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1. Long-term effective oral therapy could spare endoscopic surveillance of esophageal varices in HBV compensated cirrhotics: a 10-year study

Author

Farina, E., primary, Loglio, A., additional, Tosetti, G., additional, Viganò, M., additional, Gentile, C., additional, Perbellini, R., additional, Borghi, M., additional, Facchetti, F., additional, Renteria, SC. Uceda, additional, Rumi, MG., additional, Primignani, M., additional, and Lampertico, P., additional

Published
2021
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2. Tenofovir Alafenamide improves proximal tubular markers in CHB patients long-term treated with Tenofovir Disoproxil Fumarate: A real-life study based on the EASL switching criteria

Author

Loglio, A., primary, Viganò, M., additional, Borghi, M., additional, Gentile, C., additional, Facchetti, F., additional, Sambarino, D., additional, Perbellini, R., additional, Soffredini, R., additional, Renteria, SC. Uceda, additional, Rumi, MG., additional, and Lampertico, P., additional

Published
2021
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3. Advanced liver disease outcomes after hepatitis C eradication by human immunodeficiency virus infection in PITER cohort

Author

Quaranta, M, Ferrigno, L, Monti, M, Filomia, R, Biliotti, E, Iannone, A, Migliorino, G, Coco, B, Morisco, F, Vinci, M, D'Ambrosio, R, Chemello, L, Massari, M, Ieluzzi, D, Russo, F, Blanc, P, Verucchi, G, Puoti, M, Rumi, M, Barbaro, F, Santantonio, T, Federico, A, Chessa, L, Gentile, I, Zuin, M, Parruti, G, Morsica, G, Kondili, L, Quaranta MG, Ferrigno L, Monti M, Filomia R, Biliotti E, Iannone A, Migliorino G, Coco B, Morisco F, Vinci M, D'Ambrosio R, Chemello L, Massari M, Ieluzzi D, Russo FP, Blanc P, Verucchi G, Puoti M, Rumi MG, Barbaro F, Santantonio TA, Federico A, Chessa L, Gentile I, Zuin M, Parruti G, Morsica G, Kondili LA, Quaranta, M, Ferrigno, L, Monti, M, Filomia, R, Biliotti, E, Iannone, A, Migliorino, G, Coco, B, Morisco, F, Vinci, M, D'Ambrosio, R, Chemello, L, Massari, M, Ieluzzi, D, Russo, F, Blanc, P, Verucchi, G, Puoti, M, Rumi, M, Barbaro, F, Santantonio, T, Federico, A, Chessa, L, Gentile, I, Zuin, M, Parruti, G, Morsica, G, Kondili, L, Quaranta MG, Ferrigno L, Monti M, Filomia R, Biliotti E, Iannone A, Migliorino G, Coco B, Morisco F, Vinci M, D'Ambrosio R, Chemello L, Massari M, Ieluzzi D, Russo FP, Blanc P, Verucchi G, Puoti M, Rumi MG, Barbaro F, Santantonio TA, Federico A, Chessa L, Gentile I, Zuin M, Parruti G, Morsica G, and Kondili LA

Abstract

Background: Liver disease progression after Hepatitis C Virus (HCV) eradication following direct-acting antiviral (DAA) treatment in the real-life setting according to Human Immunodeficiency Virus (HIV) coinfection was evaluated. Methods: Patients consecutively enrolled in PITER between April 2014 and June 2019 and with at least 12-weeks follow-up following treatment were analysed. Cox regression analysis were used to evaluate HIV coinfection and factors independently associated with liver disease outcomes following viral eradication in DAA treated patients with pre-treatment liver cirrhosis. Results: 93 HIV/HCV coinfected and 1109 HCV monoinfected patients were evaluated during a median follow-up of 26.7 (range 6–44.6) and 24.6 (range 6.8–47.3) months, respectively. No difference in the cumulative HCC incidence and hepatic decompensation was observed between coinfected and monoinfected patients. Age (Hazard Ratio [HR] = 1.08; 95% CI 1.04–1.13), male sex (HR = 2.76; 95% CI 1.28–5.96), lower albumin levels (HR = 3.94; 95% CI 1.81–8.58), genotype 3 (HR = 5.05; 95% CI 1.75–14.57) and serum anti-HBc positivity (HR = 1.99, 95% CI 1.01–3.95) were independently associated with HCC incidence. Older age (HR = 1.03; 95% CI 1.00–1.07), male sex (HR = 2.13; 95% CI 1.06–4.26) and lower albumin levels (HR = 3.75; 95% CI 1.89–7.46) were independently associated with the appearance of a decompensating event after viral eradication. Conclusion: Different demographic, clinical and genotype distribution between HIV coinfected vs those monoinfected, was observed in a representative cohort of HCV infected patients in Italy. Once liver cirrhosis is established the disease progression is decreased, but still persists regardless of viral eradication in both coinfected and monoinfected patients. In patients with cirrhosis, HIV coinfection was not associated with a higher probability of liver complications, after viral eradication.

Published
2020

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. 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

6. Modeling cost-effectiveness and health gains of a “universal” versus “prioritized” 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 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 when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814–1825).

Published
2017

8. 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

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

Author

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

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

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

Published
2010

10. Trattamento della Epatite da HCV

Author

Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, Zignego L., BRILLANTI, STEFANO, MAZZELLA, GIUSEPPE, Alberti A, Bonino F, Bortolotti F, Colombo M, Craxì A, Mele A, Rizzetto M, Almasio P, Androne P, Ascione A, Benvegnù L, Brillanti S, Brunetto M, Bruno S, Cammaà C, Di Marco V, Fattovich G, Ferrari C, Ideo G, Levriero M, Mazzella G, Pagliaro L, Pastore G, Piccinino F, Pontisso P, Puoti C, Puoti M, Raimondo G, Rumi MG, Saracco G, Santantonio T, Smedile A, and Zignego L.

Subjects
TERAPIA, HCV, EPATITE
Published
2004

16. Pegylated IFN-alpha2a and ribavirin in the treatment of hepatitis C.

Author

Aghemo A, Rumi MG, Colombo M, Aghemo, Alessio, Rumi, Maria Grazia, and Colombo, Massimo

Abstract

Chronic hepatitis C is a major worldwide health problem with an estimated prevalence of 1.6-2%. The prognosis of chronic hepatitis C depends on the rate of fibrosis progression which, over a 20-30-year time span, may determine the risk of developing cirrhosis and its complications, namely hepatocellular carcinoma, liver decompensation, hepatic encefalopathy and espohageal variceal bleeding. The only therapeutic measure able to halt this progressive process is HCV eradication by interferon (IFN)-based therapies. HCV clearance benefits patients with chronic hepatitis C, by preventing the progression to cirrhosis, as well as those with established cirrhosis, by effectively reducing the risk of liver-related complications. The latest innovation in anti-HCV treatment has been the pegylation of the IFN molecule through the attachment of one or more polyethylene glycols to the IFN molecule, drastically modifying the immunological, pharmacokinetic and pharmacodynamic properties of the drug. Following the demonstration of a more potent antiviral effect in terms of sustained virological response rates in Phase III randomized trials, pegylated IFN coupled with ribavirin has become the standard of care for chronic hepatitis C. Currently, two forms of pegylated IFN exist (alpha2a and alpha2b), which differ significantly in terms of pharmacokinetics and dynamics, is whether these peculiarities translate into different efficacy rates being still being debated. [ABSTRACT FROM AUTHOR]

Published
2009
Full Text
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24. 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

25. 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

26. 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

27. HCV E1E2-MF59 vaccine in chronic hepatitis C patients treated with PEG-IFNα2a and Ribavirin: a randomized controlled trial

Author

Almasio, P., Colombatto, P., Brunetto, M., Maina, A., Romagnoli, V., Rumi, M., Ascione, A., Pinzello, G., Mondelli, M., Muratori, L., Rappuoli, R., Rosa, D., Houghton, M., Abrignani, S., Bonino, F., Almasio, PL, Colombatto, P, Brunetto, MR, Maina, AM, Romagnoli, V, Almasio, P, Rumi, MG, Ascione, A, Pinzello, G, Mondelli, M, Muratori, L, Rappuoli, R, Rosa, D, Houghton, M, Abrignani, S, and Bonino, F

Subjects
HCV vaccine
Abstract

Hepatitis C virus (HCV) vaccines may be able to increase viral clearance in combination with antiviral therapy. We analysed viral dynamics and HCV-specific immune response during retreatment for experienced patients in a phase Ib study with E1E2MF59 vaccine. Seventy-eight genotype 1a/1b patients [relapsers (30), partial responders (16) and nonresponders (32) to interferon-(IFN)/ribavirin-(RBV)] were randomly assigned to vaccine (V:23), Peg-IFNα2a-180-ug/qw and ribavirin 1000-1200-mg/qd for 48 weeks (P/R:25), or their combination (P/R + V:30). Vaccine (100 μg/0.5 mL) was administered intramuscularly at week 0-4-8-12-24-28-32-36. Neutralizing of binding (NOB) antibodies and lymphocyte proliferation assay (LPA) for E1E2-specific-CD4 + T cells were performed at week 0-12-16-48. Viral kinetics were analysed up to week 16. The vaccine was safe, and a sustained virological response (SVR) was achieved in 4 P/R + V and 2 P/R patients. Higher SVR rates were observed in prior relapsers (P/R + V = 27.3%; P/R = 12.5%). Higher NOB titres and LPA indexes were found at week 12 and 16 in P/R + V as compared to P/R patients (P = 0.023 and 0.025, P = 0.019 and

Published
2014

28. Hepatitis B virus precore mutants in HBeAg carriers with chronic hepatitis treated with interferon

Author

Aldo Manzin, Maria Chiara Colombo, M.G. Rumi, Stefania Paolucci, Pietro Lampertico, Ersilio Del Ninno, M. Dementi, Lampertico, P, Manzin, A, Rumi, Mg, Paolucci, S, Delninno, E, Clementi, Massimo, and Colombo, M.

Subjects
Adult, Male, Hepatitis B virus, Time Factors, Adolescent, Molecular Sequence Data, Mutant, medicine.disease_cause, Polymerase Chain Reaction, law.invention, Hepatitis B Antigens, Interferon, law, Virology, medicine, Humans, Hepatitis B e Antigens, Seroconversion, Polymerase chain reaction, Base Sequence, Hepatology, business.industry, Middle Aged, Hepatitis B, Hepatitis B Core Antigens, Recombinant Proteins, Stop codon, Infectious Diseases, HBeAg, Carrier State, Interferon Type I, Mutation, Recombinant DNA, Female, business, medicine.drug
Abstract

Summary. Precore mutants of hepatitis B virus (HBV) were looked for in 18 hepatitis B e antigen (HBeAg) carriers who were treated with recombinant interferon-a (rIFN) and the results were compared with those obtained in 12 untreated carriers who underwent spontaneous HBeAb seroconversion. Molecular analysis of the HBV precore region was carried out by polymerase chain reaction (PCR) amplification and direct sequencing. Precore mutants with a stop codon at codon 28 were detectable at baseline in 19/30 carriers. However, wild-type strains predominated in the baseline sera of both treated (n= 16) and untreated (n= 10) patients. Sera from the remaining four patients contained predominantly or exclusively mutant virions. Following IFN treatment, there was a shift from the wild-type pattern to the mutant pattern in all patients, with the precore pattern prevailing in long-term responders (six out of nine) compared with the non-responders (none of nine). The wild-type pattern predominated among the non-responders (eight vs three), suggesting that the long-term response to IFN was associated with take-over of precore mutants. There were no relationships between any pre-treatment precore molecular pattern and disease severity or outcome of treatment. Precore mutants also took over in 10 of the 12 untreated patients (83%), who underwent spontaneous HBeAb seroconversion. Thus, a shift from wild-type to precore mutant pattern occurs in most Italian patients undergoing IFN-induced or spontaneous HBeAb seroconversion.

Published
1995

29. Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient data

Author

Savino Bruno, V. Di Marco, A. Chiesa, Maria Grazia Rumi, Andrea Crosignani, Angelo Andriulli, Filippo Schepis, L Cino, Freni Ma, Pietro Andreone, Nicola Caporaso, Annagiulia Gramenzi, Calogero Cammà, Giorgio Maria Saracco, O. Lo Iacono, Aldo Spadaro, Massimo Puoti, Antonio Craxì, Filomena Morisco, Alessandra Mangia, Camma, C, Bruno, S, Schepis, F, LO IACONO, O, Andreone, P, Gramenzi, Ag, Mangia, A, Andriulli, A, Puoti, M, Spadaro, A, Freni, Mg, Caporaso, Nicola, Cino, L, Saracco, G, Chiesa, A, Crosignani, A, Caporaso, N, Morisco, Filomena, Rumi, Mg, and Craxi, A.

Subjects
HCV interferon ribavirin, Adult, Male, medicine.medical_specialty, Combination therapy, medicine.medical_treatment, Alpha interferon, Gastroenterology, Antiviral Agents, Drug Administration Schedule, chemistry.chemical_compound, Drug Therapy, Internal medicine, Ribavirin, medicine, Humans, Immunologic Factors, Treatment Failure, Chronic, Adverse effect, Chemotherapy, Chi-Square Distribution, Combination, Female, Hepatitis C, Interferon-alpha, Logistic Models, Middle Aged, gamma-Glutamyltransferase, business.industry, Liver Disease, Hepatitis C, Chronic, medicine.disease, Confidence interval, humanities, Surgery, chemistry, Tolerability, Drug Therapy, Combination, business
Abstract

Background and aims: Retreatment with a combination of α interferon (IFN) plus ribavirin of patients with chronic hepatitis C who did not respond to IFN monotherapy has not been assessed in large controlled studies. Methods: To assess the effectiveness and tolerability of IFN/ribavirin retreatment of non-responders to IFN and to identify predictors of complete (biochemical and virological) sustained response, we performed a meta-analysis of individual data on 581 patients from 10 centres. Retreatment with various IFN schedules (mean total dose 544 mega units) and a fixed ribavirin dose (1000–1200 mg/daily depending on body weight) was given for 24–60 (mean 39.5) weeks. Results: Biochemical end of treatment and sustained responses were observed in 271/581 (46.6%; 95% confidence interval (CI) 42.6–50.7%) and in 109/581 (18.7%; 95% CI 15.6–22.0%) cases, respectively. Two hundred and six of 532 patients (38.7%; 95% CI 34.6–42.9%) had an end of treatment complete response to retreatment while a complete sustained response occurred in 88 of 559 (15.7%; 95% CI 12.8–18.8%). Fifty four of 581 patients (9.2%; 95% CI 7.0–11.7%) stopped retreatment due to adverse effects. By logistic regression, complete sustained response was predicted independently by age

Published
2002

30. A randomized, controlled trial of a 24-month course of interferon alfa 2b in patients with chronic hepatitis B who had hepatitis B virus DNA without hepatitis B e antigen in serum

Author

Maria Francesca Donato, Giovanna Lunghi, Aldo Manzin, M.G. Rumi, M. Colombo, E. Del Ninno, Massimo Clementi, Alberto Morabito, Pietro Lampertico, Lampertico, P, Delninno, E, Manzin, A, Donato, Mf, Rumi, Mg, Lunghi, G, Morabito, A, Clementi, Massimo, and Colombo, M.

Subjects
Adult, Male, Hepatitis B virus, medicine.medical_specialty, Biopsy, Alpha interferon, Interferon alpha-2, medicine.disease_cause, Gastroenterology, Hepatitis B, Chronic, Orthohepadnavirus, Internal medicine, medicine, Humans, Hepatitis B e Antigens, Prospective Studies, Hepatitis B Antibodies, Interferon alfa, Hepatitis, Hepatitis B Surface Antigens, Hepatology, biology, business.industry, Interferon-alpha, Alanine Transaminase, Middle Aged, biology.organism_classification, medicine.disease, Recombinant Proteins, Liver, Alanine transaminase, Hepadnaviridae, HBeAg, DNA, Viral, Immunology, biology.protein, Female, business, Follow-Up Studies, medicine.drug
Abstract

Short-term interferon treatment of serum hepatitis B e antigen (HBeAg)-negative carriers with serum hepatitis B virus (HBV) DNA and histological features of chronic hepatitis B has been largely unsuccessful. In a pilot study of long-term treatment, 42 such patients were randomly assigned to 6 million units of interferon alfa 2b (IFN-alpha2b) three times per week for 24 consecutive months (n = 21, 4 with cirrhosis) or to no therapy (n = 21, 3 with cirrhosis). Five patients (24%) discontinued therapy because of treatment-related adverse reactions. Serum levels of alanine transaminase (ALT) became persistently normal and HBV DNA undetectable by dot-blot assay in 8 patients receiving interferon and in 2 untreated controls (38% vs. 10%; P = .03). Hepatitis flare-ups disappeared in 17 patients during therapy compared with 6 controls (81% vs. 29%; P.001). During a median period of 22 months after interferon was stopped, 2 treated patients (10%) lost serum hepatitis B surface antigen (HBsAg) and seroconverted to antibodies to hepatitis B surface antigen (anti-HBs). Serum ALT remained persistently normal and HBV DNA undetectable by dot-blot assay in 6 initial responders and 1 initial nonresponder, compared with none of the 21 untreated controls (sustained response: 33% vs. 0; P.001). Comparative analysis of pre- and posttreatment liver biopsies showed that mean Knodell scores dropped in the treated group (10.3 to 5.3; P = .01), but not in the untreated group (9.3 to 9.8; not significant). In conclusion, a 24-month course of treatment with 6 MU IFN-alpha2b was well tolerated by most patients, led to sustained suppression of HBV in one third, and attenuated hepatitis in 81% of patients.

31. Direct detection of HBV preC mutants in heterogeneous viral populations by a modified DNA sequencing method

Author

Stefano Menzo, Massimo Clementi, Pietro Lampertico, Aldo Manzin, M.G. Rumi, Stefania Paolucci, Maria Chiara Colombo, Manzin, A, Paolucci, S, Lampertico, P, Menzo, S, Rumi, Mg, Colombo, M, and Clementi, Massimo

Subjects
Hepatitis B virus, Molecular Sequence Data, Immunology, Population, medicine.disease_cause, Polymerase Chain Reaction, Virus, law.invention, law, Virology, medicine, Humans, Protein Precursors, education, Polymerase chain reaction, education.field_of_study, Base Sequence, biology, Nucleic acid sequence, Genetic Variation, Sequence Analysis, DNA, Hepatitis B, biology.organism_classification, Hepatitis B Core Antigens, Molecular biology, Stop codon, Hepadnaviridae, HBeAg, Chronic Disease, Mutation
Abstract

Summary A modified method for the direct sequencing of double-stranded DNA products of PCR amplification is described and has been applied to the analysis of hepatitis B virus (HBV) preC/C region in samples from persistently infected patients with chronic hepatitis. Data was obtained from both hepatitis B e antigen(HBeAg)-positive and -negative chronic carriers. A high prevalence of mixed viral populations (wild-type genomes and mutated sequences with a TAG stop codon in the distal preC region at position 1895–1897) was shown in the HBeAg-positive group; a homogeneous (either mutated or wild-type) viral population was detected in all but one of the long-term HBeAg-negative, untreated chronic carriers, thus suggesting that pre-core mutants can be rapidly generated and selected during the natural course of HBV infection.

33. Approaches for Selective Vaccinations in Cirrhotic Patients.

Author

Casella G, Ingravalle F, Ingravalle A, Andreotti S, Bonetti F, Monti C, Falbo R, and Rumi MG

Abstract

Bacterial and viral infections are common in cirrhotic patients, and their occurrence is associated with the severity of liver disease. Bacterial infection may increase the probability of death by 3.75 times in patients with decompensated cirrhosis, with ranges of 30% at 1 month and 63% at 1 year after infection. We illustrate the indications and the modalities for vaccinating cirrhotic patients. This topic is important for general practitioners and specialists.

Published
2023
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34. Accuracy of FIB-4 to Detect Elevated Liver Stiffness Measurements in Patients with Non-Alcoholic Fatty Liver Disease: A Cross-Sectional Study in Referral Centers.

Author

Viganò M, Pugliese N, Cerini F, Turati F, Cimino V, Ridolfo S, Rocchetto S, Foglio F, Terrin M, La Vecchia C, Rumi MG, and Aghemo A

Subjects
Humans, Middle Aged, Cross-Sectional Studies, gamma-Glutamyltransferase, Liver Cirrhosis complications, Liver pathology, Referral and Consultation, Non-alcoholic Fatty Liver Disease pathology
Abstract

The identification of advanced fibrosis by applying noninvasive tests is still a key component of the diagnostic algorithm of NAFLD. The aim of this study is to assess the concordance between the FIB-4 and liver stiffness measurement (LSM) in patients referred to two liver centers for the ultrasound-based diagnosis of NAFLD. Fibrosis 4 Index for Liver Fibrosis (FIB-4) and LSM were assessed in 1338 patients. A total of 428 (32%) had an LSM ≥ 8 kPa, whereas 699 (52%) and 113 (9%) patients had an FIB-4 < 1.3 and >3.25, respectively. Among 699 patients with an FIB-4 < 1.3, 118 (17%) had an LSM ≥ 8 kPa (false-negative FIB-4). This proportion was higher in patients ≥60 years, with diabetes mellitus (DM), arterial hypertension or a body mass index (BMI) ≥ 27 kg/m2. In multiple adjusted models, age ≥ 60 years (odds ratio (OR) = 1.96, 95% confidence interval (CI) 1.19−3.23)), DM (OR = 2.59, 95% CI 1.63−4.13), body mass index (BMI) ≥ 27 kg/m2 (OR = 2.17, 95% CI 1.33−3.56) and gamma-glutamyltransferase ≥ 25 UI/L (OR = 2.68, 95% CI 1.49−4.84) were associated with false-negative FIB-4. The proportion of false-negative FIB-4 was 6% in patients with none or one of these risk factors and increased to 16, 31 and 46% among those with two, three and four concomitant risk factors, respectively. FIB-4 is suboptimal to identify patients to refer to liver centers, because about one-fifth may be false negative at FIB-4, having instead an LSM ≥ 8 KPa.

Published
2022
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35. Liver stiffness measurement identifies subclinical myocardial dysfunction in non-advanced non-alcoholic fatty liver disease patients without overt heart disease.

Author

Sonaglioni A, Cerini F, Cerrone A, Argiento L, Nicolosi GL, Rigamonti E, Lombardo M, Rumi MG, and Viganò M

Subjects
Echocardiography, Female, Humans, Male, Reproducibility of Results, Heart Diseases, Non-alcoholic Fatty Liver Disease complications, Non-alcoholic Fatty Liver Disease diagnostic imaging, Ventricular Dysfunction, Left
Abstract

Patients with non-advanced non-alcoholic fatty liver disease (NAFLD) have an increased cardiovascular risk. The present study was designed to evaluate the relationship between liver stiffness measurement (LSM) by transient elastography (TE) and myocardial deformation indices of all cardiac chambers in NAFLD patients without overt heart disease. All consecutive NAFLD patients diagnosed with LSM < 12.5 kPa on TE between September 2021 and December 2021 entered the study. All participants underwent blood tests, TE and two-dimensional (2D) transthoracic echocardiography (TTE) implemented with speckle-tracking echocardiography (STE) analysis of left ventricular (LV) global longitudinal strain (GLS), global circumferential strain (GCS) and global radial strain (GRS), right ventricular (RV) GLS, left atrial (LA) total global strain (TGSA) and right atrial (RA) TGSA. Main independent predictors of impaired LV-GLS (defined as absolute value less negative than - 20%) were evaluated. A total of 92 NAFLD patients (54.0 ± 11.1 years, 50% males) were prospectively analyzed. Mean LSM was 6.2 ± 2.4 kPa. Fibroscan results revealed that 76.1% of patients had F0-F1, 5.4% F2 and 18.5% F3 liver fibrosis. Despite normal biventricular systolic function on 2D-TTE, LV-GLS, LV-GCS and LV-GRS, RV-GLS, LA-TGSA and RA-TGSA were reduced in 64.1%, 38.0%, 38.0%, 31.5%, 39.1% and 41.3% of patients, respectively. Body mass index (BMI) (OR 1.76, 95% CI 1.18-2.64), neutrophil-to-lymphocyte ratio (NLR) (OR 4.93, 95% CI 1.15-31.8) and LSM (OR 9.26, 95% CI 2.24-38.3) were independently associated to impaired LV-GLS. BMI ≥ 29.3 kg/m 2 , NLR ≥ 1.8 and LSM ≥ 5.5 kPa were the best cut-off values for detecting outcome. LSM ≥ 5.5 kPa identifies NAFLD patients with subclinical myocardial dysfunction., (© 2022. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Published
2022
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37. 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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38. Left ventricular strain predicts subclinical atherosclerosis in nonadvanced nonalcoholic fatty liver disease patients.

Author

Sonaglioni A, Cerini F, Nicolosi GL, Lombardo M, Rumi MG, and Viganò M

Subjects
Carotid Intima-Media Thickness, Echocardiography methods, Female, Humans, Male, Middle Aged, Ventricular Function, Left, Atherosclerosis diagnostic imaging, Cardiomyopathies, Non-alcoholic Fatty Liver Disease complications, Non-alcoholic Fatty Liver Disease diagnostic imaging, Ventricular Dysfunction, Left diagnostic imaging, Ventricular Dysfunction, Left etiology
Abstract

Objectives: The association between nonalcoholic fatty liver disease (NAFLD) and carotid atherosclerosis is still controversial. The present study was designed to assess the relationship between left ventricular systolic mechanics, noninvasively assessed by two-dimensional (2D) speckle-tracking echocardiography (STE) and common carotid artery (CCA) intima-media thickness (IMT), in patients with nonadvanced NAFLD., Methods: All consecutive NAFLD patients diagnosed with liver stiffness measurement (LSM) <12.5 kPa on transient elastography between September 2021 and December 2021 were prospectively enrolled. All participants underwent blood tests, transient elastography, 2D transthoracic echocardiography (TTE) implemented with 2D-STE analysis of left ventricular (LV) global longitudinal strain (GLS) and finally carotid ultrasonography. Main independent predictors of subclinical atherosclerosis, defined as CCA-IMT >0. 9 mm, were evaluated., Results: A total of 92 NAFLD patients (54.0 ± 11.1 years, 50% males) were prospectively analyzed. Mean LSM was 6.2 ± 2.4 kPa. FibroScan results revealed that 76.1% of patients had F0-F1, 5.4% F2 and 18.5% F3 liver fibrosis. Despite normal biventricular systolic function on 2D-TTE, LV-GLS was reduced (less negative than -20%) in 64.1% of patients. However, 62.0% of NAFLD patients were found with CCA-IMT >0. 9 mm. Age [odds ratio (OR),1.19; 95% confidence interval (CI), 1.05-1.36], hypertension (OR, 3.73; 95% CI, 1.53-9.11), LSM (OR, 4.83; 95% CI, 2.43-9.59), LV-GLS (OR, 0.49; 95% CI, 0.36-0.68) and statin therapy (OR, 0.10; 95% CI, 0.02-0.60) were independently associated with subclinical atherosclerosis. Age ≥51 years, LSM ≥5.5 kPa and LV-GLS less negative than -20% were the best cutoff values for predicting subclinical atherosclerosis., Conclusions: Subclinical myocardial dysfunction and subclinical atherosclerosis are simultaneously present in patients with nonadvanced NAFLD., (Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.)

Published
2022
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39. Dysmetabolism, Diabetes and Clinical Outcomes in Patients Cured of Chronic Hepatitis C: A Real-Life Cohort Study.

Author

Valenti L, Pelusi S, Aghemo A, Gritti S, Pasulo L, Bianco C, Iegri C, Cologni G, Degasperi E, D'Ambrosio R, Del Poggio P, Soria A, Puoti M, Carderi I, Pigozzi MG, Carriero C, Spinetti A, Zuccaro V, Memoli M, Giorgini A, Viganò M, Rumi MG, Re T, Spinelli O, Colombo MC, Quirino T, Menzaghi B, Lorini G, Pan A, D'Arminio Monforte A, Buscarini E, Autolitano A, Bonfanti P, Terreni N, Aimo G, Mendeni M, Prati D, Lampertico P, Colombo M, and Fagiuoli S

Subjects
Antiviral Agents therapeutic use, Cohort Studies, Humans, Liver Cirrhosis diagnosis, Sustained Virologic Response, Carcinoma, Hepatocellular epidemiology, Cardiovascular Diseases complications, Diabetes Mellitus drug therapy, Hepatitis C, Chronic complications, Liver Neoplasms epidemiology
Abstract

The aim of this study was to examine the impact of features of dysmetabolism on liver disease severity, evolution, and clinical outcomes in a real-life cohort of patients treated with direct acting antivirals for chronic hepatitis C virus (HCV) infection. To this end, we considered 7,007 patients treated between 2014 and 2018, 65.3% with advanced fibrosis, of whom 97.7% achieved viral eradication (NAVIGATORE-Lombardia registry). In a subset (n = 748), liver stiffness measurement (LSM) was available at baseline and follow-up. Higher body mass index (BMI; odds ratio [OR] 1.06 per kg/m 2 , 1.03-1.09) and diabetes (OR 2.01 [1.65-2.46]) were independently associated with advanced fibrosis at baseline, whereas statin use was protective (OR 0.46 [0.35-0.60]; P < 0.0001 for all). The impact of BMI was greater in those without diabetes (P = 0.003). Diabetes was independently associated with less pronounced LSM improvement after viral eradication (P = 0.001) and in patients with advanced fibrosis was an independent predictor of the most frequent clinical events, namely de novo hepatocellular carcinoma (HCC; hazard ratio [HR] 2.09 [1.20-3.63]; P = 0.009) and cardiovascular events (HR 2.73 [1.16-6.43]; P = 0.021). Metformin showed a protective association against HCC (HR 0.32 [0.11-0.96]; P = 0.043), which was confirmed after adjustment for propensity score (P = 0.038). Diabetes diagnosis further refined HCC prediction in patients with compensated advanced chronic liver disease at high baseline risk (P = 0.024). Conclusion: Metabolic comorbidities were associated with advanced liver fibrosis at baseline, whereas statins were protective. In patients with advanced fibrosis, diabetes increased the risk of de novo HCC and of cardiovascular events. Optimization of metabolic comorbidities treatment by a multi-disciplinary management approach may improve cardiovascular and possibly liver-related outcomes., (© 2021 The Authors. Hepatology Communications published by Wiley Periodicals LLC on behalf of American Association for the Study of Liver Diseases.)

Published
2022
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41. High rates of 30-day mortality in patients with cirrhosis and COVID-19.

Author

Iavarone M, D'Ambrosio R, Soria A, Triolo M, Pugliese N, Del Poggio P, Perricone G, Massironi S, Spinetti A, Buscarini E, Viganò M, Carriero C, Fagiuoli S, Aghemo A, Belli LS, Lucà M, Pedaci M, Rimondi A, Rumi MG, Invernizzi P, Bonfanti P, and Lampertico P

Subjects
Aged, Antiviral Agents administration & dosage, Antiviral Agents adverse effects, Betacoronavirus isolation & purification, COVID-19, COVID-19 Testing, Clinical Laboratory Techniques methods, Comorbidity, Female, Humans, Italy epidemiology, Male, Mortality, Retrospective Studies, Risk Factors, SARS-CoV-2, Coronavirus Infections diagnosis, Coronavirus Infections drug therapy, Coronavirus Infections mortality, Coronavirus Infections physiopathology, Liver Cirrhosis diagnosis, Liver Cirrhosis epidemiology, Liver Cirrhosis physiopathology, Liver Function Tests methods, Liver Function Tests statistics & numerical data, Pandemics, Pneumonia, Viral diagnosis, Pneumonia, Viral drug therapy, Pneumonia, Viral mortality, Pneumonia, Viral physiopathology, Pneumonia, Viral virology
Abstract

Background & Aims: Coronavirus disease 2019 (COVID-19) poses a major health threat to healthy individuals and those with comorbidities, but its impact on patients with cirrhosis is currently unknown. Herein, we aimed to evaluate the impact of COVID-19 on the clinical outcome of patients with cirrhosis., Methods: In this multicentre retrospective study, patients with cirrhosis and a confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection were enrolled between 1 st and 31 th March 2020. Clinical and biochemical data at diagnosis of COVID-19 and at the last outpatient visit were obtained through review of medical records., Results: Fifty patients with cirrhosis and confirmed SARS-CoV-2 infection were enrolled (age 67 years, 70% men, 38% virus-related, 52% previously compensated cirrhosis). At diagnosis, 64% of patients presented fever, 42% shortness of breath/polypnea, 22% encephalopathy, 96% needed hospitalization or a prolonged stay if already in hospital. Respiratory support was necessary in 71%, 52% received antivirals, 80% heparin. Serum albumin significantly decreased, while bilirubin, creatinine and prothrombin time significantly increased at COVID-19 diagnosis compared to last available data. The proportion of patients with a model for end-stage liver disease (MELD) score ≥15 increased from 13% to 26% (p = 0.037), acute-on-chronic liver failure and de novo acute liver injury occurred in 14 (28%) and 10 patients, respectively. Seventeen patients died after a median of 10 (4-13) days from COVID-19 diagnosis, with a 30-day-mortality rate of 34%. The severity of lung and liver (according to CLIF-C, CLIF-OF and MELD scores) diseases independently predicted mortality. In patients with cirrhosis, mortality was significantly higher in those with COVID-19 than in those hospitalized for bacterial infections., Conclusion: COVID-19 is associated with liver function deterioration and elevated mortality in patients with cirrhosis., Lay Summary: Coronavirus disease 2019 (COVID-19) poses a major health threat to healthy individuals and those with comorbidities. Herein, we assessed its impact on patients with cirrhosis. Infection with COVID-19 was associated with liver function deterioration and elevated mortality in patients with cirrhosis., Competing Interests: Conflict of interest Massimo Iavarone: Speaking/Teaching, consultant and advisory board for Bayer, Gilead Sciences, BMS, Janssen, Ipsen, MSD, BTG-Boston Scientific, AbbVie, Guerbet, EISAI; Roberta D'Ambrosio: teaching and speaking for AbbVie, Gilead, MSD; Advisory Board for AbbVie, MSD, Research Grant from Gilead; Alessandro Soria: Speaking/Teaching, consultant and advisory board for AbbVie, MSD, Gilead; Mauro Viganò: speaking and teaching for Fujirebio, Intercept, Gilead; Alessio Aghemo: Advisory Board/Speaker Bureau for: Gilead, AbbVie, Intercept, MSD, Mylan and Alfasigma, Research grants from Gilead and Abbvie; Stefano Fagiuoli: Advisory Board/Speaker Bureau for Gilead, AbbVie, Novartis, MSD, Bayer, Intercept, Kedrion; Pietro Invernizzi: Advisory Board/Speaker Bureau for Gilead, Intercept, Bruschettini, AbbVie, MSD; Pietro Lampertico: Advisory Board/Speaker Bureau for BMS, Roche, Gilead, GSK, AbbVie, MSD, Arrowhead, Alnylam, Janssen, Spring Bank, MYR, Eiger. The other authors declare no conflict of interest. Please refer to the accompanying ICMJE disclosure forms for further details., (Copyright © 2020 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Published
2020
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43. Advanced liver disease outcomes after hepatitis C eradication by human immunodeficiency virus infection in PITER cohort.

Author

Quaranta MG, Ferrigno L, Monti M, Filomia R, Biliotti E, Iannone A, Migliorino G, Coco B, Morisco F, Vinci M, D'Ambrosio R, Chemello L, Massari M, Ieluzzi D, Russo FP, Blanc P, Verucchi G, Puoti M, Rumi MG, Barbaro F, Santantonio TA, Federico A, Chessa L, Gentile I, Zuin M, Parruti G, Morsica G, and Kondili LA

Subjects
Coinfection, Disease Progression, Female, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Prognosis, Sustained Virologic Response, Antiviral Agents therapeutic use, Carcinoma, Hepatocellular pathology, Carcinoma, Hepatocellular physiopathology, Carcinoma, Hepatocellular virology, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections epidemiology, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic epidemiology, Liver physiopathology, Liver virology, Liver Cirrhosis diagnosis, Liver Cirrhosis physiopathology, Liver Cirrhosis virology, Liver Neoplasms pathology, Liver Neoplasms physiopathology, Liver Neoplasms virology
Abstract

Background: Liver disease progression after Hepatitis C Virus (HCV) eradication following direct-acting antiviral (DAA) treatment in the real-life setting according to Human Immunodeficiency Virus (HIV) coinfection was evaluated., Methods: Patients consecutively enrolled in PITER between April 2014 and June 2019 and with at least 12-weeks follow-up following treatment were analysed. Cox regression analysis were used to evaluate HIV coinfection and factors independently associated with liver disease outcomes following viral eradication in DAA treated patients with pre-treatment liver cirrhosis., Results: 93 HIV/HCV coinfected and 1109 HCV monoinfected patients were evaluated during a median follow-up of 26.7 (range 6-44.6) and 24.6 (range 6.8-47.3) months, respectively. No difference in the cumulative HCC incidence and hepatic decompensation was observed between coinfected and monoinfected patients. Age (Hazard Ratio [HR] = 1.08; 95% CI 1.04-1.13), male sex (HR = 2.76; 95% CI 1.28-5.96), lower albumin levels (HR = 3.94; 95% CI 1.81-8.58), genotype 3 (HR = 5.05; 95% CI 1.75-14.57) and serum anti-HBc positivity (HR = 1.99, 95% CI 1.01-3.95) were independently associated with HCC incidence. Older age (HR = 1.03; 95% CI 1.00-1.07), male sex (HR = 2.13; 95% CI 1.06-4.26) and lower albumin levels (HR = 3.75; 95% CI 1.89-7.46) were independently associated with the appearance of a decompensating event after viral eradication., Conclusion: Different demographic, clinical and genotype distribution between HIV coinfected vs those monoinfected, was observed in a representative cohort of HCV infected patients in Italy. Once liver cirrhosis is established the disease progression is decreased, but still persists regardless of viral eradication in both coinfected and monoinfected patients. In patients with cirrhosis, HIV coinfection was not associated with a higher probability of liver complications, after viral eradication.

Published
2020
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44. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort.

Author

Soria A, Fava M, Bernasconi DP, Lapadula G, Colella E, Valsecchi MG, Migliorino GM, D'Ambrosio R, Landonio S, Schiavini M, Spinetti A, Carriero C, Degasperi E, Cologni G, Gatti F, Viganò P, Hasson H, Uberti-Foppa C, Pasulo L, Baiguera C, Rossotti R, Vinci M, Puoti M, Giorgini A, Menzaghi B, Lombardi A, Pan A, Aghemo A, Grossi PA, Boldizzoni R, Colombo S, Viganò M, Rumi MG, Del Poggio P, Valenti L, Giglio O, De Bona A, d'Arminio Monforte A, Colombo A, Spinelli O, Pigozzi MG, Molteni C, Bonfanti P, Terreni N, Perini P, Capretti A, Bella D, Liani C, Polo S, Aimo G, Pagnucco L, Bhoori S, Centenaro R, Graffeo M, Ciaccio A, Dionigi E, Lazzaroni S, Carderi I, Di Marco M, Rizzardini G, Noventa F, Lampertico P, and Fagiuoli S

Subjects
Antiviral Agents therapeutic use, Drug Therapy, Combination, Female, Genotype, Hepacivirus genetics, Humans, Male, Ribavirin therapeutic use, Sofosbuvir therapeutic use, Treatment Outcome, Hepatitis C drug therapy, Hepatitis C, Chronic drug therapy
Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap., Methods: Sustained virological response 12 weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression., Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF + DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF + DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P = .065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P = .007) and lower median pretreatment Log 10 HCV-RNA (5.87 vs 6.20, P = .001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF + DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12., Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF + DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype., (© 2020 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2020
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45. Direct-Acting Antivirals in Hepatitis C Virus-Associated Diffuse Large B-cell Lymphomas.

Author

Merli M, Frigeni M, Alric L, Visco C, Besson C, Mannelli L, Di Rocco A, Ferrari A, Farina L, Pirisi M, Piazza F, Loustaud-Ratti V, Arcari A, Marino D, Sica A, Goldaniga M, Rusconi C, Gentile M, Cencini E, Benanti F, Rumi MG, Ferretti VV, Grossi P, Gotti M, Sciarra R, Tisi MC, Cano I, Zuccaro V, Passamonti F, and Arcaini L

Subjects
Adult, Aged, Aged, 80 and over, Cyclophosphamide administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Hepatitis C, Chronic epidemiology, Hepatitis C, Chronic pathology, Hepatitis C, Chronic virology, Humans, Incidence, Italy epidemiology, Lymphoma, Large B-Cell, Diffuse epidemiology, Lymphoma, Large B-Cell, Diffuse pathology, Male, Middle Aged, Prednisone administration & dosage, Retrospective Studies, Rituximab administration & dosage, Vincristine administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antiviral Agents therapeutic use, Hepacivirus drug effects, Hepatitis C, Chronic drug therapy, Lymphoma, Large B-Cell, Diffuse drug therapy, Lymphoma, Large B-Cell, Diffuse virology
Abstract

Background: International guidelines suggest hepatitis C virus (HCV) eradication by direct-acting antivirals (DAAs) after first-line immunochemotherapy (I-CT) in patients with HCV-positive diffuse large B-cell lymphoma (DLBCL), although limited experiences substantiate this recommendation. Moreover, only a few data concerning concurrent administration of DAAs with I-CT have been reported., Subjects, Materials, and Methods: We analyzed hematological and virological outcome and survival of 47 consecutive patients with HCV-positive DLBCL treated at 23 Italian and French centers with DAAs either concurrently (concurrent cohort [ ConC ]: n = 9) or subsequently (sequential cohort [ SeqC ]: n = 38) to first-line I-CT (mainly rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone [R-CHOP]-like)., Results: Median age was 61 years, 89% of patients had stage III/IV, and 25% presented evidence of cirrhosis. Genotype was 1 in 56% and 2 in 34% of cases. Overall, 46 of 47 patients obtained complete response to I-CT. All patients received appropriate DAAs according to genotype, mainly sofosbuvir-based regimens ( n = 45). Overall, 45 patients (96%) achieved sustained virological response, 8 of 9 in ConC and 37 of 38 in SeqC . DAAs were well tolerated, with only 11 patients experiencing grade 1-2 adverse events. Twenty-three patients experienced hepatic toxicity (grade 3-4 in seven) following I-CT in SeqC, compared to only one patient in ConC . At a median follow-up of 2.8 years, two patients died (2-year overall survival, 97.4%) and three progressed (2-year progression-free survival, 93.1%)., Conclusion: Excellent outcome of this cohort of HCV-positive DLBCL suggests benefit of HCV eradication by DAAs either after or during I-CT. Moreover, concurrent DAAs and R-CHOP administration appeared feasible, effective, and ideally preferable to deferred administration of DAAs for the prevention of hepatic toxicity., Implications for Practice: Hepatitis C virus (HCV)-associated diffuse large B-cell lymphomas (DLBCLs) represent a great therapeutic challenge, especially in terms of hepatic toxicity during immune-chemotherapy (I-CT) and long-term hepatic complications. The advent of highly effective and toxicity-free direct-acting antivirals (DAAs) created an exciting opportunity to easily eradicate HCV shortly after or in concomitance with first-line immunochemotherapy (usually R-CHOP). This retrospective international study reports the real-life use of the combination of these two therapeutic modalities either in the concurrent or sequential approach (DAAs after I-CT) in 47 patients. The favorable reported results on long-term outcome seem to support the eradication of HCV with DAAs in all patients with HCV-positive DLBCL. Moreover, the results from the concurrent approach were effective and safe and displayed an advantage in preventing hepatic toxicity during I-CT., Competing Interests: Disclosures of potential conflicts of interest may be found at the end of this article., (© AlphaMed Press 2018.)

Published
2019
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46. Contrast imaging techniques to diagnose hepatocellular carcinoma in cirrhotics outside regular surveillance.

Author

Iavarone M, Viganò M, Piazza N, Occhipinti V, Sangiovanni A, Maggioni M, D'Ambrosio G, Forzenigo LV, Motta F, Lampertico P, Rumi MG, and Colombo M

Subjects
Adult, Aged, Aged, 80 and over, Biopsy, Fine-Needle, Carcinoma, Hepatocellular etiology, Female, Humans, Image-Guided Biopsy, Liver Cirrhosis complications, Liver Neoplasms etiology, Male, Middle Aged, Neoplasm Grading, Predictive Value of Tests, Prospective Studies, Reproducibility of Results, Tumor Burden, Carcinoma, Hepatocellular diagnostic imaging, Contrast Media administration & dosage, Incidental Findings, Liver Cirrhosis diagnostic imaging, Liver Neoplasms diagnostic imaging, Magnetic Resonance Imaging, Multidetector Computed Tomography, Ultrasonography
Abstract

Introduction and Aim: The American Association for the Study of the Liver (AASLD) recommends contrast computerized tomography (CT-scan) and magnetic resonance (MRI) to diagnose hepatocellular carcinoma (HCC) arising in cirrhotic patients under semiannual surveillance with abdominal ultrasound (US). A US guided fine needle biopsy (FNB) serves the same purpose in radiologically undiagnosed tumors and incidentally detected nodules in cirrhotics outside surveillance. In this population, we evaluated the performance of radiological diagnosis of HCC according to 2010 AASLD recommendations., Materials and Methods: All cirrhotic patients with a liver nodule incidentally detected by US were prospectively investigated with a sequential application of CT-scan/MRI examination and a FNB., Results: Between 2011 and 2015, 94 patients (mean age 67 years) had a liver nodule (total 120) detected by US in the context of histologically confirmed cirrhosis. Mean nodules diameter was 40 (10-160) mm, 87 (73%) <5cm. At histology, 84 (70%) nodules were HCC, 8 (7%) intrahepatic cholangiocarcinoma, 6 (5%) metastases, 2 (2%) neuroendocrine tumors and 20 (16%) benign lesions. Hyperenhancement in arterial phase followed by wash-out in venous phases on at least one radiological technique was demonstrated in 62 nodules (61 HCC, 1 high grade dysplastic nodule), with a specificity of 97% (IC95%: 85-100%), sensitivity 73% (IC95%: 62-81%) and diagnostic accuracy 80%, being 64% for ≥5cm HCC. Sensitivity of AFP >200ng/mL was 12% (IC95%: 6-23%)., Conclusion: A single contrast imaging technique showing a typical contrast pattern confidently identifies HCC also in cirrhotic patients with an incidental liver nodule, thereby reducing the need for FNB examinations., (Copyright © 2019 Fundación Clínica Médica Sur, A.C. Published by Elsevier España, S.L.U. All rights reserved.)

Published
2019
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47. Real-world effectiveness and safety of glecaprevir/pibrentasvir in 723 patients with chronic hepatitis C.

Author

D'Ambrosio R, Pasulo L, Puoti M, Vinci M, Schiavini M, Lazzaroni S, Soria A, Gatti F, Menzaghi B, Aghemo A, Capelli F, Rumi MG, Morini L, Giorgini A, Pigozzi MG, Rossini A, Maggiolo F, Pan A, Memoli M, Spinelli O, Del Poggio P, Saladino V, Spinetti A, De Bona A, Capretti A, Uberti-Foppa C, Bonfanti P, Terreni N, Menozzi F, Colombo AE, Giglio O, Centenaro R, Borghi M, Baiguera C, Picciotto V, Landonio S, Gori A, Magnani C, Noventa F, Paolucci S, Lampertico P, and Fagiuoli S

Subjects
Aminoisobutyric Acids, Antiviral Agents administration & dosage, Antiviral Agents adverse effects, Biopsy methods, Cohort Studies, Cyclopropanes, Drug Combinations, Elasticity Imaging Techniques methods, Female, Hepacivirus drug effects, Hepacivirus genetics, Humans, Italy epidemiology, Lactams, Macrocyclic, Leucine analogs & derivatives, Liver Cirrhosis diagnosis, Liver Cirrhosis etiology, Male, Middle Aged, Proline analogs & derivatives, Pyrrolidines, RNA, Viral analysis, Sustained Virologic Response, Treatment Outcome, Benzimidazoles administration & dosage, Benzimidazoles adverse effects, Hepatitis C, Chronic complications, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic epidemiology, Liver pathology, Quinoxalines administration & dosage, Quinoxalines adverse effects, Sulfonamides administration & dosage, Sulfonamides adverse effects
Abstract

Background and Aims: The efficacy and safety of glecaprevir/pibrentasvir (G/P) for patients infected with hepatitis C virus (HCV) have only been investigated in clinical trials, with no real-world data currently available. The aim of our study was to investigate the effectiveness and safety of G/P in a real-world setting., Methods: All patients with HCV consecutively starting G/P between October 2017 and January 2018 within the NAVIGATORE-Lombardia Network were analyzed. G/P was administered according to drug label (8, 12 or 16 weeks). Fibrosis was staged either histologically or by liver stiffness measurement. Sustained virological response (SVR) was defined as undetectable HCV-RNA 12 weeks after the end of treatment., Results: A total of 723 patients (50% males) were treated with G/P, 89% for 8 weeks. The median age of our cohort was 58 years, with a median body mass index of 23.9 kg/m 2 , and median liver stiffness measurement of 6.1 kPa; 84% were F0-2 and 16% were interferon-experienced. Median HCV-RNA was 1,102,600 IU/ml, and 49% of patients had HCV genotype 1 (32% 1b), 28% genotype 2, 10% genotype 3 and 13% genotype 4. The median estimated glomerular filtration rate was 90.2 ml/min, platelet count 209x10 3 /mm 3 and albumin 4.3 g/dl. The SVR rates were 94% in intention-to-treat and 99.3% in per protocol analysis (8-week vs. 12 or 16-week: 99.2% vs. 100%). Five patients failed therapy because of post-treatment relapse; a post-treatment NS5A resistance-associated substitution was detected in 1 case. SVR rates were lower in males (p = 0.002) and in HCV genotype-3 (p = 0.046) patients treated for 8 weeks, but independent of treatment duration, fibrosis stage, baseline HCV-RNA, HIV co-infection, chronic kidney disease stage and viral kinetics. Mild adverse events were reported in 8.3% of the patients, and 0.7% of them prematurely withdrew treatment. Three patients died of drug-unrelated causes., Conclusions: In a large real-world cohort of Italian patients, we confirmed the excellent effectiveness and safety of G/P administered for 8, 12 or 16 weeks., Lay Summary: A large number of patients with hepatitis C virus have been treated with glecaprevir/pibrentasvir (G/P) within the NAVIGATORE-Lombardia Network, in Italy. This is the first real-world study evaluating effectiveness and safety of G/P in patients with hepatitis C virus treated according to international recommendations. This study demonstrated excellent effectiveness (with sustained virological response rates of 99.3%) and safety profiles., (Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Published
2019
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48. 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

Subjects
Antiviral Agents therapeutic use, Carcinoma, Hepatocellular mortality, Cost of Illness, Hepatitis C diagnosis, Hepatitis C drug therapy, Humans, Italy epidemiology, Liver Cirrhosis mortality, Liver Neoplasms mortality, Markov Chains, Sustained Virologic Response, Viremia diagnosis, Viremia drug therapy, World Health Organization, Cause of Death, Disease Eradication trends, Hepatitis C epidemiology, Mortality trends, Viremia epidemiology
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., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2018
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49. Persistence of hepatocellular carcinoma risk in hepatitis C patients with a response to IFN and cirrhosis regression.

Author

D'Ambrosio R, Aghemo A, Rumi MG, Degasperi E, Sangiovanni A, Maggioni M, Fraquelli M, Perbellini R, Rosenberg W, Bedossa P, Colombo M, and Lampertico P

Subjects
Aged, Antiviral Agents therapeutic use, Carcinoma, Hepatocellular mortality, Female, Fibrosis, Humans, Interferons therapeutic use, Italy, Liver Cirrhosis pathology, Liver Neoplasms mortality, Liver Neoplasms pathology, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Regression Analysis, Risk Factors, Sustained Virologic Response, Carcinoma, Hepatocellular complications, Hepatitis C complications, Hepatitis C drug therapy, Liver Cirrhosis complications, Liver Neoplasms complications
Abstract

Background and Aim: In patients with HCV-related cirrhosis, a sustained virological response may lead to cirrhosis regression. Whether histological changes translate into prevention of long-term complications, particularly hepatocellular carcinoma is still unknown. This was investigated in a cohort of histological cirrhotics who had been prospectively followed-up for 10 years after the achievement of a sustained virological response to IFN., Methods: In all, 38 sustained virological response cirrhotics who underwent a liver biopsy 5 years post-SVR were prospectively followed to assess the impact of cirrhosis regression on clinical endpoints., Results: During a follow-up of 86 (30-96) months from liver biopsy, no patients developed clinical decompensation, whilst 5 (13%) developed hepatocellular carcinoma after 79 (7-88) months. The 8-year cumulative probability of hepatocellular carcinoma was 17%, without differences between patients with or without cirrhosis regression (19% [95% CI 6%-50%] vs 14% [95% CI 4%-44%], P = .88). Patients who developed or did not an hepatocellular carcinoma had similar rates of residual cirrhosis (P = 1.0), collagen content (P = .48), METAVIR activity (P = .34), portal inflammation (P = .06) and steatosis (P = .17). At baseline, patients who developed an hepatocellular carcinoma had higher γGT (HR 1.03, 95% CI 1.00-1.06; P = .014) and glucose (HR 1.02, 95% CI 1.00-1.02; P = .012) values; moreover, they had increased Forns Score (HR 12.8, 95% CI 1.14-143.9; P = .039), Lok Index (HR 6.24, 95% CI 1.03-37.6; P = .046) and PLF (HR 19.3, 95% CI 1.72-217.6; P = .016) values. One regressor died of lung cancer. The 8-year cumulative survival probability was 97%, independently on cirrhosis regression (96% vs 100%, P = 1.0) or hepatocellular carcinoma (100% vs 97%, P = 1.0)., Conclusions: Post-SVR cirrhosis regression does not prevent hepatocellular carcinoma occurrence., (© 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Published
2018
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