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Hepatitis: HELP
Articles by Giovanni Raimondo
Based on 48 articles published since 2009
(Why 48 articles?)
||||

Between 2009 and 2019, G. Raimondo wrote the following 48 articles about Hepatitis.
 
+ Citations + Abstracts
Pages: 1 · 2
1 Guideline Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN). 2018

Minutolo, Roberto / Aghemo, Alessio / Chirianni, Antonio / Fabrizi, Fabrizio / Gesualdo, Loreto / Giannini, Edoardo G / Maggi, Paolo / Montinaro, Vincenzo / Paoletti, Ernesto / Persico, Marcello / Perticone, Francesco / Petta, Salvatore / Puoti, Massimo / Raimondo, Giovanni / Rendina, Maria / Zignego, Anna Linda / Anonymous2741138. ·Division of Nephrology, Department of Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dvecchiamento, University of Campania "Luigi Vanvitelli", Via M. Longo 50, 80138 Naples, Italy. Electronic address: roberto.minutolo@unicampania.it. · Department of Biomedical Sciences, Humanitas University, Milan, Italy; Division of Internal Medicine and Hepatology, Humanitas Clinical and Research Center, Milan, Italy. · Third Department of Infectious Diseases Azienda Ospedaliera Ospedali dei Colli, Naples, Italy. · Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milan, Italy. · Division of Nephrology, Azienda Ospedaliero-Universitaria Policlinico di Bari, Bari, Italy. · Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. · Infectious Disease Clinic, University of Bari, Bari, Italy. · Nephrology, Dialysis, and Transplantation, University of Genoa and Policlinico San Martino, Genoa, Italy. · Internal Medicine and Hepatology Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy. · Department of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy. · Gastroenterology and Hepatology Unit, Di.Bi.M.I.S., University of Palermo, Palermo, Italy. · Division of Infectious Diseases, Niguarda Cà Granda Hospital, Milan, Italy. · Department of Medicina Clinica e Sperimentale, University of Messina, Messina, Italy. · Department of Emergency and Organ Transplantation, Section of Gastroenterology, University Hospital, Bari, Italy. · Department of Experimental and Clinical Medicine, Interdepartmental Hepatology Center MaSVE, University of Florence, Florence, Italy. ·Dig Liver Dis · Pubmed #30266305.

ABSTRACT: Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.

2 Guideline Treatment of chronic hepatitis B: update of the recommendations from the 2007 Italian Workshop. 2011

Carosi, Giampiero / Rizzetto, Mario / Alberti, Alfredo / Cariti, Giuseppe / Colombo, Massimo / Craxì, Antonio / Filice, Gaetano / Levrero, Massimo / Mazzotta, Francesco / Pastore, Giuseppe / Piccinino, Felice / Prati, Daniele / Raimondo, Giovanni / Sagnelli, Evangelista / Toti, Mario / Brunetto, Maurizia / Bruno, Raffaele / Di Marco, Vito / Ferrari, Carlo / Gaeta, Giovanni B / Lampertico, Pietro / Marzano, Alfredo / Pollicino, Teresa / Puoti, Massimo / Santantonio, Teresa / Smedile, Antonina. ·Department of Infectious and Tropical Diseases, University of Brescia, Brescia, Italy. carosi@bsnet.it ·Dig Liver Dis · Pubmed #21276760.

ABSTRACT: The Italian recommendations for the therapy of hepatitis B virus (HBV)-related disease were issued in 2008. Subsequently in 2008 the nucleotide analogue (NA) Tenofovir was approved for antiviral treatment. The introduction of this important new drug has called for the current guidelines update, which includes some additional revisions: (a) the indication for therapy is extended to mild liver fibrosis and the indication for treatment is graded as "possible", "optional" or "mandatory" according to the fibrosis stage; (b) two different treatment strategies are described: first line definite duration treatment with interferon, long-term treatment of indefinite duration with NA; (c) the indication to follow either strategy is also based on the stage of liver fibrosis; (d) virological monitoring is modified to include the definitions of failure and of sustained virological response to interferon therapy; (e) the recommendation to use HBV DNA assays with high sensitivity and wide linear ranges is underlined (f) guidelines on post-treatment follow-up after finite treatment with NA, potential side effects of therapy and non-virological monitoring are defined; (g) definitions and treatment of patients without optimal response to NA are reported; (f) treatment and monitoring of compensated or decompensated cirrhosis and hepatocellular carcinoma are updated.

3 Review Real life experiences in HCV management in 2018. 2019

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. ·a Hepatology Unit, Ospedale San Giuseppe , University of Milan , Milan , Italy. · b Department Medicine of Systems , University Tor Vergata , Rome , Italy. · c Department of Laboratory Medicine, Niguarda Hospital , University of Milan , Milan , Italy. · d Department of Gastroenterology, DiBiMIS , University of Palermo , Palermo , Italy. · e UO Medicina Interna ed Epatologia , Humanitas University and Research Hospital , Milano , Italy. · f Department of Molecular Medicine , University of Padua , Padua , Italy. · g Centro per lo Studio e Ricerche delle Epatiti, Dipartimento di Scienze Mediche e Chirurgiche , Università di Bologna , Bologna , Italy. · h Infectious Diseases Department, AOU Sassari , University of Sassari , Sassari , Italy. · i Unit of Infectious Diseases, Department of Medical Sciences , University of Turin , Turin , Italy. · j Dipartimento di Medicina Clinica e Sperimentale Università di Pisa , UO Epatologia Azienda Ospedaliero-Universitaria Pisana , Pisa , Italy. · k Division of Infectious Diseases, Fondazione IRCCS Policlinico San Matteo , University of Pavia , Pavia , Italy. · l Department of Internal Medicine , Humanitas University Medicine , Rozzano , Italy. · m Department of Clinical Medicine and Surgery, Gastroenterology Unit , University of Naples "Federico II" , Naples , Italy. · n Department of Internal Medicine , Buccheri La Ferla Hospital Fatebenefratelli , Palermo , Italy. · o Department of Experimental Medicine and Surgery , University of Rome Tor Vergata , Rome , Italy. · p Dipartimento di Scienze Mediche , Università di Torino , Torino , Italy. · q Infectious Diseases Unit, AORN Caserta , University of Campania , Caserta , Italy. · r USC Gastroenterologia Epatologia e Trapiantologia, Dipartimento di Medicina Specialistica e dei Trapianti , ASST Papa Giovanni XXIII , Bergamo , Italy. · s Malattie Infettive , Università della Campania "Luigi Vanvitelli" , Napoli , Italy. · t Fondazione Policlinico Gemelli IRCCS , Universita' Cattolica del Sacro Cuore , Roma , Italy. · u Gastroenterology and Hepatology Division, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico , Università di Milano , Milano , Italy. · v UOC Malattie del Fegato Dipartimento Interaziendale Trapianti Azienda Ospedaliera San Camillo Forlanini , Rome , Italy. · w Infectious Diseases Unit and Centre for Migration and Health ARNAS , Civico-Benfratelli Hospital , Palermo , Italy. · x SC Malattie Infettive, Department of Infectious Diseases , ASST Grande Ospedale Metropolitano Niguarda , Milano , Italy. · y Division of Clinical and Molecular Hepatology, Department of Internal Medicine , University Hospital of Messina , Messina , Italy. · z Infectious Diseases Department ASST Fatebenefratelli Sacco, School of Clinical Medicine, Faculty of Health Science , University of the Witwatersrand , Johannesburg , South Africa. · aa Infectious Diseases Unit and School of Tropical Medicine , Sapienza of Rome University , Rome , Italy. · ab Department of Experimental and Clinical Medicine and Department of Oncology, Interdepartmental Hepatology Center MASVE , Azienda Ospedaliero-Universitaria Careggi (AOUC) , Florence , Italy. ·Expert Rev Anti Infect Ther · Pubmed #30582384.

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.

4 Review Hepatitis B vaccination. 2015

Romanò, Luisa / Paladini, Sara / Galli, Cristina / Raimondo, Giovanni / Pollicino, Teresa / Zanetti, Alessandro R. ·a Dipartimento di Scienze Biomediche per la Salute; Università degli Studi di Milano; Milano, Italy. ·Hum Vaccin Immunother · Pubmed #25483515.

ABSTRACT: Hepatitis B virus is a worldwide leading cause of acute and chronic liver disease including cirrhosis and hepatocellular carcinoma. Effective vaccines have been available since the early '80s and vaccination has proved highly successful in reducing the disease burden, the development of the carrier state and the HB-related morbidity and mortality in the countries where vaccination has been implemented.   Neutralizing (protective) antibodies (anti-HBs) induced by vaccination are targeted largely towards the amino acid hydrophilic region, referred to as the common a determinant which is present on the outer protein coat or surface antigen (HBsAg), spanning amino acids 124-149. This provides protection against all HBV genotypes (from A to H) and is responsible for the broad immunity afforded by hepatitis B vaccination. Thus, alterations of residues within this region of the surface antigen may determine conformational changes that can allow replication of the mutated HBV in vaccinated people. An important mutation in the surface antigen region was identified in Italy some 25 years ago in infants born to HBsAg carrier mothers who developed breakthrough infections despite having received HBIG and vaccine at birth. This virus had a point mutation from guanosine to adenosine at nucleotide position 587, resulting in aa substitution from glycine (G) to arginine (R) at position 145 in the a determinant. Since the G145R substitution alters the projecting loop (aa 139-147) of the a determinant, the neutralizing antibodies induced by vaccination are no longer able to recognize the mutated epitope. Beside G145R, other S-gene mutations potentially able to evade neutralizing anti-HBs and infect vaccinated people have been described worldwide. In addition, the emergence of Pol mutants associated with resistance to treatment with nucleos(t)ide analogues can select viruses with crucial changes in the overlapping S-gene, potentially able to alter the S protein immunoreactivity. Thus such mutants have the potential to infect both naïve and immunized people, negatively affecting the efficacy of both the antiviral treatment and the vaccination programs. Despite concern, at present the overall impact of vaccine escapes mutants seems to be low and they do not pose a public health threat or a need to modify the established hepatitis B vaccination programs. The development of novel NAs with a high barrier to resistance is warranted.

5 Review Hepatitis B virus and hepatitis C virus dual infection. 2014

Caccamo, Gaia / Saffioti, Francesca / Raimondo, Giovanni. ·Gaia Caccamo, Francesca Saffioti, Giovanni Raimondo, Division of Clinical and Molecular Hepatology, Department of Internal Medicine, University Hospital of Messina, 98124 Messina, Italy. ·World J Gastroenterol · Pubmed #25356020.

ABSTRACT: Hepatitis B virus (HBV) and hepatitis C virus (HCV) share common mode of transmission and both are able to induce a chronic infection. Dual HBV/HCV chronic coinfection is a fairly frequent occurrence, especially in high endemic areas and among individuals at high risk of parenterally transmitted infections. The intracellular interplay between HBV and HCV has not yet been sufficiently clarified, also due to the lack of a proper in vitro cellular model. Longitudinal evaluation of serum HBV DNA and HCV RNA amounts has revealed that complex virological profiles may be present in coinfected patients. Dual HBV/HCV infection has been associated to a severe course of the liver disease and to a high risk of developing hepatocellular carcinoma. Despite the clinical importance, solid evidence and clear guidelines for treatment of this special population are still lacking. This review summarizes the available data on the virological and clinical features as well as the therapeutic options of the dual HBV/HCV infection, and highlights the aspects that need to be better clarified.

6 Review Hepatitis B virus PreS/S gene variants: pathobiology and clinical implications. 2014

Pollicino, Teresa / Cacciola, Irene / Saffioti, Francesca / Raimondo, Giovanni. ·Division of Clinical and Molecular Hepatology, University Hospital of Messina, Via Consolare Valeria, 1, 98124 Messina, Italy; Department of Pediatric, Gynecologic, Microbiological and Biomedical Sciences, University Hospital of Messina, Via Consolare Valeria, 1, 98124 Messina, Italy. Electronic address: tpollicino@unime.it. · Division of Clinical and Molecular Hepatology, University Hospital of Messina, Via Consolare Valeria, 1, 98124 Messina, Italy; Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy. · Division of Clinical and Molecular Hepatology, University Hospital of Messina, Via Consolare Valeria, 1, 98124 Messina, Italy; Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy. Electronic address: raimondo@unime.it. ·J Hepatol · Pubmed #24801416.

ABSTRACT: The emergence and takeover of hepatitis B virus (HBV) variants carrying mutation(s) in the preS/S genomic region is a fairly frequent event that may occur spontaneously or may be the consequence of immunoprophylaxis or antiviral treatments. Selection of preS/S mutants may have relevant pathobiological and clinical implications. Both experimental data and studies in humans show that several specific mutations in the preS/S gene may induce an imbalance in the synthesis of the surface proteins and their consequent retention within the endoplasmic reticulum (ER) of the hepatocytes. The accumulation of mutated surface proteins may cause ER stress with the consequent induction of oxidative DNA damage and genomic instability. Viral mutants with antigenically modified surface antigen may be potentially infectious to immune-prophylaxed patients and may account for cases of occult HBV infection. In addition, preS/S variants were reported to be associated with cases of fulminant hepatitis as well as of fibrosing cholestatic hepatitis, and they are associated with cirrhosis and hepatocellular carcinoma development.

7 Review Occult HBV infection. 2013

Raimondo, Giovanni / Caccamo, Gaia / Filomia, Roberto / Pollicino, Teresa. ·Unit of Clinical and Molecular Hepatology, Department of Internal Medicine, University Hospital of Messina, Messina, Italy. raimondo@unime.it ·Semin Immunopathol · Pubmed #22829332.

ABSTRACT: The long-lasting persistence of hepatitis B virus (HBV) genomes in the liver (with detectable or undetectable HBV DNA in the serum) of individuals testing negative for the HBV surface antigen (HBsAg) is termed occult HBV infection (OBI). Although in a minority of cases the lack of HBsAg detection is due to infection with variant viruses unrecognized by available assays (S-escape mutants), the typical OBI is related to replication-competent HBVs strongly suppressed in their replication activity. The causes of HBV suppression are not yet well clarified, although the host's immune surveillance and epigenetic mechanisms are likely involved. OBI is a worldwide diffused entity, but the available data of prevalence in various categories of individuals are often contrasting because of the different sensitivity and specificity of the methods used for its detection in many studies. OBI may have an impact in several different clinical contexts. In fact, it can be transmitted (i.e., through blood transfusion and liver transplantation) causing classic forms of hepatitis B in newly infected individuals. The development of an immunosuppressive status (mainly by immunotherapy or chemotherapy) may induce OBI reactivation and development of acute and often severe hepatitis. Finally, evidence suggests that OBI can favor the progression of liver fibrosis, in particular in HCV-infected patients. The possible contribution of OBI to the establishment of cirrhosis also implies its possible indirect role in the development of hepatocellular carcinoma. On the other hand, OBI may maintain most of the direct transforming properties of the overt HBV infection, such as the capacity to integrate in the host's genome and to synthesize pro-oncogenic proteins.

8 Review Hepatocellular carcinoma: the point of view of the hepatitis B virus. 2011

Pollicino, Teresa / Saitta, Carlo / Raimondo, Giovanni. ·Department of Internal Medicine, Unit of Clinical and Molecular Hepatology, University Hospital of Messina, Via Consolare Valeria, Messina, Italy. tpollicino@unime.it ·Carcinogenesis · Pubmed #21665892.

ABSTRACT: -- No abstract --

9 Review A 2010 update on occult hepatitis B infection. 2010

Raimondo, G / Pollicino, T / Romanò, L / Zanetti, A R. ·Unit of clinical and molecular hepatology, department of internal medicine, Policlinico Universitario di Messina, Messina, Italy. ·Pathol Biol (Paris) · Pubmed #20303674.

ABSTRACT: Occult hepatitis B virus infection is a challenging issue whose virological and clinical relevance has been a source of long-lasting debate. By definition, OBI is characterized by the persistence of HBV-DNA in the liver tissue (and in some cases also in the serum) in absence of HBsAg. According to the HBV serological profile, OBI may be antibody (anti-HBc alone or together with anti-HBs) positive (seropositive OBI) or antibody negative (seronegative OBI). OBI is a complex biological entity with possible relevant clinical implications, mainly related to the intrahepatic persistence of viral cccDNA and to a strong suppression of viral replication and gene expression. Clinical observations suggest that OBI carriers may be a source of HBV transmission through blood transfusion or orthotopic liver transplantation (OLT). The state of suppression of viral replication and gene expression may be discontinued when an immunosuppressive status occurs, leading to typical hepatitis B with severe - and some times - fulminant course. The long-lasting persistence of the virus in the liver may provoke a very mild but continuing necro-inflammation that (if other causes of liver damage cohexist) may contribute over time to the progression of the chronic liver damage towards cirrhosis. In addition, OBI is supposed to be an important risk factor to HCC development since it maintains the pro-oncogenic properties typical of the overt infection.

10 Review Control of cccDNA function in hepatitis B virus infection. 2009

Levrero, Massimo / Pollicino, Teresa / Petersen, Jorg / Belloni, Laura / Raimondo, Giovanni / Dandri, Maura. ·Department of Internal Medicine, Sapienza University of Rome, Policlinico Umberto I, 0061 Rome, Italy. massimo.levrero@uniroma1.it ·J Hepatol · Pubmed #19616338.

ABSTRACT: The template of hepatitis B virus (HBV) transcription, the covalently closed circular DNA (cccDNA), plays a key role in the life cycle of the virus and permits the persistence of infection. Novel molecular techniques have opened new possibilities to investigate the organization and the activity of the cccDNA minichromosome in vivo, and recent advances have started to shed light on the complexity of the mechanisms controlling cccDNA function. Nuclear cccDNA accumulates in hepatocyte nuclei as a stable minichromosome organized by histone and non-histone viral and cellular proteins. Identification of the molecular mechanisms regulating cccDNA stability and its transcriptional activity at the RNA, DNA and epigenetic levels in the course of chronic hepatitis B (CH-B) infection may reveal new potential therapeutic targets for anti-HBV drugs and hence assist in the design of strategies aimed at silencing and eventually depleting the cccDNA reservoir.

11 Article Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN). 2019

Minutolo, Roberto / Aghemo, Alessio / Chirianni, Antonio / Fabrizi, Fabrizio / Gesualdo, Loreto / Giannini, Edoardo G / Maggi, Paolo / Montinaro, Vincenzo / Paoletti, Ernesto / Persico, Marcello / Perticone, Francesco / Petta, Salvatore / Puoti, Massimo / Raimondo, Giovanni / Rendina, Maria / Zignego, Anna Linda / Anonymous1951125 / Anonymous1961125 / Anonymous1971125 / Anonymous1981125. ·Division of Nephrology, Department of Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell'Invecchiamento, University of Campania "Luigi Vanvitelli", Via M. Longo 50, 80138, Naples, Italy. roberto.minutolo@unicampania.it. · Department of Biomedical Sciences, Humanitas University, Milan, Italy. · Division of Internal Medicine and Hepatology, Humanitas Clinical and Research Center, Milan, Italy. · Third Department of Infectious Diseases Azienda Ospedaliera Ospedali dei Colli, Naples, Italy. · Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milan, Italy. · Division of Nephrology, Azienda Ospedaliero-Universitaria Policlinico di Bari, Bari, Italy. · Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. · Infectious Disease Clinic, University of Bari, Bari, Italy. · Nephrology, Dialysis, and Transplantation, University of Genoa and Policlinico San Martino, Genoa, Italy. · Internal Medicine and Hepatology Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy. · Department of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy. · Gastroenterology and Hepatology Unit, Di.Bi.M.I.S., University of Palermo, Palermo, Italy. · Division of Infectious Diseases, Niguarda Cà Granda Hospital, Milan, Italy. · Department of Medicina Clinica e Sperimentale, University of Messina, Messina, Italy. · Department of Emergency and Organ Transplantation, Section of Gastroenterology, University Hospital, Bari, Italy. · Department of Experimental and Clinical Medicine, Interdepartmental Hepatology Center MaSVE, University of Florence, Florence, Italy. ·Infection · Pubmed #30255389.

ABSTRACT: Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.

12 Article How infectious is the hepatitis B virus? Readings from the occult. 2019

Locarnini, Stephen / Raimondo, Giovanni. ·Divisional of Molecular Research and Development, Victorian Infectious Diseases Reference Laboratory at the Doherty Institute, Melbourne, Victoria, Australia. · Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy. ·Gut · Pubmed #30068661.

ABSTRACT: -- No abstract --

13 Article Management of hepatitis C virus infection in patients with chronic kidney disease: position statement of the joint committee of Italian association for the study of the liver (AISF), Italian society of internal medicine (SIMI), Italian society of infectious and tropical disease (SIMIT) and Italian society of nephrology (SIN). 2018

Minutolo, Roberto / Aghemo, Alessio / Chirianni, Antonio / Fabrizi, Fabrizio / Gesualdo, Loreto / Giannini, Edoardo G / Maggi, Paolo / Montinaro, Vincenzo / Paoletti, Ernesto / Persico, Marcello / Perticone, Francesco / Petta, Salvatore / Puoti, Massimo / Raimondo, Giovanni / Rendina, Maria / Zignego, Anna Linda / Anonymous2091208 / Anonymous2101208 / Anonymous2111208 / Anonymous2121208. ·Division of Nephrology, Department of Scienze Mediche, Chirurgiche, Neurologiche, Metaboliche e dell'Invecchiamento, University of Campania "Luigi Vanvitelli", Via M. Longo 50, 80138, Naples, Italy. roberto.minutolo@unicampania.it. · Department of Biomedical Sciences, Humanitas University, Milan, Italy. · Division of Internal Medicine and Hepatology, Humanitas Clinical and Research Center, Milan, Italy. · Third Department of Infectious Diseases Azienda Ospedaliera Ospedali dei Colli, Naples, Italy. · Division of Nephrology, Maggiore Hospital and IRCCS Foundation, Milan, Italy. · Division of Nephrology, Azienda Ospedaliero-Universitaria Policlinico di Bari, Bari, Italy. · Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. · Infectious Disease Clinic, University of Bari, Bari, Italy. · Nephrology, Dialysis, and Transplantation, University of Genoa and Policlinico San Martino, Genoa, Italy. · Internal Medicine and Hepatology Unit, AOU San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy. · Department of Medical and Surgical Sciences, University Magna Græcia, Catanzaro, Italy. · Gastroenterology and Hepatology Unit, Di.Bi.M.I.S., University of Palermo, Palermo, Italy. · Division of Infectious Diseases, Niguarda Cà Granda Hospital, Milan, Italy. · Department of Medicina Clinica e Sperimentale, University of Messina, Messina, Italy. · Department of Emergency and Organ Transplantation, Section of Gastroenterology, University Hospital, Bari, Italy. · Department of Experimental and Clinical Medicine, Interdepartmental Hepatology Center MaSVE, University of Florence, Florence, Italy. ·Intern Emerg Med · Pubmed #30255464.

ABSTRACT: Hepatitis C virus (HCV) infection is now considered a systemic disease due to the occurrence of extra-hepatic manifestations. Among these, the renal involvement is frequent. HCV infection, in fact, is strongly associated with proteinuria and chronic kidney disease (CKD) and negatively affects the prognosis of renal patients. In the last few years, availability of more specific and effective drugs against HCV has dramatically changed the clinical course of this disease. These drugs may provide further advantages in the CKD population as a whole by reducing progression of renal disease, mortality rate and by increasing the survival of graft in renal transplant recipients. The strict pathogenetic and prognostic link between HCV infection and CKD requires an ongoing relationship among the healthcare professionals involved in the treatment of both HCV infection and CKD. Therefore, Scientific Societies involved in the care of this high-risk population in Italy have organized a joint expert panel. The aim of the panel is to produce a position statement that can be used in daily clinical practice for the management of HCV infected patients across the whole spectrum of renal disease, from the conservative phase to renal replacement treatments (dialysis and transplantation). Sharing specific evidence-based expertise of different professional healthcare is the first step to obtain a common ground of knowledge on which to instate a model for multidisciplinary management of this high-risk population. Statements cover seven areas including epidemiology of CKD, HCV-induced glomerular damage, HCV-related renal risk, staging of liver disease in patients with CKD, prevention of transmission of HCV in hemodialysis units, treatment of HCV infection and management of HCV in kidney transplantation.

14 Article NS3 Variability in Hepatitis C Virus Genotype 1A Isolates from Liver Tissue and Serum Samples of Treatment-Naïve Patients with Chronic Hepatitis C. 2018

D'Aliberti, Deborah / Cacciola, Irene / Musolino, Cristina / Raffa, Giuseppina / Filomia, Roberto / Alibrandi, Angela / Benfatto, Salvatore / Beninati, Concetta / Saitta, Carlo / Giosa, Domenico / Romeo, Orazio / Raimondo, Giovanni / Pollicino, Teresa. ·Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy. · Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy. · Department of Economics, University of Messina, Messina, Italy. · Department of Human Pathology, University Hospital of Messina, Messina, Italy. · Department of Chemical, Biological, Pharmaceutical and Environmental Sciences (ChiBioFarAm), University of Messina, Messina, Italy. · IRCCS Centro Neurolesi Bonino-Pulejo, Messina, Italy. ·Intervirology · Pubmed #30021203.

ABSTRACT: BACKGROUND: Hepatitis C virus (HCV) NS3 resistance-associated substitutions (RASs) reduce HCV susceptibility to protease inhibitors. Little is known about NS3 RASs in viral isolates from the liver of chronic hepatitis C (CHC) patients infected with HCV genotype-1a (G1a). AIM: The objective of this work was to study NS3 variability in isolates from the serum and liver of HCV-G1a-infected patients naïve to direct-acting antivirals (DAAs). METHODS: NS3 variability of HCV-G1a isolates from the serum and liver of 11 naïve CHC patients, and from sera of an additional 20 naïve CHC patients, was investigated by next-generation sequencing. RESULTS: At a cutoff of 1%, NS3 RASs were detected in all the samples examined. At a cutoff of 15%, they were found in 54.5% (6/11) and 27.3% (3/11) of the paired liver and serum samples, respectively, and in 22.5% (7/31) of the overall serum samples examined. Twenty-six out of thirty-one (84%) patients showed NS3 variants with multiple RASs. Phylogenetic analysis showed that NS3 sequences clustered within 2 clades, with 10/31 (32.2%) patients infected by clade I, 15/31 (48.8%) by clade II, and 6/31 (19.3%) by both clades. CONCLUSIONS: Though the number of patients examined was limited, NS3 variants with RASs appear to be major components of both intrahepatic and circulating viral quasispecies populations in DAA-naïve patients.

15 Article Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals? 2018

Kondili, Loreta A / Robbins, Sarah / Blach, Sarah / Gamkrelidze, Ivane / Zignego, Anna L / Brunetto, Maurizia R / Raimondo, Giovanni / Taliani, Gloria / Iannone, Andrea / Russo, Francesco P / Santantonio, Teresa A / Zuin, Massimo / Chessa, Luchino / Blanc, Pierluigi / Puoti, Massimo / Vinci, Maria / Erne, Elke M / Strazzabosco, Mario / Massari, Marco / Lampertico, Pietro / Rumi, Maria G / Federico, Alessandro / Orlandini, Alessandra / Ciancio, Alessia / Borgia, Guglielmo / Andreone, Pietro / Caporaso, Nicola / Persico, Marcello / Ieluzzi, Donatella / Madonia, Salvatore / Gori, Andrea / Gasbarrini, Antonio / Coppola, Carmine / Brancaccio, Giuseppina / Andriulli, Angelo / Quaranta, Maria G / Montilla, Simona / Razavi, Homie / Melazzini, Mario / Vella, Stefano / Craxì, Antonio / Anonymous1251369. ·Center for Global Health, Istituto Superiore di Sanità, Rome, Italy. · Center for Disease Analysis, CDA Foundation | Polaris Observatory, Lafayette, CO, USA. · Department of Experimental and Clinical Medicine, Interdepartmental Centre MASVE, University of Florence, Florence, Italy. · Internal Medicine, Department of Clinical and Experimental Medicine University of Pisa and Liver Unit, Pisa University Hospital, Pisa, Italy. · Department of Internal Medicine, University Hospital of Messina, Messina, Italy. · Infectious and Tropical Diseases Unit, Umberto I Hospital, Sapienza University, Rome, Italy. · Department of Gastroenterology, University Hospital of Bari, Bari, Italy. · Department of Gastroenterology, University Hospital of Padua, Padua, Italy. · Department of Infectious Disease, Ospedali Riuniti, Foggia, Italy. · Liver and Gastroenterology Unit, ASST Santi Paolo e Carlo, Milan, Italy. · Liver Unit, University of Cagliari, Cagliari, Italy. · Department of Infectious Disease, S.M. Annunziata Hospital, Florence, Italy. · Department of Infectious Disease, Niguarda Hospital, Milan, Italy. · Hepatitis Center, Niguarda Hospital, Milan, Italy. · Department of Infectious Disease, University Hospital of Padua, Padua, Italy. · Department of Hepatology, San Gerardo Hospital, Monza, Italy. · Department of Infectious Disease, Arcispedale Santa Maria Nuova, Reggio Emilia, Italy. · Department of Gastroenterology and Hepatology, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy. · Department of Gastroenterology and Hepatology, San Giuseppe Hospital, Milan, Italy. · Department of Hepatology and Gastroenterology, Università della Campania Luigi Vanvitelli, Naples, Italy. · Department of Infectious Disease and Hepatology, University of Parma, Parma, Italy. · Gastoenterology Unit, Città della Salute e della Scienza-Ospedale Molinette, Turin, Italy. · Department of Infectious Disease, Federico II University, Naples, Italy. · Department of Hepatology, University of Bologna, Bologna, Italy. · Gastroenterology Unit, Federico II University, Naples, Italy. · Department of Internal Medicine and Hepatology, University of Salerno, Salerno, Italy. · Liver Unit, University Hospital of Verona, Verona, Italy. · Internal Medicine, Villa Sofia-Cervello Hospital, Palermo, Italy. · Department of Infectious Disease, San Gerardo Hospital, Monza, Italy. · Department of Internal Medicine and Gastroenterology, Catholic University of Rome, Rome, Italy. · Department of Hepatology, Gragnano Hospital, Naples, Italy. · Infectious Diseases, Department of Mental and Physical Health and Preventive Medicine, Università della Campania Luigi Vanvitelli, Naples, Italy. · Division of Gastroenterology, Istituto di Ricovero e Cura a Carattere Scientifico, Casa Sollievo Sofferenza Hospital, San Giovanni Rotondo, Foggia, Italy. · Italian Medicines Agency (AIFA), Rome, Italy. · Gastroenterolgy and Liver Unit, DiBiMIS, University of Palermo, Palermo, Italy. ·Liver Int · Pubmed #29900654.

ABSTRACT: BACKGROUND & AIMS: Advances in direct-acting antiviral treatment of HCV have reinvigorated public health initiatives aimed at identifying affected individuals. We evaluated the possible impact of only diagnosed and linked-to-care individuals on overall HCV burden estimates and identified a possible strategy to achieve the WHO targets by 2030. METHODS: Using a modelling approach grounded in Italian real-life data of diagnosed and treated patients, different linkage-to-care scenarios were built to evaluate potential strategies in achieving the HCV elimination goals. RESULTS: Under the 40% linked-to-care scenario, viraemic burden would decline (60%); however, eligible patients to treat will be depleted by 2025. Increased case finding through a targeted screening strategy in 1948-1978 birth cohorts could supplement the pool of diagnosed patients by finding 75% of F0-F3 cases. Under the 60% linked-to-care scenario, viraemic infections would decline by 70% by 2030 but the patients eligible for treatment will run out by 2028. If treatment is to be maintained, a screening strategy focusing on 1958-1978 birth cohorts could capture 55% of F0-F3 individuals. Under the 80% linked-to-care scenario, screening limited in 1968-1978 birth cohorts could sustain treatment at levels required to achieve the HCV elimination goals. CONCLUSION: In Italy, which is an HCV endemic country, the eligible pool of patients to treat will run out between 2025 and 2028. To maintain the treatment rate and achieve the HCV elimination goals, increased case finding in targeted, high prevalence groups is required.

16 Article Integration of hepatitis B virus DNA in chronically infected patients assessed by Alu-PCR. 2018

Larsson, Simon B / Tripodi, Gianluca / Raimondo, Giovanni / Saitta, Carlo / Norkrans, Gunnar / Pollicino, Teresa / Lindh, Magnus. ·Department of Infectious Diseases, Institute of Biomedicine, University of Gothenburg, Gothenburg, Sweden. · Division of Clinical and Molecular Hepatology, Department of Internal Medicine, University Hospital of Messina, Messina, Italy. ·J Med Virol · Pubmed #29797342.

ABSTRACT: Hepatitis B virus (HBV) infection is the main risk factor for hepatocellular carcinoma (HCC) worldwide. Integration of HBV DNA into the human genome has been found in >80% of HBV-related HCC cases. Some studies have, however, found similar integration patterns in tumorous and nontumorous tissues. Thus, the role of integrations for the development of HCC as well as the rate of integration in different stages of infection remain unclear. The aim of this study was to investigate integrations in patients without HCC, representing different stages of chronic HBV (CHB) infection. Extracted DNA in liver biopsies from 74 patients (one with 2 available biopsies) with CHB infection was analyzed by Alu-PCR. Amplicons were further analyzed by Sanger sequencing. Integration was detected in 39 biopsies (52%) as an amplicon containing both human and HBV sequences by Alu-PCR with one primer targeting a region in the HBV genome. Integrations were found in patients representing the different stages of CHB infection. A majority of the HBV sequences were located upstream or downstream of nucleotide position 1820, which previously has been identified as a common breakpoint in the HBV genome in integrated sequences. Approximately 60% of the HBV integrations were found in noncoding regions of the human genome. Integrations of HBV DNA into the human genome is an event frequently found in mild phases of chronic hepatitis.

17 Article Incidence of Hepatocellular Carcinoma in Patients With HCV-Associated Cirrhosis Treated With Direct-Acting Antiviral Agents. 2018

Calvaruso, Vincenza / Cabibbo, Giuseppe / Cacciola, Irene / Petta, Salvatore / Madonia, Salvatore / Bellia, Alessandro / Tinè, Fabio / Distefano, Marco / Licata, Anna / Giannitrapani, Lydia / Prestileo, Tullio / Mazzola, Giovanni / Di Rosolini, Maria Antonietta / Larocca, Licia / Bertino, Gaetano / Digiacomo, Antonio / Benanti, Francesco / Guarneri, Luigi / Averna, Alfonso / Iacobello, Carmelo / Magro, Antonio / Scalisi, Ignazio / Cartabellotta, Fabio / Savalli, Francesca / Barbara, Marco / Davì, Antonio / Russello, Maurizio / Scifo, Gaetano / Squadrito, Giovanni / Cammà, Calogero / Raimondo, Giovanni / Craxì, Antonio / Di Marco, Vito / Anonymous1661061. ·Sezione di Gastroenterologia e Epatologia, Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S.), University of Palermo, Palermo, Italy. · UOC Epatologia Clinica e Biomolecolare and AOUP G Martino, Dipartimento di Medicina Interna e Sperimentale, University of Messina, Messina, Italy. · UOC Medicina Interna, AO Villa Sofia-Cervello, Palermo, Italy. · UOS Epatologia, ARNAS Garibaldi-Nesima, Catania, Italy. · UOC Gastroenterologia, AO Villa Sofia-Cervello, Palermo, Italy. · UOC Malattie Infettive, Ospedale Vittorio Emanuele di Siracusa, ASP Siracusa, Siracusa, Italy. · UOC Medicina Interna, AOUP Paolo Giaccone, Palermo, Italy. · UOC Malattie Infettive, ARNAS Civico-Di Cristina-Benefratelli, Palermo, Italy. · UOC Malattie Infettive, Azienda Ospedaliera Universitaria Paolo Giaccone, Palermo, Italy. · UOC Malattie Infettive, Ospedale di Modica, ASP Ragusa, Ragusa, Italy. · UOC Malattie infettive, AOUP G Rodolico, Catania, Italy. · UOC Medicina Interna, AOUP G Rodolico, Catania, Italy. · UOC Medicina Interna, Ospedale di Comiso, ASP Ragusa, Ragusa, Italy. · UOC Malattie Infettive, ARNAS Garibaldi-Nesima, Catania, Italy. · UOC Malattie Infettive, Ospedale di Enna, ASP Enna, Enna, Italy. · UOC Malattie Infettive, Ospedale di Caltanissetta, ASP Caltanissetta, Caltanissetta, Italy. · UOC Malattie Infettive, AO Cannizzaro, Catania, Italy. · UOC Medicina Interna, Ospedale di Agrigento, ASP Agrigento, Agrigento, Italy. · UOC Medicina Interna, Ospedale di Mazzara del Vallo, ASP, Trapani, Italy. · UOC Medicina Interna, Ospedale Buccheri La Ferla, Palermo, Italy. · UOC Malattie Infettive, Ospedale di Trapani, ASP Trapani, Trapani, Italy. · Sezione di Gastroenterologia e Epatologia, Dipartimento Biomedico di Medicina Interna e Specialistica (Di.Bi.M.I.S.), University of Palermo, Palermo, Italy. Electronic address: vito.dimarco@unipa.it. ·Gastroenterology · Pubmed #29655836.

ABSTRACT: BACKGROUND & AIMS: Studies have produced conflicting results of the incidence of hepatocellular carcinoma (HCC) in patients with hepatitis C virus-associated cirrhosis treated with direct-acting antivirals (DAAs). Data from clinics are needed to accurately assess the occurrence rate of HCC in patients with cirrhosis in the real world. METHODS: We collected data from a large prospective study of 2,249 consecutive patients (mean age = 65.4 years, 56.9% male) with hepatitis C virus-associated cirrhosis (90.5% with Child-Pugh class A and 9.5% with Child-Pugh class B) treated with DAAs from March 2015 through July 2016 at 22 academic and community liver centers in Sicily, Italy. HCC occurrence was evaluated by Kaplan-Meier curves. Cox regression analysis was used to identify variables associated with HCC development. RESULTS: A sustained virologic response (SVR) was achieved by 2,140 patients (total = 95.2%; 95.9% with Child Pugh class A and 88.3% with Child Pugh class B; P < .001). Seventy-eight patients (3.5%) developed HCC during a mean follow-up of 14 months (range = 6-24 months). At 1 year after exposure to DAAs, HCC developed in 2.1% of patients with Child-Pugh class A with an SVR and 6.6% of patients with no SVR and in 7.8% of patients with Child-Pugh class B with an SVR and 12.4% of patients with no SVR (P < .001 by log-rank test). Albumin level below 3.5 g/dL (hazard ratio = 1.77, 95% confidence interval = 1.12-2.82, P = .015), platelet count below 120 × 10 CONCLUSIONS: In an analysis of data from a large prospective study of patients with hepatitis C virus-associated compensated or decompensated cirrhosis, we found that the SVR to DAA treatment decreased the incidence of HCC over a mean follow-up of 14 months.

18 Article Incidence of DAA failure and the clinical impact of retreatment in real-life patients treated in the advanced stage of liver disease: Interim evaluations from the PITER network. 2017

Kondili, Loreta A / Gaeta, Giovanni Battista / Brunetto, Maurizia Rossana / Di Leo, Alfredo / Iannone, Andrea / Santantonio, Teresa Antonia / Giammario, Adele / Raimondo, Giovanni / Filomia, Roberto / Coppola, Carmine / Amoruso, Daniela Caterina / Blanc, Pierluigi / Del Pin, Barbara / Chemello, Liliana / Cavalletto, Luisa / Morisco, Filomena / Donnarumma, Laura / Rumi, Maria Grazia / Gasbarrini, Antonio / Siciliano, Massimo / Massari, Marco / Corsini, Romina / Coco, Barbara / Madonia, Salvatore / Cannizzaro, Marco / Zignego, Anna Linda / Monti, Monica / Russo, Francesco Paolo / Zanetto, Alberto / Persico, Marcello / Masarone, Mario / Villa, Erica / Bernabucci, Veronica / Taliani, Gloria / Biliotti, Elisa / Chessa, Luchino / Pasetto, Maria Cristina / Andreone, Pietro / Margotti, Marzia / Brancaccio, Giuseppina / Ieluzzi, Donatella / Borgia, Guglielmo / Zappulo, Emanuela / Calvaruso, Vincenza / Petta, Salvatore / Falzano, Loredana / Quaranta, Maria Giovanna / Weimer, Liliana Elena / Rosato, Stefano / Vella, Stefano / Giannini, Edoardo Giovanni. ·Istituto Superiore di Sanità, Rome, Italy. · Second University of Naples, Naples, Italy. · University Hospital of Pisa, Pisa, Italy. · University of Pisa, Pisa, Italy. · University of Bari, Bari, Italy. · University of Foggia, Foggia, Italy. · University Hospital of Messina, Messina, Italy. · Gragnano Hospital, Gragnano, Italy. · S.M. Annunziata Hospital, Florence, Italy. · University Hospital of Padua, Padua, Italy. · University of Naples Federico II, Naples, Italy. · University of Milan, Milan, Italy. · Catholic University of Rome, Rome, Italy. · Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy. · Villa-Sofia Cervello Hospital, Palermo, Italy. · University of Florence, Florence, Italy. · University of Padua, Padua, Italy. · University of Salerno, Salerno, Italy. · University of Modena and Reggio Emilia, Modena, Italy. · Sapienza University of Rome, Rome, Italy. · University of Cagliari, Cagliari, Italy. · University of Bologna, Bologna, Italy. · University Hospital of Verona, Verona, Italy. · University of Palermo, Palermo, Italy. · University of Genova, Genova, Italy. ·PLoS One · Pubmed #28977040.

ABSTRACT: BACKGROUND: Few data are available on the virological and clinical outcomes of advanced liver disease patients retreated after first-line DAA failure. AIM: To evaluate DAA failure incidence and the retreatment clinical impact in patients treated in the advanced liver disease stage. METHODS: Data on HCV genotype, liver disease severity, and first and second line DAA regimens were prospectively collected in consecutive patients who reached the 12-week post-treatment and retreatment evaluations from January 2015 to December 2016 in 23 of the PITER network centers. RESULTS: Among 3,830 patients with advanced fibrosis (F3) or cirrhosis, 139 (3.6%) failed to achieve SVR. Genotype 3, bilirubin levels >1.5mg/dl, platelet count <120,000/mm3 and the sofosbuvir+ribavirin regimen were independent predictors of failure by logistic regression analysis. The failure rate was 7.6% for patients treated with regimens that are no longer recommended or considered suboptimal (sofosbuvir+ribavirin or simeprevir+sofosbuvir±ribavirin), whereas 1.4% for regimens containing sofosbuvir combined with daclatasvir or ledipasvir or other DAAs. Of the patients who failed to achieve SVR, 72 (51.8%) were retreated with a second DAA regimen, specifically 38 (52.7%) with sofosbuvir+daclatasvir, 27 (37.5%) with sofosbuvir+ledipasvir, and 7 (9.7%) with other DAAs ±ribavirin. Among these, 69 (96%) patients achieved SVR12 and 3 (4%) failed. During a median time of 6 months (range: 5-14 months) between failure and the second DAA therapy, the Child-Pugh class worsened in 12 (16.7%) patients: from A to B in 10 patients (19.6%) and from B to C in 2 patients (10.5%), whereas it did not change in the remaining 60 patients. Following the retreatment SVR12 (median time of 6 months; range: 3-12 months), the Child-Pugh class improved in 17 (23.6%) patients: from B to A in 14 (19.4%) patients, from C to A in 1 patient (1.4%) and from C to B in 2 (2.9%) patients; it remained unchanged in 53 patients (73.6%) and worsened in 2 (2.8%) patients. Of patients who were retreated, 3 (4%) had undergone OLT before retreatment (all reached SVR12 following retreatment) and 2 (2.8%) underwent OLT after having achieved retreatment SVR12. Two (70%) of the 3 patients who failed to achieve SVR12 after retreatment, and 2 (2.8%) of the 69 patients who achieved retreatment SVR12 died from liver failure (Child-Pugh class deteriorated from B to C) or HCC complications. CONCLUSIONS: Failure rate following the first DAA regimen in patients with advanced disease is similar to or lower than that reported in clinical trials, although the majority of patients were treated with suboptimal regimens. Interim findings showed that worsening of liver function after failure, in terms of Child Pugh class deterioration, was improved by successful retreatment in about one third of retreated patients within a short follow-up period; however, in some advanced liver disease patients, clinical outcomes (Child Pugh class, HCC development, liver failure and death) were independent of viral eradication.

19 Article Low prevalence of hepatitis B and hepatitis C virus serum markers in a cohort of pregnant women from Southern Italy. 2017

Lembo, Tindaro / Saffioti, Francesca / Chiofalo, Benito / Granese, Roberta / Filomia, Roberto / Grasso, Roberta / Triolo, Onofrio / Raimondo, Giovanni. ·Department of Clinical and Experimental Medicine, University Hospital of Messina, Italy; Division of Clinical and Molecular Hepatology, University Hospital of Messina, Italy. · Department of Clinical and Experimental Medicine, University Hospital of Messina, Italy. · Department of Human Pathology, University Hospital of Messina, Italy; Division of Obstetrics and Gynecology, University Hospital of Messina, Italy. · Division of Clinical and Molecular Hepatology, University Hospital of Messina, Italy. · Department of Clinical and Experimental Medicine, University Hospital of Messina, Italy; Division of Clinical and Molecular Hepatology, University Hospital of Messina, Italy. Electronic address: raimondo@unime.it. ·Dig Liver Dis · Pubmed #28818677.

ABSTRACT: BACKGROUND: Mother-to-child transmission is still considered a major factor in the spread of hepatitis viruses. Nevertheless, epidemiological data on hepatitis B virus (HBV) and hepatitis C virus (HCV) in reproductive-age women are limited even in areas like the South of Italy where both viruses had been widespread. AIM: The aim of this study was to investigate the prevalence of HBV and HCV serum markers in a large cohort of pregnant women from Southern Italy. METHODS: Data concerning 7558 pregnant women consecutively admitted to an Obstetric Division of a Sicilian University Hospital over a six-year period (January 2010-December 2015) were retrospectively collected from clinical notes. RESULTS: Positivity for both HBV s-antigen (HBsAg) and antibodies to HCV (anti- HCV) was very low (0.5% and 0.2%, respectively). HBsAg prevalence was significantly higher in non-Italian than in Italian women (p<0.001). On the contrary, all the anti-HCV positive cases were of Italian origin. Age was not significantly different between positive and negative women. CONCLUSION: These results confirm the dramatic decline of HBV and HCV prevalence that recently occurred in Southern Italy, and highlight the importance and cost-effectiveness of systematic HBV and HCV screening in childbearing age women in order to properly apply the available preventive measures and definitively eliminate the risk of vertical transmission for both viruses.

20 Article Is early recurrence of hepatocellular carcinoma in HCV cirrhotic patients affected by treatment with direct-acting antivirals? A prospective multicentre study. 2017

Cabibbo, G / Petta, S / Calvaruso, V / Cacciola, I / Cannavò, M R / Madonia, S / Distefano, M / Larocca, L / Prestileo, T / Tinè, F / Bertino, G / Giannitrapani, L / Benanti, F / Licata, A / Scalisi, I / Mazzola, G / Cartabellotta, F / Alessi, N / Barbàra, M / Russello, M / Scifo, G / Squadrito, G / Raimondo, G / Craxì, A / Di Marco, V / Cammà, C / Anonymous4290915. ·Palermo, Italy. · Messina, Italy. · Catania, Italy. · Siracusa, Italy. · Castelvetrano, Italy. ·Aliment Pharmacol Ther · Pubmed #28791711.

ABSTRACT: BACKGROUND: Data on HCV-related hepatocellular carcinoma (HCC) early recurrence in patients whose HCC was previously cured, and subsequently treated by direct-acting antivirals (DAAs), are equivocal. AIM: To assess the risk of HCC early recurrence after DAAs exposure in a large prospective cohort of HCV-cirrhotic patients with previous successfully treated HCC, also looking for risk factors for cancer early recurrence. METHODS: We enrolled 143 consecutive patients with complete response after curative treatment of HCC, subsequently treated with DAAs and monitored by the web-based RESIST-HCV database. Clinical, biological, and virological data were collected. The primary endpoint was the probability of HCC early recurrence from DAA starting by Kaplan-Meier method. RESULTS: Eighty-six per cent of patients were in Child-Pugh class A and 76% of patients were BCLC A. Almost all patients (96%) achieved sustained virological response. Twenty-four HCC recurrences were observed, with nodular or infiltrative pattern in 83% and 17% of patients, respectively. The 6-, 12- and 18-month HCC recurrence rates were 12%, 26.6% and 29.1%, respectively. Main tumour size and history of prior HCC recurrence were independent risk factors for HCC recurrence by Cox multivariate model. CONCLUSIONS: Probability of HCC early recurrence in patients who had HCC previously cured remains high, despite HCV eradication by DAAs. Risk was comparable but not higher to that reported in literature in DAA-untreated patients. Previous HCC recurrence and tumour size can be used to stratify the risk of HCC early recurrence. Further studies are needed to assess impact of DAAs on late recurrence and mortality.

21 Article Modeling cost-effectiveness and health gains of a "universal" versus "prioritized" hepatitis C virus treatment policy in a real-life cohort. 2017

Kondili, Loreta A / Romano, Federica / Rolli, Francesca Romana / Ruggeri, Matteo / Rosato, Stefano / Brunetto, Maurizia Rossana / Zignego, Anna Linda / Ciancio, Alessia / Di Leo, Alfredo / Raimondo, Giovanni / Ferrari, Carlo / Taliani, Gloria / Borgia, Guglielmo / Santantonio, Teresa Antonia / Blanc, Pierluigi / Gaeta, Giovanni Battista / Gasbarrini, Antonio / Chessa, Luchino / Erne, Elke Maria / Villa, Erica / Ieluzzi, Donatella / Russo, Francesco Paolo / Andreone, Pietro / Vinci, Maria / Coppola, Carmine / Chemello, Liliana / Madonia, Salvatore / Verucchi, Gabriella / Persico, Marcello / Zuin, Massimo / Puoti, Massimo / Alberti, Alfredo / Nardone, Gerardo / Massari, Marco / Montalto, Giuseppe / Foti, Giuseppe / Rumi, Maria Grazia / Quaranta, Maria Giovanna / Cicchetti, Americo / Craxì, Antonio / Vella, Stefano / Anonymous610914. ·Istituto Superiore di Sanità, Rome, Italy. · Catholic University, Rome, Italy. · University of Pisa, Pisa, Italy. · University of Florence, Florence, Italy. · University of Turin, Turin, Italy. · University of Bari, Bari, Italy. · University Hospital of Messina, Messina, Italy. · Azienda Ospedaliero-Universitaria di Parma, Parma, Italy. · Sapienza University of Rome, Rome, Italy. · University of Naples Federico II, Naples, Italy. · University of Foggia, Foggia, Italy. · Ospedale Santa Maria Annunziata, Florence, Italy. · Second University of Naples, Naples, Italy. · University of Cagliari, Cagliari, Italy. · University of Padua, Padua, Italy. · University of Modena and Reggio Emilia, Modena, Italy. · Azienda Ospedaliero Universitaria di Verona, Verona, Italy. · University of Bologna, Bologna, Italy. · Niguarda Ca' Granda Hospital, Milan, Italy. · Gragnano Hospital, Naples, Italy. · Cervello Hospital, Palermo, Italy. · University of Salerno, Salerno, Italy. · University of Milan, Milan, Italy. · IRCSS-Azienda Ospedaliera Santa Maria Nuova, Reggio Emilia, Italy. · University of Palermo, Palermo, Italy. · Bianchi Melacrino-Morelli Hospital, Reggio Calabria, Italy. ·Hepatology · Pubmed #28741307.

ABSTRACT: We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. CONCLUSION: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).

22 Article Ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, plus ribavirin for patients with hepatitis C virus genotype 1 or 4 infection with cirrhosis (ABACUS): a prospective observational study. 2017

Petta, Salvatore / Marzioni, Marco / Russo, Pierluigi / Aghemo, Alessio / Alberti, Alfredo / Ascione, Antonio / Antinori, Andrea / Bruno, Raffaele / Bruno, Savino / Chirianni, Antonio / Gaeta, Giovanni Battista / Giannini, Edoardo G / Merli, Manuela / Messina, Vincenzo / Montilla, Simona / Perno, Carlo Federico / Puoti, Massimo / Raimondo, Giovanni / Rendina, Maria / Silberstein, Francesca Ceccherini / Villa, Erica / Zignego, Anna Linda / Pani, Luca / Craxì, Antonio / Anonymous2430906 / Anonymous2440906. ·Section of Gastroenterology and Hepatology, Biomedical Department of Internal and Specialized Medicine (DiBiMIS), University of Palermo, Palermo, Italy. Electronic address: salvatore.petta@unipa.it. · Clinic of Gastroenterology and Hepatology, Università Politecnica delle Marche, Ancona, Italy. · Italian Medicines Agency, Rome, Italy. · L'Unità Operativa Gastroenterologia ed Epatologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan, Italy. · Department of Molecular Medicine, University of Padova, Padova, Italy. · Centro per le malattie del Fegato, Ospedale Fatebenefratelli, Napoli, Italy. · National Institute for Infectious Diseases, "Lazzaro Spallanzani" Istituto di Ricovero e Cura a Carattere Scientific (IRCCS), Rome, Italy. · Dipartimento Malattie Infettive, Fondazione IRCCS Policlinico San Matteo Pavia Italia, Università degli studi di Pavia, Pavia, Italy. · Humanitas University and Humanitas Research Hospital Rozzano, Milan, Italy. · UOC Infezioni sistemiche e dell'immunodepresso, AO Ospedali dei Colli Napoli, Napoli, Italy. · Infectious Diseases and Viral Hepatitis, Second University of Naples, Naples, Italy. · Gastroenterology Unit, Department of Internal Medicine, University of Genoa, Genoa, Italy. · Gastroenterology Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy. · Infectious Diseases Unit, AORN Sant'Anna e San Sebastiano, Caserta, Italy. · Department of Experimental Medicine and Surgery, University of Rome Tor Vergata, Rome, Italy. · Department of Infectious Diseases, AO Niguarda Ca' Granda, Milan, Italy. · Division of Clinical and Molecular Hepatology, Department of Clinical and Experimental Medicine, University Hospital of Messina, Messina, Italy. · Gastroenterology and Digestive Endoscopy, University Hospital Policlinico Bari, Bari, Italy. · Division of Gastroenterology, Azienda Ospedaliero, Universitaria Policlinico di Modena, Italy Università degli Studi di Modena e Reggio Emilia, Modena, Italy. · Interdepartmental Centre MASVE, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. · Section of Gastroenterology and Hepatology, Biomedical Department of Internal and Specialized Medicine (DiBiMIS), University of Palermo, Palermo, Italy. ·Lancet Gastroenterol Hepatol · Pubmed #28497758.

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

23 Article Real-life data on potential drug-drug interactions in patients with chronic hepatitis C viral infection undergoing antiviral therapy with interferon-free DAAs in the PITER Cohort Study. 2017

Kondili, Loreta A / Gaeta, Giovanni Battista / Ieluzzi, Donatella / Zignego, Anna Linda / Monti, Monica / Gori, Andrea / Soria, Alessandro / Raimondo, Giovanni / Filomia, Roberto / Di Leo, Alfredo / Iannone, Andrea / Massari, Marco / Corsini, Romina / Gulminetti, Roberto / Gatti Comini, Alberto / Toniutto, Pierluigi / Dissegna, Denis / Russo, Francesco Paolo / Zanetto, Alberto / Rumi, Maria Grazia / Brancaccio, Giuseppina / Danieli, Elena / Brunetto, Maurizia Rossana / Weimer, Liliana Elena / Quaranta, Maria Giovanna / Vella, Stefano / Puoti, Massimo. ·Department of Therapeutic Research and Medicine Evaluation, Istituto Superiore di Sanità, Rome, Italy. · Infectious Diseases, Second University of Naples, Naples, Italy. · Clinical Unit of Gastroenterology, Azienda Ospedaliera Universitaria Integrata Verona, Verona, Italy. · Center for Systemic Manifestations of Hepatitis Viruses (MaSVE), Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. · Department of Infectious Diseases, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy. · Department of Internal Medicine, University Hospital of Messina, Messina Italy. · Section of Gastroenterology, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. · Infectious Diseases, Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia, Reggio Emilia, Italy. · Infectious Diseases, University of Pavia, Pavia, Italy. · Gastroenterology, Department of Surgical and Gastroenterological Sciences, University of Udine, Udine, Italy. · Department of Surgical and Gastroenterological Sciences, University Hospital of Padua, Padua, Italy. · Division of Hepatology, Ospedale San Giuseppe, Università degli Studi di Milano, Milan, Italy. · Division of Infectious Diseases, Azienda Ospedaliera Ospedale Niguarda Ca' Granda, Milan, Italy. · Hepatology Unit, University Hospital of Pisa, Pisa, Italy. ·PLoS One · Pubmed #28245248.

ABSTRACT: BACKGROUND: There are few real-life data on the potential drug-drug interactions (DDIs) between anti-HCV direct-acting antivirals (DAAs) and the comedications used. AIM: To assess the potential DDIs of DAAs in HCV-infected outpatients, according to the severity of liver disease and comedication used in a prospective multicentric study. METHODS: Data from patients in 15 clinical centers who had started a DAA regimen and were receiving comedications during March 2015 to March 2016 were prospectively evaluated. The DDIs for each regimen and comedication were assigned according to HepC Drug Interactions (www.hep-druginteractions.org). RESULTS: Of the 449 patients evaluated, 86 had mild liver disease and 363 had moderate-to-severe disease. The use of a single comedication was more frequent among patients with mild liver disease (p = 0.03), whereas utilization of more than three drugs among those with moderate-to-severe disease (p = 0.05). Of the 142 comedications used in 86 patients with mild disease, 27 (20%) may require dose adjustment/closer monitoring, none was contraindicated. Of the 322 comedications used in 363 patients with moderate-to-severe liver disease, 82 (25%) were classified with potential DDIs that required only monitoring and dose adjustments; 10 (3%) were contraindicated in severe liver disease. In patients with mild liver disease 30% (26/86) used at least one drug with a potential DDI whereas of the 363 patients with moderate-to-severe liver disease, 161 (44%) were at risk for one or more DDI. CONCLUSIONS: Based on these results, we can estimate that 30-44% of patients undergoing DAA and taking comedications are at risk of a clinically significant DDI. This data indicates the need for increased awareness of potential DDI during DAA therapy, especially in patients with moderate-to-severe liver disease. For several drugs, the recommendation related to the DDI changes from "dose adjustment/closer monitoring", in mild to moderate liver disease, to "the use is contraindicated" in severe liver disease.

24 Article Evaluation of liver enzyme levels and identification of asymptomatic liver disease patients in primary care. 2017

Cacciola, Irene / Scoglio, Riccardo / Alibrandi, Angela / Squadrito, Giovanni / Raimondo, Giovanni / Anonymous6240881. ·Department of Internal Medicine, University Hospital of Messina, Via Consolare Valeria, 1, 98124, Messina, Italy. icacciola@unime.it. · SIMG-Messina Hypertransaminasemia Study Group, Messina, Italy. · SEFISAST Department, University of Messina, Messina, Italy. · Department of Internal Medicine, University Hospital of Messina, Via Consolare Valeria, 1, 98124, Messina, Italy. · Department of Internal Medicine, University Hospital of Messina, Via Consolare Valeria, 1, 98124, Messina, Italy. raimondo@unime.it. ·Intern Emerg Med · Pubmed #27644706.

ABSTRACT: The evaluation of serum liver enzyme levels is the most used surrogate marker of liver injury in clinical practice. The prevalence and association of abnormal enzyme values with hepatitis B virus (HBV) and hepatitis C virus (HCV) infections, and with other major causes of liver damage (obesity, diabetes, dyslipidemia, and alcohol abuse) were evaluated in individuals attending the surgeries of 14 general practitioners (GPs) working in Messina. Alanine-amino-transferase, aspartate-amino-transferase, and gamma-glutamyl-transpeptidase measurements were measured in 7816 individuals consecutively attending the GP surgeries between January 1, 2011 and June 30, 2012. Five-thousand-eight-hundred-six subjects (74.3 %) had the tests performed, and 1189 of them (20.5 %) showed increased liver enzyme levels. Sixty-nine of these 1189 individuals (5.8 %) were HCV positive and 12 HBV positive (1 %), 755 (63.5 %) were overweight or obese, 288 (24.2 %) had diabetes, and 351 (29.5 %) had dyslipidemia; 262 (22 %) drank >2 alcoholic units/day. Overall, 57 % of individuals with abnormal liver enzymes had multiple possible causes of liver disease, 28 % one cause, and 15 % no apparent cause. In conclusion, this study shows that 1/5 of individuals attending GP surgeries have altered liver biochemistry and that overweight and metabolic disorders have become the major causes of liver damage even in South Italy, where HBV and HCV were endemic in the past century. Notably, many HCV and HBV patients are still unaware of their infected status, and GPs are essential for their timely identification.

25 Article A combination of different diagnostic tools allows identification of inactive hepatitis B virus carriers at a single time point evaluation. 2017

Maimone, Sergio / Caccamo, Gaia / Squadrito, Giovanni / Alibrandi, Angela / Saffioti, Francesca / Spinella, Rosaria / Raffa, Giuseppina / Pollicino, Teresa / Raimondo, Giovanni. ·Division of Clinical and Molecular Hepatology, University Hospital of Messina, Messina, Italy. · Department of Human Pathology, University of Messina, Messina, Italy. · Department of Economics, University of Messina, Messina, Italy. · Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy. ·Liver Int · Pubmed #27606573.

ABSTRACT: BACKGROUND & AIMS: Serial evaluation of hepatitis B virus (HBV) DNA and aminotransferase values is required for identification of inactive HBV carriers (ICs). Recently, HBV surface antigen quantification (qHBsAg) and liver stiffness measurement (LSM) have been proposed as diagnostic tools in chronic HBV infection. The aim of this study was to evaluate the efficacy of HBV DNA quantification, qHBsAg and LSM in diagnosing ICs at a single time point. METHODS: Fifty-seven previously characterized ICs and 90 untreated HBsAg-/anti-HBe-positive patients [49 chronic hepatitis (CH), 41 cirrhosis] were enrolled. HBV DNA ≤2000 IU/mL, LSM ≤6.2 kPa and qHBsAg ≤1000 IU/mL were used as cut-offs to evaluate sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and diagnostic accuracy (DA). RESULTS: Combined HBV DNA quantification and qHBsAg correctly identified 30/57 (52.6%) ICs showing 94% sensitivity, 96% specificity, 98% PPV, 87% NPV and 95% DA. HBV DNA coupled with LSM identified 40/57 (70.2%) ICs showing 97% sensitivity, 97% specificity, 98% PPV, 95% NPV and 97% DA. Combined LSM and qHBsAg identified 33/57 (57.9%) ICs showing 95% sensitivity, 78% specificity, 89% PPV, 89% NPV and 89% DA. The evaluation of the three parameters altogether allowed the identification of 23/57 (40.3%) ICs showing 100% specificity, 96% sensitivity, 100% PPV, 92% NPV and 97% DA. Similar results were obtained when either CH or cirrhotic patients were excluded from the analysis. CONCLUSIONS: Combined evaluation of HBV DNA amount with LSM and/or qHBsAg is a highly reliable tool allowing the identification of a considerable number of HBV ICs at a single time point evaluation.

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