutively enrolled in the multicentric Italian Platform for the Study of Viral Hepatitis Therapy cohort, were prospectively evaluated. Cumulative incidence Kaplan-Meier curves were reported for response, clinical deterioration, relapse and relapse-free survival rates. Cox regression analysis evaluated factors associated with different outcomes. A clinical response was reported in at least one follow-up point for 373 of 423 (88%) patients with CV who achieved SVR. Clinical response increased over time with a 76% improvement rate at month 12 after the end of treatment. A full complete response (FCR) was reached by 164 (38.8%) patients in at least one follow-up point. CV clinical response fluctuated, with some deterioration of the initial response in 49.6% of patients (median time of deterioration, 19 months). In patients who achieved FCR and had an available follow-up (137 patients) a relapse was observed in 13% and it was transient in 66.7% of patients. The rate of patients without any deterioration was 58% and 41% at 12 and 24 months, respectively. After achieving SVR, a clinical nonresponse was associated with older age and renal involvement; a clinical deterioration/relapse was associated with high pretreatment rheumatoid factor values, and FCR was inversely associated with age, neuropathy, and high cryocrit levels., Conclusion: In patients with CV, HCV eradication may not correspond to a persistent clinical improvement, and clinical response may fluctuate. This implies an attentive approach to post-SVR evaluation through prognostic factors and tailored treatment., (© 2022 The Authors. Hepatology published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)
Published: 2022
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45. Absent or suboptimal response to booster dose of COVID-19 vaccine in patients with autoimmune systemic diseases.

Author: Ferri C, Gragnani L, Raimondo V, Visentini M, Giuggioli D, Lorini S, Foti R, Cacciapaglia F, Caminiti M, Olivo D, Cuomo G, Pellegrini R, Pigatto E, Urraro T, Naclerio C, Tavoni A, Puccetti L, Cavazzana I, Ruscitti P, Vadacca M, La Gualana F, Cozzi F, Spinella A, Visalli E, Bosco YD, Amato G, Masini F, Mariano GP, Brittelli R, Aiello V, Scorpiniti D, Rechichi G, Varcasia G, Monti M, Elia G, Franceschini F, Casato M, Ursini F, Giacomelli R, Fallahi P, Santini SA, Iannone F, Salvarani C, Zignego AL, and Antonelli A
Subjects: Antibodies, Viral, BNT162 Vaccine, Humans, Immunization, Secondary, Vaccination, COVID-19 prevention & control, COVID-19 Vaccines
Abstract: Autoimmune systemic diseases (ASD) show impaired immunogenicity to COVID-19 vaccines. Our prospective observational multicenter study aimed at evaluating the seroconversion elicited by COVID-19 vaccine over the entire vaccination cycle including the booster dose. Among 478 unselected ASD patients originally evaluated at the end of the first vaccination cycle (time 1), 344 individuals were re-evaluated after a 6-month period (time 2), and 244 after the booster vaccine dose (time 3). The immunogenicity of mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) was assessed by measuring serum IgG-neutralizing antibody (NAb) on samples obtained at the three time points in both patients and 502 age-matched controls. In the 244 ASD group that received booster vaccine and monitored over the entire follow-up, the mean serum NAb levels (time 1, 2, and 3: 696.8 ± 52.68, 370.8 ± 41.92, and 1527 ± 74.16SD BAU/mL, respectively; p < 0.0001) were constantly lower compared to controls (p < 0.0001), but they significantly increased after the booster dose compared to the first two measurements (p < 0.0001). The percentage of patients with absent/suboptimal response to vaccine significantly decreased after the booster dose compared to the first and second evaluations (time 1, 2, and 3: from 28.2% to 46.3%, and to 7.8%, respectively; p < 0.0001). Of note, the percentage of patients with absent/suboptimal response after the booster dose was significantly higher compared to controls (19/244, 7.8% vs 1/502, 0.2%; p < 0.0001). Similarly, treatment with immune-modifiers increased the percentage of patients exhibiting absent/suboptimal response (16/122, 13.1% vs 3/122, 2.46%; p = 0.0031). Overall, the above findings indicate the usefulness of booster vaccine administration in ASD patients. Moreover, the persistence of a significantly higher percentage of individuals without effective seroconversion (7.8%), even after the booster dose, warrants for careful monitoring of NAb levels in all ASD patients to identify those with increased risk of infection. In this particularly frail patients' setting, tailored vaccination and/or therapeutic strategy are highly advisable., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
Published: 2022
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46. Flares of mixed cryoglobulinaemia vasculitis after vaccination against SARS-CoV-2.

Author: Visentini M, Gragnani L, Santini SA, Urraro T, Villa A, Monti M, Palladino A, Petraccia L, La Gualana F, Lorini S, Marri S, Madia F, Stefanini L, Basili S, Fiorilli M, Ferri C, Zignego AL, and Casato M
Subjects: Adult, Aged, Female, Humans, Male, Middle Aged, Symptom Flare Up, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Cryoglobulinemia immunology, SARS-CoV-2 immunology, Vasculitis chemically induced
Abstract: Competing Interests: Competing interests: None declared.
Published: 2022
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47. Predictors of long-term cryoglobulinemic vasculitis outcomes after HCV eradication with direct-acting antivirals in the real-life.

Author: Gragnani L, Lorini S, Marri S, Vacchi C, Madia F, Monti M, Ferri C, and Zignego AL
Subjects: Antiviral Agents therapeutic use, Hepacivirus, Humans, Persistent Infection, Cryoglobulinemia complications, Cryoglobulinemia drug therapy, Hepatitis C, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis complications, Vasculitis drug therapy
Abstract: Cryoglobulinemic vasculitis (CV) is the most frequent extrahepatic manifestation during HCV-chronic infection. An effective Direct Acting Antiviral-treatment leads to CV clinical response in the majority of CV-patients although symptoms may persist/recur despite a sustained virological response. At present, no standardized clinical predictive factors for disease maintenance/recurrence were proposed, as emerged from a complete literature review we performed and reported. Here we provided a detailed descriptive analysis of a wide population of CV patients treated with DAA-based regimes and followed-up after therapy completion for longer than 72 weeks, in order to identify clinical or laboratory predictors of disease outcome and to optimize the patient management. Together with some baseline symptoms (neuropathy, weakness and sicca syndrome), two newly created scores, CV- and Global Severity Index, emerged as reliable and standardized tools to predict CV clinical response before initiating an antiviral therapy. In addition to predictive parameters previously proposed in the world literature, these novel Indexes could fill an unmet gap in the clinical management of the complex HCV-related CV., (Copyright © 2021 Elsevier B.V. All rights reserved.)
Published: 2022
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48. Rapid improvement of psychiatric stigmata after IFN-free treatment in HCV patients with and without cryoglobulinemic vasculitis.

Author: Gragnani L, Lorini S, Martini L, Stasi C, Visentini M, Petraccia L, Marello N, Monti M, Marri S, Madia F, Ricca V, and Zignego AL
Subjects: Antiviral Agents therapeutic use, Hepacivirus, Humans, Quality of Life, Cryoglobulinemia complications, Cryoglobulinemia drug therapy, Hepatitis C complications, Hepatitis C drug therapy, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Vasculitis drug therapy
Abstract: Objective: Hepatitis C virus (HCV) causes neuropsychiatric disorders and quality of life impairment, especially in patients with cryoglobulinemic vasculitis (CV). Direct acting antivirals (DAAs) are effective in most extrahepatic HCV diseases, but limited information exists regarding the outcome of psychiatric disorders in patients with and without CV, after therapy. We aimed to evaluate psychiatric outcomes, in HCV-patients with and without CV, before and after successful DAA therapy., Methods: We prospectively studied DAA-treated HCV-patients, stratified into presence (CV) or absence of CV (NON-CV). Four psychometric scales were administered to assess depression (HAM-D and MADRS), anxiety (HAM-A), and mania (MRS). Short-Form-36 questionnaires evaluated quality of life., Results: Seventy-six patients were recruited, and 47 CV and 29 NON-CV were treated with antivirals. At baseline, depression and anxiety, from mild to severe, were frequently shown, with the most advanced cases in thee CV group; no patients achieved the scores for mania. A significant improvement emerged for all the psychometric scales in the entire population and in the subgroups, after viral eradication even in the short-term outcome. The Short-Form-36 summary components showed benefits., Conclusions: After HCV eradication, the depression and anxiety scores significantly improved and severity grade generally lowered. DAA-positive effects on mental disorders should be considered part of the therapy outcome, being beneficial especially in CV patients who usually have worse baseline mental scores. Key Points • HCV frequently causes psychiatric disorders and an often-invalidating autoimmune/lymphoproliferative disease called cryoglobulinemic vasculitis. • The new direct acting antivirals (DAAs) are very effective and well tolerated by HCV-patients. • This study shows DAA-induced benefits on depression and anxiety in HCV-patients that are especially evident in CV patients who usually have worse baseline mental scores. • DAA-induced benefits are observed in the short-term post-therapy follow-up, in contrast with data previously obtained in HCV patients treated with IFN-based anti-HCV therapy., (© 2021. The Author(s).)
Published: 2022
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49. Prevalence and Death Rate of COVID-19 in Autoimmune Systemic Diseases in the First Three Pandemic Waves. Relationship with Disease Subgroups and Ongoing Therapies.

Author: Ferri C, Raimondo V, Gragnani L, Giuggioli D, Dagna L, Tavoni A, Ursini F, L'Andolina M, Caso F, Ruscitti P, Caminiti M, Foti R, Riccieri V, Guiducci S, Pellegrini R, Zanatta E, Varcasia G, Olivo D, Gigliotti P, Cuomo G, Murdaca G, Cecchetti R, De Angelis R, Romeo N, Ingegnoli F, Cozzi F, Codullo V, Cavazzana I, Colaci M, Abignano G, De Santis M, Lubrano E, Fusaro E, Spinella A, Lumetti F, De Luca G, Bellando-Randone S, Visalli E, Bosco YD, Amato G, Giannini D, Bilia S, Masini F, Pellegrino G, Pigatto E, Generali E, Mariano GP, Pettiti G, Zanframundo G, Brittelli R, Aiello V, Caminiti R, Scorpiniti D, Ferrari T, Campochiaro C, Brusi V, Fredi M, Moschetti L, Cacciapaglia F, Paparo SR, Ragusa F, Mazzi V, Elia G, Ferrari SM, Di Cola I, Vadacca M, Lorusso S, Monti M, Lorini S, Aprile ML, Tasso M, Miccoli M, Bosello S, D'Angelo S, Doria A, Franceschini F, Meliconi R, Matucci-Cerinic M, Iannone F, Giacomelli R, Salvarani C, Zignego AL, Fallahi P, and Antonelli A
Subjects: Aged, Humans, Male, Middle Aged, Pandemics, Prevalence, Prospective Studies, Antirheumatic Agents therapeutic use, Autoimmune Diseases drug therapy, Autoimmune Diseases epidemiology, COVID-19 epidemiology, Lung Diseases, Interstitial drug therapy, Lung Diseases, Interstitial epidemiology, Scleroderma, Systemic, COVID-19 Drug Treatment
Abstract: Objective: Autoimmune systemic diseases (ASD) represent a predisposing condition to COVID-19. Our prospective, observational multicenter telephone survey study aimed to investigate the prevalence, prognostic factors, and outcomes of COVID-19 in Italian ASD patients., Methods: The study included 3,918 ASD pts (815 M, 3103 F; mean age 59±12SD years) consecutively recruited between March 2020 and May 2021 at the 36 referral centers of COVID-19 and ASD Italian Study Group. The possible development of COVID-19 was recorded by means of a telephone survey using a standardized symptom assessment questionnaire., Results: ASD patients showed a significantly higher prevalence of COVID-19 (8.37% vs. 6.49%; p<0.0001) but a death rate statistically comparable to the Italian general population (3.65% vs. 2.95%). Among the 328 ASD patients developing COVID-19, 17% needed hospitalization, while mild-moderate manifestations were observed in 83% of cases. Moreover, 12/57 hospitalized patients died due to severe interstitial pneumonia and/or cardiovascular events; systemic sclerosis (SSc) patients showed a significantly higher COVID-19-related death rate compared to the general population (6.29% vs. 2.95%; p=0.018). Major adverse prognostic factors to develop COVID-19 were: older age, male gender, SSc, pre-existing ASD-related interstitial lung involvement, and long-term steroid treatment. Of note, patients treated with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) showed a significantly lower prevalence of COVID-19 compared to those without (3.58% vs. 46.99%; p=0.000), as well as the SSc patients treated with low dose aspirin (with 5.57% vs. without 27.84%; p=0.000)., Conclusion: During the first three pandemic waves, ASD patients showed a death rate comparable to the general population despite the significantly higher prevalence of COVID-19. A significantly increased COVID-19- related mortality was recorded in only SSc patients' subgroup, possibly favored by preexisting lung fibrosis. Moreover, ongoing long-term treatment with csDMARDs in ASD might usefully contribute to the generally positive outcomes of this frail patients' population., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
Published: 2022
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50. COVID-19 vaccine immunogenicity in 16 patients with autoimmune systemic diseases. Lack of both humoral and cellular response to booster dose and ongoing disease modifying therapies.

Author: Gragnani L, Visentini M, Lorini S, La Gualana F, Santini SA, Cacciapaglia F, Tavoni A, Cuomo G, Fallahi P, Iannone F, Antonelli A, Casato M, Zignego AL, and Ferri C
Abstract: Background: Patients with autoimmune systemic diseases (ASDs) represent a frail population during the ongoing COVID-19 pandemic. The vaccination is the major preventive measure; however, a significant number of ASD patients show an impaired production of anti-COVID-19 neutralizing antibodies (NAb), possibly counterbalanced by adequate T-cell response. The present study aimed at evaluating both humoral and cellular response to COVID-19 vaccine booster dose in this particular setting., Patients and Methods: Serum NAb titer and T-cell response (measuring interferon gamma -IFN-γ- release) were evaluated 3 weeks after the COVID-19 vaccine booster dose, in 17 patients (12 F, mean age 68.8 ± 15.3 SD yrs) with different ASDs, compared to 17 healthy controls (HCs)., Results: The analysis excluded one patient reporting symptoms of COVID-19 only after the immunogenicity tests had been performed.The NAb levels were significantly lower in ASD compared to HCs (p < 0.0001); moreover, patients showed a higher percentage of negative/sub-optimal humoral response (31% vs 0% of HCs; p = 0.0184).The study of cellular response showed lower levels of IFN-γ for both Ag1 ( p = 0.0032) and Ag2 (p = 0.0136) in ASD patients compared to HCs, as well lower rate of adequate T-cell response compared to HCs (50% vs 94%; p = 0.0066).Disease modifying therapies (DMT) were administered in all patients with deficient NAb production (5/5, 100%), but in only 3/11 (27%) of responders ( p = 0.025).Worthy to note, 3/16 (19%) ASD patients developed neither humoral nor cellular responses, all treated with DMT., Conclusions: The impaired immunogenicity to COVID-19 vaccine booster and even more the concomitant lack of both humoral and cellular response might represent a high risk for severe COVID-19, particularly in ASD patients undergoing DMT.These frail subjects should be tightly monitored for their immune protection and prioritized for the fourth dose of COVID-19 vaccine. Moreover, in the occurrence of SARS-CoV2 infection, treatments with specific monoclonal antibodies and/or antivirals may be highly recommendable., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 The Authors.)
Published: 2022
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