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1. Hepatitis delta coinfection in persons with HIV: misdiagnosis and disease burden in Italy

Author

Brancaccio, G, Shanyinde, M, Puoti, M, Gaeta, G, D'Arminio Monforte, A, Vergori, A, Rusconi, S, Mazzarelli, A, Castagna, A, Antinori, A, Cozzi-Lepri, A, Gaeta, GB, Brancaccio, G, Shanyinde, M, Puoti, M, Gaeta, G, D'Arminio Monforte, A, Vergori, A, Rusconi, S, Mazzarelli, A, Castagna, A, Antinori, A, Cozzi-Lepri, A, and Gaeta, GB

Abstract

Hepatitis Delta virus (HDV) causes severe liver disease. Due to similarities in transmission routes, persons living with HIV (PLWH) are at risk of HDV infection. This analysis investigates the prevalence and the long-term clinical outcome of people with HDV in a large cohort of PLWH. We retrieved HBsAg ± anti-HDV positive PLWH enrolled from 1997 to 2015 in the multicentre, prospective ICONA study. The primary endpoint was a composite clinical outcome (CCO = having experienced ≥1 of the following: Fib4 score >3.25; diagnosis of cirrhosis; decompensation; hepatocellular carcinoma or liver-related death). Kaplan–Meier curves and unweighted and weighted Cox regression models were used for data analysis. Less than half of HBsAg positive patients had been tested for anti-HDV in clinical practice. After testing stored sera, among 617 HBV/HIV cases, 115 (19%) were anti-HDV positive; 405 (65%) HBV monoinfected; 99 (16%) undeterminate. The prevalence declined over the observation period. HDV patients were more often males, intravenous drug users, HCV coinfected. After a median of 26 months, 55/115 (48%) developed CCO among HDV+; 98/403 (24%) among HBV monoinfected; 18/99 (18%) in HDV unknown (p < 0.001). After controlling for geographical region, alcohol consumption, CD4 count, anti-HCV status and IFN-based therapies, the association with HDV retained statistical significance [HR = 1.67 (1.15, 2.95; p = 0.025)]. HDV infection among PLWH is underdiagnosed, although HDV entails an high risk of liver disease progression. Because effective drugs to treat HDV are now available, it is even more crucial to identify PLWH at an early stage of liver disease.

Published
2023

2. Patterns of treatment and costs of intermediate and advanced hepatocellular carcinoma management in four Italian centers

Author

Colombo GL, Cammà C, Attili AF, Ganga R, Gaeta GB, Brancaccio G, Franzini JM, Volpe M, and Turchetti G

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Giorgio Lorenzo Colombo,1 Calogero Cammà,2 Adolfo Francesco Attili,3 Roberto Ganga,4 Giovanni Battista Gaeta,5 Giuseppina Brancaccio,5 Jean Marie Franzini,6 Marco Volpe,6 Giuseppe Turchetti7 1Department of Drug Sciences, University of Pavia, Pavia, Italy; 2Section of Gastroenterology, Di.Bi.M.I.S., University of Palermo, Palermo, Italy; 3Department of Clinical Medicine, University of Rome (La Sapienza) Rome, Italy; 4Clinical Medicine Division, Ospedale Brotzu, Cagliari, Italy; 5Viral Hepatitis Unit, Second University, Naples, Italy; 6Business Integration Partners S.p.A., Milan, Italy; 7Scuola Superiore Sant’Anna, Pisa, Italy Background: Hepatocellular carcinoma (HCC) is a severe health condition associated with high hospitalizations and mortality rates, which also imposes a relevant economic burden.Purpose: The aim of the present survey is to investigate treatment strategies and related costs for HCC in the intermediate and advanced stages of the disease. Patients and methods: The survey was conducted in four Italian centers through structured interviews with physicians. Information regarding the stage of disease, treatments performed, and related health care resource consumption was included in the questionnaire. Direct health care cost per patient associated with the most relevant treatments such as sorafenib, transarterial chemoembolization (TACE), and transarterial radioembolization (TARE) was evaluated.Results: Between 2013 and 2014, 285 patients with HCC were treated in the four participating centers; of these, 80 were in intermediate stage HCC (Barcelona Clinic Liver Cancer Classification [BCLC] B), and 57 were in the advanced stage of the disease (BCLC C). In intermediate stage HCC, the most frequent first-line treatment was TACE (63%) followed by sorafenib (15%), radiofrequency ablation (14%), and TARE (1.3%). In the advanced stage of HCC, the most frequently used first-line therapy was sorafenib (56%), followed by best supportive care (21%), TACE (18%), and TARE (3.5%). The total costs of treatment per patient amounted to €12,214.54 with sorafenib, €13,418.49 with TACE, and €26,106.08 with TARE. Both in the intermediate and in the advanced stage of the disease, variability in treatment patterns among centers was observed.Conclusion: The present analysis raises for the first time the awareness of the overall costs incurred by the Italian National Healthcare System for different treatments used in intermediate and advanced HCC. Further investigations would be important to better understand the effective health care resource usage. Keywords: disease costs, drugs cost, transarterial embolization, sorafenib

Published
2015

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

Author

Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, Mr, Chessa, L, Ciancio, A, Craxì, A, Gaeta, Gb, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, As, Zignego, Al, MARS Study Group, Aghemo A., Alberti A., Andreone P., Angelico M., Brunetto M.R., Chessa L., Ciancio A., Craxi A., Gaeta G.B., Galli M., Gasbarrini A., Giorgini A., Grilli E., Lampertico P., Lichtner M., Milella M., Morisco F., Persico M., Pirisi M., Puoti M., Raimondo G., Romano A., Russello M., Sangiovanni V., Schiavini M., Serviddio G., Villa E., Vinci M., De Michina A., Gallinaro V., Gualberti G., Roscini A.S., Zignego A.L., Aghemo, A, Alberti, A, Andreone, P, Angelico, M, Brunetto, M, Chessa, L, Ciancio, A, Craxi, A, Gaeta, G, Galli, M, Gasbarrini, A, Giorgini, A, Grilli, E, Lampertico, P, Lichtner, M, Milella, M, Morisco, F, Persico, M, Pirisi, M, Puoti, M, Raimondo, G, Romano, A, Russello, M, Sangiovanni, V, Schiavini, M, Serviddio, G, Villa, E, Vinci, M, De Michina, A, Gallinaro, V, Gualberti, G, Roscini, A, Zignego, A, Aghemo, A., Alberti, A., Andreone, P., Angelico, M., Brunetto, M. R., Chessa, L., Ciancio, A., Craxi, A., Gaeta, G. B., Galli, M., Gasbarrini, A., Giorgini, A., Grilli, E., Lampertico, P., Lichtner, M., Milella, M., Morisco, F., Persico, M., Pirisi, M., Puoti, M., Raimondo, G., Romano, A., Russello, M., Sangiovanni, V., Schiavini, M., Serviddio, G., Villa, E., Vinci, M., De Michina, A., Gallinaro, V., Gualberti, G., Roscini, A. S., and Zignego, A. L.

Subjects
Male, Adult, medicine.medical_specialty, Pyrrolidines, Quinoxaline, Sustained Virologic Response, Settore MED/12 - GASTROENTEROLOGIA, Population, Antiviral Agents, elderly, Benzimidazole, GLE/PIB, Quinoxalines, Internal medicine, Drug Combination, Clinical endpoint, medicine, Product Surveillance, Postmarketing, Humans, Prospective Studies, education, Adverse effect, Aged, Antiviral Agent, Sulfonamides, education.field_of_study, Hepatology, business.industry, Settore MED/09 - MEDICINA INTERNA, Gastroenterology, PWUD, Glecaprevir, Middle Aged, HCV, Hepatitis C, Chronic, Pibrentasvir, Discontinuation, Drug Combinations, Italy, Cohort, Quality of Life, Benzimidazoles, Female, Observational study, business
Abstract

Background and Aims The MARS post-marketing, observational study evaluates glecaprevir/pibrentasvir in a large population of Italian patients who are infected with HCV. Patients and Methods Achievement of SVR12 was the primary endpoint in the overall population and by subpopulations of interest (treatment-naive and treatment-experienced patients, subjects infected with different HCV genotype/sub-genotype, cirrhotic and non-cirrhotic patients, patients with different severity of fibrosis, patients with an APRI score ≥1, subjects with comorbidities, HIV-coinfected patients, elderly patients and people who use drugs). Safety and quality of life (assessed by SF-36 and Work Productivity and Activity Impairment) were also evaluated. Results The SVR12 rate was 99.4% (319/321; 95% CI: 97.8–99.8%) in the core population with sufficient follow-up (n = 321), 99.7% (289/290) in 8-week treated patients, and high (>96%) across subgroups. Only three patients (0.9%) had treatment-related adverse events that led to treatment discontinuation. In total, 30.1% of patients showed an improvement of ≥2.5 points in the Physical Component Summary of the SF-36 from baseline to the end of treatment, and this figure raised to 37.5% with the achievement of SVR12. Corresponding values for MCS were 42.2% and 42.8%, respectively. Conclusion Glecaprevir/pibrentasvir is safe and effective across subpopulations who are underserved in clinical trials.

Published
2021

5. Correction

Author

Sebastiani, M, Milazzo, L, Atzeni, F, Vacchi, C, Manfredi, A, Quartuccio, L, Scire, C, Gaeta, GB, Lapadula, G, Armignacco, O, Tavio, M, D'Angelo, S, Meroni, P, Bazzichi, L, Grassi, W, Mathieu, A, Mastroianni, C, Sagnelli, E, Santantonio, T, Uberti Foppa, C, Puoti, M, Sarmati, L, Airo, P, Epis, OM, Scrivo, R, Gargiulo, M, Riva, A, Ciancio, G, Zehender, G, Taliani, G, Meroni, L, Sollima, S, Sarzi-Puttini, P, Galli, M, Sebastiani, M, Milazzo, L, Atzeni, F, Vacchi, C, Manfredi, A, Quartuccio, L, Scire, C, Gaeta, Gb, Lapadula, G, Armignacco, O, Tavio, M, D'Angelo, S, Meroni, P, Bazzichi, L, Grassi, W, Mathieu, A, Mastroianni, C, Sagnelli, E, Santantonio, T, Uberti Foppa, C, Puoti, M, Sarmati, L, Airo, P, Epis, Om, Scrivo, R, Gargiulo, M, Riva, A, Ciancio, G, Zehender, G, Taliani, G, Meroni, L, Sollima, S, Sarzi-Puttini, P, and Galli, M

Published
2019

7. Hepatitis C late relapse in patients with directly acting antiviral-related sustained virological response at week 12

Author

Pisaturo M, Minichini C, Starace M, Caroprese M, Macera M, Brancaccio G, De Pascalis S, Santonicola A, Galeota Lanza A, Zampino R, Cotticelli G, Sagnelli E, Gaeta GB, Coppola N, Pisaturo, M, Minichini, C, Starace, M, Caroprese, M, Macera, M, Brancaccio, G, De Pascalis, S, Santonicola, A, Galeota Lanza, A, Zampino, R, Cotticelli, G, Sagnelli, E, Gaeta, Gb, and Coppola, N

Published
2018

8. VIROLOGICAL PATTERNS OF HCV PATIENTS WITH FAILURE TO INTERFERON-FREE REGIMENS

Author

Starace M, Minichini C, De Pascalis S, Macera M, Occhiello L, Messina V, Sangiovanni V, Adinolfi LE, Claar E, Precone D, Stornaiuolo G, Stanzione M, Ascione T, Caroprese M, Zampino R, Parrilli G, Gentile I, Brancaccio G, Iovinella V, Martini S, Masarone M, Fontanella L, Masiello A, Sagnelli E, Punzi R, Salomone Megna A, Santoro R, Gaeta GB, Coppola N., Zampino R. Parrilli G, Masarone M., Starace, Mario, Minichini, Carmine, De Pascalis, Stefania, Macera, Margherita, Occhiello, Laura, Messina, Vincenzo, Sangiovanni, Vincenzo, Adinolfi, Luigi E, Claar, Ernesto, Precone, Davide, Stornaiuolo, Gianfranca, Stanzione, Maria, Ascione, Tiziana, Caroprese, Mara, Zampino, Rosa, Parrilli, Gianpaolo, Gentile, Ivan, Brancaccio, Giuseppina, Iovinella, Vincenzo, Martini, Salvatore, Masarone, Mario, Fontanella, Luca, Masiello, Addolorata, Sagnelli, Evangelista, Punzi, Rodolfo, Salomone Megna, Angelo, Santoro, Renato, Gaeta, Giovanni B, Coppola, Nicola, Starace, M, Minichini, C, De Pascalis, S, Macera, M, Occhiello, L, Messina, V, Sangiovanni, V, Adinolfi, Le, Claar, E, Precone, D, Stornaiuolo, G, Stanzione, M, Ascione, T, Caroprese, M, Zampino, R, Parrilli, G, Gentile, I, Brancaccio, G, Iovinella, V, Martini, S, Masarone, M, Fontanella, L, Masiello, A, Sagnelli, E, Punzi, R, Salomone Megna, A, Santoro, R, Gaeta, Gb, Coppola, N., Zampino R., Parrilli G, and Masarone, M.

Subjects
0301 basic medicine, Simeprevir, Male, Hepacivirus, Viral Nonstructural Proteins, Hospitals, University, 0302 clinical medicine, Genotype, antiviral therapy, Prevalence, Treatment Failure, Sanger sequencing, Aged, 80 and over, education.field_of_study, virus diseases, Middle Aged, chronic HCV hepatitis, Infectious Diseases, Italy, symbols, DAA failure, 030211 gastroenterology & hepatology, Female, Adult, RASs, medicine.medical_specialty, Population, Mutation, Missense, Antiviral Agents, 03 medical and health sciences, symbols.namesake, Virology, Internal medicine, Drug Resistance, Viral, medicine, Humans, In patient, NS5A, education, DAAs, DAA, Aged, business.industry, Interferon free, Genetic Variation, Sequence Analysis, DNA, Hepatitis C, Chronic, digestive system diseases, Regimen, 030104 developmental biology, Amino Acid Substitution, business, RAS
Abstract

The study characterized the virological patterns and the resistance-associated substitutions (RASs) in patients with failure to IFN-free regimens enrolled in the real-life setting. All 87 consecutive HCV patients with failed IFN-free regimens, observed at the laboratory of the University of Campania, were enrolled. All patients had been treated with DAA regimens according to the HCV genotype, international guidelines, and local availability. Sanger sequencing of NS3, NS5A, and NS5B regions was performed at failure by home-made protocols. Of the 87 patients enrolled, 13 (14.9%) showed a misclassified HCV genotype, probably causing DAA failure, 16 had been treated with a sub-optimal DAA regimen, 19 with a simeprevir-based regimen and 39 with an optimal DAA regimen. A major RAS was identified more frequently in the simeprevir regimen group (68.4%) and in the optimal regimen group (74.4%) than in the sub-optimal regimen group (56.3%). The prevalence of RASs in NS3 was similar in the three groups (30.8-57.9%), that in NS5A higher in the optimal regimen group (71.8%) than in the sub-optimal regimen group (12.5%, P < 0.0001) and in the simeprevir regimen group (31.6%, P < 0.0005), and that in NS5B low in all groups (0-25%). RASs in two or more HCV regions were more frequently identified in the optimal regimen group (46.6%) than in the simeprevir-based regimen group (31.6%) and sub-optimal regimen group (18.7%). In our real-life population the prevalence of RASs was high, especially in NS3 and NS5A and in those treated with suitable DAA regimens. © 2018 Wiley Periodicals, Inc.

Published
2018

9. Influence of ITPase activity on decreases of hemoglobin during treatment with Interferon-free DAA-based and ribavirin in HCV-related cirrhosis

Author

Coppola, N, De Pascalis, S, Messina, V, Di Caprio, G, Martini, S, de Stefano, G, Starace, M, Stornaiuolo, G, Sangiovanni, V, Stanzione, M, Zampino, R, Calo, F, Rinaldi, L, Persico, M, Federico, A, Gaeta, Gb, Filippini, P, BUONOMO, ANTONIO RICCARDO, BORGIA, GUGLIELMO, GENTILE, Ivan, Coppola, N, De Pascalis, S, Messina, V, Di Caprio, G, Martini, S, de Stefano, G, Starace, M, Stornaiuolo, G, Sangiovanni, V, Stanzione, M, Zampino, R, Calo, F, Rinaldi, L, Persico, M, Federico, A, Buonomo, ANTONIO RICCARDO, Borgia, Guglielmo, Gaeta, Gb, Filippini, P, and Gentile, Ivan

Published
2017

10. Interferon-Free Regimens in Hepatitis B Surface Antigen/Anti-Hepatitis C Virus Positive Patients: The Need to Control Hepatitis B Virus Replication to Avoid Hepatitis B Virus Reactivation

Author

Macera M, Stanzione M, Messina V, D'Adamo G, Sangiovanni V, Mioglioresi L, Fontanella L, De Pascalis S, Stornaiuolo G, Galeota Lanza A, Ascione T, Sagnelli E, Gentile I, Piai G, Gaeta GB, Coppola N., Macera, M, Stanzione, M, Messina, V, D'Adamo, G, Sangiovanni, V, Mioglioresi, L, Fontanella, L, De Pascalis, S, Stornaiuolo, G, Galeota Lanza, A, Ascione, T, Sagnelli, E, Gentile, I, Piai, G, Gaeta, Gb, and Coppola, N.

Published
2017

11. AISF position paper on HCV in immunocompromised patients

Author

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

Abstract

This report summarizes the clinical features and the indications for treating HCV infection in immunocompromised and transplanted patients in the Direct Acting Antiviral drugs era.

Published
2019

12. The Italian compassionate use of sofosbuvir in HCV patients waitlisted for liver transplantation: A national real-life experience

Author

Martini, Silvia, Donato, Maria Francesca, Mazzarelli, Chiara, Rendina, Maria, Visco-Comandini, Ubaldo, Filì, Daniela, Gianstefani, Alice, Fagiuoli, Stefano, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Carrai, Paola, Caraceni, Paolo, ITACOPS study group, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, Gb, Ganga, R, Ginanni Corradini, S, Iemmolo, Rm, Lenci, I, Lionetti, R, Montalbano, M, Morelli, Mc, Picciotto, A, Sapere, C, Serviddio, G, Tamè, M, Verucchi, G, Zignego, A. L., Martini, Silvia, Donato, Maria Francesca, Mazzarelli, Chiara, Rendina, Maria, Visco-Comandini, Ubaldo, Filì, Daniela, Gianstefani, Alice, Fagiuoli, Stefano, Melazzini, Mario, Montilla, Simona, Pani, Luca, Petraglia, Sandra, Russo, Pierluigi, Trotta, Maria Paola, Carrai, Paola, Caraceni, Paolo, Martini, S, Donato, M, Mazzarelli, C, Rendina, M, Visco-Comandini, U, Fili, D, Gianstefani, A, Fagiuoli, S, Melazzini, M, Montilla, S, Pani, L, Petraglia, S, Russo, P, Trotta, M, Carrai, P, Caraceni, P, Angeli, P, Ballardini, G, Bernabucci, V, Bhoori, S, Burra, P, Civolani, A, D'Offizi, G, Felder, M, Gaeta, G, Ganga, R, Ginanni Corradini, S, Iemmolo, R, Lenci, I, Lionetti, R, Montalbano, M, Morelli, M, Picciotto, A, Sapere, C, Serviddio, G, Tame, M, Verucchi, G, and Zignego, A

Subjects
Compassionate Use Trials, Liver Cirrhosis, Male, Cirrhosis, Sofosbuvir, bridging therapy, decompensated cirrhosis, delisting, direct-acting antivirals, hepatitis C, liver transplantation, Adult, Aged, Antiviral Agents, Carcinoma, Hepatocellular, Drug Therapy, Combination, Female, Hepacivirus, Hepatitis C, Chronic, Humans, Italy, Kaplan-Meier Estimate, Liver Neoplasms, Middle Aged, Prospective Studies, Ribavirin, Liver Transplantation, Waiting Lists, Hepatology, medicine.medical_treatment, Liver transplantation, chemistry.chemical_compound, 0302 clinical medicine, Chronic, Hepatitis C, 030220 oncology & carcinogenesis, Combination, 030211 gastroenterology & hepatology, medicine.drug, medicine.medical_specialty, 03 medical and health sciences, Drug Therapy, Internal medicine, medicine, direct-acting antiviral, business.industry, decompensated cirrhosi, Carcinoma, Hepatocellular, medicine.disease, Surgery, Transplantation, chemistry, business
Abstract

Background & aims This study aimed to assess the real-life clinical and virological outcomes of HCV waitlisted patients for liver transplantation (LT) who received sofosbuvir/ribavirin (SOF/R) within the Italian compassionate use program. Methods Clinical and virological data were collected in 224 patients with decompensated cirrhosis and/or hepatocellular carcinoma (HCC) receiving daily SOF/R until LT or up a maximum of 48 weeks. Results Of 100 transplanted patients, 51 were HCV-RNA negative for >4 weeks before LT (SVR12: 88%) and 49 negative for

Published
2018

14. Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update 2016

Author

Antinori, Andrea, Di Biagio, Antonio, Marcotullio, Simone, Andreoni, Massimo, Chirianni, Antonio, d'Arminio Monforte, Antonella, Galli, Massimo, Mazzotta, Francesco, Mussini, Cristina, Puoti, Massimo, Lazzarin, Adriano, Matteelli, Alberto, Andreoni, M, Chirianni, A, Antinori, A, Galli, M, Lazzarin, A, d'Arminio Monforte, A, Di Perri, G, Perno, Cf, Puoti, M, Vella, S, Di Biagio, A, Marcotullio, S, Ammassari, A, Angarano, G, Armignacco, O, Babudieri, S, Bini, T, Bonfanti, P, Bonora, S, Borderi, M, Breveglieri, M, Calza, L, Capobianchi, Mr, Cagarelli, R, Calcagno, A, Castagna, A, Castelli, F, Cattelan, Am, Cauda, R, Cingolani, A, Cinque, P, Corbelli, Gm, D'Ettorre, G, De Carli, G, De Luca, A, Di Pietro, M, El Hamad, I, Errico, M, Gaeta, Gb, Gargiulo, M, Gervasoni, C, Giacomet, V, Giannini, A, Gianotti, N, Giaquinto, C, Girardi, E, Gori, A, Grossi, P, Guaraldi, G, Lichtner, M, Liuzzi, G, Lo Caputo, S, Maggi, P, Maggiolo, F, Marchetti, G, Maserati, R, Mastroianni, C, Matteelli, A, Mazzotta, F, Menichetti, F, Mussini, C, Nozza, S, Oldrini, M, Parruti, G, Pascucci, Mg, Parrella, R, Prestileo, T, Puro, V, Rancilio, L, Marina, R, Rezza, G, Rizzardini, G, Rusconi, S, Santoro, M, Sighinolfi, L, Stagnitta, M, Starnini, G, Tamburrini, E, Tambussi, G, Tavio, M, Torti, C, Vaccher, E, Viscoli, C, Visintini, R, Vullo, V, Zaccarelli, M, Zuccotti, Gv., Antinori, Andrea, Di Biagio, Antonio, Marcotullio, Simone, Andreoni, Massimo, Chirianni, Antonio, Antonella, Galli, Massimo, Mazzotta, Francesco, Mussini, Cristina, Puoti, Massimo, Lazzarin, Adriano, Italian Hiv Guidelines Working, Group, and Castagna, Antonella

Subjects
Settore MED/17 - Malattie Infettive, Anti-HIV Agents, Health Policy, Antiretroviral agents, Guidelines, HIV, Italy, Anti-HIV Agent, HIV Infections, Guideline, antiretroviral agents, Drug Administration Schedule, Drug Therapy, Combination, HIV-1, Practice Guidelines as Topic, Drug Therapy, antiretroviral agent, Combination, HIV Infection
Abstract

The Italian Society of Infectious and Tropical Diseases (SIMIT) of the Technical Health Committee, Ministry of Health (Sections L and M) of Italy have supported recommendations for the Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. This publication summarizes the latest updates to the 2016 version of the Italian Guidelines for the management of HIV-1 infected patients and the use of antiretroviral drugs. In particular, new recommendations were released concerning the following topics: estimate of the HIV continuum of care in Italy, optimal timing and preferred drug combinations for starting antiretroviral therapy, treatment optimization, and pre-exposure prophilaxis (PrEP). For a complete review of clinical and therapeutic relevant topics we refer the reader to the extended version of the Guidelines.

Published
2017

15. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, Collaborators (129) Mariani R, HCV Italian Resistance Network Study Group., Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio VC, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, Ms, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, HCV Italian Resistance Network Study Group., Collaborators (129) Mariani R, Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio, Vc, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, M, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V. C, Bellocchi, M. C, Antonucci, F. P, Nicolini, L. A, Magni, C. F, Mura, M. S, Vespasiani Gentilucci, U, Morisco, Filomena, Perno, C. F, Ceccherini Silberstein, F., Caporaso, Nicola, Di Maio, V., Cento, V., Di Paolo, D., Aragri, M., De Leonardis, F., Tontodonati, M., Micheli, V., Bellocchi, M., Antonucci, F., Bertoli, A., Lenci, I., Milana, M., Gianserra, L., Melis, M., Di Biagio, A., Sarrecchia, C., Sarmati, L., Landonio, S., Francioso, S., Lambiase, L., Nicolini, L., Marenco, S., Nosotti, L., Giannelli, V., Siciliano, M., Romagnoli, D., Pellicelli, A., Vecchiet, J., Magni, C., Babudieri, S., Mura, M., Taliani, G., Mastroianni, C., Vespasiani-Gentilucci, U., Romano, M., Morisco, F., Gasbarrini, A., Vullo, V., Bruno, S., Baiguera, C., Pasquazzi, C., Tisone, G., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Paoloni, M., Iapadre, N., Grimaldi, A., Menzaghi, B., Quirino, T., Bruzzone, B., De Maria, A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Mancon, A., Monico, S., Niero, F., Puoti, M., Russo, M., Alfieri, R., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Caporaso, N., Gaeta, G., Lembo, V., Calvaruso, V., Craxã­, A., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pace Palitti, V., Pieri, A., Polilli, E., Antenucci, F., Armenia, D., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Sanctis, A., Furlan, C., Gallo, P., Grieco, A., Grieco, S., Lattanzi, B., Malagnino, V., Manuelli, M., Merli, M., Miglioresi, L., Palazzo, D., Santopaolo, F., Santoro, M., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Teti, E., Mangia, A., Maida, I., Falconi, L., and Di Giammartino, D.

Subjects
0301 basic medicine, ns3, Genotyping Techniques, viruses, Drug Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Telaprevir, chemistry.chemical_compound, genotype, genotyping techniques, hepacivirus, hepatitis C, humans, RNA viral, retrospective studies, sequence analysis, DNA, viral nonstructural proteins, drug resistance, viral, mutation, pharmacology, infectious diseases, 0302 clinical medicine, Retrospective Studie, Genotype, Pharmacology (medical), Viral, Hepatitis C, Humans, RNA, Viral, Retrospective Studies, Sequence Analysis, DNA, Drug Resistance, Viral, Mutation, Proteolytic enzymes, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, hcv-rna levels, Infectious Diseases, HCV-RNA, 030211 gastroenterology & hepatology, Sequence Analysis, medicine.drug, Human, Microbiology (medical), medicine.medical_specialty, Hepatitis C virus, Concordance, Settore MED/12 - GASTROENTEROLOGIA, Pharmacology, Biology, 03 medical and health sciences, Boceprevir, Internal medicine, medicine, hcv, Genotyping, Hepaciviru, Viral Nonstructural Protein, Settore MED/09 - MEDICINA INTERNA, Virology, digestive system diseases, 030104 developmental biology, chemistry, Sequence Analysi, RNA, Genotyping Technique
Abstract

OBJECTIVES: This study aims to evaluate the reliability and clinical utility of NS3 sequencing in hepatitis C virus (HCV) 1-infected patients who were candidates to start a PI-containing regimen. METHODS: NS3 protease sequencing was performed by in-house-developed HCV-1 subtype-specific protocols. Phylogenetic analysis was used to test sequencing reliability and concordance with previous genotype/subtype assignment by commercial genotyping assays. RESULTS: Five hundred and sixty-seven HCV plasma samples with quantifiable HCV-RNA from 326 HCV-infected patients were collected between 2011 and 2014. Overall, the success rate of NS3 sequencing was 88.9%. The success rate between the two subtype protocols (HCV-1a/HCV-1b) was similarly high for samples with HCV-RNA >3 log IU/mL (>92% success rate), while it was slightly lower for HCV-1a samples with HCV-RNA ≤3 log IU/mL compared with HCV-1b samples. Phylogenetic analysis confirmed the genotype/subtype given by commercial genotyping assays in 92.9% (303/326) of cases analysed. In the remaining 23 cases (7.1%), 1 was HCV-1g (previously defined as subtype 1a), 1 was HCV-4d (previously defined as genotype 1b) and 1 was HCV-1b (previously defined as genotype 2a/2c). In the other cases, NS3 sequencing precisely resolved the either previous undetermined/discordant subtype 1 or double genotype/subtype assignment by commercial genotyping assays. Resistance-associated variants (RAVs) to PI were detected in 31.0% of samples. This prevalence changed according to PI experience (17.1% in PI-naive patients versus 79.2% in boceprevir/telaprevir/simeprevir-failing patients). Among 96 patients with available virological outcome following boceprevir/telaprevir treatment, a trend of association between baseline NS3 RAVs and virological failure was observed (particularly for HCV-1a-infected patients: 3/21 failing patients versus 0/22 achieving sustained virological response; P = 0.11). CONCLUSIONS: HCV-NS3 sequencing provides reliable results and at the same time gives two clinically relevant pieces of information: a correct subtype/genotype assignment and the detection of variants that may interfere with the efficacy of PI.

Published
2016
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16. 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

17. Recommendations for the management of acute hepatitis B: position paper of the italian Society for the study of infectious and tropical diseases

Author

Bruno R, Carosi G, Coppola N, Gaeta GB, Puoti M, Santantonio T, Taliani G, Armignacco O, Sagnelli E, Andreoni M, Angarano G, Di Perri G, D’Offizi G, Galli M, Rizzardini G, Bruno, R, Carosi, G, Coppola, N, Gaeta, Gb, Puoti, M, Santantonio, T, Taliani, G, Armignacco, O, Sagnelli, E, Andreoni, M, Angarano, G, Di Perri, G, D’Offizi, G, Galli, M, and Rizzardini, G

Published
2014

18. Who is more likely to respond to dual treatment with pegylated-interferon and ribavirin for chronic hepatitis C? A gender-oriented analysis

Author

DI MARCO, Vito, Covolo, L, CALVARUSO, Vincenza, Levrero, M, Puoti, M, Suter, F, Gaeta, GB, Ferrar,i C, Raimondo, G, Fattovich, G, Santantonio, T, Alberti, A, Bruno, R, Mussini, C, Mondelli, M, Donato, F, CRAXI, Antonio, Multicenter Italian Group for the Study of Hepatitis C., Di Marco, V, Covolo, L, Calvaruso, V, Levrero, M, Puoti, M, Suter, F, Gaeta, GB, Ferrar,i C, Raimondo, G, Fattovich, G, Santantonio, T, Alberti, A, Bruno, R, Mussini, C, Mondelli, M, Donato, F, Craxì, A, Multicenter Italian Group for the Study of Hepatitis C., Gaeta, Giovanni Battista, Ferrari, C, and Craxì, A.

Subjects
Male, HCV-RNA levels, Hepacivirus, Logistic regression, Gastroenterology, Cohort Studies, chemistry.chemical_compound, Pegylated interferon, Genotype, antiviral therapy, gender, Prospective Studies, peg-interferon and ribavirin, Prospective cohort study, biology, sustained virologic response, virus diseases, chronic hepatitis C, IL28B polymorphisms, Middle Aged, Viral Load, Treatment Outcome, Infectious Diseases, Drug Therapy, Combination, Female, Viral load, Adult, Aged, Hepatitis C, Chronic, Humans, Interferons, Ribavirin, Sex Factors, medicine.drug, medicine.medical_specialty, Virology, Internal medicine, medicine, Rapid Virologic Response, Hepatology, business.industry, biology.organism_classification, digestive system diseases, chemistry, Immunology, business
Abstract

Summary We assessed, in real-life practice, viral, demographic, genetic and metabolic factors influencing the sustained virologic response (SVR), with a gender-oriented analysis, in patients with chronic hepatitis C virus (HCV) treated with pegylated interferon and ribavirin. Six hundred and seventy naive patients were treated with dual therapy and evaluated by gender and HCV genotype. Associations between baseline variables and SVR were assessed by multivariate logistic regression analysis. Among 362 genotype 1 patients, SVR was achieved in 158 patients (44%), and SVR was independently associated with age less than 50 years (OR 2.12; 95% CI 1.09–4.30; P = 0.039) and C/C genotype rs12979860 SNP (OR 2.83; 1.19–6.74; P = 0.002) in 163 females, while absence of visceral obesity (OR 2.491; 1.131–5.487; P = 0.023), HCV-RNA lower than 400 000 IU/mL (OR 2.66; 1.273–5.558; P = 0.009) and C/C genotype rs12979860 SNP (OR 4.969; 2.401–10.283; P

Published
2013

19. 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

20. Italian consensus Guidelines for the management of hepatitis B virus infections in patients with rheumatoid arthritis

Author

Sebastiani, M, Atzeni, F, Milazzo, L, Quartuccio, L, Scirè, C, Gaeta, G, Lapadula, G, Armignacco, O, Tavio, M, Olivieri, I, Meroni, P, Bazzichi, L, Grassi, W, Mathieu, A, Mastroianni, C, Sagnelli, E, Santantonio, T, Uberti Foppa, C, Puoti, M, Sarmati, L, Airò, P, Epis, O, Scrivo, R, Gargiulo, M, Riva, A, Manfredi, A, Ciancio, G, Zehender, G, Taliani, G, Meroni, L, Sollima, S, Sarzi-Puttini, P, Galli, M, Sebastiani M, Atzeni F, Milazzo L, Quartuccio L, Scirè C, Gaeta GB, Lapadula G, Armignacco O, Tavio M, Olivieri I, Meroni P, Bazzichi L, Grassi W, Mathieu A, Mastroianni C, Sagnelli E, Santantonio T, Uberti Foppa C, Puoti M, Sarmati L, Airò P, Epis OM, Scrivo R, Gargiulo M, Riva A, Manfredi A, Ciancio G, Zehender G, Taliani G, Meroni L, Sollima S, Sarzi-Puttini P, Galli M., Sebastiani, M, Atzeni, F, Milazzo, L, Quartuccio, L, Scirè, C, Gaeta, G, Lapadula, G, Armignacco, O, Tavio, M, Olivieri, I, Meroni, P, Bazzichi, L, Grassi, W, Mathieu, A, Mastroianni, C, Sagnelli, E, Santantonio, T, Uberti Foppa, C, Puoti, M, Sarmati, L, Airò, P, Epis, O, Scrivo, R, Gargiulo, M, Riva, A, Manfredi, A, Ciancio, G, Zehender, G, Taliani, G, Meroni, L, Sollima, S, Sarzi-Puttini, P, Galli, M, Sebastiani M, Atzeni F, Milazzo L, Quartuccio L, Scirè C, Gaeta GB, Lapadula G, Armignacco O, Tavio M, Olivieri I, Meroni P, Bazzichi L, Grassi W, Mathieu A, Mastroianni C, Sagnelli E, Santantonio T, Uberti Foppa C, Puoti M, Sarmati L, Airò P, Epis OM, Scrivo R, Gargiulo M, Riva A, Manfredi A, Ciancio G, Zehender G, Taliani G, Meroni L, Sollima S, Sarzi-Puttini P, and Galli M.

Abstract

Objectives Hepatitis B (HBV) infection, which is prevalent worldwide, is also frequently seen in patients with rheumatoid arthritis (RA). The Italian Society of Rheumatology (SIR) and the Italian Society of Infectious and Tropical Diseases (SIMIT) endorsed a national consensus process to review the available evidence on HBV management in RA patients and to produce practical, hospital-wide recommendations. Methods The consensus panel consisted of infectious disease consultants, rheumatologists and epidemiologists and used the criteria of the Oxford Center for Evidence-based Medicine to assess the quality of the evidence and the strength of their recommendations. Results A core-set of statements has been developed to help clinicians in the management of patients with RA and HBV infection. Vaccination and prophylaxis of RA patients treated with biological drugs have been also discussed. Conclusions HBV infection is not rare in clinical practice; a screening for HBV in all patients with early arthritis is not universally accepted, while it is considered mandatory before starting any immunosuppressive or hepatotoxic treatment. In fact, a specific risk, associated with the use of biologic treatments, exists for patients with HBV infection, although longitudinal studies of viral reactivation are generally reassuring. RA patients with HBV infection should be referred to the hepatologist and correctly classified into active or inactive carriers. Patients with active hepatitis B should undergo antiviral treatment before starting immunosuppressive treatments. Occult HBV carriers should be monitored or receive prophylaxis on the basis of the risk of reactivation associated with the administered treatment.

Published
2017

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

Author

Petta, S, Marzioni, M, Russo, P, Aghemo, A, Alberti, A, Ascione, A, Antinori, A, Bruno, R, Bruno, S, Chirianni, A, Gaeta, G, Giannini, E, Merli, M, Messina, V, Montilla, S, Perno, C, Puoti, M, Raimondo, G, Rendina, M, Silberstein, F, Villa, E, Zignego, A, Pani, L, Craxì, A, Fagiuoli, S, Gaeta, GB, Giannini, EG, Perno, CF, Silberstein, FC, Zignego, AL, FAGIUOLI, STEFANO, Petta, S, Marzioni, M, Russo, P, Aghemo, A, Alberti, A, Ascione, A, Antinori, A, Bruno, R, Bruno, S, Chirianni, A, Gaeta, G, Giannini, E, Merli, M, Messina, V, Montilla, S, Perno, C, Puoti, M, Raimondo, G, Rendina, M, Silberstein, F, Villa, E, Zignego, A, Pani, L, Craxì, A, Fagiuoli, S, Gaeta, GB, Giannini, EG, Perno, CF, Silberstein, FC, Zignego, AL, and FAGIUOLI, STEFANO

Abstract

Background We ran a compassionate use nationwide programme (ABACUS) to provide access to ombitasvir, paritaprevir, and ritonavir, with dasabuvir, plus ribavirin for hepatitis C virus (HCV) genotype 1 infection and ombitasvir, paritaprevir, and ritonavir, plus ribavirin for HCV genotype 4 infection in patients with cirrhosis at high risk of decompensation while approval of these regimens was pending in Italy. Methods In this prospective observational study, we collected data from a compassionate use nationwide programme from March 17, 2014, to May 28, 2015. Patients with HCV genotype 1 infection and cirrhosis at high risk of decompensation were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once daily and dasabuvir (250 mg) twice daily for 12 weeks (patients with HCV genotype 1b infection) or 24 weeks (patients with HCV genotype 1a infection). Patients with HCV genotype 4 infection were given coformulated ombitasvir (25 mg), paritaprevir (150 mg), and ritonavir (100 mg) once per day for 24 weeks. All patients were given weight-based ribavirin. The primary efficacy endpoint was sustained virological response at week 12 after the end of treatment (SVR12), analysed by intention-to-treat. Univariate and multivariate logistic regression analyses were used to identify baseline characteristics associated with SVR12. Adverse events were recorded throughout the study. Findings 728 (96%) of 762 patients with cirrhosis who were given ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin therapy for 12 or 24 weeks achieved SVR12. Logistic regression analyses identified that bilirubin concentrations of less than 2 mg/dL were associated with SVR12 (odds ratio [OR] 4·76 [95% CI 1·83–12·3]; p=0·001). 166 (23%) of 734 patients included in safety analyses had an adverse event. 25 (3%) patients discontinued treatment because of adverse events. Asthenia was the most commonly reported adverse event, occurring in 36 (5%) p

Published
2017

23. 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

24. Italian guidelines for the use of antiretroviral agents and the diagnostic-clinical management of HIV-1 infected persons. Update December 2014

Author

Antinori, A, Marcotullio, S, Andreoni, M, Ammassari, A, d'Arminio Monforte, A, Galli, M, Girardi, Enrico, Mazzotta, F, Mussini, C, Puoti, M, Lazzarin, A, Angarano, G, Armignacco, O, Babudieri, S, Bini, T, Bonfanti, P, Bonora, S, Borderi, M, Breveglieri, M, Bruno, R, Capobianchi, Mr, Cagarelli, R, Calcagno, A, Castagna, A, Castelli, F, Cattelan, Am, Cauda, R, Cerioli, A, Chirianni, A, Cinque, P, Corbelli, Gm, D'Ettorre, G, De Carli, G, De Luca, A, Di Biagio, A, Di Perri, G, Di Pietro, M, El Hamad, I, Errico, M, Finarelli Alba, C, Gaeta, Gb, Gervasoni, C, Giacomet, V, Gianotti, N, Giaquinto, C, Girardi, E, Gori, A, Grossi, P, Guaraldi, G, Ivanovic, J, Lichtner, M, Liuzzi, G, Lo Caputo, S, Maggi, P, Maggiolo, F, Malena, M, Marchetti, G, Maserati, R, Mastroianni, C, Matteelli, Alberto, Nicastri, E, Nozza, S, Oldrini, M, Pascucci, Mg, Perno, Cf, Prestileo, T, Puro, V, Rancilio, L, Ravizza, M, Rizzardini, G, Rusconi, S, Santoro, M, Sighinolfi, L, Stagnitta, M, Starnini, G, Tamburrini, E, Tambussi, G, Tavio, M, Torti, C, Viscoli, C, Visintini, R, Vullo, V, Zaccarelli, M, and Zuccotti, G. v.

Subjects
Italy, Anti-HIV Agents, HIV-1, Humans, HIV Infections
Published
2015

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

Author

Stroffolini, T, Sagnelli, E, Mele, A, Gaeta, GB, ALMASIO, Pier Luigi, Stroffolini, T, Almasio, PL, Sagnelli, E, Mele, A, and Gaeta, GB

Subjects
HBV, hepatitis, epidemiology
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

29. Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study

Author

BRUNO S, STROFFOLINI T, COLOMBO M, BOLLANI S, BENVEGNU L, MAZZELLA G, ASCIONE A, SANTANTONIO T, PICCININO F, ANDREONE P, MANGIA A, GAETA GB, PERSICO M, FAGIUOLI S, ALMASIO, Pier Luigi, ITALIAN ASSOCIATION OF THE STUDY OF THE LIVER DISEASE AISF, S. Bruno, T. Stroffolini, M. Colombo, S. Bollani, L. Benvegnu, G. Mazzella, A. Ascione, T. Santantonio, F. Piccinino, P. Andreone, A. Mangia, G.B. Gaeta, M. Persico, S. Fagiuoli, P.L. Almasio, BRUNO S, STROFFOLINI T, COLOMBO M, BOLLANI S, BENVEGNU L, MAZZELLA G, ASCIONE A, SANTANTONIO T, PICCININO F, ANDREONE P, MANGIA A, GAETA GB, PERSICO M, FAGIUOLI S, ALMASIO PL, ITALIAN ASSOCIATION OF THE STUDY OF THE LIVER DISEASE AISF, Bruno, S, Stroffolini, T, Colombo, M, Bollani, S, Benvegnù, L, Mazzella, G, Ascione, A, Santantonio, T, Piccinino, F, Andreone, P, Mangia, A, Gaeta, G, Persico, M, Fagiuoli, S, and Almasio, P

Subjects
Liver Cirrhosis, Male, ANTIVIRAL TREATMENT, Multivariate analysis, Cirrhosis, Hepacivirus, drug therapy/mortality/virology, Gastroenterology, Cohort Studies, INTERFERON, HEPATITIS C, CIRRHOSIS, CHRONIC HEPATITIS C, SUSTAINED VIROLOGICAL RESPONSE, Liver cirrhosis, Medicine, genetics, Longitudinal Studies, Viral, Hazard ratio, virus diseases, Hepatitis C, Adult, Antiviral Agents, therapeutic use, Cohort Studies, Female, Hepacivirus, genetics, Hepatitis C, blood/complications/drug therapy/mortality, Humans, Interferon-alpha, therapeutic use, Liver Cirrhosis, drug therapy/mortality/virology, Longitudinal Studies, Male, Middle Aged, Multivariate Analysis, RNA, blood, Retrospective Studies, Survival Analysis, Treatment Outcome, Middle Aged, Treatment Outcome, Liver Cirrhosis/drug therapy, Liver Cirrhosis/virology, RNA, Viral, Female, Adult, medicine.medical_specialty, Antiviral Agents, blood, Internal medicine, Humans, Retrospective Studies, Sustained virological response, interferon-alpha, HCV-related cirrhosis, Hepatology, business.industry, Proportional hazards model, Interferon-alpha, Retrospective cohort study, blood/complications/drug therapy/mortality, medicine.disease, Survival Analysis, digestive system diseases, Discontinuation, Surgery, therapeutic use, Multivariate Analysis, RNA, business
Abstract

The effect of achieving a sustained virological response (SVR) following interferon-α (IFNα) treatment on the clinical outcomes of patients with HCV-related cirrhosis is unknown. In an attempt to assess the risk of liver-related complications, HCC and liver-related mortality in patients with cirrhosis according to the response to IFNα treatment, a retrospective database was developed including all consecutive patients with HCV-related, histologically proven cirrhosis treated with IFNα monotherapy between January 1992 and December 1997. SVR was an undetectable serum HCV-RNA by PCR 24 weeks after IFNα discontinuation. HCC was assessed by ultrasound every 6 months. Independent predictors of all outcomes were assessed by Cox regression analysis. Of 920 patients, 124 (13.5%) were classified as achieving a SVR. During a mean follow-up of 96.1 months (range: 6-167) the incidence rates per 100 person-years of liver-related complications, HCC and liver-related death were 0, 0.66, and 0.19 among SVR and 1.88, 2.10, and 1.44 among non-SVR (P < 0.001 by log-rank test). Multivariate analyses found that non-SVR was associated with a higher risk of liver-related complications (hazard ratio, HR, not applicable), HCC (HR 2.59; 95% CI 1.13-5.97) and liver-related mortality (HR 6.97; 95% CI 1.71-28.42) as compared to SVR. Conclusion: Thus, in patients with HCV-related, histologically proven cirrhosis, achievement of a SVR after IFNα therapy was associated with a reduction of liver-related mortality lowering both the risk of complications and HCC development. Irrespective of SVR achievement, all patients should continue surveillance because the risk of occurrence of HCC was not entirely avoided. (HEPATOLOGY 2007;45:579–587.)

Published
2007

31. Characteristics at presentation and outcome of hepatocellular carcinoma (HCC) in the elderly. A study of the Cancer of the Liver Italian Program (CLIP)

Author

PIGNATA S, GALLO C, DANIELE B, ELBA S, GIORGIO A, ADINOLFI LE, SIO I, IZZO F, FARINATI F, DEL NAJA C, STANZIONE M, MARONE G, CUOMO O, FELDER M, GAETA GB, DE MAIO E, DI MAIO M, SIGNORIELLO G, PERRONE F, CLIP INVESTIGATORS, CAPUANO, GAETANO, CASTIGLIONE, FABIANA, Pignata, S, Gallo, C, Daniele, B, Elba, S, Giorgio, A, Capuano, Gaetano, Adinolfi, Le, De, Sio, I, Izzo, F, Farinati, F, DEL NAJA, C, Stanzione, M, Castiglione, Fabiana, Marone, G, Cuomo, O, Felder, M, Gaeta, Gb, DE MAIO, E, DI MAIO, M, Signoriello, G, Perrone, F, and Clip, Investigators

Published
2006

32. Expert Consensus Conference - The screening for hepatitis C virus infection in adults in Italy, May 5-6, 2005

Author

Pagliaro, L, Bianco, E, Mariano, A, Mele, A, Sagliocca, L, Amoroso, P, Ascione, A, Brunetto, M, D'Amico, G, Franco, E, Gaeta, GB, Persico, M, Petrosillo, N, Romano, L, Smedille, A, Stroffolini, T, Taliani, G, Tine, F, Addis, A, Almasio, P, Andreone, P, Andriulli, A, Angelico, M, Savino, B, Coppola, R, Craxi, A, De Masi, S, Fargion, S, Fattovich, G, Gardini, I, Gasbarrini, G, Grieco, A, Levrero, M, Magrini, N, Masutti, F, Pendino, G, Piccinino, F, Pietrangelo, A, Pisani, G, Prati, D, Puccetti, L, Rapicetta, M, Sagnelli, E, Satolli, R, Toti, M, Velati, C, Villa, E, Vitiello, E, Pietrangelo, A., CAPORASO, NICOLA, MORISCO, FILOMENA, Pagliaro, L, Bianco, E, Mariano, A, Mele, A, Sagliocca, L, Amoroso, P, Ascione, A, Brunetto, M, D'Amico, G, Franco, E, Gaeta, Gb, Persico, M, Petrosillo, N, Romano, L, Smedille, A, Stroffolini, T, Taliani, G, Tine, F, Addis, A, Almasio, P, Andreone, P, Andriulli, A, Angelico, M, Savino, B, Caporaso, Nicola, Coppola, R, Craxi, A, De Masi, S, Fargion, S, Fattovich, G, Gardini, I, Gasbarrini, G, Grieco, A, Levrero, M, Magrini, N, Masutti, F, Morisco, Filomena, Pendino, G, Piccinino, F, Pietrangelo, A, Pisani, G, Prati, D, Puccetti, L, Rapicetta, M, Sagnelli, E, Satolli, R, Toti, M, Velati, C, Villa, E, Vitiello, E, and Pietrangelo, A.

Published
2006

33. AISF position paper on liver disease and pregnancy

Author

Morisco, F, Bruno, R, Bugianesi, E, Burra, P, Calvaruso, V, Cannoni, A, Caporaso, N, Caviglia, G, Ciancio, A, Fargion, S, Federico, A, Floreani, A, Gaeta, G, Guarino, M, Invernizzi, P, Licata, A, Loguercio, C, Mazzella, G, Petraglia, F, Primignani, M, Rodriguez Castro, K, Smedile, A, Valenti, L, Vanni, E, Vannuccini, S, Voltolini, C, Villa, E, Caviglia, GP, Gaeta, GB, INVERNIZZI, PIETRO, Villa, E., Morisco, F, Bruno, R, Bugianesi, E, Burra, P, Calvaruso, V, Cannoni, A, Caporaso, N, Caviglia, G, Ciancio, A, Fargion, S, Federico, A, Floreani, A, Gaeta, G, Guarino, M, Invernizzi, P, Licata, A, Loguercio, C, Mazzella, G, Petraglia, F, Primignani, M, Rodriguez Castro, K, Smedile, A, Valenti, L, Vanni, E, Vannuccini, S, Voltolini, C, Villa, E, Caviglia, GP, Gaeta, GB, INVERNIZZI, PIETRO, and Villa, E.

Abstract

The relationship between liver disease and pregnancy is of great clinical impact. Severe liver disease in pregnancy is rare; however, pregnancy-related liver disease is the most frequent cause of liver dysfunction during pregnancy and represents a severe threat to foetal and maternal survival. A rapid differential diagnosis between liver disease related or unrelated to pregnancy is required in women who present with liver dysfunction during pregnancy. This report summarizes the recommendation of an expert panel established by the Italian Association for the Study of the Liver (AISF) on the management of liver disease during pregnancy. The article provides an overview of liver disease occurring in pregnancy, an update on the key mechanisms involved in its pathogenesis, and an assessment of the available treatment options. The report contains in three sections: (1) specific liver diseases of pregnancy; (2) liver disease occurring during pregnancy; and (3) pregnancy in patients with pre-existing chronic liver disease. Each topic is discussed considering the most relevant data available in literature; the final statements are formulated according to both scientific evidence and clinical expertise of the involved physicians, and the AISF expert panel recommendations are reported.

Published
2016

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

Author

Foster, GR, Chayama, K, Chuang, W-L, Fainboim, H, Farkkila, M, Gadano, A, Gaeta, GB, Hezode, C, Inada, Y, Heo, J, Kumada, H, Lu, S-N, Marcellin, P, Moreno, C, Roberts, SK, Strasser, SI, Thompson, AJ, Toyota, J, Paik, SW, Vierling, JM, Zignego, AL, Cohen, D, McPhee, F, Wind-Rotolo, M, Srinivasan, S, Hruska, M, Myler, H, Portsmouth, SD, Foster, GR, Chayama, K, Chuang, W-L, Fainboim, H, Farkkila, M, Gadano, A, Gaeta, GB, Hezode, C, Inada, Y, Heo, J, Kumada, H, Lu, S-N, Marcellin, P, Moreno, C, Roberts, SK, Strasser, SI, Thompson, AJ, Toyota, J, Paik, SW, Vierling, JM, Zignego, AL, Cohen, D, McPhee, F, Wind-Rotolo, M, Srinivasan, S, Hruska, M, Myler, H, and Portsmouth, SD

Abstract

BACKGROUND AND PURPOSE: Peginterferon Lambda was being developed as an alternative to alfa interferon for the treatment of chronic hepatitis C virus (HCV) infection. We compared peginterferon Lambda-1a plus ribavirin (Lambda/RBV) and Lambda/RBV plus daclatasvir (DCV; pangenotypic NS5A inhibitor) with peginterferon alfa-2a plus RBV (alfa/RBV) in treatment-naive patients with HCV genotype 2 or 3 infection. METHODS: In this multicenter, double-blind, phase 3 randomized controlled trial, patients were assigned 2:2:1 to receive 24 weeks of Lambda/RBV, 12 weeks of Lambda/RBV + DCV, or 24 weeks of alfa/RBV. The primary outcome measure was sustained virologic response at post-treatment Week 12 (SVR12). RESULTS: Overall, 874 patients were treated: Lambda/RBV, n = 353; Lambda/RBV + DCV, n = 349; alfa/RBV, n = 172. Patients were 65 % white and 33 % Asian, 57 % male, with a mean age of 47 years; 52 % were infected with genotype 2 (6 % cirrhotic) and 48 % with genotype 3 (9 % cirrhotic). In the Lambda/RBV + DCV group, 83 % (95 % confidence interval [CI] 78.5, 86.5) achieved SVR12 (90 % genotype 2, 75 % genotype 3) whereas SVR12 was achieved by 68 % (95 % CI 63.1, 72.9) with Lambda/RBV (72 % genotype 2, 64 % genotype 3) and 73 % (95 % CI 66.6, 79.9) with peginterferon alfa/RBV (74 % genotype 2, 73 % genotype 3). Lambda/RBV + DCV was associated with lower incidences of flu-like symptoms, hematological abnormalities, and discontinuations due to adverse events compared with alfa/RBV. CONCLUSION: The 12-week regimen of Lambda/RBV + DCV was superior to peginterferon alfa/RBV in the combined population of treatment-naive patients with genotype 2 or 3 infection, with an improved tolerability and safety profile compared with alfa/RBV.

Published
2016

36. Increased serum reverse triiodothyronine levels at diagnosis of hepatocellular carcinoma in patients with compensated HCV-related liver cirrhosis

Author

SORVILLO F, MAZZIOTTI G, CARBONE A, MORISCO A, CIOFFI M, ROTONDI M, STORNAIUOLO G, AMATO G, GAETA GB, CAPORASO, NICOLA, CARELLA C., Sorvillo, F, Mazziotti, G, Carbone, A, Morisco, F, Cioffi, Michele, Rotondi, M, Stornaiuolo, G, Amato, G, Gaeta, Giovanni Battista, Caporaso, N, Carella, C., Morisco, A, Cioffi, M, Gaeta, Gb, and Caporaso, Nicola

Subjects
Aged, 80 and over, Liver Cirrhosis, Male, Carcinoma, Hepatocellular, Triiodothyronine, Reverse, Liver Neoplasms, Hepacivirus, Middle Aged, Hepatitis C, ROC Curve, Predictive Value of Tests, Case-Control Studies, Biomarkers, Tumor, Humans, Female, Aged, Retrospective Studies
Abstract

The aim of this study was to investigate changes in thyroid hormone metabolism in relation to the development of hepatocellular carcinoma (HCC) in patients with HCV-related liver cirrhosis.The study group (Group A) comprised 31 patients (25 M, 6 F; median age 62.1 years, range 54.0-81.5 years) affected by HCV-related liver cirrhosis with superimposed HCC. Acute and chronic systemic disease, other than cirrhosis, inducing 'euthyroid sick syndrome' was excluded in all patients. Serum TSH, FT4, FT3, rT3, and thyroxine-binding globulin (TBG) levels were retrospectively evaluated in frozen aliquots drawn at the time of tumour diagnosis and every 6 months for 3-7 years before HCC diagnosis. The control group (Group B) comprised 29 patients affected by HCV-related liver cirrhosis without HCC, matched for sex, age and grade of liver dysfunction.At the time of HCC diagnosis, all patients in Group A were euthyroid with serum TSH, FT4, FT3 and TBG values not significantly different from those of cirrhotic patients of Group B. However, at diagnosis Group A patients had serum rT3 values that were significantly higher than those in Group B (35.0 ng/dl, range 12.0-162.0 vs. 19.0 ng/dl, range 10.0-51.0; Group A vs. Group B; P0.001). Serum rT3 values above the normal range were found in 12 patients in Group A (38.7%) but in only one of the patients from Group B (3.4%) (chi2 10.2; P = 0.001). The serum rT3 levels were not significantly correlated to the Child grade of liver cirrhosis (rho 0.1; P = 0.5). The intrasubject analysis demonstrated that a significant increase in serum rT3 levels occurred at the time of HCC diagnosis but serum FT4, FT3 and TSH values did not change significantly. A receiver operating curve (ROC) demonstrated that a 6-monthly increase in serum rT3 levels of at least +22.5% identified patients with HCC with a diagnostic accuracy of 81.7%.Our study has demonstrated that development of hepatocellular carcinoma is accompanied by a significant increase in serum rT3 levels in patients with low-grade HCV-related liver cirrhosis who had no other illness causing the 'euthyroid sick syndrome'.

Published
2003

37. Hepatic resection and percutaneous ethanol injection as treatments of small hepatocellular carcinoma: a Cancer of the Liver Italian Program (CLIP 08) retrospective case-control study

Author

DANIELE B, DE SIO I, IZZO F, ANDREANA A, MAZZANTI R, AIELLO A, VALLONE P, FIORE F, GAETA GB, PERRONE F, PIGNATA S, GALLO C, CLIP INVESTIGATORS, CAPUANO, GAETANO, Daniele, B, DE SIO, I, Izzo, F, Capuano, Gaetano, Andreana, A, Mazzanti, R, Aiello, A, Vallone, P, Fiore, F, Gaeta, Gb, Perrone, F, Pignata, S, Gallo, C, and Clip, Investigators

Published
2003

38. Tamoxifen in the treatment of hepatocellular carcinoma: 5-year results of the CLIP-1 multicentre randomised controlled trial

Author

PERRONE F, GALLO C, DANIELE B, GAETA GB, IZZO F, ADINOLFI LE, MAZZANTI R, FARINATI F, ELBA S, PIAI G, CALANDRA M, STANZIONE M, MATTERA D, AIELLO A, DE SIO I, CASTIGLIONE, FABIANA, RUSSO M, PERSICO M, FELDER M, MANGHISI OG, MAIO E, DI MAIO M, PIGNATA S, CANCER OF LIVER ITALIAN PROGRAM CLIP, INVESTIGATORS, CAPUANO, GAETANO, Perrone, F, Gallo, C, Daniele, B, Gaeta, Gb, Izzo, F, Capuano, Gaetano, Adinolfi, Le, Mazzanti, R, Farinati, F, Elba, S, Piai, G, Calandra, M, Stanzione, M, Mattera, D, Aiello, A, DE SIO, I, Castiglione, Fabiana, Russo, M, Persico, M, Felder, M, Manghisi, Og, De, Maio, E, DI MAIO, M, Pignata, S, CANCER OF LIVER ITALIAN PROGRAM, Clip, and Investigators

Published
2002

40. Serum IGF-1 evaluation as an useful tool to predict the risk of developing hepatocellular carcinoma in patients with HCV-related cirrhosis: a prostective study

Author

MAZZIOTTI G, SORVILLO F, CARSICO F, CARBONE A, ROTONDI M, STORNAIUOLO G, PRECONE DF, GAETA, Giovanni Battista, CAPORASO N, GAETA GB AND CARELLA C., CIOFFI, Michele, Mazziotti, G, Sorvillo, F, Carsico, F, Carbone, A, Rotondi, M, Stornaiuolo, G, Precone, Df, Cioffi, Michele, Gaeta, Giovanni Battista, Caporaso, N, and GAETA GB AND CARELLA, C.

Published
2002

41. Serum insulin-like growth factor Ievaluation as a useful tool foe predictimg the risk of developing hepatocellular carcinoma in patients with hepatitis C virus-related cirrhosis

Author

MAZZIOTTI G, SORVILLO F, CARBONE A, ROTONDI M, STORNAIUOLO G, PRECONE DF, CIOFFI M, GAETA GB, CAPORASO, NICOLA, CARELLA C., MORISCO, FILOMENA, Mazziotti, G, Sorvillo, F, Morisco, Filomena, Carbone, A, Rotondi, M, Stornaiuolo, G, Precone, Df, Cioffi, M, Gaeta, Gb, Caporaso, Nicola, and Carella, C.

Published
2002

42. La gestione nel presente dell’epatite cronica B per risultati a lungo termine

Author

Carosi, G, Gaeta, GB, Fagiuoli, S, Lampertico, P, Levrero, M, Marzano, A, Santantonio, TA, Rizzetto, M, Carosi, G, Gaeta, G, Fagiuoli, S, Lampertico, P, Levrero, M, Marzano, A, Santantonio, T, and Rizzetto, M

Subjects
epatite cronica B
Abstract

L’infezione cronica da virus dell'epatite B (HBV) è un grave problema di salute pubblica che interessa milioni di persone nelle quali il decorso della malattia può portare allo sviluppo di cirrosi, epatocarcinoma, scompenso epatico, riducendo così la sopravvivenza dei pazienti. Nonostante la vaccinazione obbligatoria, nel nostro paese si contano ancora centinaia di migliaia di cittadini italiani e immigrati da aree ad alta endemia con epatite cronica B, contratta alla nascita o nei primi anni di vita, che in molti casi può rimanere misconosciuta e asintomatica per decenni ma che nel tempo può progredire e favorire lo sviluppo di cirrosi ed epatocarcinoma (1). Negli ultimi anni sono molto migliorate l’efficacia e la sicurezza dei trattamenti disponibili, sia per l’avvento dei nuovi farmaci antivirali che per la disponibilità di più accurate tecniche diagnostiche per la stadiazione dell’epatopatia e il monitoraggio della risposta alla terapia. Nonostante i risultati fino a qualche anno fa insperati, sussistono bisogni insoddisfatti e ulteriori margini di miglioramento terapeutico per incrementare l’attesa di vita dei pazienti.

Published
2012

43. IL28B genotype, differential expression of intrahepatis interferon-stimulated genes and response to PEG-IFN and ribavirin therapy in an Italian prospective cohort of genotype 1 hepatitis C patients in 'real life'

Author

Testoni, B, Scisciani, C, Grimaudo, S, Maimone, S, Pollicino, T, Di Marco, V, Gaeta, Gb, Fattovich, Giovanna, Santantonio, T, Raimondo, G, Craxì, A, and Levriero, M.

Subjects
chronic hepatitis C, HCV genotype 1, response to interferon therapy, IL-28B genotype, intrahepatic interferon stimulated genes
Published
2012

45. Italian HIV GuidelinesWorking Group. Italian guidelines for the use of antiretroviral agents and thediagnostic-clinical management of HIV-1 infected persons. Update 2011

Author

Antinori, A, Marcotullio, S, Ammassari, A, Andreoni, M, Angarano, G, Armignacco, O, Carosi, G, Cinque, P, d'Arminio Monforte, A, Di Perri, G, Ensoli, B, Floridia, M, Galli, M, Mastroianni, C, Matteelli, A, Mazzotta, F, Moroni, M, Pal, G, Puoti, M, Puro, V, Rizzardini, G, Sagnelli, E, Vella, S, Vullo, V, Lazzarin, A, Collaborators: Ensoli B, Italian HIV Guidelines Working G. r. o. u. p., Babudieri, S, Baldelli, F, Bini, T, Bonfanti, P, Bonora, S, Borderi, M, Bruno, R, Bucciardini, R, Castagna, A, Castelli, F, Cattelan, Am, Cauda, R, Cerioli, A, Chirianni, A, Cingolani, A, Monforte, Ad, De Carli, G, De Luca, A, Di Pietro, M, El Hamad, I, Errico, M, Filice, G, Gabrielli, E, Gaeta, Gb, Gervasoni, C, Giacomet, V, Giaquinto, C, Girardi, E, Gori, A, Grossi, P, Guaraldi, G, Liuzzi, G, Caputo, Sl, Maggi, P, Maggiolo, F, Malena, M, Maserati, R, Morrone, A, Murri, R, Mussini, C, Nasta, P, Oldrini, M, Oleari, F, Orlando, G, Pali, G, Perno, Cf, Prestileo, T, Pompa, Mg, Rancilio, L, Ravizza, M, Savasi, Vm, Signorini, L, Sighinolfi, L, Stagnitta, M, Starace, F, Starnini, G, Sterrantino, G, Tamburrini, E, Tambussi, G, Tavio, M, Torti, Carlo, Tozzi, V, Trotta, Mp, Vaccher, E, Visintini, R, and Zuccotti, V.

Published
2012

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