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Start Over Author "Babudieri, Sergio" Topic antiviral agents Topic hepatitis c
12 results on '"Babudieri, Sergio"'

1. A systematic review on models of care effectiveness and barriers to Hepatitis C treatment in prison settings in the EU/EEA.

Author

Vroling H, Oordt-Speets AM, Madeddu G, Babudieri S, Monarca R, O'Moore E, Vonk Noordegraaf-Schouten M, Wolff H, Montanari M, Hedrich D, and Tavoschi L

Subjects
Antiviral Agents economics, European Union, Health Care Costs, Humans, Patient Acceptance of Health Care, Prevalence, Sustained Virologic Response, Treatment Outcome, Antiviral Agents therapeutic use, Hepatitis C drug therapy, Hepatitis C epidemiology, Prisons
Abstract

Hepatitis C prevalence in prison populations is much higher than in the community. Effective hepatitis C treatment within this population does not only have a direct individual health benefit, but may lead to substantial community dividend. We reviewed available evidence on hepatitis C treatment in prison settings, with a focus on the European Union/European Economic Area. A systematic review of the literature (PubMed, EMBASE, Cochrane library) was performed and complemented with searches for conference abstracts and grey literature. Thirty-four publications were included reporting on the effectiveness, acceptability and economic aspects of hepatitis C virus treatment models of care to achieve treatment completion and sustained viral response in prison settings. Available evidence shows that hepatitis C treatment in prison settings is feasible and the introduction of direct-acting antivirals will most likely result in increased treatment completion and better clinical outcomes for the prison population, given the caveats of affordability and the need for increased funding for prison health, with the resulting benefits accruing mostly in the community., (© 2018 John Wiley & Sons Ltd.)

Published
2018
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2. Current and future challenges in HCV: insights from an Italian experts panel.

Author

Andreoni M, Babudieri S, Bruno S, Colombo M, Zignego AL, Di Marco V, Di Perri G, Perno CF, Puoti M, Taliani G, Villa E, and Craxì A

Subjects
Comorbidity, Humans, Italy, Antiviral Agents administration & dosage, Antiviral Agents pharmacokinetics, Antiviral Agents therapeutic use, Hepatitis C drug therapy
Abstract

Background: The recent availability of direct acting antiviral drugs (DAAs) has drastically changed hepatitis C virus (HCV) treatment scenarios, due to the exceedingly high rates of sustained virological response (SVR) and excellent tolerability allowing for treatment at all disease stages., Methods: A panel of Italian experts was convened twice, in November 2016 and January 2017, to provide further support on some open issues and provide guidance for personalized HCV care, also in light of forthcoming regimens., Results and Conclusions: Treatment recommendations issued by international and national liver societies to guide clinicians in the management of HCV infection are constantly updated due to accumulating new data. Such recommendations may not be applicable to all healthcare settings for a variety of reasons. Moreover, some gaps still remain and the spectrum of patients to be treated is also evolving.

Published
2018
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3. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens.

Author

Cento V, Nguyen THT, Di Carlo D, Biliotti E, Gianserra L, Lenci I, Di Paolo D, Calvaruso V, Teti E, Cerrone M, Romagnoli D, Melis M, Danieli E, Menzaghi B, Polilli E, Siciliano M, Nicolini LA, Di Biagio A, Magni CF, Bolis M, Antonucci FP, Di Maio VC, Alfieri R, Sarmati L, Casalino P, Bernardini S, Micheli V, Rizzardini G, Parruti G, Quirino T, Puoti M, Babudieri S, D'Arminio Monforte A, Andreoni M, Craxì A, Angelico M, Pasquazzi C, Taliani G, Guedj J, Perno CF, and Ceccherini-Silberstein F

Subjects
Administration, Oral, Aged, Alanine Transaminase metabolism, Antiviral Agents administration & dosage, Drug Therapy, Combination, Female, Hepacivirus genetics, Humans, Interferons pharmacology, Kinetics, Male, Middle Aged, Oligopeptides administration & dosage, Oligopeptides pharmacology, RNA, Viral blood, Ribavirin administration & dosage, Ribavirin pharmacology, Simeprevir administration & dosage, Simeprevir pharmacology, Sofosbuvir administration & dosage, Sofosbuvir pharmacology, Treatment Outcome, Alanine Transaminase blood, Antiviral Agents pharmacology, Hepatitis C drug therapy, Viral Nonstructural Proteins antagonists & inhibitors
Abstract

Background: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR., Study Design: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization., Results: HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p<0.001), reflecting higher efficacy in blocking assembly/secretion. The second-phase, noted δ and attributed to infected-cell loss, was faster in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.27 vs 0.21 d-1, respectively, p = 0.0012). In contrast the rate of ALT-normalization, noted λ, was slower in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.17 vs 0.27 d-1, respectively, p<0.001). There was no significant association between the second-phase of viral-decline and ALT normalization rate and, for a given level of viral reduction, ALT-normalization was more profound in patients receiving DAA, and NS5A in particular, than TVR+PR., Conclusions: Our data support a process of HCV-clearance by all-DAA regimens potentiated by NS5A-inhibitor, and less relying upon hepatocyte death than IFN-containing regimens. This may underline a process of "cell-cure" by DAAs, leading to a fast improvement of liver homeostasis.

Published
2017
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4. Management of HCV infection in the penitentiary setting in the direct-acting antivirals era: practical recommendations from an expert panel.

Author

Ranieri R, Starnini G, Carbonara S, Pontali E, Leo G, Romano A, Panese S, Monarca R, Prestileo T, Barbarini G, and Babudieri S

Subjects
Health Services Accessibility, Hepatitis C prevention & control, Humans, Practice Guidelines as Topic, Antiviral Agents therapeutic use, Hepatitis C diagnosis, Hepatitis C drug therapy, Prisons
Abstract

Background: The prevalence of HCV infection is higher among prisoners than in the general population. The introduction of HCV direct-acting antivirals (DAA) holds the potential to improve clinical outcomes also in inmates. However, treatment of hepatitis C in inmates has to face several clinical and logistical issues which are peculiar of prison environment. Recommendations on the management of HCV infection specific for the penitentiary setting in the DAA era remain scant. The Italian Society for Penitentiary Medicine and Healthcare has, therefore, issued these recommendations, to provide clinicians with a guide for the comprehensive management of HCV infection in the restriction setting, taking into account its peculiar characteristics., Results: Dedicated diagnostic and treatment procedures should be established in each prison. In particular, the use of DAAs appears crucial to provide patients with an effective therapeutic option, able to overcome the limitations of IFN-based regimens with a short period of treatment. DAA treatment should be initiated as soon as possible in all eligible subjects with the aim to cure the patient, as well as to limit the transmission of HCV infection both inside the penitentiary system and to the free community, once the inmates ends his/her release. Importantly, efforts should be made to open a discussion with regulatory bodies, to define specific regulations aimed to guarantee wide access to effective therapies of all eligible patients, to optimize the management of and the adherence to the HCV treatment, and to ensure the therapeutic continuity after discharge from prison.

Published
2017
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5. Acute hepatitis C: a 24-week course of pegylated interferon α-2b versus a 12-week course of pegylated interferon α-2b alone or with ribavirin.

Author

Santantonio T, Fasano M, Sagnelli E, Tundo P, Babudieri S, Fabris P, Toti M, Di Perri G, Marino N, Pizzigallo E, and Angarano G

Subjects
Acute Disease, Adolescent, Adult, Antiviral Agents adverse effects, Drug Therapy, Combination, Female, Humans, Interferon alpha-2, Interferon-alpha adverse effects, Male, Medication Adherence, Middle Aged, Polyethylene Glycols adverse effects, Recombinant Proteins administration & dosage, Recombinant Proteins adverse effects, Ribavirin adverse effects, Treatment Outcome, Young Adult, Antiviral Agents administration & dosage, Hepatitis C drug therapy, Interferon-alpha administration & dosage, Polyethylene Glycols administration & dosage, Ribavirin administration & dosage
Abstract

Unlabelled: Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated., Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration., (© 2014 by the American Association for the Study of Liver Diseases.)

Published
2014
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6. Tuberculosis screening before anti-hepatitis C virus therapy in prisons.

Author

Babudieri S, Soddu A, Murino M, Molicotti P, Muredda AA, Madeddu G, Fois AG, Zanetti S, Pirina P, and Mura MS

Subjects
Adult, Antiviral Agents therapeutic use, Hepatitis C drug therapy, Humans, Interferon-alpha therapeutic use, Male, Mass Screening, Polyethylene Glycols therapeutic use, Prisoners, Radiography, Recombinant Proteins adverse effects, Recombinant Proteins therapeutic use, Recurrence, Ribavirin therapeutic use, Antiviral Agents adverse effects, Hepatitis C diagnosis, Interferon-alpha adverse effects, Polyethylene Glycols adverse effects, Ribavirin adverse effects, Tuberculosis, Pulmonary diagnostic imaging, Tuberculosis, Pulmonary prevention & control
Published
2012
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7. Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

Author

Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio Maria, Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxì, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini Silberstein, Francesca, Mariani, R., Iapadre, N., Grimaldi, A., Cozzolongo, R., Andreone, P., Verucchi, G., Menzaghi, B., Quirino, T., Pisani, V., Torti, MARIA CHIARA, Vecchiet, J., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L. A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, Miriam, Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Magni, C. F., Mancon, A., Monico, S., Niero, F., Russo, M. L., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Gaeta, G. B., Lembo, V., Sangiovanni, V., Di Marco, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Aragri, M., Baiocchi, L., Barbaliscia, S., Biliotti, Elisa, Biolato, M., Carioti, L., Ceccherini Silberstein, F., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Maio, V. C., Di Paolo, D., Furlan, Caterina, Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lenci, I., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, Donatella, Pellicelli, A., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M. C., Spaziante, M., Svicher, V., Tisone, G., Vespasiani Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M. S., Falconi, L., Di Giammartino, D., Di Maio, V., Cento, V., Lenci, I., Aragri, M., Rossi, P., Barbaliscia, S., Melis, M., Verucchi, G., Magni, C., Teti, E., Bertoli, A., Antonucci, F., Bellocchi, M., Micheli, V., Masetti, C., Landonio, S., Francioso, S., Santopaolo, F., Pellicelli, A., Calvaruso, V., Gianserra, L., Siciliano, M., Romagnoli, D., Cozzolongo, R., Grieco, A., Vecchiet, J., Morisco, F., Merli, M., Brancaccio, G., Di Biagio, A., Loggi, E., Mastroianni, C., Pace Palitti, V., Tarquini, P., Puoti, M., Taliani, G., Sarmati, L., Picciotto, A., Vullo, V., Caporaso, N., Paoloni, M., Pasquazzi, C., Rizzardini, G., Parruti, G., Craxã¬, A., Babudieri, S., Andreoni, M., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Iapadre, N., Grimaldi, A., Andreone, P., Menzaghi, B., Quirino, T., Pisani, V., Torti, C., Bruzzone, B., De Maria, A., Marenco, S., Nicolini, L., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Boccaccio, V., Bruno, S., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Lleo, A., Mancon, A., Monico, S., Niero, F., Russo, M., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Gaeta, G., Lembo, V., Sangiovanni, V., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pieri, A., Polilli, E., Sozio, F., Antenucci, F., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Leonardis, F., De Sanctis, A., Di Paolo, D., Furlan, C., Gallo, P., Gasbarrini, A., Giannelli, V., Grieco, S., Lambiase, L., Lattanzi, B., Lula, R., Malagnino, V., Manuelli, M., Miglioresi, L., Milana, M., Moretti, A., Nosotti, L., Palazzo, D., Romano, M., Sarrecchia, C., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Tisone, G., Vespasiani-Gentilucci, U., D'Adamo, G., Mangia, A., Maida, I., Mura, M., Falconi, L., Di Giammartino, D., Di Maio, V, Cento, V, Lenci, I, Aragri, M, Rossi, P, Barbaliscia, S, Melis, M, Verucchi, G, Magni, C, Teti, E, Bertoli, A, Antonucci, F, Bellocchi, M, Micheli, V, Masetti, C, Landonio, S, Francioso, S, Santopaolo, F, Pellicelli, A, Calvaruso, V, Gianserra, L, Siciliano, M, Romagnoli, D, Cozzolongo, R, Grieco, A, Morisco, F, Merli, M, Brancaccio, G, Di Biagio, A, Loggi, E, Mastroianni, C, Pace Palitti, V, Tarquini, P, Puoti, M, Taliani, G, Sarmati, L, Picciotto, A, Vullo, V, Caporaso, N, Paoloni, M, Pasquazzi, C, Rizzardini, G, Parruti, G, Craxì, A, Babudieri, S, Andreoni, M, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Velia C. Di Maio, Valeria Cento, Ilaria Lenci, Marianna Aragri, Piera Rossi, Silvia Barbaliscia, Michela Meli, Gabriella Verucchi, Carlo F. Magni, Elisabetta Teti, Ada Bertoli, Francesco Paolo Antonucci, Maria C. Bellocchi, Valeria Micheli, Chiara Masetti, Simona Landonio, Simona Francioso, Francesco Santopaolo, Adriano M. Pellicelli, Vincenza Calvaruso, Laura Gianserra, Massimo Siciliano, Dante Romagnoli, Raffaele Cozzolongo, Antonio Grieco, Jacopo Vecchiet, Filomena Morisco, Manuela Merli, Giuseppina Brancaccio, Antonio Di Biagio, Elisabetta Loggi, Claudio M. Mastroianni, Valeria Pace Palitti, Pierluigi Tarquini, Massimo Puoti, Gloria Taliani, Loredana Sarmati, Antonino Picciotto, Vincenzo Vullo, Nicola Caporaso, Maurizio Paoloni, Caterina Pasquazzi, Giuliano Rizzardini, Giustino Parruti, Antonio Craxì, Sergio Babudieri, Massimo Andreoni, Mario Angelico, Carlo F. Perno, Francesca Ceccherini-Silberstein, for the HCV Italian Resistance Network Study Group: [.., P. Andreone, E. Loggi, G. Verucchi, ], Di Maio, Velia C., Cento, Valeria, Lenci, Ilaria, Aragri, Marianna, Rossi, Piera, Barbaliscia, Silvia, Melis, Michela, Verucchi, Gabriella, Magni, Carlo F., Teti, Elisabetta, Bertoli, Ada, Antonucci, Francescopaolo, Bellocchi, Maria C., Micheli, Valeria, Masetti, Chiara, Landonio, Simona, Francioso, Simona, Santopaolo, Francesco, Pellicelli, Adriano M., Calvaruso, Vincenza, Gianserra, Laura, Siciliano, Massimo, Romagnoli, Dante, Cozzolongo, Raffaele, Grieco, Antonio, Vecchiet, Jacopo, Morisco, Filomena, Merli, Manuela, Brancaccio, Giuseppina, Di Biagio, Antonio, Loggi, Elisabetta, Mastroianni, Claudio M., Pace Palitti, Valeria, Tarquini, Pierluigi, Puoti, Massimo, Taliani, Gloria, Sarmati, Loredana, Picciotto, Antonino, Vullo, Vincenzo, Caporaso, Nicola, Paoloni, Maurizio, Pasquazzi, Caterina, Rizzardini, Giuliano, Parruti, Giustino, Craxã¬, Antonio, Babudieri, Sergio, Andreoni, Massimo, Angelico, Mario, Perno, Carlo F., Ceccherini-Silberstein, Francesca, Nicolini, L. A., Magni, C. F., Russo, M. L., Gaeta, G. B., Di Marco, V., Di Maio, V. C., Sorbo, M. C., Mura, M. S., Di Maio, Velia C, Magni, Carlo F, Bellocchi, Maria C, Pellicelli, Adriano M, Mastroianni, Claudio M, Craxì, Antonio, Perno, Carlo F, and Ceccherini Silberstein, Francesca

Subjects
Male, 0301 basic medicine, hepatitis C virus, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Drug Resistance, resistance-associated substitutions, Viral Nonstructural Proteins, VARIANTS, NS5A, medicine.disease_cause, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Recurrence, INFECTION, antiviral therapy, Medicine, hepatitis C viru, Viral, Treatment Failure, Chronic, direct-acting antivirals, resistance test, hepatology, biology, GENOTYPE 1, virus diseases, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Hepatitis C, Italy, Combination, Interferon, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Author Keywords:antiviral therapy, RIBAVIRIN, Sequence Analysis, Human, medicine.drug, medicine.medical_specialty, Daclatasvir, Genotype, Hepatitis C virus, Antiviral Agents, LONG-TERM PERSISTENCE, DACLATASVIR, 03 medical and health sciences, Drug Therapy, Aged, Drug Resistance, Viral, Hepatitis C, Chronic, Humans, Interferons, Mutation, Ribavirin, Sequence Analysis, DNA, Hepatology, TREATMENT-NAIVE, Internal medicine, Antiviral Agent, resistance-associated substitution, direct-acting antiviral, Hepaciviru, resistance test KeyWords Plus:HEPATITIS-C VIRUS, business.industry, Viral Nonstructural Protein, DNA, biology.organism_classification, Clinical trial, 030104 developmental biology, SOFOSBUVIR, chemistry, Sequence Analysi, Immunology, business
Abstract

Background & Aims: Despite the excellent efficacy of direct-acting antivirals (DAA) reported in clinical trials, virological failures can occur, often associated with the development of resistance-associated substitutions (RASs). This study aimed to characterize the presence of clinically relevant RASs to all classes in real-life DAA failures. Methods: Of the 200 virological failures that were analyzed in 197 DAA-treated patients, 89 with pegylated-interferon+ribavirin (PegIFN+RBV) and 111 without (HCV-1a/1b/1g/2/3/4=58/83/1/6/24/25; 56.8% treatment experienced; 65.5% cirrhotic) were observed. Sanger sequencing of NS3/NS5A/NS5B was performed by home-made protocols, at failure (N= 200) and whenever possible at baseline (N= 70). Results: The majority of the virological failures were relapsers (57.0%), 22.5% breakthroughs, 20.5% non-responders. RAS prevalence varied according to IFN/RBV use, DAA class, failure type and HCV genotype/subtype. It was 73.0% in IFN group vs 49.5% in IFN free, with the highest prevalence of NS5A-RASs (96.1%), compared to NS3-RASs (75.9% with IFN, 70.5% without) and NS5B-RASs (66.6% with IFN, 20.4% without, in sofosbuvir failures). In the IFN-free group, RASs were higher in breakthrough/non-responders than in relapsers (90.5% vs 40.0%, P= 2 DAA classes showed multiclass resistance, including 11/11 NS3+NS5A failures. Furthermore, 20.0% of patients had baseline-RASs, which were always confirmed at failure. Conclusions: In our failure setting, RAS prevalence was remarkably high in all genes, with a partial exception for NS5B, whose limited resistance is still higher than previously reported. This multiclass resistance advocates for HCV resistance testing at failure, in all three genes for the best second-line therapeutic tailoring.

Published
2017

8. Acute hepatitis C: A 24-week course of pegylated interferon alpha-2b versus a 12-week course of pegylated interferon alpha-2b alone or with ribavirin

Author

Santantonio, Teresa, Fasano, Massimo, Sagnelli, Evangelista, Tundo, Paolo, Babudieri, Sergio, Fabris, Paolo, Toti, Mario, Di Perri, Giovanni, Marino, Nicoletta, Pizzigallo, Eligio, Angarano, Gioacchino, Pastore, Giuseppe, Guastadisegni, Angela, Volpe, Anna, Stano, Francesca, Tommasi, Donato, Maci, Annamaria, Resta, Francesco, Loperfido, Pietro, Esposito, Roberto, Borghi, Vanni, Fontana, Tommaso, Francavilla, Ruggiero, Mazzola, Michele, Pipoli, Antonella, Stanzione, Marinella, Amoroso, Pietro, Lettieri, Gennaro, Messina, Vincenzo, Antonucci, Giorgio, Rosati, Silvia, Giacometti, Andrea, Costa, Chiara, De Stefano, Carlo Biagio, Cariti, Giuseppe, Tositti, Giulia, Piera Riccardi, M., Verucchi, Gabriella, Francisci, Daniela, Petrelli, Enzo, Stoppini, Laura, Raimondo, Giovanni, Squadrito, Giovanni, Caccamo, Gaia, Antonino, Picciotto, Basso, Monica, Lazzarin, Adriano, Morsica, Giulia, Mian, Peter, Pristerà, Raffael, Teresa Santantonio, Massimo Fasano, Evangelista Sagnelli, Paolo Tundo, Sergio Babudieri, Paolo Fabri, Mario Toti, Giovanni Di Perri, Nicoletta Marino, Eligio Pizzigallo, Gioacchino Angarano, the Acute Hepatitis C Study Group: [.., Gabriella Verucchi, and ]

Subjects
Adult, Male, medicine.medical_specialty, CLEARANCE, Combination therapy, Adolescent, MONOTHERAPY, VIRUS-INFECTION, Gastroenterology, Antiviral Agents, law.invention, Medication Adherence, Polyethylene Glycols, ALPHA-INTERFERON, chemistry.chemical_compound, Young Adult, Pharmacotherapy, Randomized controlled trial, Drug Therapy, law, Multicenter trial, Internal medicine, Ribavirin, medicine, Clinical endpoint, Humans, Hepatology, business.industry, Interferon-alpha, Middle Aged, Hepatitis C, Recombinant Proteins, Surgery, Acute Disease, Drug Therapy, Combination, Female, Treatment Outcome, Clinical trial, chemistry, Combination, business
Abstract

Therapy of acute hepatitis C (AHC) has not yet been standardized and several issues are still unresolved. This open, randomized, multicenter trial aimed to assess the efficacy and safety of a 24-week course of pegylated IFN (Peg-IFN) alpha-2b versus a 12-week course of Peg-IFN alpha-2b alone or with ribavirin (RBV) in AHC patients. One hundred and thirty HCV acutely infected patients who did not spontaneously resolve by week 12 after onset were consecutively enrolled and randomized to receive Peg-IFN alpha-2b monotherapy (1.5 μg/kg/week) for 24 or 12 weeks (arm 1, n = 44 and arm 2, n = 43, respectively) or in combination with RBV (10.6 mg/kg/day) for 12 weeks (arm 3, n = 43). The primary endpoint was undetectable HCV RNA at 6-month posttreatment follow-up (sustained virological response; SVR). All patients were followed for 48 weeks after therapy cessation. HCV RNA levels were determined by real-time polymerase chain reaction (limit of detection: 15 IU/mL) at the central laboratory at baseline, week 4, end of treatment, and 6 and 12 months posttreatment. Using an intent-to-treat analysis, overall SVR rate was 71.5%. In particular, an SVR was achieved in 31 of 44 (70.5%), 31 of 43 (72.1%), and 31 of 43 (72.1%) patients in arms 1, 2, and 3, respectively (P = 0.898). Sixteen patients (12.3%) prematurely discontinued therapy or were lost to follow-up; thus, sustained response rates with per-protocol analysis were 81.6%, 81.6%, and 81.6% for patients in arms 1, 2, and 3 respectively. With multivariate analysis, virologic response at week 4 of treatment was an independent predictor of SVR. Peg-IFN alpha-2b was well tolerated. Conclusion: Peg-IFN alpha-2b induces a high SVR in chronically evolving AHC patients. Response rates were not influenced by combination therapy or treatment duration. © 2014 by the American Association for the Study of Liver Diseases.

Published
2014

9. Good Safety Profile and Efficacy of Leucocyte Interferon-α in Combination with Oral Ribavirin in Treatment-Naive Patients with Chronic Hepatitis C.

Author

Barbaro, Giuseppe, Grisorio, Benvenuto, Fruttaldo, Luigi, Bacca, Donato, Babudieri, Sergio, Torre, Donato, Francavilla, Ruggiero, Rizzo, Giovanni, Belloni, Giancarlo, Lucchini, Alfio, Annese, Mauro, Matarazzo, Filippo, Hazra, Christina, and Barbarini, Giorgio

Subjects
RIBAVIRIN, LEUCOCYTES, INTERFERONS, HEPATITIS C, ANTIVIRAL agents, CHRONIC diseases
Abstract

Compares the safety profile and efficacy of the antiviral agent ribavirin combined with leucocyte interferon (IFN)-alpha or with recombinant IFNalpha-2b in treatment-naive patients with chronic hepatitis C. Lower number of adverse events in patients receiving leucocyte IFNalpha; Effectiveness of both regimens in inducing a sustained response in naive patients.

Published
2003
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10. Chronic Viral Hepatitis in the Italian Prison Setting: Prevalence, Outcomes, Literature Needs and Perspectives.

Author

Fiore, Vito, De Vito, Andrea, Pontali, Emanuele, Lucania, Luciano, Madeddu, Giordano, and Babudieri, Sergio

Subjects
VIRAL hepatitis, HEPATITIS C, COMMUNICABLE diseases, HEPATITIS C virus, GOVERNMENT agencies, ANTIVIRAL agents, GREY literature
Abstract

Compared with the general population, incarcerated people have a higher prevalence of several communicable diseases, including viral hepatitis. Nevertheless, there is still a lack of literature in field. Our review aims to shed the actual knowledge on viral hepatitis among incarcerated people in Italy. We performed a comprehensive literature search, through key electronic databases (Scopus, Pubmed–MEDLINE) and search engines (Google Scholar), of peer-reviewed publications (articles and reviews), grey literature on viral hepatitis prevalence, and models proposed for active case finding and control strategies in prison settings. We found that viral hepatitis epidemiology drastically changed in the last five years, particularly on hepatitis C virus (HCV), reporting an HCV antibody (HCV-Ab) prevalence decrease from up to 38% to ˂20% in penitentiary institutes, as well as an even more important reduction in active infections. Probably, the availability of direct-acting antivirals is contributing to this scenario. However, there is a lack of data available regarding incarcerated women. For this reason, more tailored interventions are needed for this sub-population. Judiciary and regulatory bodies should be prompted to discuss and define specific regulations to optimize case active finding strategies, guarantee wide access to effective preventive and treatment options for viral hepatitis and enhance treatment management. [ABSTRACT FROM AUTHOR]

Published
2021
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11. Erratum to: Management of HCV infection in the penitentiary setting in the direct-acting antivirals era: practical recommendations from an expert panel.

Author

Ranieri, Roberto, Starnini, Giulio, Carbonara, Sergio, Pontali, Emanuele, Leo, Guido, Romano, Antonio, Panese, Sandro, Monarca, Roberto, Prestileo, Tullio, Barbarini, Giorgio, and Babudieri, Sergio

Subjects
ANTIVIRAL agents, HEPATITIS C
Abstract

A correction is presented of the article "Management of HCV infection in the penitentiary setting in the direct‑acting antivirals era: practical recommendations from an expert panel" is presented.

Published
2017
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12. Real life experiences in HCV management in 2018

Author

Nicola Caporaso, Giovanni Battista Gaeta, Stefano Bonora, Giovanni Di Perri, Francesca Ceccherini-Silberstein, Sergio Babudieri, Raffaele Bruno, Giuliano Rizzardini, Pietro Lampertico, Pietro Andreone, Gloria Taliani, Alessio Aghemo, Tullio Prestileo, Nicola Coppola, Anna Linda Zignego, Antonio Gasbarrini, Vito Di Marco, Massimo Andreoni, F. Cartabellotta, Adriano M. Pellicelli, Alfredo Alberti, Giovanni Raimondo, Maurizia Rossana Brunetto, Valeria Cento, Alessia Ciancio, Mauro Viganò, Savino Bruno, Massimo Puoti, Carlo Federico Perno, Vincenza Calvaruso, Antonio Craxì, Piero Colombatto, Stefano Fagiuoli, Mauro Viganò, Massimo Andreoni, Carlo Federico Perno, Antonio Craxì, Alessio Aghemo, Alfredo Alberti, Pietro Andreone, Sergio Babudieri, Stefano Bonora, Maurizia Rossana Brunetto ORCID Icon, Raffaele Bruno, Savino Bruno, Vincenza Calvaruso, Nicola Caporaso, Fabio Cartabellotta, Francesca Ceccherini-Silberstein, Valeria Cento, Alessia Ciancio, Piero Colombatto ORCID Icon, Nicola Coppola, Vito Di Marco, Giovanni Di Perri, Stefano Fagiuoli, Giovanni Battista Gaeta, Antonio Gasbarrini ORCID Icon, Pietro Lampertico, Adriano Pellicelli, Tullio Prestileo, Massimo Puoti, Giovanni Raimondo, Giuliano Rizzardini, Gloria Taliani & Anna Linda Zignego (for the AdHoc (Advancing Hepatitis C for the Optimization of Cure) Working Party.) ORCID Icon, Vigano M., Andreoni M., Perno C.F., Craxi A., Aghemo A., Alberti A., Andreone P., Babudieri S., Bonora S., Brunetto M.R., Bruno R., Bruno S., Calvaruso V., Caporaso N., Cartabellotta F., Ceccherini-Silberstein F., Cento V., Ciancio A., Colombatto P., Coppola N., Di Marco V., Di Perri G., Fagiuoli S., Gaeta G.B., Gasbarrini A., Lampertico P., Pellicelli A., Prestileo T., Puoti M., Raimondo G., Rizzardini G., Taliani G., Zignego A.L., Viganò, Mauro, Andreoni, Massimo, Perno, Carlo Federico, Craxì, Antonio, Aghemo, Alessio, Alberti, Alfredo, Andreone, Pietro, Babudieri, Sergio, Bonora, Stefano, Brunetto, Maurizia Rossana, Bruno, Raffaele, Bruno, Savino, Calvaruso, Vincenza, Caporaso, Nicola, Cartabellotta, Fabio, Ceccherini-Silberstein, Francesca, Cento, Valeria, Ciancio, Alessia, Colombatto, Piero, Coppola, Nicola, Di Marco, Vito, Di Perri, Giovanni, Fagiuoli, Stefano, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Lampertico, Pietro, Pellicelli, Adriano, Prestileo, Tullio, Puoti, Massimo, Raimondo, Giovanni, Rizzardini, Giuliano, Taliani, Gloria, Zignego, Anna Linda, Vigano, M., Andreoni, M., Perno, C. F., Craxi, A., Aghemo, A., Alberti, A., Andreone, P., Babudieri, S., Bonora, S., Brunetto, M. R., Bruno, R., Bruno, S., Calvaruso, V., Caporaso, N., Cartabellotta, F., Ceccherini-Silberstein, F., Cento, V., Ciancio, A., Colombatto, P., Coppola, N., Di Marco, V., Di Perri, G., Fagiuoli, S., Gaeta, G. B., Gasbarrini, A., Lampertico, P., Pellicelli, A., Prestileo, T., Puoti, M., Raimondo, G., Rizzardini, G., Taliani, G., Zignego, A. L., Vigano, M, Andreoni, M, Perno, C, Craxi, A, Aghemo, A, Alberti, A, Andreone, P, Babudieri, S, Bonora, S, Brunetto, M, Bruno, R, Bruno, S, Calvaruso, V, Caporaso, N, Cartabellotta, F, Ceccherini-Silberstein, F, Cento, V, Ciancio, A, Colombatto, P, Coppola, N, Di Marco, V, Di Perri, G, Fagiuoli, S, Gaeta, G, Gasbarrini, A, Lampertico, P, Pellicelli, A, Prestileo, T, Puoti, M, Raimondo, G, Rizzardini, G, Taliani, G, and Zignego, A

Subjects
0301 basic medicine, hepatitis C virus, Sofosbuvir, Sustained Virologic Response, Antiviral therapy, chronic liver disease, DAAs, HCV, Microbiology, Microbiology (medical), Infectious Diseases, Virology, medicine.disease_cause, Chronic liver disease, Health Services Accessibility, 0302 clinical medicine, direct acting antivirals, hepatitis C viru, Mass Screening, 030212 general & internal medicine, Chronic, ComputingMilieux_MISCELLANEOUS, Hepatitis C, Hepatitis B, Pibrentasvir, Antiviral Agents, Disease Progression, Hepatitis C, Chronic, Humans, Italy, medicine.drug, Human, Settore MED/17 - Malattie Infettive, Hepatitis C virus, 030106 microbiology, Infectious Disease, 03 medical and health sciences, medicine, Mass screening, DAA, Hepatitis B virus, Antiviral Agent, business.industry, medicine.disease, business
Abstract

Introduction: Hepatitis C virus (HCV) infection is a major cause of chronic liver disease, with approximately 71 million chronically infected individuals worldwide. Treatment of chronic hepatitis C has considerably improved in the last few years thanks to the introduction of direct-acting antivirals able to achieve sustained virological response in more than 95% of patients. Successful anti-HCV treatment can halt liver disease progression and solve the HCV-related extra-hepatic manifestations, eventually reducing liver-related and overall mortality. Areas covered: With the aim to respond to unmet needs in patient’s identification, universal access to antiviral therapy and treatment optimization in specific setting of HCV-infected patients, a group of Italian experts met in Stresa in May 2018. The summary of the considerations arising from this meeting and the final statements are reported in this paper. Expert commentary: All the advances on HCV cure may have a real clinical impact not only in individual patients but also at the social health level if they are applied to all infected patients, independently from the stage of liver disease. Further improvements are needed in order to attain HCV elimination, such as the development of an enhanced screening program working in parallel to the present treatment options.

Published
2018

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