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154. Clinical usefulness of HCV sequencing on clinical samples with different HCV-RNA levels

Author

Ceccherini-Silberstein, F., Di Maio, V. C., Cento, V., Di Paolo, D., Aragri, M., Leonardis, F., Tontodonati, M., Valeria Micheli, Antonucci, F. P., Campoli, R., Mancon, A., Bertoli, A., Lenci, I., Cucchiarelli, S., Manunta, A., Di Biagio, A., Sarrecchia, C., Nicolini, L. A., Marenco, S., Ciotti, M., Nosotti, L., Gianelli, V., Merli, M., Siciliano, M., Landonio, S., Maria, A., Pellicelli, A., Vecchiet, J., Magni, C., Babudieri, S., Mura, M. S., Taliani, G., Lichtner, M., Maida, I., Vespasiani, U., Romano, M., Morisco, F., Gasbarrini, A., Mastroianni, C., Puoti, M., Mangia, A., Bruno, S., Tisone, G., Caporaso, N., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., and Perno, C. F.

155. Declino delle Sostituzioni associate a resistenza (RAS) ad inibitori di NS3 ed NS5A al fallimento con DAA nel virus dell’epatite C in Italia negli anni 2015-2018

Author

Paglicci, L., Redi, D., Rossetti, B., Di Maio, V. C., Aragri, M., Paolucci, S., Masetti, C., Bruzzone, B., Minichini, C., FRANCESCA MONTAGNANI, Micheli, V., Landonio, S., Degasperi, E., Giacomo Zanelli, Maserati, R., Maida, I., Callegaro, A. P., Barbaliscia, S., Bertoli, A., Paternoster, C., Marenco, S., Morisco, F., Calvaruso, V., Taliani, G., Puoti, M., Cenderello, G., Santis, A., Lichtner, M., Coppola, N., Gulminetti, R., Cento, V., Rendina, M., Teti, E., Parruti, G., Ruggiero, T., Ghisetti, V., Pasquazzi, C., Nicolini, L. A., Vullo, V., Pellicelli, A., Prestileo, T., Cozzolongo, R., Sangiovanni, V., Biolato, M., Lenci, I., Licata, A., Ciaccio, A., Pace Palitti, V., Giorgini, A., Cariti, G., Ciancio, A., Aghemo, A., Borghi, V., Andreone, P., Brunetto, M., Pollicino, T., Santantonio, T., Cuomo, N., Caudai, C., Babudieri, S., Lampertico, P., Gaeta, G. B., Raimondo, G., Andreoni, M., Rizzardini, G., Angelico, M., Perno, C. F., Craxì, A., Maurizio Zazzi, and Ceccherini-Silberstein, F.

156. Underserved populations and bacterial and protozoal sexually transmitted infections: a lost health-care opportunity

Author

Fiore, V., Latte, G., Giordano MADEDDU, Galleri, G., Rocchitta, G., Nuvoli, S., Calvisi, D., Bagella, P., Manetti, R., Serra, P. A., Spanu, A., and Babudieri, S.

Subjects
Male, Transients and Migrants, Databases, Factual, Substance-Related Disorders, Sexual Behavior, Ill-Housed Persons, Sexually Transmitted Diseases, Humans, Female, Delivery of Health Care, Anti-Bacterial Agents
Abstract

The purpose of our review is an update about the burden of sexually transmitted infections (STIs) among various types of underserved populations, such as migrants, substance abusers, homeless and incarcerated inmates. First-line test and treatment based on the latest available evidence according to the revised guidelines of Centers for Disease Control and Prevention have also been considered.We performed a comprehensive research using scientific databases such as Medline and Pubmed, followed by a review of citations and reference list. A consultation with other experts in the management of the various subpopulations was also conducted.Health-care is often influenced by social determinants, which play a vital role in the diffusion of STIs. The consequence is a socio-economical and ethnic disparity in the rate of STIs. Early screening and treatment of STIs should be implemented in clinical practice, starting from marginalized social groups, which are the most affected by this health problem.In the literature, there are very few papers containing information on STIs prevalence in various types of underserved populations, such as migrants, substance abusers, homeless and incarcerated inmates. The availability of more accurate epidemiological data is needed. In these groups, the most relevant barrier is the lower perception of health-care need, with an underestimation of risk and symptoms of STIs, causing a retard of diagnosis and health-care provision and use. For these populations, targeted interventions are needed, particularly on unaware people, responsible for most STIs transmissions.

160. HIV treatment and care among Italian inmates: a one-month point survey.

Author

Monarca, R, Madeddu, G, Ranieri, R, Carbonara, S, Leo, G, Sardo, M, Choroma, F, Casari, S, Marri, D, Muredda, A A, Nava, F A, Babudieri, S, and SIMSPe–SIMIT Group

Subjects
ANTI-HIV agents, RNA analysis, HIV infection epidemiology, COMPARATIVE studies, DRUGS, HIV, PRISONERS, RESEARCH methodology, MEDICAL cooperation, MEDICAL screening, PATIENT compliance, RESEARCH, EVALUATION research, DISEASE prevalence, CROSS-sectional method, CD4 lymphocyte count
Abstract

Background: HIV infection, with an estimated prevalence be between 2 and 50 times those of the general adult population is a major health challenge for prison authorities worldwide. Since no nationwide surveillance system is present in Italy, data on HIV prevalence and treatment in prisons are limited to only a few and small observational studies. We aimed to estimate HIV prevalence and obtain an overview on diagnostic and therapeutic activities concerning HIV infection in the Italian penitentiary system.Methods: We piloted a multi-centre cross-sectional study investigating the prevalence of HIV infection and assessing HIV-related medical activities in Italian correctional institutions.Results: A total of 15,675 prisoners from 25 institutions, accounting for approximately one-fourth of the prison inmates in Italy, were included in the study, of whom, 97.7 % were males, 37.1 % foreigners and 27 % had a history of intravenous drug addiction. HIV-tests were available in 42.3 % of the total population, with a known HIV Infection proportion of 5.1 %. In the month prior to the study, 604 of the 1,764 subjects who entered prison were tested for HIV, with a HIV-positive prevalence of 3.3 %. Among the 338 HIV-positive prisoners, 81.4 % were under antiretroviral treatment and 73.5 % showed undetectable HIV-RNA. In 23/338 (6.8 %) a coinfection with HBV and in 189/338 (55.9 %) with HCV was also present. Among the 67 (19.8 %) inmates with HIV who did not receive HIV treatment, 13 (19.5 %) had T-CD4+ count <350 cells/mm(3) and 9 (69.2 %) of these had refused the treatment. The majority of the inmates with HIV-infection were on a PI-based (62.5 %) or on NNRTIs-based (24.4 %) regimen. Only a minority of patients received once daily regimens (17.2 %).Conclusions: Although clinical and therapeutic management of HIV infection remains difficult in Italian prisons, diagnostics, treatment and care were offered to the majority of HIV-infected inmates. Specific programs should be directed towards the prison population and strict cooperation between prison and health institutions is needed to increase HIV treatment. [ABSTRACT FROM AUTHOR]

Published
2015
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161. The association between education level and chronic liver disease of any etiology

Author

Evangelista Sagnelli, Filomena Morisco, Maurizio Russello, Sergio Babudieri, Caterina Sagnelli, Caterina Furlan, Mariantonietta Pisaturo, Mario Pirisi, Piero Luigi Almasio, Antonina Smedile, Tommaso Stroffolini, Stroffolini, T., Sagnelli, E., Sagnelli, C., Morisco, F., Babudieri, S., Furlan, C., Pirisi, M., Russello, M., Smedile, A., Pisaturo, M., Almasio, P. L., Stroffolini T., Sagnelli E., Sagnelli C., Morisco F., Babudieri S., Furlan C., Pirisi M., Russello M., Smedile A., Pisaturo M., and Almasio P.L.

Subjects
Liver Cirrhosis, medicine.medical_specialty, Cirrhosis, Alcohol Drinking, Liver Cirrhosi, Disease, 030204 cardiovascular system & hematology, Educational setting, Chronic liver disease, Logistic regression, Chronic disease, 03 medical and health sciences, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Internal medicine, HBV, Internal Medicine, medicine, Humans, 030212 general & internal medicine, Stage (cooking), Association (psychology), business.industry, Liver Diseases, Liver Disease, Fatty liver, Middle Aged, medicine.disease, Italy, HCV, Etiology, Liver disorder, Alcohol, business, Human, Liver disorders
Abstract

Background The potential link between educational level and chronic liver diseases (CLD) were explored using the mortality records of liver cirrhosis, which lack accuracy and are unable to identify the different etiological factors of liver cirrhosis. Information on the association of low educational level with the severity of CLD is lacking. Aim To evaluate the potential association linking education level to etiology and clinical stage of CLD cases. Methods Consecutive enrolment of 11,107 subjects with CLD aged≥18 years prospectively recruited in two national surveys in 2001 and 2014 at one of the participating Italian liver units throughout the country. Subjects were pooled in two groups: low education level (less than high school) and high education level (completed high school or beyond). The association of demographic, etiological, and clinical stage of subjects with educational level was assessed using logistic regression analysis. In the analysis low educational level was the outcome variable. Results A total of 11,107 subjects born in Italy (mean age 55.5 years, sex ratio 1.5) were evaluated. Multiple logistic regression analysis shows that chronic HCV infection (O.R.1,38:95%,C.I.1.23-1.55), risky alcohol intake (O.R.1.96;95%,C.I.1.73-2.21) and liver cirrhosis (O.R.1.65;95%,C.I.1.46-1.85) all resulted independently associated with less than a completed high school education. HBV infection resulted independently associated with high education level (O.R.0.74;95%,C.I.0.64-0.86), reflecting changes in HBV modes of transmission in recent decades. No association was found with CLD related to non-alcoholic fatty liver disease (O.R.1.03;95%, C.I.0.81-1.30). Conclusions These findings show an independent association linking education level with viruses and alcohol-related CLD. Low educational level is associated with the severity of CLD.

Published
2020

162. Decreasing role of HCV and HBV infections as aetiological factors of hepatocellular carcinoma in Italy

Author

Maurizio Russello, Piero Luigi Almasio, Evangelista Sagnelli, Mario Pirisi, Tommaso Stroffolini, Sergio Babudieri, Caterina Sagnelli, Caterina Furlan, Mariantonietta Pisaturo, Antonina Smedile, Filomena Morisco, Stroffolini T., Sagnelli E., Sagnelli C., Morisco F., Babudieri S., Furlan C., Pirisi M., Russello M., Smedile A., Pisaturo M., Almasio P.L., Stroffolini, T., Sagnelli, E., Sagnelli, C., Morisco, F., Babudieri, S., Furlan, C., Pirisi, M., Russello, M., Smedile, A., Pisaturo, M., and Almasio, P. L.

Subjects
0301 basic medicine, Liver Cirrhosis, Male, Hepatocellular carcinoma, Prevalence, Hepacivirus, Sex Factor, Chronic liver disease, Antibodies, Viral, Gastroenterology, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, HBV, Medicine, Age Factor, 030212 general & internal medicine, Prospective Studies, education.field_of_study, Incidence (epidemiology), Incidence, Liver Neoplasms, Age Factors, General Medicine, Hepatitis C, Hepatitis B viru, Hepatitis B, Middle Aged, Infectious Diseases, Italy, Liver Neoplasm, HCV, Female, Alcohol, Human, Microbiology (medical), medicine.medical_specialty, Hepatitis B virus, Carcinoma, Hepatocellular, Liver Cirrhosi, 030106 microbiology, Population, 03 medical and health sciences, Sex Factors, Internal medicine, Humans, Risk factor, education, Aged, Cross-Sectional Studie, Hepaciviru, business.industry, Risk Factor, medicine.disease, digestive system diseases, Prospective Studie, Cross-Sectional Studies, business
Abstract

Background: The epidemiology of hepatocellular carcinoma (HCC) is characterized by a dynamical temporal trend of well-established and emerging risk factors. Methods: We evaluated the temporal trend of aetiological factors of HCC over the last two decades in Italy. HCC cases were recruited from two previously published national studies in 1996 and in 2008 and HCC cases were also enlisted from two national surveys in 2001 and in 2014 enrolling consecutive subjects with chronic liver disease (CLD) referring to more than 80 liver units scattered all over the country for a 6-monthperiod. Results: Out of the 9997 subjects with CLD recruited in 2001 and the 2408 recruited in 2014, 3.3% and 5.7% (P < 0.001), respectively, had HCC. The temporal trend of HBsAg −/HCV + HCC cases significantly linearly decreased from 71.1% in 1996 to 57.2% in 2014 (P < 0.001). Conversely, that of virus-negative cases significantly linearly increased from 12.1% to 28.3% (P < 0.001). The proportion of HBV-related HCC cases showed a steady low rate, reflecting the reduced endemicity of the infection in Italy. The proportion of HCC with compensated cirrhosis (i.e., Child–Pugh A) linearly increased over time from 55.6% in 1996 to 76.0% in 2014 (P < 0.001) reflecting the growing effectiveness of semi-annual ultrasound surveillance for early detection of HCC. Conclusion: In conclusion, with decreasing viral aetiology, an overall decrease in the incidence of HCC might be expected in the future. The proportion of metabolic diseases is conversely increasing being considered as an aetiology. The growing prevalence of metabolic disorders in the general population may further increase this trend in the years to come.

Published
2019

163. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author

Velia Chiara Di Maio, Valeria Cento, Marianna Aragri, Stefania Paolucci, Teresa Pollicino, Nicola Coppola, Bianca Bruzzone, Valeria Ghisetti, Maurizio Zazzi, Maurizia Brunetto, Ada Bertoli, Silvia Barbaliscia, Silvia Galli, William Gennari, Fausto Baldanti, Giovanni Raimondo, Carlo Federico Perno, Francesca Ceccherini-Silberstein, Pietro Andreone, Massimo Andreoni, Mario Angelico, Sergio Babudieri, Giorgio Barbarini, Vincenzo Boccaccio, Lucio Boglione, Matteo Bolis, Stefano Bonora, Vanni Borghi, Giuseppina Brancaccio, Savino Bruno, Pierluigi Cacciatore, Vincenza Calvaruso, Nicola Caporaso, Antonio Ciaccio, Alessia Ciancio, Piero Colombatto, Raffaele Cozzolongo, Antonio Craxì, Cecilia D'Ambrosio, Gabriella D'Ettorre, Andrea De Luca, Antonio Di Biagio, Giovanni Di Perri, Simona Francioso, Giovanni Battista Gaeta, Alessia Giorgini, Antonio Grieco, Guido Gubertini, Roberto Gulminetti, Lara Lambiase, Ilaria Lenci, Miriam Lichtner, Ivana Maida, Simona Marenco, Letizia Marinaro, Renato Maserati, Chiara Masetti, Michela Melis, Elisa Meregalli, Valeria Micheli, Filomena Morisco, Fosca Niero, Laura Ambra Nicolini, Valeria Pace Palitti, Maurizio Paoloni, Giustino Parruti, Caterina Pasquazzi, Adriano Pellicelli, Ennio Polilli, Maria Laura Ponti, Massimo Puoti, Maria Rendina, Giuliano Rizzardini, Barbara Rossetti, Tina Ruggiero, Vincenzo Sangiovanni, Mario Starace, Laura Sticchi, Pierluigi Tarquini, Pierluigi Toniutto, Vincenzo Vullo, Di Maio VC, Cento V, Aragri M, Paolucci S, Pollicino T3, Coppola N4, Bruzzone B5, Ghisetti V6, Zazzi M7, Brunetto M8, Bertoli A1, Barbaliscia S1, Galli S9, Gennari W10, Baldanti F2, Raimondo G3, Perno CF1, Ceccherini-Silberstein F11, Andreone P, Andreoni M, Angelico M, Babudieri S, Barbarini G, Boccaccio V, Boglione L, Bolis M, Bonora S, Borghi V, Brancaccio G, Bruno S, Cacciatore P, Calvaruso Vincenza, Caporaso N, Ciaccio A, Ciancio A, Colombatto P, Cozzolongo R, Craxì Antonio, D'Ambrosio C, D'Ettorre G, De Luca A, Di Biagio A, Di Perri G, Francioso S, Gaeta GB, Giorgini A, Grieco A, Gubertini G, Gulminetti R, Lambiase L, Lenci I, Lichtner M, Maida I, Marenco S, Marinaro L, Maserati R, Masetti C, Melis M, Meregalli E, Micheli V, Morisco F, Niero F, Nicolini LA, Palitti VP, Paoloni M, Parruti G, Pasquazzi C, Pellicelli A, Polilli E, Ponti ML, Puoti M, Rendina M, Rizzardini G, Rossetti B, Ruggiero T, Sangiovanni V, Starace M, Sticchi L, Tarquini P, Toniutto P, Vullo V., Di Maio, Vc, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, Cf, Ceccherini-Silberstein, F., Andreone P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxì, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, Gb, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, La, Palitti, Vp, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, Ml, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V., Di Maio, V, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Craxi, A, Gaeta, G, Nicolini, L, Palitti, V, Ponti, M, and Vullo, V

Subjects
0301 basic medicine, medicine.medical_specialty, hepacivirus, HCV RAS, Treatment outcome, Drug Resistance, HCV genotypes, Drug resistance, Biology, NS5A, 03 medical and health sciences, 0302 clinical medicine, Second line, drug resistance viral, humans, retreatment, treatment outcome, antiviral agents, hepatitis c chronic, Internal medicine, Drug Resistance, Viral, Humans, Retreatment, Treatment Outcome, Antiviral Agents, Hepacivirus, Hepatitis C, Chronic, medicine, Viral, Chronic, Hepatology, Hepatitis C, Settore MED/07 - Microbiologia e Microbiologia Clinica, medicine.disease, Virology, Hepatology, HCV, NS5A, 030104 developmental biology, HCV, 030211 gastroenterology & hepatology
Published
2018

164. 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

165. Current and future challenges in HCV: insights from an Italian experts panel

Author

Carlo Federico Perno, Savino Bruno, Antonio Craxì, Giovanni Di Perri, Anna Linda Zignego, Erica Villa, Massimo Colombo, Vito Di Marco, Massimo Andreoni, Sergio Babudieri, M. Puoti, Gloria Taliani, Andreoni, M, Babudieri, S, Bruno, S, Colombo, M, Zignego, A, Di Marco, V, Di Perri, G, Perno, C, Puoti, M, Taliani, G, Villa, E, Craxi, A, Andreoni, M., Babudieri, S., Bruno, S., Colombo, M., Zignego, A., DI MARCO, V., Di Perri, G., Perno, C., Puoti, M., Taliani, G., Villa, E., and Craxi, A.

Subjects
Microbiology (medical), medicine.medical_specialty, Settore MED/17 - Malattie Infettive, Disease stages, Comorbidity, Antiviral Agents, Comorbidities, Virological response, 03 medical and health sciences, 0302 clinical medicine, DAAs, HCV, Treatment, Infectious Diseases, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, DAA, High rate, business.industry, General Medicine, Hepatitis C, medicine.disease, Virology, Italy, Tolerability, Healthcare settings, 030211 gastroenterology & hepatology, Comorbiditie, business, Direct acting
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

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

Author

Carlo Magni, Barbara Menzaghi, Valeria Cento, Francesca Ceccherini-Silberstein, Giustino Parruti, Antonio Di Biagio, Velia Chiara Di Maio, Sergio Babudieri, Antonella d'Arminio Monforte, Loredana Sarmati, Laura Gianserra, Paolo Casalino, Tiziana Quirino, Elena Danieli, Jeremie Guedj, Dante Romagnoli, Ilaria Lenci, Sergio Bernardini, Laura Ambra Nicolini, Elisa Biliotti, Matteo Bolis, M. Melis, Maddalena Cerrone, Massimo Puoti, Valeria Micheli, Carlo Federico Perno, Vincenza Calvaruso, Thi Huyen Tram Nguyen, Ennio Polilli, Giuliano Rizzardini, Massimo Siciliano, Massimo Andreoni, Mario Angelico, Francesco Paolo Antonucci, Domenico Di Carlo, Caterina Pasquazzi, Antonio Craxì, Daniele Di Paolo, Elisabetta Teti, Gloria Taliani, Roberta Alfieri, Cento, V, Nguyen, T, 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, L, Di Biagio, A, Magni, C, Bolis, M, Antonucci, F, Di Maio, V, Alfieri, R, Sarmati, L, Casalino, P, Bernardini, S, Micheli, V, Rizzardini, G, Parruti, G, Quirino, T, Puoti, M, Babudieri, S, Monforte, A, Andreoni, M, Craxì, A, Angelico, M, Pasquazzi, C, Taliani, G, Guedj, J, Perno, C, Ceccherini-Silberstein, F, Cento, V., Nguyen, T., 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, L., Di Biagio, A., Magni, C., Bolis, M., Antonucci, F., Di Maio, V., Alfieri, R., Sarmati, L., Casalino, P., Bernardini, S., Micheli, V., Rizzardini, G., Parruti, G., Quirino, T., Puoti, M., Babudieri, S., Monforte, A., Andreoni, M., Craxi, A., Angelico, M., Pasquazzi, C., Taliani, G., Guedj, J., Perno, C., and Ceccherini-Silberstein, F.

Subjects
Genetics and Molecular Biology (all), Simeprevir, Male, Hepacivirus, Pharmacology, Biochemistry, Stiffness, 0302 clinical medicine, Animal Cells, Medicine, Amino Acids, lcsh:Science, Alanine, Organic Compounds, Liver Diseases, 3. Good health, Cirrhosis, Physical Sciences, Administration, Interferon, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cellular Types, Oligopeptides, Human, Oral, Materials Science, Gastroenterology and Hepatology, Microbiology, Antiviral Agents, 03 medical and health sciences, Drug Therapy, Humans, Aged, Kinetic, Hepaciviru, Biochemistry, Genetics and Molecular Biology (all), Mathematical Modeling, lcsh:R, Chemical Compounds, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, Administration, Oral, Alanine Transaminase, Female, Hepatitis C, Interferons, Kinetics, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Viral Nonstructural Proteins, Agricultural and Biological Sciences (all), 030104 developmental biology, chemistry, Aliphatic Amino Acids, lcsh:Q, 0301 basic medicine, lcsh:Medicine, Medicine (all), Telaprevir, chemistry.chemical_compound, Medicine and Health Sciences, Viral, Multidisciplinary, biology, Antimicrobials, Simulation and Modeling, Drugs, Antivirals, Chemistry, Liver, Combination, Oligopeptide, Anatomy, medicine.drug, Research Article, Settore MED/17 - Malattie Infettive, General Science & Technology, Material Properties, Research and Analysis Methods, Microbial Control, Virology, Mechanical Properties, NS5A, Antiviral Agent, business.industry, HCV DAA ALT, Viral Nonstructural Protein, Organic Chemistry, Cell Biology, biology.organism_classification, Alanine transaminase, biology.protein, Hepatocytes, RNA, business
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

Published
2017

167. 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

168. Characteristics of liver cirrhosis in Italy: Evidence for a decreasing role of HCV aetiology

Author

Tommaso Stroffolini, Evangelista Sagnelli, Giovanni Battista Gaeta, Caterina Sagnelli, Angelo Andriulli, Giuseppina Brancaccio, Mario Pirisi, Guido Colloredo, Filomena Morisco, Caterina Furlan, Piero Luigi Almasio, Sergio Babudieri, Bruno Cacopardo, Nicola Coppola, Massimo De Luca, Anna Licata, Mariantonietta Pisaturo, Floriano Rosina, Maurizio Russello, Teresa Santantonio, Antonina Smedile, Stroffolini, T., Sagnelli, E., Gaeta, G., Sagnelli, C., Andriulli, A., Brancaccio, G., Pirisi, M., Colloredo, G., Morisco, F., Furlan, C., Almasio, P., Babudieri, S., Cacopardo, B., Coppola, N., De Luca, M., Licata, A., Pisaturo, M., Rosina, F., Russello, M., Santantonio, T., Smedile, A., Stroffolini, Tommaso, Sagnelli, Evangelista, Gaeta, Giovanni Battista, Sagnelli, Caterina, Andriulli, Angelo, Brancaccio, Giuseppina, Pirisi, Mario, Colloredo, Guido, Morisco, Filomena, Furlan, Caterina, Almasio, Piero Luigi, Babudieri, S, Cacopardo, B, Coppola, N, De Luca, M, Licata, A, Pisaturo, M, Rosina, F, Russello, M, and Santantonio, T

Subjects
Male, Cirrhosis, Settore MED/09 - Medicina Interna, Alcohol abuse, HBV, HCV, Liver cirrhosis, Liver cirrhosis epidemiology, Internal Medicine, medicine.disease_cause, Gastroenterology, 0302 clinical medicine, Risk Factors, Epidemiology, 030212 general & internal medicine, Liver Neoplasms, virus diseases, Middle Aged, Hepatitis B, Hepatitis C, Alcoholism, Italy, Liver Neoplasm, Hepatocellular carcinoma, 030211 gastroenterology & hepatology, Aged, Carcinoma, Hepatocellular, Cross-Sectional Studies, Female, Humans, Liver Cirrhosis, Human, medicine.medical_specialty, Hepatitis C virus, Liver Cirrhosi, 03 medical and health sciences, Internal medicine, medicine, Decompensation, Hepatitis B virus, Cross-Sectional Studie, business.industry, Risk Factor, Carcinoma, Hepatocellular, medicine.disease, Etiology, business
Abstract

Previous cross-sectional studies have shown that hepatitis C virus (HCV) infection had been the main agent associated with liver cirrhosis in Italy. Abstract BACKGROUND: Previous cross-sectional studies have shown that hepatitis C virus (HCV) infection had been the main agent associated with liver cirrhosis in Italy. AIM: To assess epidemiological, laboratory and clinical features of liver cirrhosis in Italy in 2014. PATIENTS: Out of the 2557 consecutive subjects evaluated in 16 hospitals located throughout Italy in 2014, 832 (32.6%) had liver cirrhosis and were enrolled in this study. RESULTS: The mean age of subjects was 60.3years, with a male/female ratio of 1.7; 74.9% of cases had Child A cirrhosis and 17.9% superimposed hepatocellular carcinoma. HCV infection, alone or in combination with other aetiologic agents, was responsible of 58.6% of cases, HBV aetiology accounted for the 17.6% and alcohol abuse for the 16.0%. Compared with virus-related cirrhotic patients, those alcohol-related more frequently showed decompensation (p=0.02). CONCLUSIONS: Compared to previous surveys performed in 1992 and in 2001, we observe a statistically significant (p

Published
2016

169. Effectiveness of first-generation HCV protease inhibitors: Does HIV coinfection still play a role?

Author

Elena Ricci, Carlo Alberto Magni, Barbara Menzaghi, Tiziana Quirino, Elena Salomoni, Paolo Maggi, Francesca Vichi, Canio Martinelli, Katia Falasca, Laura Ambra Nicolini, Sergio Babudieri, Benedetto Maurizio Celesia, Giuseppe Vittorio De Socio, Paolo Bonfanti, Giustino Parruti, Antonio Di Biagio, Nicolini, L. A., Menzaghi, B., Ricci, E., Martinelli, C., Magni, C., Maggi, P., Celesia, B. M., Parruti, G., Babudieri, S., Bonfanti, P., Falasca, K., Vichi, F., De Socio, G. V., Salomoni, E., Di Biagio, A., Quirino, T., Nicolini, L, Menzaghi, B, Ricci, E, Martinelli, C, Magni, C, Maggi, P, Celesia, B, Parruti, G, Babudieri, S, Bonfanti, P, Falasca, K, Vichi, F, De Socio, G, Salomoni, E, Di Biagio, A, and Quirino, T

Subjects
0301 basic medicine, Male, Protease Inhibitor, HIV Infections, Hepacivirus, Polyethylene Glycol, Polyethylene Glycols, Telaprevir, chemistry.chemical_compound, 0302 clinical medicine, HIV Infection, Prospective Studies, 030212 general & internal medicine, education.field_of_study, Boceprevir, Sustained virologic response, Coinfection, Gastroenterology, Effectivene, virus diseases, Middle Aged, Viral Load, Interferon, Oligopeptide, RNA, Viral, Drug Therapy, Combination, Female, Oligopeptides, Viral load, medicine.drug, Human, Adult, medicine.medical_specialty, Proline, Population, Direct active agent, Antiviral Agents, 03 medical and health sciences, Internal medicine, Ribavirin, medicine, Humans, Protease Inhibitors, Adverse effect, education, Antiviral Agent, Hepaciviru, Hepatology, business.industry, HIV, Odds ratio, Hepatitis C, Chronic, medicine.disease, 030112 virology, Virology, Prospective Studie, chemistry, Interferons, business, Hepatitis C viru
Abstract

Objective HIV/hepatitis C virus (HCV) coinfected patients are usually considered a difficult-to-treat population. The aim of this study was to assess the effectiveness of telaprevir-based and boceprevir-based treatments with respect to the HIV status. Methods A prospective multicentre study was conducted among 22 Infectious Disease centres in Italy. Demographic, HIV and HCV related variables were collected, as well as data on HCV viral decay, sustained virologic response (SVR12) and grade 3-4 adverse events. Results Overall, 162 patients (24.7% HIV/HCV coinfected) received HCV treatment. Out of 145 evaluable patients, 57.2% achieved SVR12 (49.5% monoinfected, 78.9% coinfected). HIV coinfection was associated with a slight increase in the probability of SVR12 (adjusted odds ratio 1.66, 95% confidence interval 0.59-4.64, P =0.33). Premature discontinuation rates and adverse events were similar irrespective of HIV status, with the exception of skin reactions, which were more frequently in the HIV group. Conclusion In a real-life setting, with a high proportion of cirrhotic and treatment-experienced patients, the overall SVR12 rate was 57.2%. HIV coinfection was not associated with impaired outcome. Eur J Gastroenterol Hepatol 28:37-41.

Published
2016

170. Hepatitis B vaccine coverage and risk factors for lack of vaccination in subjects with HBsAg negative liver cirrhosis in Italy: still, much work should be done

Author

Massimo Marignani, R. Fontana, Maria Cristina Vinci, Tommaso Stroffolini, Alessia Ciancio, Evangelista Sagnelli, Guido Colloredo, Anna Lombardi, Luigina Ferrigno, Filomena Morisco, Sergio Babudieri, Stroffolini, T., Lombardi, A., Ciancio, A., Fontana, R., Colloredo, G., Marignani, M., Vinci, M., Morisco, F., Babudieri, S., Ferrigno, L., and Sagnelli, E.

Subjects
Male, HBsAg, medicine.medical_specialty, Vaccination Coverage, Cirrhosis, Hepatitis B vaccine, Lack of vaccination, Chronic liver disease, Hbsag negative, Surveys and Questionnaires, Internal medicine, Humans, Medicine, Hepatitis B Vaccines, Aged, Hepatology, business.industry, Gastroenterology, Middle Aged, HB vaccine, medicine.disease, Vaccination, Cross-Sectional Studies, Italy, Immunization, Liver cirrhosis, Etiology, Female, business
Abstract

Background: in Italy, Hepatitis-B-vaccine is advised and provided free-of-charge for subjects with chronic liver disease (CLD), including liver cirrhosis. Aims: to evaluate HB-vaccine-coverage and variables associated with lack of vaccination in cirrhotic patients with particular attention to cirrhosis' etiology. Methods: cirrhotic patients of any etiology (excluding HBsAg+) referring to 8 tertiary-centers were prospectively enrolled for a-six-months-period in 2019. Subjects were asked if they received HB-vaccine previously. Multiple-logistic-regression-analysis was performed to identify independent predictors of lack of vaccination. Results: 731 cases were recruited. Overall-vaccine-coverage was 16.3% (23.7% in those younger than 65y, 10.0% in those older than 64y; p64 y (OR: 4.27; CI 95%: 2.52-7.24), educational level

Published
2021

171. Correlations Between Olfactory Psychophysical Scores and SARS‐CoV‐2 Viral Load in COVID‐19 Patients

Author

Andrea Piana, Giovanna Deiana, Giacomo De Riu, Luigi Angelo Vaira, Sven Saussez, Marco Dettori, Clementina Cocuzza, Alessandro G. Fois, Arcadia Del Rio, Andrea Cossu, Claire Hopkins, Jerome R. Lechien, Giordano Madeddu, Sergio Babudieri, Andrea De Vito, Vaira, L, Deiana, G, Lechien, J, De Vito, A, Cossu, A, Dettori, M, Del Rio, A, Saussez, S, Madeddu, G, Babudieri, S, Fois, A, Cocuzza, C, Hopkins, C, De Riu, G, and Piana, A

Subjects
Male, medicine.medical_specialty, Anosmia, coronavirus, Gastroenterology, Severity of Illness Index, SARS‐CoV‐2, Correlation, Interquartile range, Hyposmia, COVID‐19, Internal medicine, Original Reports, Prevalence, Medicine, Humans, Prospective Studies, Prospective cohort study, Aged, business.industry, SARS-CoV-2, Olfaction‐Chemosensation, COVID-19, Middle Aged, Viral Load, olfactory, coronaviru, Clinical research, Otorhinolaryngology, Cohort, Female, medicine.symptom, business, Viral load
Abstract

OBJECTIVES/HYPOTHESIS: The aim of this study was to evaluate the correlations between the severity and duration of olfactory dysfunctions (OD), assessed with psychophysical tests, and the viral load on the rhino-pharyngeal swab determined with a direct method, in patients affected by coronavirus disease 2019 (COVID-19). STUDY DESIGN: Prospective cohort study. METHODS: Patients underwent psychophysical olfactory assessment with Connecticut Chemosensory Clinical Research Center test and determination of the normalized viral load on nasopharyngeal swab within 10 days of the clinical onset of COVID-19. RESULTS: Sixty COVID-19 patients were included in this study. On psychophysical testing, 12 patients (20% of the cohort) presented with anosmia, 11 (18.3%) severe hyposmia, 13 (18.3%) moderate hyposmia, and 10 (16.7%) mild hyposmia with an overall prevalence of OD of 76.7%. The overall median olfactory score was 50 (interquartile range [IQR] 30-72.5) with no significant differences between clinical severity subgroups. The median normalized viral load detected in the series was 2.56E+06 viral copies/106 copies of human beta-2microglobulin mRNA present in the sample (IQR 3.17E+04-1.58E+07) without any significant correlations with COVID-19 severity. The correlation between viral load and olfactory scores at baseline (R2 = 0.0007; P = .844) and 60-day follow-up (R2 = 0.0077; P = .519) was weak and not significant. CONCLUSIONS: The presence of OD does not seem to be useful in identifying subjects at risk for being super-spreaders or who is at risk of developing long-term OD. Similarly, the pathogenesis of OD is probably related to individual factors rather than to viral load and activity. LEVEL OF EVIDENCE: 4 Laryngoscope, 131:2312-2318, 2021.

Published
2021

172. Migratory flow and hepatitis delta infection in Italy: A new challenge at the beginning of the third millennium

Author

Tommaso Stroffolini, Alessia Ciancio, Caterina Furlan, Maria Vinci, Rosanna Fontana, Maurizio Russello, Guido Colloredo, Filomena Morisco, Nicola Coppola, Sergio Babudieri, Luigina Ferrigno, Caterina Sagnelli, Evangelista Sagnelli, Giulia Verzon, Arianna Latanza, Viviana Picciotto, Grazia Anna Niro, Rosa Grazia Benigno, Giuseppina Pontillo, Vincenzo Messina, Vito Fiore, Stroffolini, T., Ciancio, A., Furlan, C., Vinci, M., Fontana, R., Russello, M., Colloredo, G., Morisco, F., Coppola, N., Babudieri, S., Ferrigno, L., Sagnelli, C., and Sagnelli, E.

Subjects
Male, HBsAg carriers, Cirrhosis, Multivariate analysis, viruses, Emigrants and Immigrants, 03 medical and health sciences, 0302 clinical medicine, Virology, Prevalence, Advanced disease, Humans, Medicine, Multiple logistic regression analysis, Hepatitis Antibodies, 030212 general & internal medicine, Hepatology, HDV infection, HDV infection endemicity, business.industry, HEPATITIS DELTA, virus diseases, Mean age, Middle Aged, biochemical phenomena, metabolism, and nutrition, medicine.disease, Hepatitis D, HBsAg carrier, Infectious Diseases, Italy, Female, 030211 gastroenterology & hepatology, Hbsag carrier, Hepatitis Delta Virus, business, Demography
Abstract

In Italy, HDV infection endemicity has greatly decreased overtime. Migratory flow may change this scenario as migrants often come from high HDV endemicity areas. Here, we studied characteristics of HDV infection in Italy, particularly addressed to the birth area of subjects. Chronic HBsAg carriers consecutively referring to 9 units in Italy prospectively enrolled for a six-month period in 2019 were tested for anti-HDV by ELISA. Multiple logistic regression analysis was performed to identify anti-HDV positivity independent predictors. A total of 894 HBsAg-positive subjects were enrolled. Of them, 786 (87.9%) were tested for anti-HDV. Anti-HDV overall prevalence was 9.9% (6.4% in Italian natives and 26.4% in non-natives; P&nbsp

Published
2020

173. Optimizing diagnostic algorithms to advance Hepatitis C elimination in Italy: A cost effectiveness evaluation

Author

Alessio Aghemo, Murad Ruf, Claudio Galli, Francesco Saverio Mennini, Loreta A. Kondili, Sergio Babudieri, Maurizia Rossana Brunetto, Andrea Marcellusi, Massimo Andreoni, Antonio Craxì, Marcellusi A., Mennini F.S., Ruf M., Galli C., Aghemo A., Brunetto M.R., Babudieri S., Craxi A., Andreoni M., and Kondili L.A.

Subjects
Pediatrics, medicine.medical_specialty, Cost effectiveness, Cost-Benefit Analysis, cost-effectivene, Context (language use), Hepacivirus, Antiviral Agents, Liver disease, Medicine, Humans, business, health care economics and organizations, Hepatology, business.industry, screening, Disease progression, HCV chronic infection, virus diseases, Diagnostic algorithms, health, Hepatitis C, Hepatitis C, Chronic, medicine.disease, Hcv elimination, digestive system diseases, WHO target, Hcv core antigen, Algorithms
Abstract

Objectives: Optimized diagnostic algorithms to detect active infections are crucial to achieving HCV elimination. We evaluated the cost effectiveness and sustainability of different algorithms for HCV active infection diagnosis, in a context of a high endemic country for HCV infection. Methods: A Markov disease progression model, simulating six diagnostic algorithms in the birth cohort 1969‐1989 over a 10‐year horizon from a healthcare perspective was used. Conventionally diagnosis of active HCV infection is through detection of antibodies (HCV‐Ab) detection followed by HCV‐RNA or HCV core antigen (HCV‐Ag) confirmatory testing either on a second sample or by same sample reflex testing. The undiagnosed and unconfirmed rates were evaluated by assays false negative estimates and each algorithm patients’ drop‐off. Age, liver disease stages distribution, liver disease stage costs, treatment effectiveness and costs were used to evaluate the quality‐adjusted life‐years (QALYs) and the incremental cost‐effectiveness ratios (ICER). Results: The reference option was Rapid HCV‐Ab followed by second sample HCV‐Ag testing which produced the lowest QALYs (866,835 QALYs). The highest gains in health (QALYs=974,458) was obtained by HCV‐RNA reflex testing which produced a high cost‐effective ICER (€891/QALY). Reflex testing (same sample‐single visit) vs two patients’ visits algorithms, yielded the highest QALYs and high cost‐effective ICERs (€566 and €635/QALY for HCV‐Ag and HCV‐RNA, respectively), confirmed in 99.9% of the 5,000 probabilistic simulations. Conclusions: Our data confirm, by a cost effectiveness point of view, the EASL and WHO clinical practice guidelines recommending HCV reflex testing as most cost effective diagnostic option vs other diagnostic pathways.

Published
2022

174. New Onset of Smell and Taste Loss Are Common Findings Also in Patients With Symptomatic COVID-19 After Complete Vaccination

Author

Giacomo De Riu, Jerome R. Lechien, Carlos M. Chiesa-Estomba, Giordano Madeddu, Sergio Babudieri, Claire Hopkins, Paolo Boscolo-Rizzo, Andrea De Vito, Sven Saussez, Luigi Angelo Vaira, Christian Calvo-Henriquez, Miguel Mayo-Yáñez, Vaira, L. A., De Vito, A., Lechien, J. R., Chiesa-Estomba, C. M., Mayo-Yanez, M., Calvo-Henriquez, C., Saussez, S., Madeddu, G., Babudieri, S., Boscolo-Rizzo, Paolo, Hopkins, C., and De Riu, G.

Subjects
Adult, Male, medicine.medical_specialty, Taste, COVID-19 Vaccines, media_common.quotation_subject, Anosmia, olfactory dysfunction, Internal medicine, Surveys and Questionnaires, Epidemiology, medicine, Humans, Patient Reported Outcome Measures, ageusia, anosmia, COVID-19, gustatory dysfunction, vaccination, Nose, media_common, business.industry, SARS-CoV-2, Medical record, Vaccination, Appetite, Ageusia, Middle Aged, Smell, medicine.anatomical_structure, Otorhinolaryngology, Female, medicine.symptom, business
Abstract

The aim of this study is to investigate the clinical profile of patients who developed coronavirus disease 2019 (COVID-19) after full vaccination. Demographic, epidemiological and clinical data were collected through medical records and online patient-reported outcome questionnaire from patients who developed symptomatic SARS-CoV-2 infection, confirmed by nasopharyngeal swab, at least 2 weeks after completion of vaccination. A total of 153 subjects were included. The most frequent symptoms were: asthenia (82.4%), chemosensory dysfunction (63.4%), headache (59.5%), runny nose (58.2%), muscle pain (54.9%), loss of appetite (54.3%), and nasal obstruction (51.6%). Particularly, 62.3% and 53.6% of subjects reported olfactory and gustatory dysfunction, respectively. Symptom severity was mild or moderate in almost all cases. Chemosensory dysfunctions have been observed to be a frequent symptom even in subjects who contracted the infection after full vaccination. For this reason, the sudden loss of smell and taste could continue to represent a useful and specific diagnostic marker to raise the suspicion of COVID-19 even in vaccinated subjects. In the future, it will be necessary to establish what the recovery rate is in these patients. LEVEL OF EVIDENCE: 4 Laryngoscope, 132:419-421, 2022.

Published
2021

175. A mathematical model by route of transmission and fibrosis progression to estimate undiagnosed individuals with HCV in different Italian regions

Author

Loreta A. Kondili, Massimo Andreoni, Alfredo Alberti, Salvatore Lobello, Sergio Babudieri, Antonella De Michina, Rocco Merolla, Walter Marrocco, Antonio Craxì, Kondili L.A., Andreoni M., Alberti A., Lobello S., Babudieri S., De Michina A., Merolla R., Marrocco W., and Craxi A.

Subjects
Antiviral Agent, Liver Cirrhosis, Hepaciviru, Liver Cirrhosi, Research, Markov chain, Undiagnosed, Infectious and parasitic diseases, RC109-216, Hepacivirus, Hepatitis C, Chronic, Models, Theoretical, Antiviral Agents, Hepatitis C, Infectious Diseases, HCV, Prevalence, Humans, Hepatitis C infection, Human
Abstract

Background Although an increase in hepatitis C virus (HCV) prevalence from Northern to Southern Italy has been reported, the burden of asymptomatic individuals in different Italian regions is currently unknown. Methods A probabilistic approach, including a Markov chain for liver disease progression, was applied to estimate current HCV viraemic burden. The model defined prevalence by geographic area using an estimated annual historical HCV incidence by age, treatment rate, and migration rate from the Italian National database. Viraemic infection by age group was estimated for each region by main HCV transmission routes of individuals for stage F0–F3 (i.e. patients without liver cirrhosis and thus potentially asymptomatic) and F4 (patients with liver cirrhosis, thus potentially symptomatic). Results By January 2020, it was estimated that there were 409,184 Italian individuals with HCV (prevalence of 0.68%; 95% CI: 0.54–0.82%), of which 300,171 (0.50%; 95% CI: 0.4–0.6%) were stage F0–F3. Considering all individuals with HCV in stage F0–F3, the geographical distributions (expressed as the proportion of HCV infected individuals by macroarea within the overall estimated number of F0–F3 individuals and prevalence values, expressed as the percentage of individuals with HCV versus the overall number of individuals for each macroarea) were as follows: North 42.1% (0.45%; 95% CI: 0.36–0.55%), Central 24.1% (0.61%; 95% CI: 0.48–0.74%), South 23.2% (0.50%; 95% CI: 0.4–0.61%), and the Isles 10.6% (0.49%; 95% CI: 0.39–0.59%). The population of people who inject drugs accounted for 50.4% of all individuals infected (F0–F3). Undiagnosed individuals (F0–F3) were ~ 15 years younger (⁓ 50 years) compared with patients with stage F4 (⁓ 65 years), with similar age distributions across macroareas. In contrast to what has been reported on HCV epidemiology in Italy, an increasing trend in the proportion of potentially undiagnosed individuals with HCV (absolute number within the F0–F3) from South (23.2%) to North (42.1%) emerged, independent of similar regional prevalence values. Conclusion This targeted approach, which addresses the specific profile of undiagnosed individuals, is helpful in planning effective elimination strategies by region in Italy and could be a useful methodology for other countries in implementing their elimination plans.

Published
2021

176. Estimated prevalence of undiagnosed HCV infected individuals in Italy: A mathematical model by route of transmission and fibrosis progression

Author

Antonio Craxì, Sergio Babudieri, Alfredo Alberti, Walter Marrocco, Rocco Cosimo Damiano Merolla, Salvatore Lobello, Massimo Andreoni, Antonio Saverio Roscini, Loreta A. Kondili, Kondili L.A., Andreoni M., Alberti A., Lobello S., Babudieri S., Roscini A.S., Merolla R., Marrocco W., and Craxi A.

Subjects
Liver Cirrhosis, Pediatrics, Blood transfusion, Epidemiology, medicine.medical_treatment, law.invention, 0302 clinical medicine, Fibrosis, law, Prevalence, 030212 general & internal medicine, Stage (cooking), Child, Substance Abuse, Intravenous, Monte Carlo, Aged, 80 and over, education.field_of_study, Middle Aged, Hepatitis C, Infectious Diseases, Transmission (mechanics), Italy, Child, Preschool, HCV, medicine.symptom, Models, Theoretical: Young Adult, Human, Adult, medicine.medical_specialty, Sexual transmission, Adolescent, Liver Cirrhosi, 030231 tropical medicine, Population, Markov chain, Antiviral Agents, Microbiology, Asymptomatic, lcsh:Infectious and parasitic diseases, Young Adult, 03 medical and health sciences, Virology, medicine, Humans, lcsh:RC109-216, Hepatitis C infection, education, Aged, Antiviral Agent, business.industry, Public Health, Environmental and Occupational Health, Infant, Newborn, Undiagnosed, Infant, Models, Theoretical, medicine.disease, Parasitology, business
Abstract

Background The universal treatment of diagnosed patients with chronic HCV infection has been widely conducted in Italy since 2017. However, the pool of individuals diagnosed but yet to be treated in Italy has been estimated to end around 2025, leaving a significant proportion of infected individuals undiagnosed/without care. Estimates of this population are currently unknown. Methods A probabilistic modelling approach was applied to estimate annual historical HCV incident cases by their age-group (0–100 years) distribution from available literature and Italian National database (1952 to October 2019). Viraemic infection rates were modelled on the main infection routes in Italy: people who inject drugs (PWID), tattoos, sexual transmission, glass syringe use, blood transfusion and vertical transmission. Annual liver fibrosis stage transition probabilities were modelled using a Markov model. The number of HCV viraemic asymptomatic (fibrosis stage F0-F3:potentially undiagnosed/unlinked to care) and symptomatic (fibrosis stage F4: potentially linked to care) individuals was estimated. Results By October 2019, total viraemic HCV individuals in Italy (excluding treated patients since 1992) were estimated to be 410,775 (0.68 % of current population of Italy; 95 % CI: 0.64−0.71%, based on the current Italian population), of which 281,809 (0.47 %; 95 % CI:0.35−0.60%) were fibrosis stage F0-F3. Among different high risk groups in stage F0-F3, the following distribution was estimated: PWID; 52.0 % (95 % CI:37.9–66.6 %), tattoo; 28.8 % (95 % CI:23–32.3 %), sexual transmission; 12.0 % (95 % CI:9.6–13.7 %), glass syringe and transfusion; 6.4 % (95 % CI:2.4–17.8 %), and vertical transmission; 0.7 % (95 % CI:0.4–1.2 %). Conclusion Under the assumption that most untreated HCV-infected individuals with stage F0-F3 are undiagnosed, more than 280,000 individuals are undiagnosed and/or unlinked to care in Italy. Marked heterogeneity across the major routes of HCV transmission was estimated. This modelling approach may be a useful tool to characterise the HCV epidemic profile also in other countries, based on country specific epidemiology and HCV main transmission routes.

Published
2021

177. Low influenza vaccination coverage in subjects with liver cirrhosis. An alert waiting for winter season 2020-2021 during the COVID-19 pandemic

Author

Evangelista Sagnelli, Tommaso Stroffolini, Anna Lombardi, Maria Cristina Vinci, Sergio Babudieri, Luigina Ferrigno, Filomena Morisco, Alessia Ciancio, Grazia Anna Niro, Guido Colloredo, Massimo Marignani, Stroffolini, T., Lombardi, A., Ciancio, A., Niro, G. A., Colloredo, G., Marignani, M., Vinci, M., Morisco, F., Babudieri, S., Ferrigno, L., and Sagnelli, E.

Subjects
Liver Cirrhosis, Male, influenza viru, Pediatrics, medicine.medical_specialty, Cirrhosis, Vaccination Coverage, SARS coronavirus, Coronavirus disease 2019 (COVID-19), influenza virus, 03 medical and health sciences, 0302 clinical medicine, Virology, Pandemic, Epidemiology, Influenza, Human, Prevalence, Medicine, Humans, vaccines, 030212 general & internal medicine, Pandemics, Aged, SARS coronaviru, business.industry, SARS-CoV-2, Vaccination, COVID-19, Odds ratio, Middle Aged, medicine.disease, Confidence interval, Infectious Diseases, Logistic Models, Influenza Vaccines, Etiology, 030211 gastroenterology & hepatology, Female, Seasons, business
Abstract

We have evaluated flu vaccine coverage and variables associated with the lack of vaccination in cirrhotic subjects with particular attention to the cirrhosis etiology. Cirrhotic subjects consecutively referring to eight Italian centers were prospectively enrolled for a 6-month period in 2019. Subjects were asked if they had received a flu vaccine in the last 12 months. Multiple logistic regression analysis was performed to identify independent predictors of lack of vaccination. A total of 818 cases were recruited. The overall vaccine coverage was 39.6% (26.9% in those younger than 65 years and 51.9% in those older than 64 years; p < 0.001). Age < 65 years (odds ratio [OR] = 2.38; 95% confidence interval [CI] = 1.68–3.36), alcoholic etiology (OR = 2.40; 95% CI = 1.49–3.85), birth abroad (OR = 2.7; 95% CI = 1.10–6.61), and residence in South/Sardinia island (OR = 1.66; 95% CI = 1.14–2.42) all resulted independent predictors of the likelihood of lack of vaccination. The lack of information regarding the vaccine as the reason for no vaccination was reported by 71.4% of foreigners and by 34.7% of natives (p < 0.001). In conclusion, much work still should be done to improve coverage among groups at higher risk of lack of vaccination identified in this survey. The ongoing SARS-CoV-2 pandemic may represent one more alert for improving seasonal flu vaccine coverage to avoid further stress to the National Health System.

Published
2020

178. Travel-Related Typhoid Fever: Narrative Review of the Scientific Literature

Author

Sergio Babudieri, Antonio Azara, Bianca Maria Are, Marco Dettori, Andrea Cossu, Andrea Piana, Riccardo Are, Narcisa Muresu, Clementina Cocuzza, Laura Saderi, Giovanni Sotgiu, Marianna Martinelli, Muresu, N, Sotgiu, G, Are, B, Cossu, A, Cocuzza, C, Martinelli, M, Babudieri, S, Are, R, Dettori, M, Azara, A, Saderi, L, and Piana, A

Subjects
medicine.medical_specialty, Sanitation, Health, Toxicology and Mutagenesis, media_common.quotation_subject, typhoid and paratyphoid fever, 030231 tropical medicine, Developing country, lcsh:Medicine, Review, Disease, Typhoid fever, 03 medical and health sciences, 0302 clinical medicine, Hygiene, Drug Resistance, Multiple, Bacterial, Environmental health, Epidemiology, medicine, Humans, Travel medicine, 030212 general & internal medicine, Typhoid Fever, media_common, business.industry, Incidence, fungi, lcsh:R, Public Health, Environmental and Occupational Health, food and beverages, Salmonella typhi, Prognosis, medicine.disease, Anti-Bacterial Agents, Infectious disease (medical specialty), Salmonella paratyphi A, travelers, Travel-Related Illness, business, salmonella enterica, Traveller
Abstract

Enteric fever is a foodborne infectious disease caused by Salmonella enterica serotypes Typhi and Paratyphi A, B and C. The high incidence in low income countries can increase the risk of disease in travelers coming from high income countries. Pre-travel health advice on hygiene and sanitation practices and vaccines can significantly reduce the risk of acquiring infections. Although the majority of the cases are self-limiting, life-threatening complications can occur. Delayed diagnosis and cases of infections caused by multi-drug resistant strains can complicate the clinical management and affect the prognosis. More international efforts are needed to reduce the burden of disease in low income countries, indirectly reducing the risk of travelers in endemic settings. Surveillance activities can help monitor the epidemiology of cases caused by drug-susceptible and resistant strains.

Published
2020

179. Patologie virali tropicali (Flavivirus, Filovirus, Arenavirus, Bunyavirus, Togavirus: Chikungunya

Author

G. Borgia, G. B. Gaeta, I. gentile, N. Coppola, L. Alessio, G. Angarano, S. Babudieri, A. Bartoloni, F. Borgia, F. Borrelli, G. Brancaccio, A. R. Buonomo, B. S. Cacopardo, A. Cascio, C. Contini, S. Esposito, M. Fasano, M. Foggia, M. Gatti, V. Gentile, M. Macera, A. E. Maraolo, A. Marino, C. M. Mastroianni, C. Mussini, G. Nunnari, L. Onorato, M. Pacenti, G. F. Pellicanò, B. Pinchera, G. Pipitone, M. A. Pisaturo, C. Sagnelli, T. A. Santantonio, A. Santoro, A. Saracino, M. Spaziante, M. Spinicci, M. Stanzione, G. Stornaiuolo, G. Taliani, G. Tosone, C. Torti, P. Viale, L. Zammarchi, E. Zappulo, G. Borgia, G.B. Gaeta, I. Gentile, N. Coppola, Borgia, G., Gaeta, G. B., Gentile, I., Coppola, N., Alessio, L., Angarano, G., Babudieri, S., Bartoloni, A., Borgia, F., Borrelli, F., Brancaccio, G., Buonomo, A. R., Cacopardo, B. S., Cascio, A., Contini, C., Esposito, S., Fasano, M., Foggia, M., Gatti, M., Gentile, V., Macera, M., Maraolo, A. E., Marino, A., Mastroianni, C. M., Mussini, C., Nunnari, G., Onorato, L., Pacenti, M., Pellicanò, G. F., Pinchera, B., Pipitone, G., Pisaturo, M. A., Sagnelli, C., Santantonio, T. A., Santoro, A., Saracino, A., Spaziante, M., Spinicci, M., Stanzione, M., Stornaiuolo, G., Taliani, G., Tosone, G., Torti, C., Viale, P., Zammarchi, L., and Zappulo, E.

Published
2019

180. Characteristics and Changes over Time of Alcohol-Related Chronic Liver Diseases in Italy

Author

Filomena Morisco, Evangelista Sagnelli, Tommaso Stroffolini, Caterina Furlan, Sergio Babudieri, Caterina Sagnelli, Mariantonietta Pisaturo, Antonina Smedile, Piero Luigi Almasio, Maurizio Russello, Mario Pirisi, Stroffolini, Tommaso, Sagnelli, Evangelista, Sagnelli, Caterina, Morisco, Filomena, Babudieri, Sergio, Furlan, Caterina, Pirisi, Mario, Russello, Maurizio, Smedile, Antonina, Pisaturo, Mariantonietta, Almasio, Piero Luigi, Stroffolini, T., Sagnelli, E., Sagnelli, C., Morisco, F., Babudieri, S., Furlan, C., Pirisi, M., Russello, M., Smedile, A., Pisaturo, M., Almasio, P. L., and Almasio P.L.

Subjects
Liver Cirrhosis, Male, Cirrhosis, Chronic liver disease, Health Risk Behaviors, Health Risk Behavior, Liver disease, 0302 clinical medicine, Stage (cooking), Chronic, Liver Diseases, Gastroenterology, General Medicine, Hepatitis C, Health Survey, Middle Aged, Alcoholic, Alcoholism, Italy, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, Female, Sex ratio, Adult, Aged, Alcohol Drinking, Chronic Disease, Health Surveys, Hepatitis C Antibodies, Hepatitis C, Chronic, Humans, Liver Diseases, Alcoholic, Research Article, Human, medicine.medical_specialty, Article Subject, Liver Cirrhosi, 03 medical and health sciences, Internal medicine, medicine, lcsh:RC799-869, Hepatology, business.industry, medicine.disease, Ageing, lcsh:Diseases of the digestive system. Gastroenterology, business, Hepatitis C Antibodie
Abstract

Introduction. To evaluate the characteristics of alcohol-related chronic liver disease (CLD) in Italy and their potential changes over time. Patients and Methods. Subjects with CLD were enrolled in two national surveys performed in 2001 and in 2014 in Italy. The two surveys prospectively recruited patients aged ≥ 18 years referring to more than 80 Italian liver units scattered all over the country using similar clinical approach, analytical methods, and threshold of risky alcohol intake definition (≥ 3 units/day in men and ≥ 2 units/day in women). Results. Out of 12,256 enrolled subjects, 2,717 (22.2%) reported a risky alcohol intake. Of them, anti-HCV positive was observed in 48.3% of subjects. The overall sex ratio (M/F) was 3.1, decreasing from 3.8 in 2001 to 1.3 in 2014. Women were significantly older than men (58.9 versus 53.1 years; p<0.01) and an increasing ageing over time was observed in both sexes. The proportion of subjects with liver cirrhosis increased over time in both sexes, and decompensated stage (Child B or C) was detected in 55.9% of cases in 2001 and 46.0% in 2014. Conclusions. Risky alcohol intake plays a role in more than one-fifth of CLD in Italy, with a shift over time towards an older age and a more severe liver disease stage. These data put alcohol back in the spotlight with an important role in CLD in the years to come in Italy.

Published
2018

181. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, HCV Virology Italian Resistance Network, Bertoli A1, Sorbo MC1, Aragri M1, Lenci I2, Teti E3, Polilli E4, Di Maio VC1, Gianserra L5, Biliotti E6, Masetti C2, Magni CF7, Babudieri S8, Nicolini LA9, Milana M2, Cacciatore P4, Sarmati L3, Pellicelli A10, Paolucci S11, Craxì A, Morisco F13, Palitti VP14, Siciliano M15, Coppola N16, Iapadre N17, Puoti M18, Rizzardini G7, Taliani G6, Pasquazzi C5, Andreoni M3, Parruti G4, Angelico M2, Perno CF19, Cento V20, Ceccherini-Silberstein F1, HCV Virology Italian Resistance Network (VIRONET-C)., Bertoli, Ada, Sorbo, Maria Chiara, Aragri, Marianna, Lenci, Ilaria, Teti, Elisabetta, Polilli, Ennio, Di Maio, Velia Chiara, Gianserra, Laura, Biliotti, Elisa, Masetti, Chiara, Magni, Carlo F., Babudieri, Sergio, Nicolini, Laura A., Milana, Martina, Cacciatore, Pierluigi, Sarmati, Loredana, Pellicelli, Adriano, Paolucci, Stefania, Craxì, Antonio, Morisco, Filomena, Palitti, Valeria Pace, Siciliano, Massimo, Coppola, Nicola, Iapadre, Nerio, Puoti, Massimo, Rizzardini, Giuliano, Taliani, Gloria, Pasquazzi, Caterina, Andreoni, Massimo, Parruti, Giustino, Angelico, Mario, Perno, Carlo Federico, Cento, Valeria, Ceccherini-Silberstein, Francesca, Andreone, Pietro, Baldanti, Fausto, Barbarini, Giorgio, Boccaccio, Vincenzo, Boglione, Lucio, Bolis, Matteo, Bonora, Stefano, Borghi, Vanni, Brancaccio, Giuseppina, Bruno, Savino, Bruzzone, Bianca, Calvaruso, Vincenza, Caporaso, Nicola, Ciaccio, Antonio, Ciancio, Alessia, Colombatto, Piero, Cozzolongo, Raffaele, D'Ambrosio, Cecilia, D'Ettorre, Gabriella, De Leonardis, Francesco, De Luca, Andrea, Di Biagio, Antonio, Di Perri, Giovanni, Francioso, Simona, Gaeta, Giovanni Battista, Gasbarrini, Antonio, Ghisetti, Valeria, Giorgini, Alessia, Grieco, Antonio, Gubertini, Guido, Gulminetti, Roberto, Lambiase, Lara, Landonio, Simona, Lichtner, Miriam, Maida, Ivana, Marenco, Simona, Marinaro, Letizia, Maserati, Renato, Melis, Michela, Menzaghi, Barbara, Meregalli, Elisa, Micheli, Valeria, Niero, Fosca, Paoloni, Maurizio, Pieri, Alessandro, Rendina, Maria, Romagnoli, Dante, Rossetti, Barbara, Ruggiero, Tina, Sangiovanni, Vincenzo, Starace, Mario, Sticchi, Laura, Tarquini, Pierluigi, Toniutto, Pierluigi, Vullo, Vincenzo, Zazzi, Maurizio, Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Sorbo, Mc, Di Maio, Vc, Magni, Cf, Nicolini, La, Craxì, A, Palitti, Vp, Perno, Cf, Gaeta, Gb, and Zazzi, M.

Subjects
Male, 0301 basic medicine, Sofosbuvir, Hepacivirus, Drug Resistance, lcsh:Medicine, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Hepatitis C Virus, HCV resistance-test, chemistry.chemical_compound, 0302 clinical medicine, Genotype, Prevalence, Viral, lcsh:Science, Multidisciplinary, biology, Hepatitis C, Middle Aged, Settore MED/07 - Microbiologia e Microbiologia Clinica, Italy, Cohort, HCV, Female, 030211 gastroenterology & hepatology, medicine.drug, Adult, medicine.medical_specialty, HCV RAS, Hepatitis C virus, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Aged, NS5A, NS5B, business.industry, lcsh:R, Hepatitis C Virus, HCV resistance-test, biology.organism_classification, medicine.disease, 030104 developmental biology, chemistry, lcsh:Q, business
Abstract

Natural resistance-associated substitutions (RASs) are reported with highly variable prevalence across different HCV genotypes (GTs). Frequency of natural RASs in a large Italian real-life cohort of patients infected with the 4 main HCV-GTs was investigated. NS3, NS5A and NS5B sequences were analysed in 1445 HCV-infected DAA-naïve patients. Sanger-sequencing was performed by home-made protocols on 464 GT1a, 585 GT1b, 92 GT2c, 199 GT3a, 16 GT4a and 99 GT4d samples. Overall, 20.7% (301/1455) of patients showed natural RASs, and the prevalence of multiclass-resistance was 7.3% (29/372 patients analysed). NS3-RASs were particularly common in GT1a and GT1b (45.2-10.8%, respectively), mainly due to 80K presence in GT1a (17%). Almost all GTs showed high prevalence of NS5A-RASs (range: 10.2–45.4%), and especially of 93H (5.1%). NS5A-RASs with fold-change >100x were detected in 6.8% GT1a (30H/R-31M-93C/H), 10.3% GT1b (31V-93H), 28.4% GT2c (28C-31M-93H), 8.5% GT3a (30K-93H), 45.5% GT4a (28M-30R-93H) and 3.8% GT4d (28V-30S-93H). Sofosbuvir RAS 282T was never detected, while the 159F and 316N RASs were found in GT1b (13.4–19.1%, respectively). Natural RASs are common in Italian patients infected with HCV-GTs 1–4. High prevalence of clinically-relevant RASs (such as Y93H) supports the appropriateness of HCV resistance-test to properly guide DAA-based therapy.

Published
2018

182. Resistance test guided retreatment of HCV infected patients with a previous failure to a NS5A inhibitor-containing regimen: the Italian Vironet C real life experience

Author

Pietro Lampertico, Valeria Cento, Claudio Maria Mastroianni, M. Puoti, Giuliano Rizzardini, Maurizio Zazzi, M. Lichtner, Bianca Bruzzone, Ivana Maida, Elisabetta Degasperi, C.F. Perno, M. Rendina, Giustino Parruti, Vincenza Calvaruso, Gloria Taliani, F. Di Lorenzo, Ilaria Lenci, Anna Claudia Pellicelli, Caterina Pasquazzi, Stefania Paolucci, A. Raddi, Marianna Aragri, Ennio Polilli, Giulia Morsica, Mario Starace, M. Andreoni, M. Di Stefano, C. Minichini, L. Donnarumma, V. Guarneri, Simona Marenco, Simona Landonio, Raffaele Cozzolongo, V. Pace Palitti, N. Cuomo, P. Andreone, Nicola Coppola, Silvia Galli, Mario Angelico, C. Paternoster, Roberto Ganga, Vanni Borghi, Elisabetta Teti, Sergio Babudieri, Silvia Barbaliscia, Anna Licata, Giovanni Cenderello, Antonio Craxì, Filomena Morisco, Maurizia Rossana Brunetto, V.C. Di Maio, Vincenzo Sangiovanni, A. Ciancio, Piero Colombatto, Valeria Micheli, Teresa Pollicino, Laura Ambra Nicolini, Alessia Giorgini, Valeria Ghisetti, S. Novati, Annapaola Callegaro, Aldo Bertoli, E. Milano, Roberto Gulminetti, A. De Santis, F. Ceccherini-Silberstein, Teresa Santantonio, C. Masetti, G. Raimondo, Di Maio, V.C., Aragri, M., Masetti, C., Paolucci, S., Bruzzone, B., Degasperi, E., Barbaliscia, S., Pollicino, T., Minichini, C., Calvaruso, V., Rendina, M., Cento, V., Teti, E., Micheli, V., Ghisetti, V., Polilli, E., Palitti, V. Pace, Landonio, S., Lenci, I., Donnarumma, L., Nicolini, L.A., Bertoli, A., Starace, M., Pasquazzi, C., Callegaro, A.P., Morisco, F., Cenderello, G., Marenco, S., Gulminetti, R., Novati, S., Guarneri, V., Andreone, P., Galli, S., Ciancio, A., Sangiovanni, V., Cuomo, N., Raddi, A., Morsica, G., Borghi, V., Maida, I., Brunetto, M., Colombatto, P., Cozzolongo, R., De Santis, A., Lichtner, M., Babudieri, S., Taliani, G., Santantonio, T., Di Stefano, M., Paternoster, C., Ganga, R., Puoti, M., Rizzardini, G., Pellicelli, A., Milano, E., Mastroianni, C., Licata, A., Di Lorenzo, F., Giorgini, A., Lampertico, P., Parruti, G., Coppola, N., Zazzi, M., Raimondo, G., Andreoni, M., Craxì, A., Angelico, M., Perno, C.F., and Ceccherini-Silberstein, F.

Subjects
Resistance test, medicine.medical_specialty, Hepatology, business.industry, Gastroenterology, DAA failur, Vironet C, NS5A, Regimen, Internal medicine, medicine, retreatment, business
Abstract

Previous article in issueNext article in issue Introduction: There is a limited documentation about the retreatment of patients failing a recommended NS5A-containing regimen in Italy. Materials & methods: Within the VIRONET-C network, 386 NS5A-failing patients infected with different HCV-genotypes (GT) (GT1a/1b/2a-c/3a-b-g-h/4a-d-n-o-v=93/124/19/112/38) were analyzed. Retreatment of 105 failures was investigated. HCV-resistance-test was performed by Sanger-sequencing. Results: Failures following seven different NS5A-containing regimens were studied: 3D/2D (paritaprevir/ombitasvir ± dasabuvir) ± ribavirin (N = 72/4), daclatasvir/ledipasvir/velpatasvir + sofosbuvir ± ribavirin (N = 105/131/20), grazoprevir/elbasvir ± ribavirin (N = 34), glecaprevir/pibrentasvir (N = 20). Notably, 18.1% of NS5A-failing patients did not show any resistance-associated-substitutions (RAS), while 81.9% showed at least one NS5A-RAS, with multiclass-resistance in 35.5%. NS5A-RAS were observed more frequently in glecaprevir/pibrentasvir failures (GT1a 83.3%: Y93H + Q30H/D or +H58D; GT3a: 83.3% Y93H + A30K/G or +L31I) compared to sofosbuvir/velpatasvir (GT1a 16.6%: Y93H + Q30H, p = 0.08; GT3a 20.0%: Y93H/N + A30K/T, p = 0.03). To date, 105 failures have started a retreatment: sofosbuvir/velpatasvir ± ribavirin (N = 30), sofosbuvir/velpatasvir/voxilaprevir ± ribavirin (N = 67), glecaprevir/pibrentasvir (N = 4), grazoprevir/elbasvir ± sofosbuvir + ribavirin (N = 3), 3D + sofosbuvir + ribavirin (N = 1). The majority of patients were cirrhotic (51.9%) and relapsers (87.5%). The prevalence of NS5A-RASs before retreatment was 80.9%, with multiclass-resistance 29.5%. Among patients completing post-retreatment follow-up, a sustained-viral-response at week 12 (SVR12) was observed in 26/33 (78.8%). SVR4 was documented in 49/56 (87.5%). SVR12 was 76.0% with sofosbuvir/velpatasvir ± ribavirin (N = 25). Differently, SVR12 was 100% with glecaprevir/pibrentasvir for 8/12/16 weeks (N = 3), grazoprevir/elbasvir ± sofosbuvir + ribavirin for 12/24 weeks (N = 3) or 3D + sofosbuvir + ribavirin for 24 weeks (N = 1), despite the presence of NS5A-RASs. Until now, 67 patients started sofosbuvir/velpatasvir/voxilaprevir ± ribavirin recommended-retreatment for 12 weeks. 54/67 (80.6%) showed at least one baseline NS5A-RAS, 23/67 (34.3%) multiple-NS5A-RASs, and 22/67 (32.8%) multiclass-resistance. Of 25 patients with available outcome, 96.0% had SVR4. Only 1 GT1b infected patient was non-responder, without RASs before retreatment. Conclusions: In this real-life setting, NS5A-RASs were frequently detected at failure, and multiclass-resistance was around 30%. Overall, SVR after resistance-test-guided retreatment was >95%, with the exception of the sofosbuvir/velpatasvir retreatment. Our results show how HCV resistance-test at failure may be useful to optimize retreatment strategies.

Published
2019

183. Influence of universal HBV vaccination on chronic HBV infection in Italy: Results of a cross-sectional multicenter study

Author

Sagnelli, Evangelista, Stroffolini, Tommaso, Sagnelli, Caterina, Morisco, Filomena, Coppola, Nicola, Smedile, Antonina, Pisaturo, Mariantonietta, Colloredo, Guido, Babudieri, Sergio, Licata, Anna, Brancaccio, Giuseppina, Andriulli, Angelo, Almasio, Piero Luigi, Gaeta, Giovani B., Gaeta, Giovanni Battista, Cacopardo, Bruno, De Luca, Massimo, Furlan, Caterina, Pirisi, Mario, Rosina, Floriano, Russello, Maurizio, Santantonio, Teresa, Sagnelli, Evangelista, Stroffolini, Tommaso, Sagnelli, Caterina, Morisco, Filomena, Coppola, Nicola, Smedile, Antonina, Pisaturo, Mariantonietta, Colloredo, Guido, Babudieri, Sergio, Licata, Anna, Brancaccio, Giuseppina, Andriulli, Angelo, Almasio, Piero Luigi, Gaeta, Giovani B., Gaeta, Giovanni Battista, Cacopardo, Bruno, De Luca, Massimo, Furlan, Caterina, Pirisi, Mario, Rosina, Floriano, Russello, Maurizio, Santantonio, Teresa, Sagnelli, E., Stroffolini, T., Sagnelli, C., Morisco, F., Coppola, N., Smedile, A., Pisaturo, M., Colloredo, G., Babudieri, S., Licata, A., Brancaccio, G., Andriulli, A., Almasio, P., Gaeta, G., Cacopardo, B., De Luca, M., Furlan, C., Pirisi, M., Rosina, F., Russello, M., and Santantonio, T.

Subjects
Male, Time Factors, Cirrhosis, Settore MED/09 - Medicina Interna, Hbv vaccination, 0302 clinical medicine, chronic hepatitis B, HBsAg chronic carriers, HBsAg-positive chronic hepatitis, HBsAg-positive chronic hepatitis clinical presentation, HBV vaccination, Medicine, 030212 general & internal medicine, Child, Aged, 80 and over, Vaccination, Middle Aged, Infectious Diseases, Italy, Liver, Carrier State, Female, 030211 gastroenterology & hepatology, Hbsag carrier, Adult, Hepatitis B virus, Adolescent, Young Adult, 03 medical and health sciences, Hepatitis B, Chronic, Chronic hepatitis, Virology, Humans, Hepatitis B Vaccines, Hepatitis B Antibodies, Aged, HBsAg chronic carrier, Immunization Programs, business.industry, virology, infectious diseases, Infant, medicine.disease, Cross-Sectional Studies, Multicenter study, Hepatitis b vaccination, HBsAg-positive chronic hepatiti, business
Abstract

Background and Aim The universal hepatitis B vaccination for infants and 12-year-old adolescents (the latter limited to the first 12 years of application) was launched in Italy in 1991. Twenty-three years later we evaluated the impact of the vaccination campaign on the burden of HBsAg-positive chronic liver diseases (CLD). Material and Methods 513 HBsAg-positive chronic carriers referring to 16 Italian liver units were investigated and compared with HBsAg carriers enrolled in previous surveys. Results The proportion of inactive carriers decreased from 20.0% in 2001 to 3.3% in 2014, while that of cirrhotic patients increased from 22.6 to 33.2%. Regarding the age class 0–33 (fully covered by HBV vaccination in 2014), the rate of inactive carriers decreased from the 21.7% in 2001 to 5.9% in 2014, that of chronic hepatitis from 17.5 to 5.2% and that of cirrhosis cases from 26.4 to 4.1%. Instead, in the over-60 age group the rate of inactive carriers increased from 22.8 to 41.2% and that of chronic hepatitis from 16.8 to 46%; the rate of patients with cirrhosis ranged from 5 to 8% in different studies. Conclusion Twenty-three years after the introduction universal HBV vaccination in Italy, the clinical presentation of CLD had shown a shift towards older ages and more severe diseases. This article is protected by copyright. All rights reserved

Published
2017

184. Optimal efficacy of interferon-free HCV retreatment after protease inhibitor failure in real life

Author

L. Lambiase, Anna Claudia Pellicelli, Gloria Taliani, Barbara Menzaghi, Stefania Paolucci, Giuliano Rizzardini, Valeria Cento, Cesare Sarrecchia, Marianna Aragri, Francesca Ceccherini-Silberstein, M. Melis, M. Andreoni, Stefano Novati, Carlo Magni, Silvia Barbaliscia, Ilaria Lenci, V.C. Di Maio, Martina Milana, Elisabetta Teti, Mario Angelico, Caterina Pasquazzi, Aldo Bertoli, M. Puoti, A. Pecchioli, Valeria Micheli, Margherita Macera, Sergio Babudieri, Dante Romagnoli, Valeria Ghisetti, Laura Ambra Nicolini, Elisa Biliotti, Y. Troshina, Carlo Federico Perno, Fausto Baldanti, Simona Marenco, Nicola Coppola, T. Ruggiero, Manuele Koci Siciliano, Stefano Bonora, Alessia Ciancio, Cento, V, Barbaliscia, S, Lenci, I, Ruggiero, T, Magni, C, Paolucci, S, Babudieri, S, Siciliano, M, Pasquazzi, C, Ciancio, A, Perno, C, Ceccherini-Silberstein, F, Micheli, V, Troshina, Y, Biliotti, E, Milana, M, Melis, M, Teti, E, Lambiase, L, Menzaghi, B, Nicolini, L, Marenco, S, Di Maio, V, Aragri, M, Pecchioli, A, Bertoli, A, Sarrecchia, C, Macera, M, Coppola, N, Puoti, M, Romagnoli, D, Pellicelli, A, Bonora, S, Novati, S, Baldanti, F, Ghisetti, V, Andreoni, M, Taliani, G, Rizzardini, G, Angelico, M, Barbaliscia, I, and Ceccherini Silberstein, F

Subjects
0301 basic medicine, Male, Cirrhosis, Genotyping Techniques, Sustained Virologic Response, Hepacivirus, Treatment failure, chemistry.chemical_compound, Liver disease, 0302 clinical medicine, NS5A-inhibitors, Genotypic resistance testing, Treatment Failure, Chronic, HCV resistance, biology, Direct acting antivirals, HCV failure, Protease-inhibitors, Retreatment, Adult, Aged, Antiviral Agents, Female, Hepatitis C, Chronic, Humans, Microbial Sensitivity Tests, Middle Aged, Protease Inhibitors, Sequence Analysis, DNA, General Medicine, Settore MED/07 - Microbiologia e Microbiologia Clinica, Protease-inhibitor, Hepatitis C, humanities, Infectious Diseases, DIrect acting antivirals, HCVFailure, hcv-resistance, 030211 gastroenterology & hepatology, Sequence Analysis, Microbiology (medical), medicine.medical_specialty, 03 medical and health sciences, Internal medicine, medicine, In real life, Protease inhibitor (pharmacology), Cirrhosi, business.industry, Ribavirin, DNA, biology.organism_classification, medicine.disease, Surgery, Regimen, 030104 developmental biology, chemistry, NS5A-inhibitor, Direct acting antiviral, business
Abstract

Objectives First-generation protease-inhibitors (PIs) have suboptimal efficacy in GT-1 patients with advanced liver disease, and patients experiencing treatment failure may require urgent retreatment. Our objective was to analyse the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. Methods In this multi-centre observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included. Sustained-virological-response (SVR) was evaluated at week 12 of follow-up. GRT was performed by population-sequencing. Results After PI-failure, 121 patients (cirrhotic = 86.8%) were retreated following three different strategies: A) with ‘GRT-guided’ regimens (N = 18); B) with ‘AASLD/EASL recommended, not GRT-guided’ regimens (N = 72); C) with ‘not recommended, not GRT-guided’ regimens (N = 31). Overall SVR rate was 91%, but all 18 patients treated with ‘GRT-guided’ regimens reached SVR (100%), despite heterogeneity in treatment duration, use of PI and ribavirin, versus 68/72 patients (94.4%) receiving ‘AASLD/EASL recommended, not GRT-guided’ regimens. SVR was strongly reduced (77.4%) among the 31 patients who received a ‘not recommended, not GRT-guided regimen’ (p

Published
2017

185. Epidemiological and clinical scenario of chronic liver diseases in Italy: Data from a multicenter nationwide survey

Author

Caterina Sagnelli, Evangelista Sagnelli, Piero Luigi Almasio, Caterina Furlan, Giovanni Battista Gaeta, Sergio Babudieri, Antonina Smedile, Tommaso Stroffolini, Giuseppina Brancaccio, Nicola Coppola, Filomena Morisco, Sagnelli, Evangelista, Stroffolini, Tommaso, Sagnelli, Caterina, Smedile, Antonina, Morisco, Filomena, Furlan, Caterina, Babudieri, Sergio, Brancaccio, Giuseppina, Coppola, Nicola, Gaeta, Giovanni Battista, Almasio, Piero Luigi, Sagnelli E., Stroffolini T., Sagnelli C., Smedile A., Morisco F., Furlan C., Babudieri S., Brancaccio G., Coppola N., Gaeta G.B., and Almasio P.L.

Subjects
Male, Cirrhosis, Alcohol abuse, Gastroenterology, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Surveys and Questionnaires, Epidemiology, Outpatients, 80 and over, Surveys and Questionnaire, Chronic hepatitis, Chronic liver diseases, HCC, Liver cirrhosis, Adolescent, Adult, Aged, Aged, 80 and over, Alcoholism, Carcinoma, Hepatocellular, Female, Genotype, Hepatitis B, Hepatitis C, Humans, Inpatients, Italy, Liver Cirrhosis, Liver Neoplasms, Middle Aged, Young Adult, Hepatology, 030212 general & internal medicine, Young adult, Medicine (all), Chronic liver disease, virus diseases, Outpatient, Liver Neoplasm, 030211 gastroenterology & hepatology, Inpatient, Human, medicine.medical_specialty, Liver Cirrhosi, 03 medical and health sciences, Internal medicine, medicine, business.industry, Carcinoma, Hepatocellular, medicine.disease, digestive system diseases, Etiology, Chronic hepatiti, business
Abstract

The last Italian prevalence survey on chronic liver diseases (CLD) was performed in 2001. The present study evaluated the changes occurring over thirteen years. Background The last Italian prevalence survey on chronic liver diseases (CLD) was performed in 2001. The present study evaluated the changes occurring over thirteen years. Methods We enrolled 2,557 CLD consecutive patients in 16 Italian liver units in 2014. Results HBV etiology accounted for 513 (20.2%) cases, alone in 439 and associated with HCV and/or alcohol abuse in 74. Of these 513, 11.9% were anti-HDV-positive and 7.2% HBeAg-positive. HCV alone was responsible for 50.3% of CLD and with alcohol abuse for 5.9%. HCV RNA was detected in 64.0% of the anti-HCV-positive patients tested. HCV genotyping, performed for 899 patients, showed genotype-1a, 1b, 2, 3, 4 and 5 respectively in 16.5%, 45.5%, 15.4%, 8.2%, 15.1% and 0.2%. Alcohol abuse alone was responsible for 6.4% of cases and NAFLD/NASH for 6.3%. Liver cirrhosis (p

Published
2016

186. VIROLOGICAL FAILURES TO NEW DIRECT ACTING ANTIVIRALS IN A REAL LIFE SETTING MAY REQUIRE UNCONVENTIONAL REGIMENS FOR RE-TREATMENT

Author

Manuela Merli, M. Paoloni, Gabriella Verucchi, Simona Francioso, M. Melis, Vincenza Calvaruso, Caterina Pasquazzi, Marianna Aragri, F.P. Antonucci, Dante Romagnoli, Sergio Babudieri, G.B. Gaeta, M. Puoti, Ilaria Lenci, V. Pisani, Francesco Donato, Marco Biolato, Valeria Cento, D. Di Paolo, C.F. Perno, Mario Angelico, F. Ceccherini-Silberstein, Anna Claudia Pellicelli, Antonio Craxì, Filomena Morisco, V.C. Di Maio, Jacopo Vecchiet, Stefano Brillanti, Aldo Bertoli, Di Maio, VC, Cento, V, Di Paolo, D, Lenci, I, Aragri, M, Verucchi, G, Melis, M, Bertoli, A, Antonucci, FP, Francioso, S, Pellicelli, A, Calvaruso, V, Pasquazzi, C, Romagnoli, D, Biolato, M, Vecchiet, J, Morisco, F, Merli, M, Gaeta, GB, Brillanti, S, Donato, F, Puoti, M, Pisani, V, Paoloni, M, Babudieri, S, Craxi, A, Angelico, M, Perno, CF, and Ceccherini-Silberstein, F

Subjects
medicine.medical_specialty, Hepatology, business.industry, DIRECT ACTING ANTIVIRALS, Real life setting, RAS, RAVS, RAV, HCV, DAA, THERAPY, RAVS, THERAPY, RAS, RAV, HCV, DAA, 03 medical and health sciences, 0302 clinical medicine, medicine, 030211 gastroenterology & hepatology, 030212 general & internal medicine, Intensive care medicine, business
Published
2016

187. Boceprevir or telaprevir in hepatitis C virus chronic infection: The Italian real life experience

Author

Antonio Ascione, null CLEO Study Group, Luigi Elio Adinolfi, Pietro Amoroso, Angelo Andriulli, Orlando Armignacco, Tiziana Ascione, Sergio Babudieri, Giorgio Barbarini, Michele Brogna, Francesco Cesario, Vincenzo Citro, Ernesto Claar, Raffaele Cozzolongo, Giuseppe D’Adamo, Emilio D’Amico, Pellegrino Dattolo, Massimo De Luca, Vincenzo De Maria, Massimo De Siena, Giuseppe De Vita, Antonio Di Giacomo, Rosanna De Marco, Giorgio De Stefano, Giulio De Stefano, Sebastiano Di Salvo, Raffaele Di Sarno, Nunzia Farella, Laura Felicioni, Basilio Fimiani, Luca Fontanella, Giuseppe Foti, Caterina Furlan, Francesca Giancotti, Giancarlo Giolitto, Tiziana Gravina, Barbara Guerrera, Roberto Gulminetti, Angelo Iacobellis, Michele Imparato, Angelo Iodice, Vincenzo Iovinella, Antonio Izzi, Alfonso Liberti, Pietro Leo, Gennaro Lettieri, Ileana Luppino, Aldo Marrone, Ettore Mazzoni, Vincenzo Messina, Roberto Monarca, Vincenzo Narciso, Lorenzo Nosotti, Adriano Maria Pellicelli, Alessandro Perrella, Guido Piai, Antonio Picardi, Paola Pierri, Grazia Pietromatera, Francesco Resta, Luca Rinaldi, Mario Romano, Angelo Rossini, Maurizio Russello, Grazia Russo, Rodolfo Sacco, Vincenzo Sangiovanni, Antonio Schiano, Antonio Sciambra, Gaetano Scifo, Filomena Simeone, Annarita Sullo, Pierluigi Tarquini, Paolo Tundo, Alfredo Vallone, Ascione, A, Adinolfi, Luigi Elio, Amoroso, P, Andriulli, A, Armignacco, O, Ascione, T, Babudieri, S, Barbarini, G, Brogna, M, Cesario, F, Citro, V, Claar, E, Cozzolongo, R, D'Adamo, G, D'Amico, E, Dattolo, P, De Luca, M, De Maria, V, De Siena, M, De Vita, G, Di Giacomo, A, De Marco, R, De Stefano, G, Di Salvo, S, Di Sarno, R, Farella, N, Felicioni, L, Fimiani, B, Fontanella, L, Foti, G, Furlan, C, Giancotti, F, Giolitto, G, Gravina, T, Guerrera, B, Gulminetti, R, Iacobellis, A, Imparato, M, Iodice, A, Iovinella, V, Izzi, A, Liberti, 1, Leo, P, Lettieri, G, Luppino, I, Marrone, Aldo, Mazzoni, E, Messina, V1, Monarca, R, Narciso, V, Nosotti, L, Pellicelli, Am, Perrella, A, Piai, G, Picardi, A, Pierri, P, Pietromatera, G, Resta, F, Rinaldi, L, Romano, M, Rossini, A, Russello, M, Russo, G, Sacco, R, Sangiovanni, V, Schiano, A, Sciambra, A, Scifo, G, Simeone, F, Sullo, A, Tarquini, P, Tundo, P, and Vallone, A.

Subjects
viruses, Hepatitis C virus, Observational Study, Antiviral therapy, Boceprevir, Chronic hepatitis, Peg-interferon, Ribavirin, Telaprevir, Hepatology, medicine.disease_cause, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Medicine, 030212 general & internal medicine, Telaprevi, business.industry, Virology, Peg interferon, Chronic infection, chemistry, Chronic hepatiti, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

AIM:To check the safety and efficacy of boceprevir/telaprevir with peginterferon/ribavirin for hepatitis C virus (HCV) genotype 1 in the real-world settings. METHODS: This study was a non-randomized, observational, prospective, multicenter. This study involved 47 centers in Italy. A database was prepared for the homogenous collection of the data, was used by all of the centers for data collection, and was updated continuously. All of the patients enrolled in this study were older than 18 years of age and were diagnosed with chronic infection due to HCV genotype 1. The HCV RNA testing was performed using COBAS-TaqMan2.0 (Roche, LLQ 25 IU/mL). RESULTS: All consecutively treated patients were included. Forty-seven centers enrolled 834 patients as follows: Male 64%; median age 57 (range 18-78), of whom 18.3% were over 65; mean body mass index 25.6 (range 16-39); genotype 1b (79.4%); diagnosis of cirrhosis (38.2%); and fibrosis F3/4 (71.2%). The following drugs were used: Telaprevir (66.2%) and PEG-IFN-alpha2a (67.6%). Patients were naïve (24.4%), relapsers (30.5%), partial responders (14.8%) and null responders (30.3%). Overall, adverse events (AEs) occurred in 617 patients (73.9%) during the treatment. Anemia was the most frequent AE (52.9% of cases), especially in cirrhotic. The therapy was stopped for 14.6% of the patients because of adverse events or virological failure (15%). Sustained virological response was achieved in 62.7% of the cases, but was 43.8% in cirrhotic patients over 65 years of age. CONCLUSION: In everyday practice, triple therapy is safe but has moderate efficacy, especially for patients over 65 years of age, with advanced fibrosis, non-responders to peginterferon + ribavirin.

Published
2016

188. Recommendations for the prevention, diagnosis, and treatment of chronic hepatitis B and C in special population groups (migrants, intravenous drug users and prison inmates)

Author

Aldo Morrone, Piero Luigi Almasio, Sergio Babudieri, Claudio Leonardi, Pietro Dentico, Evangelista Sagnelli, Giovanni Battista Gaeta, Dario Conte, Giulio Starnini, Gaetano Scotto, Maria Rapicetta, Francesco Mazzotta, Giorgio Barbarini, Massimo Levrero, Lorenzo Nosotti, Daniele Prati, Maurizia Rossana Brunetto, Almasio, PL, Babudieri, S, Barbarini, G, Brunetto, M, Conte, D, Dentico, P, Gaeta, GB, Leonardi, C, Levrero, M, Mazzotta, F, Morrone, A, Nosotti, L, Prati, D, Rapicetta, M, Sagnelli, E, Scotto, G, Starnini, G, 7: Almasio, Pl, Gaeta, Giovanni Battista, and Starnini, G.

Subjects
medicine.medical_specialty, media_common.quotation_subject, HCV, HBV, vaccimantion, inmates, Population, Psychological intervention, Prison, Context (language use), migrants, medicine.disease_cause, Vulnerable Populations, Drug Users, Hepatitis B, Chronic, Health care, hcv, Medicine, Humans, education, Psychiatry, Substance Abuse, Intravenous, media_common, Hepatitis B virus, Transients and Migrants, education.field_of_study, Hepatology, business.industry, Public health, Prisoners, Vaccination, Gastroenterology, virus diseases, Hepatitis C, Chronic, intravenous drug users, Socioeconomic Factors, Practice Guidelines as Topic, hbv, Position paper, prison inmates, business
Abstract

The global spread of hepatitis B virus (HBV) and hepatitis C virus (HCV), their high chronicity rates and their progression to cirrhosis and hepatocellular carcinoma, are major public health problems. Research and intervention programmes for special population groups are needed in order to assess their infection risk and set up suitable prevention and control strategies. Aim of this paper is to give health care professionals information on HBV and HCV infections amongst migrants, drug users and prison inmates. The manuscript is an official Position Paper on behalf of the following Scientific Societies: Italian Association for the Study of the Liver (A.I.S.F.), Italian Society of Infectious and Tropical Diseases (S.I.M.I.T.), Italian Federation Department's Operators and Addiction Services (FederSerD), Italian Prison Medicine and Healthcare Society (S.I.M.S.Pe.). The considered population groups, having a high prevalence HBV and HCV infections, require specific interventions. In this context, the expression “special population” refers to specific vulnerable groups at risk of social exclusion, such as migrants, prison inmates, and intravenous drug users. When dealing with special population groups, social, environmental and clinical factors should be considered when selecting candidates for therapy as indicated by national and international guidelines.

Published
2011

191. Assessing ChatGPT's Potential in HIV Prevention Communication: A Comprehensive Evaluation of Accuracy, Completeness, and Inclusivity.

Author

De Vito A, Colpani A, Moi G, Babudieri S, Calcagno A, Calvino V, Ceccarelli M, Colpani G, d'Ettorre G, Di Biagio A, Farinella M, Falaguasta M, Focà E, Giupponi G, Habed AJ, Isenia WJ, Lo Caputo S, Marchetti G, Modesti L, Mussini C, Nunnari G, Rusconi S, Russo D, Saracino A, Serra PA, and Madeddu G

Subjects
Humans, Female, Male, Communication, Artificial Intelligence, HIV Testing, Health Communication methods, Health Knowledge, Attitudes, Practice, HIV Infections prevention & control
Abstract

With the advancement of artificial intelligence(AI), platforms like ChatGPT have gained traction in different fields, including Medicine. This study aims to evaluate the potential of ChatGPT in addressing questions related to HIV prevention and to assess its accuracy, completeness, and inclusivity. A team consisting of 15 physicians, six members from HIV communities, and three experts in gender and queer studies designed an assessment of ChatGPT. Queries were categorized into five thematic groups: general HIV information, behaviors increasing HIV acquisition risk, HIV and pregnancy, HIV testing, and the prophylaxis use. A team of medical doctors was in charge of developing questions to be submitted to ChatGPT. The other members critically assessed the generated responses regarding level of expertise, accuracy, completeness, and inclusivity. The median accuracy score was 5.5 out of 6, with 88.4% of responses achieving a score ≥ 5. Completeness had a median of 3 out of 3, while the median for inclusivity was 2 out of 3. Some thematic groups, like behaviors associated with HIV transmission and prophylaxis, exhibited higher accuracy, indicating variable performance across different topics. Issues of inclusivity were identified, notably the use of outdated terms and a lack of representation for some communities. ChatGPT demonstrates significant potential in providing accurate information on HIV-related topics. However, while responses were often scientifically accurate, they sometimes lacked the socio-political context and inclusivity essential for effective health communication. This underlines the importance of aligning AI-driven platforms with contemporary health communication strategies and ensuring the balance of accuracy and inclusivity., (© 2024. The Author(s).)

Published
2024
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192. Investigation of patients with new infection of echinococcal cyst in Sardinia, Italy.

Author

Santucciu C, Bozzi E, Profili S, Porcu A, Masala G, Babudieri S, and Mastrandrea S

Subjects
Animals, Humans, Male, Female, Young Adult, Adult, Genotype, Italy epidemiology, Echinococcus, Echinococcosis diagnosis, Echinococcosis epidemiology, Cysts
Abstract

Cystic Echinococcosis (CE) is a zoonotic disease caused by the larval stage of a tapeworm of Taeniidae family, genus Echinococcus and species Echinococcus granulosus sensu lato (s.l.). CE is a worldwide public health problem and is highly incident in all Mediterranean areas. Following clinical, image techniques and serological investigations all 83 subjects involved in the study were diagnosed for CE. General and clinical data were entered into a database and evaluated. The 43.37% were female and 56.63% male, mean age was 50.71 while the range most represented (22.7%) was between 61->70 years. The purposes of our survey were to investigate these 83 patients enrolled in the study and to deeply examine 20 (24.10%) patients that developed a new echinococcal cyst. Moreover, the causes at the basis of the onset of a new cyst were analysed, together with a possible correlation with different treatments related to primary infection corresponding to surgery (n=7), albendazole (n=6), PAIR (n=3) and watch and wait (n=4). A possible link with medical treatments of the primary infection was observed in the subjects who underwent surgery or PAIR and a likely correlation attributable to high environmental contamination in subjects managed with drugs or watch and wait was detected. Moreover, our analysis evidenced that patients with a new infection presented a more severe diagnosis along with a major mortality rate. Finally, these data may have an important contribution for an epidemiological point of view concerning the percentage of CE in a specific geographical endemic area, such as Sardinia., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Published
2024
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193. HBV in Italian Women's Jail: An Underestimated Problem?

Author

Geremia N, Giovagnorio F, De Vito A, Martignago L, Fiore V, Rastrelli E, Madeddu G, Parisi SG, Starnini G, Panese S, and Babudieri S

Abstract

Background: There is little information regarding the hepatitis B virus (HBV), vaccination status, and hepatitis B exposure in Italian women's jails. We aimed to describe the HBV exposure and HBs antibody (anti-HBs) protection levels in female prisoners., Material and Methods: A retrospective multicentric study was performed in Italian prisons from 2021 to 2023. Univariate and multivariate analyses were conducted to identify risk factors for HBc antibody (anti-HBc) seropositivity and non-protective anti-HBs titer., Results: We included 156 patients. The median age was 41.0 (IQR 34.0-48.0). Of the studied subjects, 31 (19.9%) had anti-HBc positive titer. Two women were HBsAg positive. In the multivariate analysis, older age [OR 1.06 (CI 1.01-1.11), p = 0.011], North-Eastern European [OR 11.67 (3.29-41.30), p < 0.001] and African origin [OR 6.92 (CI 1.51-31.60), p = 0.013], and drug use [OR 6.55 (CI 1.96-21.9), p = 0.002] were risk factors for HBV exposure. Thirty-seven (32%) women had no history of HBV vaccination. Forty-four (38%) had an anti-HBs non-protective titer. In the multivariate analysis, North-Eastern European origin [OR 4.55 (CI 1.19-17.50), p = 0.027] was associated with unprotective anti-HBs titer., Conclusion: Our results show both the low prevalence of HBV and protection in female prisoners. Age, North-Eastern European and African origin, and drug use have a role in exposure risk to HBV.

Published
2024
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194. New score to predict COVID-19 progression in vaccine and early treatment era: the COVID-19 Sardinian Progression Score (CSPS).

Author

De Vito A, Saderi L, Colpani A, Puci MV, Zauli B, Fiore V, Fois M, Meloni MC, Bitti A, Moi G, Maida I, Babudieri S, Sotgiu G, and Madeddu G

Subjects
Male, Humans, Aged, Middle Aged, Female, SARS-CoV-2, Retrospective Studies, Disease Progression, COVID-19, Vaccines
Abstract

Background: Several scores aimed at predicting COVID-19 progression have been proposed. As the variables vaccination and early SARS-CoV-2 treatment were systematically excluded from the prognostic scores, the present study's objective was to develop a new model adapted to the current epidemiological scenario., Methods: We included all patients evaluated by the Infectious Disease Unit in Sassari, with SARS-CoV-2 infection and without signs of respiratory failure at the first evaluation (P/F > 300). Disease progression was defined by the prescription of supplemental oxygen. In addition, variables related to demographics, vaccines, comorbidities, symptoms, CT scans, blood tests, and therapies were collected. Multivariate logistic regression modelling was performed to determine factors associated with progression; any variable with significant univariate test or clinical relevance was selected as a candidate for multivariate analysis. Hosmer-Lemeshow (HL) goodness of fit statistic was calculated. Odds ratio values were used to derive an integer score for developing an easy-to-use progression risk score. The discrimination performance of the risk index was determined using the AUC, and the best cut-off point, according to the Youden index, sensitivity, specificity, predictive value, and likelihood ratio, was chosen., Results: 1145 patients [median (IQR) age 74 (62-83) years; 53.5% males] were enrolled; 336 (29.3%) had disease progression. Patients with a clinical progression were older and showed more comorbidities; furthermore, they were less vaccinated and exposed to preventive therapy. In the multivariate logistic regression analysis, age ≥ 60 years, COPD, dementia, haematological tumours, heart failure, exposure to no or one vaccine dose, fever, dyspnoea, GGO, consolidation, ferritin, De Ritis ≥ 1.2, LDH, and no exposure to early anti-SARS-CoV-2 treatment were associated with disease progression. The final risk score ranged from 0 to 45. The ROC curve analysis showed an AUC of 0.92 (95% CI 0.90-0.93) with a 93.7% specificity and 72.9% sensitivity. Low risk was defined when the cut-off value was less than 23. Three risk levels were identified: low (0-23 points), medium (24-35), and high (≥ 36)., Conclusions: The proportion of patients with progression increases with high scores: the assessment of the risk could be helpful for clinicians to plan appropriate therapeutic strategies., (© 2024. The Author(s).)

Published
2024
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195. Knowledge of Sexually Transmitted Infections and HIV among People Living with HIV: Should We Be Concerned?

Author

Colpani A, De Vito A, Zauli B, Menzaghi B, Calcagno A, Celesia BM, Ceccarelli M, Nunnari G, De Socio GV, Di Biagio A, Leoni N, Angioni G, Giambenedetto SD, D'Ettorre G, Babudieri S, and Madeddu G

Abstract

Poor knowledge of sexually transmitted infections (STIs) and HIV among people with HIV (PLHIV) could worsen life quality. We aimed to investigate their STI and HIV knowledge, disclosure and undetectable = untransmittable (U=U). We proposed an anonymous questionnaire regarding STI and HIV to PLHIV attending ten Italian outpatient infectious diseases clinics. Moreover, disclosure and U=U were investigated. The calculated sample size was 178 people. Considering a missing response of 10%, the final sample size was 196. We enrolled 200 PLHIV (73.5% males), with a median age of 52.5 (IQR 41-59) years. The mean score was 7.61 ± 1.22 with no difference by gender, education, and employment. Significant statistical difference was observed by sexual orientation; bisexuals and those who preferred not to answer had a lower score than heterosexuals and MSM ( p = 0.0032). PLHIV showed poor knowledge about HIV transmission (25% appropriately answered). Nearly 30% responded that virologically suppressed PLHIV could transmit the infection. Finally, 137 (68.5%) and 158 (79.0%) disclosed to the general practitioner and family and friends, respectively. Nearly 52.0% knew the meaning of U=U, and 83.6% highlighted its positive rebound. In conclusion, important knowledge gaps are present among PLHIV regarding U=U, and its implications are little-known. Improving PLHIVs' awareness will undermine self-stigma and enhance life quality.

Published
2024
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196. Differences in HCV Seroprevalence, Clinical Features, and Treatment Outcomes between Female and Male Incarcerated Population: Results from a Matched Cohort Study.

Author

Fiore V, De Vito A, Rastrelli E, Manca V, De Matteis G, Ranieri R, Pontali E, Geremia N, Panese S, Starnini G, Madeddu G, and Babudieri S

Subjects
Humans, Male, Female, Cohort Studies, Seroepidemiologic Studies, Retrospective Studies, Treatment Outcome, Hepacivirus genetics, HIV Infections drug therapy, HIV Infections epidemiology, Prisoners, Hepatitis C drug therapy, Hepatitis C epidemiology
Abstract

Background: Women represent less than 5% of the incarcerated population in Italy, with very limited data on HCV infection. Higher HCV seroprevalence and active infection rates have been described among incarcerated females in available studies. Our aim is to compare the prevalence and cascade of care of HCV between male and female populations in Italian penitentiaries., Methods: We conducted a multicentre, retrospective study comparing HCV seroprevalence, active infections, treatment, and SVR rates between female (Group A) and male (Group B) populations in Italian prison settings., Results: No significant differences were found between the two groups regarding PWIDs ( p = 0.16), nor in people living with HIV ( p = 0.35) or HBV co-infection ( p = 0.36). HCV seroprevalence was higher in Group A ( p = 0.002). There was no statistically significant difference between the two groups regarding active infections ( p = 0.41). Both groups showed a low level of fibrosis, and the dominant genotype was 3a. Almost all patients underwent antiviral treatment. All treated patients achieved SVR12., Conclusions: Our findings illuminate the importance of recognizing and addressing gender differences in HCV seroprevalence within penitentiary settings. Moving forward, addressing the unique needs of incarcerated females and optimizing HCV care for all incarcerated individuals are essential steps in the pursuit of achieving HCV micro-elimination goals.

Published
2023
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197. Incidence and burden of long COVID in Africa: a systematic review and meta-analysis.

Author

Frallonardo L, Segala FV, Chhaganlal KD, Yelshazly M, Novara R, Cotugno S, Guido G, Papagni R, Colpani A, De Vito A, Barbagallo M, Madeddu G, Babudieri S, Lochoro P, Ictho J, Putoto G, Veronese N, Saracino A, and Di Gennaro F

Subjects
Humans, Post-Acute COVID-19 Syndrome, Incidence, Africa epidemiology, COVID-19 epidemiology, Mental Disorders epidemiology
Abstract

Long COVID, also known as "post-acute sequelae of COVID-19," affects at least 65 million individuals worldwide with a wide spectrum of symptoms that may last weeks, months, or permanently. Its epidemiology and burden in Africa are unclear. This meta-analysis examines long-term COVID-19 effects in the WHO African Region. A systematic search in several databases was carried out up to 12 February 2023 including observational studies from African countries reporting the cumulative incidence of long COVID signs and symptoms. Only studies conducted in African countries were included. Several sensitivity and meta-regression analyses were performed. Among 1547 papers initially screened, 25 were included, consisting of 29,213 participants. The incidence of any long COVID symptomatology was 48.6% (95% CI 37.4-59.8) as psychiatric conditions were the most frequent, particularly post-traumatic stress disorder reaching a cumulative incidence of 25% (95% CI 21.1-30.4). Higher age (p = 0.027) and hospitalization (p = 0.05) were associated with a higher frequency of long COVID. Long COVID poses a significant burden in Africa, particularly concerning psychiatric conditions. The study recommends identifying at-risk people and defining treatment strategies and recommendations for African long-COVID patients. High-quality studies addressing this condition in African setting are urgently needed., (© 2023. The Author(s).)

Published
2023
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198. Diet-Related Risk Factors for Chronic Noncommunicable Diseases in Italian Prisoners: B.A.C.I. (Benessere All'interno delle Carceri Italiane, Well-Being Inside the Italian Prisons) Project by the Italian Society of Penitentiary Medicine and Public Health (S.I.M.S.Pe. Società Italiana di Medicina e Sanità Penitenziaria).

Author

Verde L, Pagano AM, de Leo M, Vetrani C, Ambretti A, Lucania L, Babudieri S, De Chiara A, Colao A, Corsi M, Muscogiuri G, and Barrea L

Subjects
Humans, Prisons, Public Health, Risk Factors, Diet, Noncommunicable Diseases epidemiology, Prisoners
Abstract

Purpose of Review: The review aims to present an overview of inmate health, focusing on lifestyle-related diseases, physical activity levels, and nutritional status. It also presents the B.A.C.I. (Benessere All'interno delle Carceri Italiane, well-being inside the Italian prisons) project, which aims to offers an innovative path of prevention, diagnosis, and treatment of noncommunicable diseases (NCDs) related to unhealthy lifestyles in prisons in the Campania region, Italy., Recent Findings: The global prison population has risen by 24% since the year 2000, with over 10.77 million people detained worldwide in 2021. In Italy alone, there are currently over 57,000 inmates. Inmates face a higher risk of NCDs such as cardiovascular disease due to unhealthy lifestyles characterized by poor diets and lack of physical activity. Additionally, sleep disorders, particularly insomnia, are prevalent among inmates, further contributing to health disparities. While physical activity has shown positive effects on inmate well-being, there is limited research on nutritional status and interventions in prison populations. Providing quality healthcare to inmates is an international policy norm, but the standards vary globally and are often inadequate. The economic burden of NCDs is rising, and this is exacerbated in prisons, making it challenging for individuals to reintegrate into society after release., (© 2023. The Author(s).)

Published
2023
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199. Quick diagnostic approach for HIV/STDs among migrants: results from a monocentric Italian cohort.

Author

Fiore V, Manca V, De Vito A, Colpani A, Maida I, Madeddu G, and Babudieri S

Subjects
Humans, Male, Female, Young Adult, Adult, HIV, Sexual Behavior, Hepacivirus, Italy epidemiology, Transients and Migrants, Sexually Transmitted Diseases epidemiology, HIV Infections diagnosis, HIV Infections epidemiology, Hepatitis C, Condylomata Acuminata
Abstract

Introduction: Migration has a direct influence on sexual health. Differences both in sexual networks and the risk of sexually transmitted diseases (STDs) between racial or ethnic minorities and the native population have been described in the literature., Methodology: We collected data on medical history, physical examination, and human immunodeficiency virus (HIV)/STDs tests. Screenings were proposed basing on Centers for Disease Control (CDC) 2018 guidelines on STDs. Patients underwent peer-to-peer counselling before screening., Results: We included data of 391 patients (both outpatients and migrants living in facility centers). The median age was 30 (range 24-38) years, and the majority were male (198/391; 50.6%). Among them, 389 (99.4%) were counselled, and 371 (94.8%) accepted the screening. We found 155 (41.7%) HBsAg/Anti-HBc positive tests, 4 (1%) HIV positive screenings, 1 (0.2%) hepatitis C virus (HCV) infection, 47 (12%) genital/perianal warts, 29 (2.3%) cases of syphilis, and 13 (3.3%) molluscum contagiosum., Conclusions: Migrants have high-risk sexual behavior. Despite this, they may have a low perception of risk and healthcare needs. An approach based on quick tests was demonstrated to be useful in increasing the screening acceptance. However, the retainment in care was low, as in previous studies. Access to HIV/STDs screening and treatment should be implemented. The development of specific retainment in care pathways is still needed to reduce the lack of follow-up., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2023 Vito Fiore, Valentina Manca, Andrea De Vito, Agnese Colpani, Ivana Maida, Giordano Madeddu, Sergio Babudieri.)

Published
2023
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200. Vaccination and Antiviral Treatment Reduce the Time to Negative SARS-CoV-2 Swab: A Real-Life Study.

Author

De Vito A, Moi G, Saderi L, Puci MV, Colpani A, Firino L, Puggioni A, Uzzau S, Babudieri S, Sotgiu G, and Madeddu G

Subjects
Aged, Humans, SARS-CoV-2, Vaccination, Antiviral Agents therapeutic use, COVID-19 diagnosis, COVID-19 prevention & control, Vaccines
Abstract

Clinical trials demonstrated the role of vaccines and antiviral treatments against SARS-CoV-2 in reducing the likelihood of disease progression and death. However, there are limited data available regarding the time to negativity of people who received these treatments. Further, several comorbidities and risk factors might affect the impact of vaccines and antiviral treatments. To this end, we aimed to evaluate and disentangle the impact of anti-SARS-CoV-2 treatments and that of underlying clinical factors associated with a shortened length of SARS-CoV-2 infection. Hence, we recorded the timeframe of positive nasopharyngeal swab in people infected while being hospitalized for reasons other than SARS-CoV-2 infection. All patients who died or were discharged with a positive swab were excluded from the study. A total of 175 patients were included in this study. Clinical conditions encompass malignancies, immunological disorders, cardiovascular, metabolic, neurodegenerative, and chronic kidney disease. Most of the participants (91.4%) were vaccinated before admission to the hospital, and 65.1% received antiviral treatment within three days after the symptom's onset. Unvaccinated patients had a longer median time to negativity than people who received at least two doses of vaccine (18 vs. 10 days). Concerning the clinical conditions of all patients, multivariate analysis highlighted a lower probability of 14-day conversion of antigenic test positivity in patients with hematological malignancy, including those vaccinated and those exposed to antiviral therapies. In conclusion, our data showed that prompt administration of antiviral treatments accelerates the clearance of SARS-CoV-2. Further, in the elderly patients under study, previous vaccination and antiviral treatment synergize to reduce time to negativity. This translates into a shorter hospitalization time and a lower risk of transmission through patients and connected healthcare workers in a hospital ward setting, with considerable improvement in cost-effective care management.

Published
2023
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