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4. Field-practice study of sorafenib therapy for hepatocellular carcinoma: a prospective multicenter study in Italy

Author

Iavarone, M, Piscaglia, F, Zavaglia, C, Grieco, A, Villa, E, Colombo, M, Sangiovanni, A, Vavassori, S, Romeo, R, Borghi, A, Granito, A, Bolondi, L, Airoldi, A, Pinzello, G, Biolato, M, Racco, S, Pompili, M, Lei, B, De Maria, N., CABIBBO, Giuseppe, CAMMA', Calogero, DI MARCO, Vito, CRAXI, Antonio, Iavarone, M, Cabibbo, G, Piscaglia, F, Zavaglia, C, Grieco, A, Villa, E, Cammà, C, Colombo, M, Sangiovanni, A, Vavassori, S, Romeo, R, Di Marco, V, Craxì, A, Borghi, A, Granito, A, Bolondi, L, Airoldi, A, Pinzello, G, Biolato, M, Racco, S, Pompili, M, Lei, B, De Maria, N, Iavarone M, Cabibbo G, Piscaglia F, Zavaglia C, Grieco A, Villa E, Cammà C, Colombo M, Sangiovanni A, Vavassori S, Romeo R, di Marco V, Craxì A, Borghi A, Granito A, Bolondi L, Airoldi A, Pinzello G, Bidato M, Racco S, Pompili M, Lei B, and De Maria N.

Subjects
Sorafenib, Niacinamide, Male, medicine.medical_specialty, Carcinoma, Hepatocellular, Drug-Related Side Effects and Adverse Reactions, Pyridines, Antineoplastic Agents, EPATOCARCINOMA, law.invention, Randomized controlled trial, law, Drug Toxicity, Internal medicine, medicine, Humans, Prospective Studies, HCC, Prospective cohort study, Survival analysis, Aged, sorafenib, Hepatology, business.industry, Phenylurea Compounds, Benzenesulfonates, Liver Neoplasms, Carcinoma, Settore MED/09 - MEDICINA INTERNA, Hepatocellular, Middle Aged, medicine.disease, Survival Analysis, digestive system diseases, Surgery, Hepatocellular carcinoma, sorafenib, Regimen, TUMORI DEL FEGATO, Tolerability, Italy, Hepatocellular carcinoma, Disease Progression, Female, Liver cancer, business, medicine.drug
Abstract

A multicenter randomized controlled trial established sorafenib as a standard of care for patients with advanced hepatocellular carcinoma (HCC). Because the study was prematurely interrupted due to survival benefits in the sorafenib arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice. Starting in 2008, all clinically compensated patients with advanced HCC and those with an intermediate HCC who were unfit or failed to respond to ablative therapies were consecutively evaluated in six liver centers in Italy, for tolerability as well as radiologic and survival response to 800-mg/d sorafenib therapy. Treatment was down-dosed or interrupted according to drug label. Two hundred ninety-six patients (88% Child-Pugh A, 75% Barcelona Clinic Liver Cancer [BCLC]-C, and 25% BCLC-B) received sorafenib for 3.8 months (95% CI 3.3-4.4). Two hundred sixty-nine (91%) patients experienced at least one adverse event (AE), whereas 161 (54%) had to reduce dosing. Treatment was interrupted in 103 (44%) for disease progression, in 95 (40%) for an AE, and in 38 (16%) for liver deterioration. The median survival was 10.5 months in the overall cohort, 8.4 months in BCLC-C versus 20.6 months in BCLC-B patients (P < 0.0001), and 21.6 months in the 77 patients treated for >70% of the time with a half dose versus 9.6 months in the 219 patients treated for >70% of the time with a full dose. At month 2 of treatment, the overall radiologic response was 8%. Eastern Cooperative Oncology Group performance status, macrovascular invasion, extrahepatic spread of the tumor, radiologic response at month 2, and sorafenib dosing were independent predictors of shortened survival. Conclusion: Overall, safety, effectiveness, and generalizability of sorafenib therapy in HCC was validated in field practice. The effectiveness of half-dosed sorafenib may have implications for tailored therapy.

Published
2011

5. 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

6. Evolving clinical landscape of chronic hepatitis B: A multicenter Italian study

Author

Stroffolini T., Almasio P. L., Sagnelli E., Mele A., Gaeta G. B., Italian Hospitals' Collaborating Group, Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., ANDREONE, PIETRO, Infectious and Tropical Diseases, Università degli Studi di Roma 'La Sapienza' = Sapienza University [Rome], Gastroenterology, Università degli studi di Palermo - University of Palermo, Public,Clinical and Preventive Medicine, University of Naples Federico II, Laboratory of Epidemiology, Clinical Epidemiology Unit, Istituto Superiore di Sanita [Rome], Infectious Diseases Dept, Stroffolini T., Almasio P.L., Sagnelli E., Mele A., Gaeta G.B., Italian Hospitals' Collaborating Group, Andreone P., Scuteri A., Antonucci G., Iacomi F., Babudieri S., Pintus A., Stornaiuolo G., Brancaccio G., Brunetto M., Sasso R., Caporaso N., Morisco F., Chiaramonte M., Lattanzi E., Di Marco V., Venezia G., Fagiuoli S., Boninsegna S., Fattovich G., Olivari N., Ferrari C., Giuberti T., Ferrigno L., Magnani G., Massari M., Mangano C., Caserta C., Messina V., Pastore G., Palattella S., Piccinino F., Stanzione M., Pinzello G., Vinci M., Raimondo G., Caccamo G., Roffi L., Bellia V., Rizzetto M., Smedile A., Ciancio A., Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, and Ciancio, A

Subjects
Male, HBsAg, viruses, HIV Infections, Antibodies, Viral, HBeAg, Hepatitis, Liver disease, CHRONIC HEPATITIS B, epidemiology, GEOGRAPHICAL LANDSCAPE, 0302 clinical medicine, 80 and over, Prevalence, Viral, Chronic, Aged, 80 and over, 0303 health sciences, Geography, Age Factors, virus diseases, Hepatitis C, Hepatitis B, Middle Aged, Hepatitis D, 3. Good health, Infectious Diseases, Cirrhosis, Italy, Medicine, 030211 gastroenterology & hepatology, Female, Hepatitis D virus, Human, Adult, Hepatitis, Viral, Human, Adolescent, Antibodies, 03 medical and health sciences, Hepatitis B, Chronic, HDV, Virology, Cirrhosis, HBeAg, HDV, Hepatitis B, Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Antibodies, Viral, Cross-Sectional Studies, Female, Geography, HIV, HIV Infections, Hepatitis B, Chronic, Hepatitis, Viral, Human, Humans, Italy, Male, Middle Aged, Prevalence, Virology, Infectious Diseases, medicine, Aged, Cross-Sectional Studies, HIV, Humans, 030304 developmental biology, Cirrhosi, business.industry, medicine.disease, digestive system diseases, business
Abstract

The aim of the study was to evaluate the characteristics of chronic hepatitis B with special reference to the geographical origin of the patients and to the prevalence of HBeAg and viral and non-viral co-factors of liver disease. A cross-sectional multicenter survey was undertaken, which enrolled 1,386 HBsAg chronic carriers observed consecutively in 21 referral centers over a 6-month period. The prevalence of HBeAg in patients was 11%; the presence of HBeAg was associated independently with a younger age and co-infection with HIV. Anti-HDV, anti-HCV, or anti-HIV antibodies were detected in 8.1%, 6.5%, and 2%, respectively. However, among the patients first diagnosed during the study period (incident cases), 14.3% were anti-HDV positive. Seven percent of the patients were immigrants; they were younger than Italian patients and 18% were HBeAg positive; no difference was observed in the prevalence of anti-HDV, anti-HCV, or anti-HIV antibodies. The presence of cirrhosis was associated independently with an age >52 years, the presence of anti-HDV or anti-HCV, alcohol use >4 drinks/day, and a high BMI. The clinical epidemiology of chronic hepatitis B virus (HBV) infection shows a dynamic profile, with the potential for re-emergence of cases with HBeAg or anti-HDV and an emerging impact of metabolic factors on the evolution of liver disease.

Published
2009
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7. Antiviral therapy and fibrosis progression in patients with mild-moderate hepatitis C recurrence after liver transplantation. A randomized controlled study

Author

Belli, L, Volpes, R, Graziadei, I, Fagiuoli, S, Starkel, P, Burra, P, Alberti, A, Gridelli, B, Vogel, W, Pasulo, L, De Martin, E, Guido, M, DE CARLIS, L, Lerut, J, Cillo, U, Burroughs, A, Pinzello, G, DE CARLIS, LUCIANO GREGORIO, Pinzello, G., Belli, L, Volpes, R, Graziadei, I, Fagiuoli, S, Starkel, P, Burra, P, Alberti, A, Gridelli, B, Vogel, W, Pasulo, L, De Martin, E, Guido, M, DE CARLIS, L, Lerut, J, Cillo, U, Burroughs, A, Pinzello, G, DE CARLIS, LUCIANO GREGORIO, and Pinzello, G.

Abstract

Backgrounds/aims: We evaluated the effect of antiviral therapy on fibrosis progression in patients with histological features of mild/moderate HCV disease recurrence defined by a Grading score. ≥. 4 and Staging score up to 3 (Ishak) at 1 year after liver transplantation. Methods: Seventy-three consecutive patients with mild/moderate recurrence were randomized either to no treatment or to receive Pegilated-Interferon-alfa-2b and ribavirin for 52 weeks. Liver biopsies obtained at baseline (1 year after transplantation) and 2 years afterwards were evaluated for assessment of disease progression, defined as worsening of at least 2 staging points or progression to stage 4 or higher. Results: As for these two major histological end points there were no statistically significant differences between the 2 groups (36.1% vs. 50%, . p=. 0.34 and 36.1% vs. 38.9%, . p=. 1). Fifteen treated patients (41%) achieved a sustained virological response which was associated with a reduced risk of fibrosis worsening for both endpoints when compared to viremic patients (. p=. 0.04). Conclusions: Although antiviral-therapy was beneficial in preventing fibrosis progression in patients achieving a sustained virological response, the majority of the overall population of our patients with mild-moderate disease recurrence could not benefit from antiviral therapy either because they either could not be treated or did not respond to treatment (EudraCT number: 2005-005760). © 2012

Published
2012

9. Evolving clinical landscape of chronic hepatitis B: A multicenter Italian study

Author

Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, Andreone P, Scuteri A, Antonucci G, Iacomi F, Babudieri S, Pintus A, Stornaiuolo G, Brancaccio G, Brunetto M, Sasso R, Caporaso N, Morisco F, Chiaramonte M, Lattanzi E, Di Marco V, Venezia G, Fagiuoli S, Boninsegna S, Fattovich G, Olivari N, Ferrari C, Giuberti T, Ferrigno L, Magnani G, Massari M, Mangano C, Caserta C, Messina V, Pastore G, Palattella S, Piccinino F, Stanzione M, Pinzello G, Vinci M, Raimondo G, Caccamo G, Roffi L, Bellia V, Rizzetto M, Smedile A, Ciancio A. Italian Hospitals' Collaborating Group., Stroffolini, T, Almasio, P, Sagnelli, E, Mele, A, Gaeta, G, Andreone, P, Scuteri, A, Antonucci, G, Iacomi, F, Babudieri, S, Pintus, A, Stornaiuolo, G, Brancaccio, G, Brunetto, M, Sasso, R, Caporaso, N, Morisco, F, Chiaramonte, M, Lattanzi, E, Di Marco, V, Venezia, G, Fagiuoli, S, Boninsegna, S, Fattovich, G, Olivari, N, Ferrari, C, Giuberti, T, Ferrigno, L, Magnani, G, Massari, M, Mangano, C, Caserta, C, Messina, V, Pastore, G, Palattella, S, Piccinino, F, Stanzione, M, Pinzello, G, Vinci, M, Raimondo, G, Caccamo, G, Roffi, L, Bellia, V, Rizzetto, M, Smedile, A, Ciancio, A, Stroffolini T, Almasio PL, Sagnelli E, Mele A, Gaeta GB, Andreone P, Scuteri A, Antonucci G, Iacomi F, Babudieri S, Pintus A, Stornaiuolo G, Brancaccio G, Brunetto M, Sasso R, Caporaso N, Morisco F, Chiaramonte M, Lattanzi E, Di Marco V, Venezia G, Fagiuoli S, Boninsegna S, Fattovich G, Olivari N, Ferrari C, Giuberti T, Ferrigno L, Magnani G, Massari M, Mangano C, Caserta C, Messina V, Pastore G, Palattella S, Piccinino F, Stanzione M, Pinzello G, Vinci M, Raimondo G, Caccamo G, Roffi L, Bellia V, Rizzetto M, Smedile A, and Ciancio A. Italian Hospitals' Collaborating Group.

Abstract

The aim of the study was to evaluate the characteristics of chronic hepatitis B with special reference to the geographical origin of the patients and to the prevalence of HBeAg and viral and non-viral co-factors of liver disease. A cross-sectional multicenter survey was undertaken, which enrolled 1,386 HBsAg chronic carriers observed consecutively in 21 referral centers over a 6-month period. The prevalence of HBeAg in patients was 11%; the presence of HBeAg was associated independently with a younger age and co-infection with HIV. Anti-HDV, anti-HCV, or anti-HIV antibodies were detected in 8.1%, 6.5%, and 2%, respectively. However, among the patients first diagnosed during the study period (incident cases), 14.3% were anti-HDV positive. Seven percent of the patients were immigrants; they were younger than Italian patients and 18% were HBeAg positive; no difference was observed in the prevalence of anti-HDV, anti-HCV, or anti-HIV antibodies. The presence of cirrhosis was associated independently with an age >52 years, the presence of anti-HDV or anti-HCV, alcohol use >4 drinks/day, and a high BMI. The clinical epidemiology of chronic hepatitis B virus (HBV) infection shows a dynamic profile, with the potential for re-emergence of cases with HBeAg or anti-HDV and an emerging impact of metabolic factors on the evolution of liver disease.

Published
2009

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

Author

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

Published
2009

11. Genotype 2 and 3 Reccurent Hepatitis C after Liver Transplantation: Excellent Results with Suboptimal Doses of Antiviral Therapy

Author

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

Published
2009

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

Author

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

Published
2009

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

Author

Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, De Martin, E, Burra, P, Boninsegna, S, Donato, F, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Gasbarrini, A, Fagiuoli, S, Ponziani FR, Vigano R, Belli L, Pinzello G, Colledan M, De Martin E, Burra P, Boninsegna S, Donato F, Di Paolo D, Angelico M, Rendina M, Pompili M, Gasbarrini A, Fagiuoli S, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, De Martin, E, Burra, P, Boninsegna, S, Donato, F, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Gasbarrini, A, Fagiuoli, S, Ponziani FR, Vigano R, Belli L, Pinzello G, Colledan M, De Martin E, Burra P, Boninsegna S, Donato F, Di Paolo D, Angelico M, Rendina M, Pompili M, Gasbarrini A, and Fagiuoli S

Published
2009

14. FIBROSIS PROGRESSION AFTER ANTIVIRAL TREATMENT (AT) FOR HCV RECURRENCE FOLLOWING LIVER TRANSPLANTATION

Author

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

Published
2009

15. ANTIVIRAL TREATMENT (AT) FOR HCV RECURRENCE FOLLOWING LIVER TRANSPLANTATION: THE IMPACT ON FIBROSIS PROGRESSION

Author

De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, F, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Gasbarrini, A, Russo, F, Cillo, U, Fagiuoli, S, De Martin E, Senzolo M, Ponziani FR, Vigano R, Belli L, Pinzello G, Colledan M, Donato F, Di Paolo D, Angelico M, Rendina M, Pompili M, Gasbarrini A, Russo FP, Cillo U, Fagiuoli S, De Martin, E, Senzolo, M, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, Donato, F, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Gasbarrini, A, Russo, F, Cillo, U, Fagiuoli, S, De Martin E, Senzolo M, Ponziani FR, Vigano R, Belli L, Pinzello G, Colledan M, Donato F, Di Paolo D, Angelico M, Rendina M, Pompili M, Gasbarrini A, Russo FP, Cillo U, and Fagiuoli S

Published
2009

16. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia

Author

Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Bessonova E, Bilodeau M, Bloomer J, Botta Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, ANDREONE, PIETRO, MAZZELLA, GIUSEPPE, Afdhal, NH, Giannini, EG, Tayyab, G, Mohsin, A, Lee, JW, Andriulli, A, Jeffers, L, McHutchison, J, Chen, PJ, Han, KH, Campbell, F, Hyde, D, Brainsky, A, Theodore, D, Craxi, A, Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Andreone P, Bessonova E, Bilodeau M, Bloomer J, Botta-Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin-Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Mazzella G, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, and …]

Subjects
Liver Cirrhosis, Male, Cirrhosis, Chronic liver disease, Benzoates, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Receptors, Clinical endpoint, 80 and over, Medicine, CIRRHOSIS, Aged, 80 and over, Benzoic Acids, General Medicine, CHRONIC LIVER DISEASE, Middle Aged, Hydrazines, Thrombopoietin, Elective Surgical Procedures, Anesthesia, Female, Elective Surgical Procedure, Receptors, Thrombopoietin, Adult, Adolescent, Eltrombopag, ELTROMBOPAG, Hemorrhage, Platelet Transfusion, Placebo, Young Adult, Double-Blind Method, Elective, Surgical Procedures, Elective, Humans, Aged, THROMBOCYTOPENIA, Surgical Procedures, business.industry, Platelet Count, cirrhosis, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Thrombocytopenia, Platelet transfusion, chemistry, Chronic Disease, Pyrazoles, business
Abstract

Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure.We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period.A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups.Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number, NCT00678587.).

Published
2012

17. Long term follow-up of liver transplantation (OLT) for cholestatic and autoimmune end stage liver diseases

Author

Blasone, L, Fagiuoli, S, Colledan, M, Strazzabosco, M, Lenzi, M, Floreani, A, Burra, P, Cillo, U, Merenda, R, Donato, M, Rossi, G, Salizzoni, M, Franchello, A, Rizzetto, M, Pinzello, G, De Carlis, L, Toniutto, P, Andorno, E, Blasone L, Fagiuoli S, Colledan M, Strazzabosco M, Lenzi M, Floreani A, Burra P, Cillo U, Merenda R, Donato MF, Rossi G, Salizzoni M, Franchello A, Rizzetto M, Pinzello G, De Carlis L, Toniutto P, Andorno E, Blasone, L, Fagiuoli, S, Colledan, M, Strazzabosco, M, Lenzi, M, Floreani, A, Burra, P, Cillo, U, Merenda, R, Donato, M, Rossi, G, Salizzoni, M, Franchello, A, Rizzetto, M, Pinzello, G, De Carlis, L, Toniutto, P, Andorno, E, Blasone L, Fagiuoli S, Colledan M, Strazzabosco M, Lenzi M, Floreani A, Burra P, Cillo U, Merenda R, Donato MF, Rossi G, Salizzoni M, Franchello A, Rizzetto M, Pinzello G, De Carlis L, Toniutto P, and Andorno E

Published
2007

18. FIBROSIS PROGRESSION AFTER ANTIVIRAL TREATMENT (AT) FOR HCV RECURRENCE FOLLOWING LIVER TRANSPLANTATION

Author

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

Subjects
Transplantation, Hepatology, Gastroenterology, Surgery
Published
2009

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

Author

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

Subjects
Hepatology, Gastroenterology
Published
2009

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

Author

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

Subjects
Hepatology, Gastroenterology
Published
2009

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

Author

Ponziani FR, Vigano R, Belli L, Pinzello G, Colledan M, De Martin E, Burra P, Boninsegna S, Donato F, Di Paolo D, Angelico M, Rendina M, Pompili M, Gasbarrini A, Fagiuoli S, Ponziani, F, Vigano, R, Belli, L, Pinzello, G, Colledan, M, De Martin, E, Burra, P, Boninsegna, S, Donato, F, Di Paolo, D, Angelico, M, Rendina, M, Pompili, M, Gasbarrini, A, and Fagiuoli, S

Subjects
Transplantation, Hepatology, Gastroenterology, Surgery
Published
2009

22. HCV E1E2-MF59vaccine in chronic hepatitis C patients treated with PEG-IFNα2a and Ribavirin: a randomized controlled trial

Author

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

Subjects
CD4-Positive T-Lymphocytes, Squalene, Viral Hepatitis Vaccines, Drug-Related Side Effects and Adverse Reactions, viral kinetics, Polysorbates, VACCINE, Antiviral Agents, Injections, Intramuscular, immune response, Polyethylene Glycols, viral kinetic, Adjuvants, Immunologic, Ribavirin, Humans, neutralizing antibodies, HCV, interferon, vaccine, Cell Proliferation, Vaccines, Synthetic, Interferon-alpha, Original Articles, Hepatitis C Antibodies, Hepatitis C, Chronic, Viral Load, Antibodies, Neutralizing, Combined Modality Therapy, Recombinant Proteins, Treatment Outcome, RNA, Viral
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

23. Long term follow-up of liver transplantation (OLT) for cholestatic and autoimmune end stage liver diseases

Author

Blasone L, Fagiuoli S, Colledan M, Strazzabosco M, Lenzi M, Floreani A, Burra P, Cillo U, Merenda R, Donato MF, Rossi G, Salizzoni M, Franchello A, Rizzetto M, Pinzello G, De Carlis L, Toniutto P, Andorno E, Blasone, L, Fagiuoli, S, Colledan, M, Strazzabosco, M, Lenzi, M, Floreani, A, Burra, P, Cillo, U, Merenda, R, Donato, M, Rossi, G, Salizzoni, M, Franchello, A, Rizzetto, M, Pinzello, G, De Carlis, L, Toniutto, P, and Andorno, E

Subjects
Hepatology, Gastroenterology
Published
2007

24. Early ribavirin treatment and avoidance of corticosteroids in hepatitis C virus (HCV)-positive liver transplant recipients: Interim report of a prospective randomized trial

Author

Belli, L, Alberti, A, Rondinara, G, de Carlis, L, Corti, A, Mazza, E, Airoldi, A, Cernuschi, A, de Gasperi, A, Forti, D, Pinzello, G, Belli, L. S., Alberti, A. B., Rondinara, G. F., de Carlis, L., Corti, A., Mazza, E., Airoldi, A., Cernuschi, A., de Gasperi, A., Forti, D., Pinzello, G. B., Belli, L, Alberti, A, Rondinara, G, de Carlis, L, Corti, A, Mazza, E, Airoldi, A, Cernuschi, A, de Gasperi, A, Forti, D, Pinzello, G, Belli, L. S., Alberti, A. B., Rondinara, G. F., de Carlis, L., Corti, A., Mazza, E., Airoldi, A., Cernuschi, A., de Gasperi, A., Forti, D., and Pinzello, G. B.

Published
2001

26. Prospective Italian multicenter field-practice study with sorafenib for advanced hepatocellular carcinoma

Author

Iavarone M., Cabibbo G., Sangiovanni A., Camma C., Zavaglia C., Grieco A., Airoldi A., Biolato M., Di Marco V., Pinzello G. B., Racco S., Craxi A., Colombo M., BORGHI, ALBERTO, GRANITO, ALESSANDRO, PISCAGLIA, FABIO, BOLONDI, LUIGI, Iavarone M., Cabibbo G., Sangiovanni A., Camma C., Borghi A., Zavaglia C., Grieco A., Granito A., Airoldi A., Biolato M., Di Marco V., Piscaglia F., Pinzello G.B., Racco S., Bolondi L., Craxi A., and Colombo M.

Subjects
HEPATOCELLULAR CARCINOMA
Published
2011

30. Peg-ifn-alfa 2b With Ribavirin For the Treatment of Mild-moderate Recurrent Hepatitis C After Liver Transplantation (lt) : Impact On Fibrosis Progression. A Multicenter Randomized Controlled Study

Author

Belli, L, Volpes, R, Graziadei, I, Starkel, P, Burroughs, A, Burra, P, Fagiuoli, S, Alberti, A, Guido, M, Pasula, L, Vogel, W, Gridelli, B, Cillo, U, Carlis, L, Pinzello, G, L. S. Belli, R. Volpes, I. Graziadei, P. Starkel, A. K. Burroughs, P. Burra, S. Fagiuoli, A. B. Alberti, M. Guido, L. Pasula, W. Vogel, B. Gridelli, U. Cillo, L. D. Carlis, G. Pinzello, Belli, L, Volpes, R, Graziadei, I, Starkel, P, Burroughs, A, Burra, P, Fagiuoli, S, Alberti, A, Guido, M, Pasula, L, Vogel, W, Gridelli, B, Cillo, U, Carlis, L, Pinzello, G, L. S. Belli, R. Volpes, I. Graziadei, P. Starkel, A. K. Burroughs, P. Burra, S. Fagiuoli, A. B. Alberti, M. Guido, L. Pasula, W. Vogel, B. Gridelli, U. Cillo, L. D. Carlis, and G. Pinzello

Published
2009

31. HCV E1E 2‐ MF 59vaccine in chronic hepatitis C patients treated with PEG ‐ IFN α2a and R ibavirin: a randomized controlled trial

Author

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

Published
2013
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32. 755 5-YEAR ENTECAVIR TREATMENT IN NUC-NAÏVE, FIELD-PRACTICE PATIENTS WITH CHRONIC HEPATITIS B SHOWED EXCELLENT VIRAL SUPPRESSION AND SAFETY PROFILE BUT NO PREVENTION OF HCC IN CIRRHOTICS

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Minola, E., additional, Cologni, G., additional, Rizzi, M., additional, Zaltron, S., additional, Vavassori, A., additional, Castelli, F., additional, Angeli, E., additional, Gubertini, G.A., additional, Magni, C., additional, Rizzardini, G., additional, Testa, A., additional, D'Offizi, G., additional, Vinci, M., additional, Pinzello, G., additional, Fatta, E., additional, Fargion, S., additional, Colombo, S., additional, Fracassetti, O., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Colli, A., additional, Fasano, M., additional, Santantonio, T., additional, Colloredo, G., additional, Pasulo, L., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Bellati, G., additional, Milanese, M., additional, Strazzabosco, M., additional, Pozzi, M., additional, Terreni, N., additional, Spinzi, G., additional, Quagliuolo, M., additional, Borzio, M., additional, Lunghi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2013
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33. T-12 Tenofovir suppressed viral suppression in most field practice, treatment-naïve patients with CHB followed for 3 years in a multicenter European study

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Papatheodoridis, G.V., additional, Margariti, E., additional, Buti, M., additional, Esteban, R., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Minola, E., additional, Vinci, M., additional, Pinzello, G., additional, Giorgini, A.M., additional, Zuin, M., additional, Salmi, A., additional, Colombo, S., additional, Fracassetti, O., additional, Del Poggio, P., additional, Bruno, S., additional, Pasulo, L., additional, Fagiuoli, S., additional, Andreoletti, M., additional, Colli, A., additional, Fumagalli Maldini, F., additional, Milanese, M., additional, Strazzabosco, M., additional, Colombo, A.E., additional, Bellati, G., additional, Angeli, E., additional, Magni, C., additional, Gubertini, G.A., additional, Rizzardini, G., additional, Fasano, M., additional, Santantonio, T., additional, Terreni, N.M., additional, Spinzi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2013
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34. T-11 5-year entecavir in NUC-naïve, field-practice patients with CHB showed excellent viral suppression and safety but no prevention of HCC

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Minola, E., additional, Cologni, G., additional, Rizzi, M., additional, Zaltron, S., additional, Vavassori, A., additional, Castelli, F., additional, Angeli, E., additional, Gubertini, G.A., additional, Magni, C., additional, Rizzardini, G., additional, Testa, A., additional, D'Offizi, G., additional, Vinci, M., additional, Pinzello, G., additional, Fatta, E., additional, Fargion, S., additional, Colombo, S., additional, Fracassetti, O., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Colli, A., additional, Fasano, M., additional, Santantonio, T., additional, Colloredo, G., additional, Pasulo, L., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Bellati, G., additional, Milanese, M., additional, Strazzabosco, M., additional, Pozzi, M., additional, Terreni, N.M., additional, Spinzi, G., additional, Quagliuolo, M., additional, Borzio, M., additional, Lunghi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2013
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35. Liver transplantation for HCV cirrhosis: Improved survival in recent years and increased severity of recurrent disease in female recipients: Results of a long term retrospective study

Author

Belli, L, Burroughs, A, Burra, P, Alberti, A, Samonakis, D, Cammà, C, De Carlis, L, Minola, E, Quaglia, A, Zavaglia, C, Vangeli, M, Patch, D, Dhillon, A, Cillo, U, Guido, M, Fagiuoli, S, Giacomoni, A, Slim, O, Airoldi, A, Boninsegna, S, Davidson, B, Rolles, K, Pinzello, G, Belli, Luca S., Burroughs, Andrew K., Burra, Patrizia, Alberti, Alberto B., Samonakis, Dimitrios, Cammà, Calogero, De Carlis, Luciano, Minola, Ernesto, Quaglia, Alberto, Zavaglia, Claudio, Vangeli, Marcello, Patch, David, Dhillon, Amar, Cillo, Umberto, Guido, Maria, Fagiuoli, Stefano, Giacomoni, Alessandro, Slim, Omar A., Airoldi, Aldo, Boninsegna, Sara, Davidson, Brian R., Rolles, Keith, Pinzello, Giovambattista, Belli, L, Burroughs, A, Burra, P, Alberti, A, Samonakis, D, Cammà, C, De Carlis, L, Minola, E, Quaglia, A, Zavaglia, C, Vangeli, M, Patch, D, Dhillon, A, Cillo, U, Guido, M, Fagiuoli, S, Giacomoni, A, Slim, O, Airoldi, A, Boninsegna, S, Davidson, B, Rolles, K, Pinzello, G, Belli, Luca S., Burroughs, Andrew K., Burra, Patrizia, Alberti, Alberto B., Samonakis, Dimitrios, Cammà, Calogero, De Carlis, Luciano, Minola, Ernesto, Quaglia, Alberto, Zavaglia, Claudio, Vangeli, Marcello, Patch, David, Dhillon, Amar, Cillo, Umberto, Guido, Maria, Fagiuoli, Stefano, Giacomoni, Alessandro, Slim, Omar A., Airoldi, Aldo, Boninsegna, Sara, Davidson, Brian R., Rolles, Keith, and Pinzello, Giovambattista

Abstract

In recent years, a worsening outcome of hepatitis C virus (HCV)-positive recipients and a faster progression of recurrent disease to overt cirrhosis have been reported. Our aims were to 1) assess patient survival and development of severe recurrent disease (Ishak fibrosis score > 3) in different transplant years; and 2) model the effects of pre- and post-liver transplantation (LT) variables on the severity of recurrent disease. A multicenter retrospective analysis was conducted on 502 consecutive HCV-positive transplant recipients between January 1990 and December 2002. Protocol liver biopsies were obtained at 1, 3, 5, 7, and 10 yr post-LT ir almost 90% of the patients. All 502 patients were included in the overall survival analysis, while only the 354 patients with a follow-up longer than 1 yr were considered for the analysis of predictors of disease progression. The overall Kaplan-Meier survival rates were 78.7%, 66.3%, and 58.6%, at 12, 60, and 120 months, respectively, and a trend for a better patient survival over the years emerged from all 3 centers. The cumulative probability of developing HCV-related recurrent severe fibrosis (Ishak score 4-6) in the cohort of 354 patients who survived at least 1 yr remained unchanged over the years. Multivariate analysis indicated that older donors (P = 0.0001) and female gender of recipient (P = 0.02) were the 2 major risk factors for the development of severe recurrent disease, while the adoption of antilymphocytic preparations was associated with a less aggressive course (P = 0.03). Two of these prognostic factors, donor age and recipient gender, are easily available before LT and their combination showed an important synergy, such that a female recipient not only had a much higher probability of severe recurrent disease than a male recipient but her risk increased with the increasing age of the donor, reaching almost 100% when the age of the donor was 60 or older. In conclusion, a trend for a better patient survival

Published
2007

36. HLA-DRB1 donor-recipient mismatch affects the outcome of hepatitis C disease recurrence after liver transplantation

Author

Belli, L, Burra, P, Poli, F, Alberti, A, Silini, E, Zavaglia, C, Fagiuoli, S, Prando, D, Espadas De Arias, A, Boninsegna, S, Tinelli, C, Scalamogna, M, De Carlis, L, Pinzello, G, Belli, Luca Saverio, Burra, Patrizia, Poli, Francesca, Alberti, Alberto Battista, Silini, Enrico, Zavaglia, Claudio, Fagiuoli, Stefano, Prando, Daniela, Espadas De Arias, Alejandro, Boninsegna, Sara, Tinelli, Carmine, Scalamogna, Mario, De Carlis, Luciano, Pinzello, Giovambattista, Belli, L, Burra, P, Poli, F, Alberti, A, Silini, E, Zavaglia, C, Fagiuoli, S, Prando, D, Espadas De Arias, A, Boninsegna, S, Tinelli, C, Scalamogna, M, De Carlis, L, Pinzello, G, Belli, Luca Saverio, Burra, Patrizia, Poli, Francesca, Alberti, Alberto Battista, Silini, Enrico, Zavaglia, Claudio, Fagiuoli, Stefano, Prando, Daniela, Espadas De Arias, Alejandro, Boninsegna, Sara, Tinelli, Carmine, Scalamogna, Mario, De Carlis, Luciano, and Pinzello, Giovambattista

Abstract

Background & Aims: This study extends our previously reported observations that various immunological factors are associated with the occurrence of histologically proven recurrent hepatitis C. The two specific issues investigated were to confirm the associations of MHC alleles and donor/recipient mismatch with the occurrence of recurrent hepatitis C in an independent cohort of newly transplanted patients and to look for immunologic and nonimmunologic variables affecting the severity of the recurrent disease. Methods: Two separate cohorts of consecutive patients were studied: a look-back cohort (LC) of 120 patients and a cohort for studying the disease progression (CSDP) of 190 patients. Protocol liver biopsies were obtained at least 1, 3, 5, 7, and 10 years after liver transplantation (LT). Results: A fully mismatched donor/recipient pair at the DRB1 locus was confirmed to be associated with both the recurrence of histologic hepatitis in the LC (59% vs 23%, P = .0002) and its progression beyond stage 3 in the CSPD (71.4% vs 39.3%, P = .0003). Relevant immunologic and nonimmunologic variables were included into a multivariate Cox proportional model and three variables, namely, donor age, full HLA-DRB1 donor-recipient mismatch, and HLA B14, resulted in independent risk factors for the development of severe fibrosis. Conclusion: This study provides evidence that DRB1 donor-recipient mismatch affects both the occurrence and progression of recurrent hepatitis C disease. This information is clinically relevant as it may help to better allocate organs and to recognize patients at risk for progression so that specific interventions can be implemented. © 2006 by the American Gastroenterological Association Institute

Published
2006

37. 522 MAINTAINED VIRAL SUPPRESSION AND EXCELLENT SAFETY PROFILE OF ENTECAVIR MONOTHERAPY IN 418 NUC-NAÏVE PATIENTS WITH CHRONIC HEPATITIS B: A 4-YEAR FIELD PRACTICE, MULTICENTER STUDY

Author

Lampertico, P., primary, Soffredini, R., additional, Invernizzi, F., additional, Viganò, M., additional, Facchetti, F., additional, Minola, E., additional, Fracassetti, O., additional, Suter, F., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Angeli, E., additional, Gubertini, G., additional, Magni, C., additional, Testa, A., additional, Antonucci, G., additional, Vinci, M., additional, Pinzello, G., additional, Fatta, E., additional, Fargion, S., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M., additional, Andreoletti, M., additional, Colli, A., additional, Fasano, M., additional, Santantonio, T., additional, Colloredo, G., additional, Pasulo, L., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Bellati, G., additional, Maldini, F. Fumagalli, additional, Milanese, M., additional, Pozzi, M., additional, Terreni, N., additional, Spinzi, G., additional, Quagliuolo, M., additional, Borzio, M., additional, Lunghi, G., additional, and Colombo, M., additional

Published
2012
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39. 525 TENOFOVIR MONOTHERAPY FOR NAÏVE PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER EUROPEAN STUDY IN CLINICAL PRACTICE IN 302 PATIENTS FOLLOWED FOR 30 MONTHS

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Papatheodoridis, G., additional, Ekaterini, M., additional, Buti, M., additional, Esteban, R., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Minola, E., additional, Vinci, M., additional, Pinzello, G., additional, Giorgini, A., additional, Zuin, M., additional, Salmi, A., additional, Del Poggio, P., additional, De Filippi, F., additional, Bruno, S., additional, Pasulo, L., additional, Fagiuoli, S., additional, Andreoletti, M., additional, Colli, A., additional, Maldini, F. Fumagalli, additional, Milanese, M., additional, Colombo, A.E., additional, Bellati, G., additional, Angeli, E., additional, Magni, C., additional, Gubertini, G., additional, Rizzardini, G., additional, Fasano, M., additional, Santantonio, T., additional, Terreni, N., additional, Spinzi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2012
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40. P.15.2 ENTECAVIR MONOTHERAPY IN 418 NUC-NAIVE PATIENTS WITH CHRONIC HEPATITIS B FROM FIELD PRACTICE: HIGH EFFICACY AND FAVORABLE SAFETY PROFILE OVER 3 YEARS OF TREATMENT

Author

Lampertico, P., primary, Viganò, M., additional, Soffredini, R., additional, Facchetti, F., additional, Minola, E., additional, Fracassetti, O., additional, Suter, F., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Angeli, E., additional, Gubertini, G., additional, Magni, C., additional, Testa, A., additional, Antonucci, G., additional, Vinci, M., additional, Pinzello, G., additional, Fatta, E., additional, Fargion, S., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Colli, A., additional, Fasano, M., additional, Santantonio, T., additional, Colloredo, G., additional, Pasulo, L., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Bellati, G., additional, Maldini, F. Fumagalli, additional, Milanese, M., additional, Pozzi, M., additional, Terreni, N., additional, Spinzi, G., additional, Quagliuolo, M., additional, Borzio, M., additional, Lunghi, G., additional, and Colombo, M., additional

Published
2012
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41. OC.07.1 2-YEAR EFFECTIVENESS AND SAFETY OF TENOFOVIR IN 302 NUC-NAIVE PATIENTS WITH CHRONIC HEPATITIS B: A MULTICENTER EUROPEAN STUDY IN CLINICAL PRACTICE

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Papatheodoris, G., additional, Margheriti, K., additional, Buti, M., additional, Esteban, R., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Minola, E., additional, Vinci, M., additional, Pinzello, G., additional, Giorgini, A., additional, Zuin, M., additional, Salmi, A., additional, Del Poggio, P., additional, De Filippi, F., additional, Bruno, S., additional, Pasulo, L., additional, Fagiuoli, S., additional, Andreoletti, M., additional, Colli, A., additional, Maldini, F. Fumagalli, additional, Milanese, M., additional, Colombo, A.E., additional, Bellati, G.A., additional, Angeli, E., additional, Magni, C., additional, Gubertini, G., additional, Rizzardini, G., additional, Fasano, M., additional, Santantonio, T., additional, Terreni, N., additional, Spinzi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2012
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42. T-8 Entecavir monotherapy in 418 NUC-naive patients with chronic hepatitis B from field practice: high efficacy and favorable safety profile over 3 years of treatment

Author

Lampertico, P., primary, Viganò, M., additional, Soffredini, R., additional, Facchetti, F., additional, Minola, E., additional, Fracassetti, O., additional, Suter, F., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Angeli, E., additional, Gubertini, G.A., additional, Magni, C.F., additional, Testa, A., additional, Antonucci, G., additional, Vinci, M., additional, Pinzello, G., additional, Fatta, E., additional, Fargion, S., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Colli, A., additional, Fasano, M., additional, Santantonio, T., additional, Colloredo, G., additional, Pasulo, L., additional, Fagiuoli, S., additional, Colombo, A., additional, Bellati, G.A., additional, Maldini, F. Fumagalli, additional, Milanese, M., additional, Pozzi, M., additional, Terreni, N.M., additional, Spinzi, G., additional, Quagliuolo, M., additional, Lunghi, G., additional, and Colombo, M., additional

Published
2012
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43. T-9 2-year effectiveness and safety of tenofovir in 302 NUC-naive patients with chronic hepatitis B: a multicenter European study in clinical practice

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Papatheodoridis, G.V., additional, Margariti, K., additional, Buti, M., additional, Esteban, R., additional, Zaltron, S., additional, Vavassori, A., additional, Carosi, G., additional, Minola, E., additional, Vinci, M., additional, Pinzello, G., additional, Giorgini, A.M., additional, Zuin, M., additional, Salmi, A., additional, Del Poggio, P., additional, De Filippi, F., additional, Bruno, S., additional, Pasulo, L., additional, Fagiuoli, S., additional, Andreoletti, M., additional, Colli, A., additional, Fumagalli Maldini, F., additional, Milanese, M., additional, Colombo, A., additional, Bellati, G.A., additional, Angeli, E., additional, Magni, C.F., additional, Gubertini, G.A., additional, Rizzardini, G., additional, Fasano, M., additional, Santantonio, T., additional, Terreni, N.M., additional, Spinzi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2012
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44. OC.09.2: MAINTAINED LONG-TERM SUPPRESSION OF HBV REPLICATION IN NUC-NAÏVE PATIENTS WITH CHRONIC HEPATITIS B TREATED WITH ETV MONOTHERAPY IN FIELD PRACTICE: THE ITALIAN MULTICENTER EXPERIENCE

Author

Lampertico, P., primary, Viganò, M., additional, Soffredini, R., additional, Facchetti, F., additional, Minola, E., additional, Suter, F., additional, Zaltron, S., additional, Vavassori, A., additional, Gubertini, G., additional, Magni, C., additional, Testa, A., additional, Antonucci, G., additional, Pinzello, G., additional, Vinci, M., additional, Fatta, E., additional, Fargion, S., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Santantonio, T., additional, Colloredo, G., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Maldini, F. Fumagalli, additional, Pozzi, M., additional, Terreni, N., additional, Quagliuolo, M., additional, Lunghi, G., additional, and Massimo, C., additional

Published
2011
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45. 731 EFFECTIVENESS AND SAFETY OF TENOFOVIR DISOPROXIL FUMARATE IN FIELD PRACTICE: A MULTICENTER EUROPEAN COHORT STUDY OF 302 NUC-NAIVE PATIENTS WITH CHRONIC HEPATITIS B

Author

Lampertico, P., primary, Soffredini, R., additional, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Papatheodoridis, G.V., additional, Margariti, K., additional, Buti, M., additional, Esteban, R., additional, Zaltron, S., additional, Vavassori, A., additional, Minóla, E., additional, Vinci, M., additional, Pinzello, G., additional, Giorgini, A., additional, Zuin, M., additional, Salmi, A., additional, Del Poggio, P., additional, De Filippi, F., additional, Bruno, S., additional, Pasulo, L., additional, Fagiuoli, S., additional, Andreoletti, M., additional, Colli, A., additional, Fumagalli Maldini, F., additional, Milanese, M., additional, Colombo, A.E., additional, Bellati, G., additional, Magni, C., additional, Angeli, E., additional, Gubertini, G., additional, Rizzardini, G., additional, Fasano, M., additional, Santantonio, T., additional, Terreni, N., additional, Spinzi, G., additional, Facchetti, F., additional, Invernizzi, F., additional, and Colombo, M., additional

Published
2011
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46. P.1.48: EFFECTIVENESS AND SAFETY OF TENOFOVIR DISOPROXIL FUMARATE IN FIELD PRACTICE: A MULTICENTER EUROPEAN COHORT STUDY OF 737 PATIENTS WITH CHRONIC HEPATITIS B

Author

Lampertico, P., primary, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Buti, M., additional, Esteban, R., additional, Papatheodoridis, G., additional, Pinzello, G., additional, Vinci, M., additional, Minola, E., additional, Suter, F., additional, Del Poggio, P., additional, Andreoletti, M., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Salmi, A., additional, Santantonio, T., additional, Magni, C., additional, Gubertini, C., additional, Maldini, F. Fumagalli, additional, Terreni, N., additional, Facchetti, F., additional, Soffredini, R., additional, and Colombo, M., additional

Published
2011
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47. F-34 Maintained long-term suppression of HBV replication in NUC-naïve patients with chronic hepatitis B treated with ETV monotherapy in field practice: The Italian multicenter experience

Author

Lampertico, P., primary, Viganò, M., additional, Soffredini, R., additional, Facchetti, F., additional, Minola, E., additional, Suter, F., additional, Zaltron, S., additional, Vavassori, A., additional, Gubertini, G., additional, Magni, C., additional, Testa, A., additional, Antonucci, G., additional, Pinzello, G., additional, Vinci, M., additional, Fatta, E., additional, Fargion, S., additional, Del Poggio, P., additional, Coco, B., additional, Brunetto, M.R., additional, Andreoletti, M., additional, Santantonio, T., additional, Colloredo, G., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Maldini, F. Fumagalli, additional, Pozzi, M., additional, Terreni, N., additional, Quagliuolo, M., additional, Lunghi, G., additional, and Colombo, M., additional

Published
2011
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48. F-36 Effectiveness and safety of tenofovir disoproxil fumarate in field practice: A multicenter European cohort study of 737 patients with chronic hepatitis B

Author

Lampertico, P., primary, Viganò, M., additional, Yurdaydin, C., additional, Idilman, R., additional, Buti, M., additional, Esteban, R., additional, Papatheodoridis, G.V., additional, Pinzello, G., additional, Vinci, M., additional, Minola, E., additional, Suter, F., additional, Del Poggio, P., additional, Andreoletti, M., additional, Fagiuoli, S., additional, Colombo, A.E., additional, Salmi, A., additional, Santantonio, T., additional, Magni, C., additional, Gubertini, G., additional, Maldini, F. Fumagalli, additional, Terreni, N., additional, Facchetti, F., additional, Soffredini, R., additional, and Colombo, M., additional

Published
2011
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49. Sequence variation in the hypervariable region 1 of hepatitis C virus and posttransplantation recurrent hepatitis

Author

Silini, E, Belli, L, Brambilla, S, Foti, L, Gritti, M, Lisa, A, Alberti, A, Vinci, M, De Carlis, L, Rondinara, G, Pinzello, G, Silini, Enrico, Belli, Luca, Brambilla, Sabrina, Foti, Luciana, GRITTI, MARIA CHIARA, Lisa, Antonella, Alberti, Alberto Battista, Vinci, Marilina, De Carlis, Luciano, Rondinara, Gianfranco, Pinzello, Giovanbattista, Silini, E, Belli, L, Brambilla, S, Foti, L, Gritti, M, Lisa, A, Alberti, A, Vinci, M, De Carlis, L, Rondinara, G, Pinzello, G, Silini, Enrico, Belli, Luca, Brambilla, Sabrina, Foti, Luciana, GRITTI, MARIA CHIARA, Lisa, Antonella, Alberti, Alberto Battista, Vinci, Marilina, De Carlis, Luciano, Rondinara, Gianfranco, and Pinzello, Giovanbattista

Abstract

Hepatitis C virus (HCV) shows remarkable genetic variation in both populations and individuals, in whom it circulates as quasispecies (QS). Sequence variation within an infected host has adaptive significance and reflects the modes and intensity of selection mechanisms operating on the virus. We investigated the sequence diversity of hypervariable region 1 of HCV in liver transplant recipients and correlated it with the recurrence of hepatitis. Twenty-six patients were considered during a 2-year period; all had graft reinfection, and 14 patients developed hepatitis recurrence. Cloned sequences were obtained from sera collected before or within 1 month after orthotopic liver transplantation (OLT) and at 3 and 24 months thereafter. Sequence diversity within single sera and over consecutive samples was analyzed quantitatively by matrix comparison and phylogenetic analysis. Propagation of viral QS in the graft was markedly dependent on individual factors. Viral QS in post-OLT sera were less complex and evolved slower compared with immunocompetent subjects with chronic hepatitis. Sequence variation was greater during the first 3 months post-OLT than during the remaining period. Genetic diversity within single samples was not related to hepatitis recurrence or other clinical features. Conversely, sequence diversity over consecutive samples was reduced in patients who experienced hepatitis recurrence, in particular, in those infected with genotype 1b and with an HLA-DR mismatched graft. Selection of viral sequences was markedly impaired in liver transplant recipients and tended to be greater early after OLT. Reduced sequence turnover correlated negatively with the outcome of graft reinfection

Published
2003

50. 602 THE CANDIDATE HCV E1E2MF59 VACCINE IS SAFE IN CHRONIC HEPATITIS C PATIENTS AND ACCELLERATES THE SECOND PHASE VIRAL DECLINE UPON PRIMARY RESPONSE TO PEG-INTERFERON-2A/RIBAVIRIN THERAPY

Author

Colombatto, P., primary, Brunetto, M.R., additional, Maina, A.M., additional, Romagnoli, V., additional, Craxì, A., additional, Almasio, P., additional, Madonia, S., additional, Rumi, M.G., additional, Colombo, M., additional, Fargion, S., additional, Ascione, A., additional, Pinzello, G., additional, Mondelli, M., additional, Muzzi, A., additional, Bianchi, F., additional, Barnaba, V., additional, Sarracino, M., additional, Rappuoli, R., additional, Rosa, D., additional, Montigiani, S., additional, Abrignani, S., additional, Houghton, M., additional, and Bonino, F., additional

Published
2009
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