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1. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Pasulo, Luisa, Coppola, Carmine, Pisano, Federica, Romano, Mariarosaria, Porcu, Carmen, Bottalico, Irene Francesca, Cossiga, Valentina, Tata, Xhimi, Sagnelli, Caterina, Pierotti, Piera, Degasperi, Elisabetta, Rosato, Valerio, Badia, Lorenzo, Ieluzzi, Dontella, Monti, Monica, Bavetta, Maria Grazia, Cavalletto, Luisa, Toniutto, Pierluigi, Fornasiere, Ezio, Colecchia, Antonio, Ferrarese, Alberto, Nardone, Gerardo, Rocco, Alba, Viganò, Mauro, Foschi, Francesco Giuseppe, Conti, Fabio, Morsica, Giulia, Salpietro, Stefania, Torti, Carlo, Costa, Chiara, Federico, Alessandro, Dallio, Marcello, Giorgini, Alessia, Anselmo, Marco, De Leo, Pasqualina, Zaltron, Serena, Cambianica, Anna, Piscaglia, Fabio, Serio, Ilaria, Schivazappa, Simona, Mastroianni, Antonio, Chidichimo, Luciana, Massari, Marco, Mazzaro, Cesare, Marrone, Aldo, D'Amore, Francesca Maria, D'Offizi, Gianpiero, Licata, Anna, Niro, Grazia Anna, Pollicino, Teresa, Aghemo, Alessio, Brancaccio, Giuseppina, Coco, Barbara, Nardi, Alessandra, Quaranta, Maria Giovanna, Tosti, Maria Elena, Ferrigno, Luigina, Cacciola, Irene, Messina, Vincenzo, Chessa, Luchino, Morisco, Filomena, Milella, Michele, Barbaro, Francesco, Ciancio, Alessia, Russo, Francesco Paolo, Coppola, Nicola, Blanc, Pierluigi, Claar, Ernesto, Verucchi, Gabriella, Puoti, Massimo, Zignego, Anna Linda, Chemello, Liliana, Madonia, Salvatore, Fagiuoli, Stefano, Marzano, Alfredo, Ferrari, Carlo, Lampertico, Pietro, Di Marco, Vito, Craxì, Antonio, Santantonio, Teresa Antonia, Raimondo, Giovanni, Brunetto, Maurizia R., Gaeta, Giovanni Battista, and Kondili, Loreta A.

Published
2023
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2. Hepatitis B Core-Related Antigen to Indicate High Viral Load: Systematic Review and Meta-Analysis of 10,397 Individual Participants

Author

Yoshida, Kyoko, Desbiolles, Alice, Feldman, Sarah F., Ahn, Sang Hoon, Alidjinou, Enagnon K., Atsukawa, Masanori, Bocket, Laurence, Brunetto, Maurizia R., Buti, Maria, Carey, Ivana, Caviglia, Gian Paolo, Chen, En-Qiang, Cornberg, Markus, Enomoto, Masaru, Honda, Masao, Zu Siederdissen, Christoph Höner, Ishigami, Masatoshi, Janssen, Harry L.A., Maasoumy, Benjamin, Matsui, Takeshi, Matsumoto, Akihiro, Nishiguchi, Shuhei, Riveiro-Barciela, Mar, Takaki, Akinobu, Tangkijvanich, Pisit, Toyoda, Hidenori, van Campenhout, Margo J.H., Wang, Bo, Wei, Lai, Yang, Hwai-I, Yano, Yoshihiko, Yatsuhashi, Hiroshi, Yuen, Man-Fung, Tanaka, Eiji, Lemoine, Maud, Tanaka, Yasuhito, and Shimakawa, Yusuke

Published
2021
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3. TLR7 Agonist Increases Responses of Hepatitis B Virus–Specific T Cells and Natural Killer Cells in Patients With Chronic Hepatitis B Treated With Nucleos(T)Ide Analogues

Author

Boni, Carolina, Vecchi, Andrea, Rossi, Marzia, Laccabue, Diletta, Giuberti, Tiziana, Alfieri, Arianna, Lampertico, Pietro, Grossi, Glenda, Facchetti, Floriana, Brunetto, Maurizia R., Coco, Barbara, Cavallone, Daniela, Mangia, Alessandra, Santoro, Rosanna, Piazzolla, Valeria, Lau, Audrey, Gaggar, Anuj, Subramanian, G. Mani, and Ferrari, Carlo

Published
2018
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4. Predicting de‐novoportal vein thrombosis after HCV eradication: A long‐term competing risk analysis in the ongoing PITER cohort

Author

Kondili, Loreta A., Zanetto, Alberto, Quaranta, Maria Giovanna, Ferrigno, Luigina, Panetta, Valentina, Calvaruso, Vincenza, Zignego, Anna Linda, Brunetto, Maurizia R., Raimondo, Giovanni, Biliotti, Elisa, Ieluzzi, Donatella, Iannone, Andrea, Madonia, Salvatore, Chemello, Liliana, Cavalletto, Luisa, Coppola, Carmine, Morisco, Filomena, Barbaro, Francesco, Licata, Anna, Federico, Alessandro, Cerini, Federica, Persico, Marcello, Pompili, Maurizio, Ciancio, Alessia, Piscaglia, Fabio, Chessa, Luchino, Giacometti, Andrea, Invernizzi, Pietro, Brancaccio, Giuseppina, Benedetti, Antonio, Baiocchi, Leonardo, Gentile, Ivan, Coppola, Nicola, Nardone, Gerardo, Craxì, Antonio, Russo, Francesco Paolo, Monti, Monica, Coco, Barbara, Filomia, Roberto, Bruno, Erica Maria, Cossiga, Valentina, Amodeo, Simona, Dallio, Marcello, Crapanzano, Luciano, Masarone, Mario, De Siena, Martina, Serio, Ilaria, Loi, Martina, Brescini, Lucia, Ciaccio, Antonio, Cucco, Monica, Tata, Xhimi, Sagnelli, Caterina, Sgamato, Costantino, Claar, Ernesto, Rosselli Del Turco, Elena, Rumi, Maria Grazia, Gaeta, Giovanni Battista, and Simioni, Paolo

Abstract

Sustained virological response (SVR) by direct‐acting antivirals (DAAs) may reverse the hypercoagulable state of HCV cirrhosis and the portal vein thrombosis (PVT) risk. We evaluated the incidence and predictive factors of de novo, non‐tumoral PVT in patients with cirrhosis after HCV eradication. Patients with HCV‐related cirrhosis, consecutively enrolled in the multi‐center ongoing PITER cohort, who achieved the SVR using DAAs, were prospectively evaluated. Kaplan‐Meier and competing risk regression analyses were performed. During a median time of 38.3 months (IQR: 25.1–48.7 months) after the end of treatment (EOT), among 1609 SVR patients, 32 (2.0%) developed de novo PVT. A platelet count ≤120,000/μL, albumin levels ≤3.5 mg/dL, bilirubin >1.1 mg/dL, a previous liver decompensation, ALBI, Baveno, FIB‐4, and RESIST scores were significantly different (p< 0.001), among patients who developed PVT versus those who did not. Considering death and liver transplantation as competing risk events, esophageal varices (subHR: 10.40; CI 95% 4.33–24.99) and pre‐treatment ALBI grade ≥2 (subHR: 4.32; CI 95% 1.36–13.74) were independent predictors of PVT. After HCV eradication, a significant variation in PLT count, albumin, and bilirubin (p< 0.001) versus pre‐treatment values was observed in patients who did not develop PVT, whereas no significant differences were observed in those who developed PVT (p> 0.05). After the EOT, esophageal varices and ALBI grade ≥2, remained associated with de novo PVT (subHR: 9.32; CI 95% 3.16–27.53 and subHR: 5.50; CI 95% 1.67–18.13, respectively). In patients with HCV‐related cirrhosis, a more advanced liver disease and significant portal hypertension are independently associated with the de novo PVT risk after SVR.

Published
2024
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5. Trends in chronic hepatitis B virus infection in Italy over a 10-year period: Clues from the nationwide PITER and MASTER cohorts toward elimination

Author

Brancaccio, Giuseppina, primary, Coco, Barbara, additional, Nardi, Alessandra, additional, Quaranta, Maria Giovanna, additional, Tosti, Maria Elena, additional, Ferrigno, Luigina, additional, Cacciola, Irene, additional, Messina, Vincenzo, additional, Chessa, Luchino, additional, Morisco, Filomena, additional, Milella, Michele, additional, Barbaro, Francesco, additional, Ciancio, Alessia, additional, Russo, Francesco Paolo, additional, Coppola, Nicola, additional, Blanc, Pierluigi, additional, Claar, Ernesto, additional, Verucchi, Gabriella, additional, Puoti, Massimo, additional, Zignego, Anna Linda, additional, Chemello, Liliana, additional, Madonia, Salvatore, additional, Fagiuoli, Stefano, additional, Marzano, Alfredo, additional, Ferrari, Carlo, additional, Lampertico, Pietro, additional, Di Marco, Vito, additional, Craxì, Antonio, additional, Santantonio, Teresa Antonia, additional, Raimondo, Giovanni, additional, Brunetto, Maurizia R., additional, Gaeta, Giovanni Battista, additional, Kondili, Loreta A., additional, Pasulo, Luisa, additional, Coppola, Carmine, additional, Pisano, Federica, additional, Romano, Mariarosaria, additional, Porcu, Carmen, additional, Bottalico, Irene Francesca, additional, Cossiga, Valentina, additional, Tata, Xhimi, additional, Sagnelli, Caterina, additional, Pierotti, Piera, additional, Degasperi, Elisabetta, additional, Rosato, Valerio, additional, Badia, Lorenzo, additional, Ieluzzi, Dontella, additional, Monti, Monica, additional, Bavetta, Maria Grazia, additional, Cavalletto, Luisa, additional, Toniutto, Pierluigi, additional, Fornasiere, Ezio, additional, Colecchia, Antonio, additional, Ferrarese, Alberto, additional, Nardone, Gerardo, additional, Rocco, Alba, additional, Viganò, Mauro, additional, Foschi, Francesco Giuseppe, additional, Conti, Fabio, additional, Morsica, Giulia, additional, Salpietro, Stefania, additional, Torti, Carlo, additional, Costa, Chiara, additional, Federico, Alessandro, additional, Dallio, Marcello, additional, Giorgini, Alessia, additional, Anselmo, Marco, additional, De Leo, Pasqualina, additional, Zaltron, Serena, additional, Cambianica, Anna, additional, Piscaglia, Fabio, additional, Serio, Ilaria, additional, Schivazappa, Simona, additional, Mastroianni, Antonio, additional, Chidichimo, Luciana, additional, Massari, Marco, additional, Mazzaro, Cesare, additional, Marrone, Aldo, additional, D'Amore, Francesca Maria, additional, D'Offizi, Gianpiero, additional, Licata, Anna, additional, Niro, Grazia Anna, additional, Pollicino, Teresa, additional, and Aghemo, Alessio, additional

Published
2023
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6. Hepatitis D double reflex testing of all hepatitis B carriers in low-HBV- and high-HBV/HDV-prevalence countries

Author

Razavi, Homie A, Buti, Maria, Terrault, Norah A, Zeuzem, Stefan, Yurdaydin, Cihan, Tanaka, Junko, Aghemo, Alessio, Akarca, Ulus S, Al Masri, Nasser M, Alalwan, Abduljaleel M, Aleman, Soo, Alghamdi, Abdullah S, Alghamdi, Saad, Al-Hamoudi, Waleed K, Aljumah, Abdulrahman A, Altraif, Ibrahim H, Asselah, Tarik, Ben-Ari, Ziv, Berg, Thomas, Biondi, Mia J, Blach, Sarah, Braga, Wornei S M, Brandão-Mello, Carlos E, Brunetto, Maurizia R, Cabezas, Joaquin, Cheinquer, Hugo, Chen, Pei-Jer, Cheon, Myeong-Eun, Chuang, Wan-Long, Coffin, Carla S, Coppola, Nicola, Craxi, Antonio, Crespo, Javier, De Ledinghen, Victor, Duberg, Ann-Sofi, Etzion, Ohad, Ferraz, Maria Lucia G, Ferreira, Paulo R A, Forns, Xavier, Foster, Graham R, Gaeta, Giovanni B, Gamkrelidze, Ivane, García-Samaniego, Javier, Gheorghe, Liliana S, Gholam, Pierre M, Gish, Robert G, Glenn, Jeffrey, Hercun, Julian, Hsu, Yao-Chun, Hu, Ching-Chih, Huang, Jee-Fu, Janjua, Naveed, Jia, Jidong, Kåberg, Martin, Kaita, Kelly D E, Kamal, Habiba, Kao, Jia-Horng, Kondili, Loreta A, Lagging, Martin, Lázaro, Pablo, Lazarus, Jeffrey V, Lee, Mei-Hsuan, Lim, Young-Suk, Marotta, Paul J, Navas, Maria-Cristina, Naveira, Marcelo C M, Orrego, Mauricio, Osiowy, Carla, Pan, Calvin Q, Pessoa, Mário G, Raimondo, Giovanni, Ramji, Alnoor, Razavi-Shearer, Devin M, Razavi-Shearer, Kathryn, Ríos-Hincapié, Cielo Y, Rodríguez, Manuel, Rosenberg, William M C, Roulot, Dominique M, Ryder, Stephen D, Safadi, Rifaat, Sanai, Faisal M, Santantonio, Teresa A, Sarrazin, Christoph, Shouval, Daniel, Tacke, Frank, Tergast, Tammo L, Villalobos-Salcedo, Juan Miguel, Voeller, Alexis S, Yang, Hwai-I, Yu, Ming-Lung, Zuckerman, Eli, Razavi, Homie A, Buti, Maria, Terrault, Norah A, Zeuzem, Stefan, Yurdaydin, Cihan, Tanaka, Junko, Aghemo, Alessio, Akarca, Ulus S, Al Masri, Nasser M, Alalwan, Abduljaleel M, Aleman, Soo, Alghamdi, Abdullah S, Alghamdi, Saad, Al-Hamoudi, Waleed K, Aljumah, Abdulrahman A, Altraif, Ibrahim H, Asselah, Tarik, Ben-Ari, Ziv, Berg, Thomas, Biondi, Mia J, Blach, Sarah, Braga, Wornei S M, Brandão-Mello, Carlos E, Brunetto, Maurizia R, Cabezas, Joaquin, Cheinquer, Hugo, Chen, Pei-Jer, Cheon, Myeong-Eun, Chuang, Wan-Long, Coffin, Carla S, Coppola, Nicola, Craxi, Antonio, Crespo, Javier, De Ledinghen, Victor, Duberg, Ann-Sofi, Etzion, Ohad, Ferraz, Maria Lucia G, Ferreira, Paulo R A, Forns, Xavier, Foster, Graham R, Gaeta, Giovanni B, Gamkrelidze, Ivane, García-Samaniego, Javier, Gheorghe, Liliana S, Gholam, Pierre M, Gish, Robert G, Glenn, Jeffrey, Hercun, Julian, Hsu, Yao-Chun, Hu, Ching-Chih, Huang, Jee-Fu, Janjua, Naveed, Jia, Jidong, Kåberg, Martin, Kaita, Kelly D E, Kamal, Habiba, Kao, Jia-Horng, Kondili, Loreta A, Lagging, Martin, Lázaro, Pablo, Lazarus, Jeffrey V, Lee, Mei-Hsuan, Lim, Young-Suk, Marotta, Paul J, Navas, Maria-Cristina, Naveira, Marcelo C M, Orrego, Mauricio, Osiowy, Carla, Pan, Calvin Q, Pessoa, Mário G, Raimondo, Giovanni, Ramji, Alnoor, Razavi-Shearer, Devin M, Razavi-Shearer, Kathryn, Ríos-Hincapié, Cielo Y, Rodríguez, Manuel, Rosenberg, William M C, Roulot, Dominique M, Ryder, Stephen D, Safadi, Rifaat, Sanai, Faisal M, Santantonio, Teresa A, Sarrazin, Christoph, Shouval, Daniel, Tacke, Frank, Tergast, Tammo L, Villalobos-Salcedo, Juan Miguel, Voeller, Alexis S, Yang, Hwai-I, Yu, Ming-Lung, and Zuckerman, Eli

Abstract

Hepatitis D virus (HDV) infection occurs as a coinfection with hepatitis B and increases the risk of hepatocellular carcinoma, decompensated cirrhosis, and mortality compared to hepatitis B virus (HBV) monoinfection. Reliable estimates of the prevalence of HDV infection and disease burden are essential to formulate strategies to find coinfected individuals more effectively and efficiently. The global prevalence of HBV infections was estimated to be 262,240,000 in 2021. Only 1,994,000 of the HBV infections were newly diagnosed in 2021, with more than half of the new diagnoses made in China. Our initial estimates indicated a much lower prevalence of HDV antibody (anti-HDV) and HDV RNA positivity than previously reported in published studies. Accurate estimates of HDV prevalence are needed. The most effective method to generate estimates of the prevalence of anti-HDV and HDV RNA positivity and to find undiagnosed individuals at the national level is to implement double reflex testing. This requires anti-HDV testing of all hepatitis B surface antigen-positive individuals and HDV RNA testing of all anti-HDV-positive individuals. This strategy is manageable for healthcare systems since the number of newly diagnosed HBV cases is low. At the global level, a comprehensive HDV screening strategy would require only 1,994,000 HDV antibody tests and less than 89,000 HDV PCR tests. Double reflex testing is the preferred strategy in countries with a low prevalence of HBV and those with a high prevalence of both HBV and HDV. For example, in the European Union and North America only 35,000 and 22,000 cases, respectively, will require anti-HDV testing annually.

Published
2023
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8. Case Report: MIS-C With Prominent Hepatic and Pancreatic Involvement in a Vaccinated Adolescent – A Critical Reasoning

Author

Consolini, Rita, Costagliola, Giorgio, Spada, Erika, Colombatto, Piero, Orsini, Alessandro, Bonuccelli, Alice, Brunetto, Maurizia R., and Peroni, Diego G.

Subjects
Pediatrics, Perinatology and Child Health
Abstract

Multisystem inflammatory syndrome in children (MIS-C) is a pathologic condition that has emerged during the coronavirus disease 2019 (COVID-19) pandemic. Although the epidemiological evidence of association between MIS-C and SARS-CoV-2 infection has been demonstrated, its pathogenic mechanism is still undefined. We describe the case of a 17-year old female, previously vaccinated against SARS-CoV-2, presenting with a history of asthenia, fever, cough, anorexia, abdominal pain, and vomiting. During the hospitalization, the patient developed bilateral conjunctivitis, hand vasculitis, cutaneous rash, and multiple pulmonary nodules, following by hepatitis and pancreatitis. As she reported a high-risk contact with a SARS-CoV-2 positive patient 10 days before admission, the epidemiological link and the clinical picture characterized by multi-system organ disfunction and inflammatory biomarkers increase led us to the diagnosis of MIS-C. Therefore, the patient was treated with intravenous immunoglobulin and corticosteroids, resulting in a rapid resolution of fever, cutaneous, and pulmonary involvement, while the recovery of hepatitis and pancreatitis was observed in the following weeks. This case leads to the discussion on whether SARS-CoV-2 immunized children and adolescents should be considered at risk of developing MIS-C and on their possible presentation with non-classic clinical features. Additionally, due to the increasing number of vaccinated children and adolescents, the issues resulting either from the diagnostic suspect of MIS-C or from the consequent need of an early therapeutic approach are discussed.

Published
2022

10. Global change in hepatitis C virus prevalence and cascade of care between 2015 and 2020:a modelling study

Author

Blach, Sarah, Terrault, Norah A., Tacke, Frank, Gamkrelidze, Ivane, Craxi, Antonio, Tanaka, Junko, Waked, Imam, Dore, Gregory J., Abbas, Zaigham, Abdallah, Ayat R., Abdulla, Maheeba, Aghemo, Alessio, Aho, Inka, Akarca, Ulus S., Alalwan, Abduljaleel M., Alanko Blomé, Marianne, Al-Busafi, Said A., Aleman, Soo, Alghamdi, Abdullah S., Al-Hamoudi, Waleed K., Aljumah, Abdulrahman A., Al-Naamani, Khalid, Al Serkal, Yousif M., Altraif, Ibrahim H., Anand, Anil C., Anderson, Motswedi, Andersson, Monique I., Athanasakis, Kostas, Baatarkhuu, Oidov, Bakieva, Shokhista R., Ben-Ari, Ziv, Bessone, Fernando, Biondi, Mia J., Bizri, Abdul Rahman N., Brandão-Mello, Carlos E., Brigida, Krestina, Brown, Kimberly A., Brown,, Robert S., Bruggmann, Philip, Brunetto, Maurizia R., Busschots, Dana, Buti, Maria, Butsashvili, Maia, Cabezas, Joaquin, Chae, Chungman, Chaloska Ivanova, Viktorija, Chan, Henry Lik Yuen, Cheinquer, Hugo, Cheng, Kent Jason, Weis, Nina, Blach, Sarah, Terrault, Norah A., Tacke, Frank, Gamkrelidze, Ivane, Craxi, Antonio, Tanaka, Junko, Waked, Imam, Dore, Gregory J., Abbas, Zaigham, Abdallah, Ayat R., Abdulla, Maheeba, Aghemo, Alessio, Aho, Inka, Akarca, Ulus S., Alalwan, Abduljaleel M., Alanko Blomé, Marianne, Al-Busafi, Said A., Aleman, Soo, Alghamdi, Abdullah S., Al-Hamoudi, Waleed K., Aljumah, Abdulrahman A., Al-Naamani, Khalid, Al Serkal, Yousif M., Altraif, Ibrahim H., Anand, Anil C., Anderson, Motswedi, Andersson, Monique I., Athanasakis, Kostas, Baatarkhuu, Oidov, Bakieva, Shokhista R., Ben-Ari, Ziv, Bessone, Fernando, Biondi, Mia J., Bizri, Abdul Rahman N., Brandão-Mello, Carlos E., Brigida, Krestina, Brown, Kimberly A., Brown,, Robert S., Bruggmann, Philip, Brunetto, Maurizia R., Busschots, Dana, Buti, Maria, Butsashvili, Maia, Cabezas, Joaquin, Chae, Chungman, Chaloska Ivanova, Viktorija, Chan, Henry Lik Yuen, Cheinquer, Hugo, Cheng, Kent Jason, and Weis, Nina

Abstract

Background: Since the release of the first global hepatitis elimination targets in 2016, and until the COVID-19 pandemic started in early 2020, many countries and territories were making progress toward hepatitis C virus (HCV) elimination. This study aims to evaluate HCV burden in 2020, and forecast HCV burden by 2030 given current trends. Methods: This analysis includes a literature review, Delphi process, and mathematical modelling to estimate HCV prevalence (viraemic infection, defined as HCV RNA-positive cases) and the cascade of care among people of all ages (age ≥0 years from birth) for the period between Jan 1, 2015, and Dec 31, 2030. Epidemiological data were collected from published sources and grey literature (including government reports and personal communications) and were validated among country and territory experts. A Markov model was used to forecast disease burden and cascade of care from 1950 to 2050 for countries and territories with data. Model outcomes were extracted from 2015 to 2030 to calculate population-weighted regional averages, which were used for countries or territories without data. Regional and global estimates of HCV prevalence, cascade of care, and disease burden were calculated based on 235 countries and territories. Findings: Models were built for 110 countries or territories: 83 were approved by local experts and 27 were based on published data alone. Using data from these models, plus population-weighted regional averages for countries and territories without models (n=125), we estimated a global prevalence of viraemic HCV infection of 0·7% (95% UI 0·7–0·9), corresponding to 56·8 million (95% UI 55·2–67·8) infections, on Jan 1, 2020. This number represents a decrease of 6·8 million viraemic infections from a 2015 (beginning of year) prevalence estimate of 63·6 million (61·8–75·8) infections (0·9% [0·8–1·0] prevalence). By the end of 2020, an estimated 12·9 million (12·5–15·4) people were living with a diagnosed viraemic inf

Published
2022

12. Add-on peginterferon alfa-2a to nucleos(t)ide analogue therapy for Caucasian patients with hepatitis B ‘e’ antigen-negative chronic hepatitis B genotype D

Author

Lampertico, Pietro, Brunetto, Maurizia R., Craxì, Antonio, Gaeta, Giovanni B., Rizzetto, Mario, Rozzi, Antonella, Colombo, Massimo, Antonio, D., Andreone, P., Brancaccio, G., Bronte, F., Bruzzone, L., Caccamo, G., Caccianotti, B., Calvaruso, V., Chessa, L., Ciarallo, M., Coco, B., Colombatto, P., Cursaro, C., D'Aluisio, D., Demelia, L., Di Marco, V., Dissegna, D., Invernizzi, F., Lenisa, I., Lembo, T., Levrero, M., Marchese, V., Mangia, G., Picciotto, A., Pierconti, S., Raimondo, G., Rastelli, C., Rizzo, V., Santantonio, T., Scuteri, A., Sorbello, O., Squadrito, G., Subic, M., Toniutto, P., Vukotic, R., Lampertico, Pietro, Brunetto, Maurizia R., Craxì, Antonio, Gaeta, Giovanni B., Rizzetto, Mario, Rozzi, Antonella, Colombo, Massimo, Antonio, D., Andreone, P., Brancaccio, G., Bronte, F., Bruzzone, L., Caccamo, G., Caccianotti, B., Calvaruso, V., Chessa, L., Ciarallo, M., Coco, B., Colombatto, P., Cursaro, C., D'Aluisio, D., Demelia, L., Di Marco, V., Dissegna, D., Invernizzi, F., Lenisa, I., Lembo, T., Levrero, M., Marchese, V., Mangia, G., Picciotto, A., Pierconti, S., Raimondo, G., Rastelli, C., Rizzo, V., Santantonio, T., Scuteri, A., Sorbello, O., Squadrito, G., Subic, M., Toniutto, P., Vukotic, R., Brunetto, Maurizia R, Gaeta, Giovanni B, Brancaccio, Giuseppina, Lampertico P1, Brunetto MR2, Craxì Antonio, Gaeta GB4, Rizzetto M5, Rozzi A6, Colombo M7, and Antonio D, Andreone P, Antonio D, Brancaccio G, Bronte F, Bruzzone L, Caccamo G, Caccianotti B, Calvaruso V, Chessa L, Ciarallo M, Coco B, Colombatto P, Cursaro C, D'Aluisio D, Demelia L, Di Marco V, Dissegna D, Invernizzi F, Lenisa I, Lembo T, Levrero M, Marchese V, Mangia G, Picciotto A, Pierconti S, Antonio D, Raimondo G, Rastelli C, Rizzo V, Santantonio T, Scuteri A, Sorbello O, Squadrito G, Subic M, Toniutto P, Vukotic R.

Subjects
Male, HBsAg, Gastroenterology, Polyethylene Glycols, chronic hepatitis B, HBeAg-negative, nucleos(t)ide analogues, peginterferon, treatment, Hepatology, Infectious Diseases, Virology, 0302 clinical medicine, Interferon, Genotype, HBV, Hepatitis B e Antigens, chronic hepatitis b, hbeag-negative, adult, antiviral agents, drug administration schedule, drug therapy, combination, female, genotype, hepatitis b e antigens, hepatitis b virus, hepatitis b, chronic, humans, interferon-alpha, male, middle aged, nucleosides, polyethylene glycols, recombinant proteins, treatment outcome, education.field_of_study, virus diseases, Nucleosides, Middle Aged, Recombinant Proteins, Treatment Outcome, nucleos(t)ide analogue, HBeAg, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Peginterferon alfa-2a, medicine.drug, Adult, Hepatitis B virus, medicine.medical_specialty, Combination therapy, Population, Infectious Disease, Antiviral Agents, Drug Administration Schedule, 03 medical and health sciences, Hepatitis B, Chronic, Internal medicine, medicine, Humans, education, business.industry, Interferon-alpha, Confidence interval, business
Abstract

Nucleos(t)ide analogues (NAs) and peginterferon have complementary effects in chronic hepatitis B, but it is unclear whether combination therapy improves responses in genotype D-infected patients. We conducted an open-label study of peginterferon alfa-2a 180 μg/week added to ongoing NA therapy in hepatitis B e antigen (HBeAg)-negative, genotype D-infected patients with HBV DNA

Published
2019

13. Hepatitis B Core-related Antigen Identify Patients With High Viral Load: Systematic Review and Meta-analysis of Individual Participant Data

Author

Yoshida, Kyoko, Desbiolles, Alice, Feldman, Sarah F, Ahn, Sang Hoon, Alidjinou, Enagnon K, Atsukawa, Masanori, Bocket, Laurence, Brunetto, Maurizia R, Buti, Maria, Carey, Ivana, Caviglia, Gian Paolo, Chen, En-Qiang, Cornberg, Markus, Enomoto, Masaru, Honda, Masao, Zu Siederdissen, Christoph Höner, Ishigami, Masatoshi, Janssen, Harry LA, Maasoumy, Benjamin, Matsui, Takeshi, Matsumoto, Akihiro, Nishiguchi, Shuhei, Riveiro-Barciela, Mar, Takaki, Akinobu, Tangkijvanich, Pisit, Toyoda, Hidenori, van Campenhout, Margo Jh, Wang, Bo, Wei, Lai, Yang, Hwai-I, Yano, Yoshihiko, Yatsuhashi, Hiroshi, Yuen, Man-Fung, Tanaka, Eiji, Lemoine, Maud, Tanaka, Yasuhito, and Shimakawa, Yusuke

Subjects
real-world, developing nation, diagnosis, diagnostic test
Published
2021

14. Maturation of the Visceral (Gut-Adipose-Liver) Network in Response to the Weaning Reaction versus Adult Age and Impact of Maternal High-Fat Diet

Author

Instituto de Salud Carlos III, European Commission, Guzzardi, Maria Angela, La Rosa, Federica, Campani, Daniela, Cacciato Insilla, Andrea, De Sena, Vincenzo, Panetta, Daniele, Brunetto, Maurizia R., Bonino, Ferruccio, Collado, María Carmen, Iozzo, Patricia, Instituto de Salud Carlos III, European Commission, Guzzardi, Maria Angela, La Rosa, Federica, Campani, Daniela, Cacciato Insilla, Andrea, De Sena, Vincenzo, Panetta, Daniele, Brunetto, Maurizia R., Bonino, Ferruccio, Collado, María Carmen, and Iozzo, Patricia

Abstract

Metabolic-associated fatty liver disease is a major cause of chronic pathologies, of which maternal obesity is a frequent risk factor. Gut wall and microbiota, visceral fat, and liver form a pre-systemic network for substrates and pro-inflammatory factors entering the body, undergoing accelerated maturation in early-life when the weaning reaction, i.e., a transitory inflammatory condition, affects lifelong health. We aimed to characterize organ metabolism in the above network, in relation to weaning reaction and maternal obesity. Weaning or 6-months-old offspring of high-fat-diet and normal-diet fed dams underwent in vivo imaging of pre-/post-systemic glucose uptake and tissue radiodensity in the liver, visceral fat, and intestine, a liver histology, and microbiota and metabolic pathway analyses. Weaning mice showed the dominance of gut Clostridia and Bacteroidia members, overexpressing pathways of tissue replication and inflammation; adulthood increased proneness to steatohepatitis, and Desulfovibrio and RF39 bacteria, and lipopolysaccharide, bile acid, glycosaminoglycan, and sphingolipid metabolic pathways. In vivo imaging could track organ maturation, liver inflammation, and protective responses. A maternal high-fat diet amplified the weaning reaction, elevating liver glucose uptake, triglyceride levels, and steatohepatitis susceptibility along the lifespan. The visceral network establishes a balance between metabolism and inflammation, with clear imaging biomarkers, and crucial modulation in the weaning time window.

Published
2021

15. Guidance for design and endpoints of clinical trials in chronic hepatitis B - Report from the 2019 EASL-AASLD HBV Treatment Endpoints Conferences

Author

Cornberg, Markus Lok, Anna Suk-Fong Terrault, Norah A. and Zoulim, Fabien Berg, Thomas Brunetto, Maurizia R. Buchholz, Stephanie Buti, Maria Chan, Henry L. Y. Chang, Kyong-Mi and Dandri, Maura Dusheiko, Geoffrey Feld, Jordan J. Ferrari, Carlo Ghany, Marc Janssen, Harry L. A. Kennedy, Patrick and Lampertico, Pietro Liang, Jake Locarnini, Stephen Maini, Mala K. Mishra, Poonam Papatheodoridis, George Petersen, Joerg Schlottmann, Silke Wang, Su Wedemeyer, Heiner EASL AASLD HBV Treatment

Subjects
virus diseases, digestive system diseases
Abstract

Representatives from academia, industry, regulatory agencies, and patient groups convened in March 2019 with the primary goal of developing agreement on chronic HBV treatment endpoints to guide clinical trials aiming to ‘cure’ HBV. Agreement among the conference participants was reached on some key points. ‘Functional’ but not sterilising cure is achievable and should be defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment. The primary endpoint of phase III trials should be functional cure; HBsAg loss in >= 30% of patients was suggested as an acceptable rate of response in these trials. Sustained virologic suppression (undetectable serum HBV DNA) without HBsAg loss 6 months after discontinuation of treatment would be an intermediate goal. Demonstrated validity for the prediction of sustained HBsAg loss was considered the most appropriate criterion for the approval of new HBV assays to determine efficacy endpoints. Clinical trials aimed at HBV functional cure should initially focus on patients with HBeAg-positive or negative chronic hepatitis, who are treatment-naive or virally suppressed on nucleos(t)ide analogues. A hepatitis flare associated with an increase in bilirubin or international normalised ratio should prompt temporary or permanent cessation of an investigational treatment. New treatments must be as safe as existing nucleos(t)ide analogues. The primary endpoint for phase III trials for HDV coinfection should be undetectable serum HDV RNA 6 months after stopping treatment. On treatment HDV RNA suppression associated with normalisation of alanine aminotransferase is considered an intermediate goal. In conclusion, regarding HBV ‘functional cure’, the primary goal is sustained HBsAg loss with undetectable HBV DNA after completion of treatment and the intermediate goal is sustained undetectable HBV DNA without HBsAg loss after stopping treatment. (C) 2019 European Association for the Study of the Liver and American Association for the Study of Liver Diseases. Published by Elsevier B.V. All rights reserved.

Published
2020

16. Mo1537 EFFICACY AND SAFETY OF BULEVIRTIDE MONOTHERAPY GIVEN AT 2 MG OR 10 MG DOSE LEVEL ONCE DAILY FOR TREATMENT OF CHRONIC HEPATITIS DELTA: WEEK 48 PRIMARY ENDPOINT RESULTS FROM A PHASE 3 RANDOMIZED, MULTICENTER, PARALLEL-DESIGN STUDY

Author

Wedemeyer, Heiner, Aleman, Soo, Brunetto, maurizia R., Blank, Antje, Andreone, Pietro, Bogomolov, Pavel, Chulanov, Vladimir, Mamonova, Nina, Geyvandova, Natalia, Morozov, Viacheslav, Sagalova, Olga, Stepanova, Tatyana V., Manuilov, Dmitry, Shah, Vicki, Suri, Vithika, An, Qi, Flaherty, John F., Osinusi, Anu, Wiesch, Julian Schulze zur, Cornberg, Markus, Zeuzem, Stefan, and Lampertico, Pietro

Published
2023
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17. Incremental value of HBcrAg to classify 1582 HBeAg‐negative individuals in chronic infection without liver disease or hepatitis

Author

Brunetto, Maurizia R., primary, Carey, Ivana, additional, Maasoumy, Benjamin, additional, Marcos‐Fosch, Cristina, additional, Boonstra, André, additional, Caviglia, Gian Paolo, additional, Loglio, Alessandro, additional, Cavallone, Daniela, additional, Scholtes, Caroline, additional, Ricco, Gabriele, additional, Smedile, Antonina, additional, Riveiro‐Barciela, Mar, additional, van Bömmel, Florian, additional, van der Eijk, Annemiek, additional, Zoulim, Fabien, additional, Berg, Thomas, additional, Cornberg, Markus, additional, Lampertico, Pietro, additional, Agarwal, Kosh, additional, and Buti, Maria, additional

Published
2021
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19. RETRACTION: Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients with Chronic HBV Infection

Author

Seto, Wai-Kay, Asahina, Yasuhiro, Brown, Todd T., Peng, Cheng-Yuan, Stanciu, Carol, Abdurakhmanov, Dzhamal, Tabak, Fehmi, Nguyen, Tuan T., Chuang, Wan-Long, Inokuma, Tetsuro, Ikeda, Fusao, Santantonio, Teresa Antonia, Habersetzer, François, Ramji, Alnoor, Lau, Audrey H., Suri, Vithika, Flaherty, John F., Wang, Hongyuan, Gaggar, Anuj, Subramanian, G. Mani, Mukewar, Shrikant, Brunetto, Maurizia R., Fung, Scott, and Lik-Yuen Chan, Henry

Published
2018
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20. Combined GS-4774 and Tenofovir Therapy Can Improve HBV-Specific T-Cell Responses in Patients With Chronic Hepatitis

Author

Boni, Carolina, primary, Janssen, Harry L.A., additional, Rossi, Marzia, additional, Yoon, Seung Kew, additional, Vecchi, Andrea, additional, Barili, Valeria, additional, Yoshida, Eric M., additional, Trinh, Huy, additional, Rodell, Timothy C., additional, Laccabue, Diletta, additional, Alfieri, Arianna, additional, Brillo, Federica, additional, Fisicaro, Paola, additional, Acerbi, Greta, additional, Pedrazzi, Giuseppe, additional, Andreone, Pietro, additional, Cursaro, Carmela, additional, Margotti, Marzia, additional, Santoro, Rosanna, additional, Piazzolla, Valeria, additional, Brunetto, Maurizia R., additional, Coco, Barbara, additional, Cavallone, Daniela, additional, Zhao, Yang, additional, Joshi, Adarsh, additional, Woo, Jacky, additional, Lau, Audrey H., additional, Gaggar, Anuj, additional, Subramanian, G. Mani, additional, Massetto, Benedetta, additional, Fung, Scott, additional, Ahn, Sang Hoon, additional, Ma, Xiaoli, additional, Mangia, Alessandra, additional, and Ferrari, Carlo, additional

Published
2019
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21. Forecasting Hepatitis C liver disease burden on real-life data. Does the hidden iceberg matter to reach the elimination goals?

Author

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 Rosaria, 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, Vinci, Maria, Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), 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 Rosaria, 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, Vinci, Maria, and Gasbarrini, Antonio (ORCID:0000-0002-7278-4823)

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.

Published
2018

22. No association between IFNL3 (IL28B) genotype and response to peginterferon alfa-2a in HBeAg-positive or -negative chronic hepatitis B

Author

Wei, Lai, primary, Wedemeyer, Heiner, additional, Liaw, Yun-Fan, additional, Chan, Henry Lik-Yuen, additional, Piratvisuth, Teerha, additional, Marcellin, Patrick, additional, Jia, Jidong, additional, Tan, Deming, additional, Chow, Wan-Cheng, additional, Brunetto, Maurizia R., additional, Diago, Moisés, additional, Gurel, Selim, additional, Morozov, Viacheslav, additional, He, Hua, additional, Zhu, Yonghong, additional, Wat, Cynthia, additional, Surujbally, Bernadette, additional, and Thompson, Alexander J., additional

Published
2018
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23. Digital liver biopsy: Bio-imaging of fatty liver for translational and clinical research

Author

Mancini, Marcello, primary, Summers, Paul, additional, Faita, Francesco, additional, Brunetto, Maurizia R, additional, Callea, Francesco, additional, Nicola, Andrea De, additional, Lascio, Nicole Di, additional, Farinati, Fabio, additional, Gastaldelli, Amalia, additional, Gridelli, Bruno, additional, Mirabelli, Peppino, additional, Neri, Emanuele, additional, Salvadori, Piero A, additional, Rebelos, Eleni, additional, Tiribelli, Claudio, additional, Valenti, Luca, additional, Salvatore, Marco, additional, and Bonino, Ferruccio, additional

Published
2018
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24. Direct antiviral agents for treatment-naïve patients with genotype 1 hepatitis C: A statistical model for comparing outcomes between real world and clinical trials

Author

Messori, Andrea, Brunetto, Maurizia R., De Luca, Andrea, and Zignego, Anna Linda

Subjects
Antiviral Agents, Bayes Theorem, Benzimidazoles, Clinical Trials as Topic, Drug Therapy, Combination, Fluorenes, Genotype, Hepacivirus, Hepatitis C, Chronic, Humans, Sofosbuvir, Models, Statistical, Hepatology, Gastroenterology
Published
2015

25. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection

Author

Dore, Gregory J, Lawitz, Eric, Hézode, Christophe, Shafran, Stephen D, Ramji, Alnoor, Tatum, Harvey A, Taliani, Gloria, Tran, Albert, Brunetto, Maurizia R, Zaltron, Serena, Strasser, Simone I, Weis, Nina, Ghesquiere, Wayne, Lee, Samuel S, Larrey, Dominique, Pol, Stanislas, Harley, Hugh, George, Jacob, Fung, Scott K, de Lédinghen, Victor, Hagens, Peggy, McPhee, Fiona, Hernandez, Dennis, Cohen, David, Cooney, Elizabeth, Noviello, Stephanie, Hughes, Eric A, Dore, Gregory J, Lawitz, Eric, Hézode, Christophe, Shafran, Stephen D, Ramji, Alnoor, Tatum, Harvey A, Taliani, Gloria, Tran, Albert, Brunetto, Maurizia R, Zaltron, Serena, Strasser, Simone I, Weis, Nina, Ghesquiere, Wayne, Lee, Samuel S, Larrey, Dominique, Pol, Stanislas, Harley, Hugh, George, Jacob, Fung, Scott K, de Lédinghen, Victor, Hagens, Peggy, McPhee, Fiona, Hernandez, Dennis, Cohen, David, Cooney, Elizabeth, Noviello, Stephanie, and Hughes, Eric A

Abstract

BACKGROUND & AIMS: Twenty-four weeks of treatment with peginterferon and ribavirin for chronic hepatitis C virus (HCV) genotype 2 or 3 infection produces a sustained virologic response (SVR) in 70%-80% of patients. We performed a randomized, double-blind, phase 2b study to assess whether adding daclatasvir, a nonstructural protein 5A (NS5A) inhibitor that is active against these genotypes, improves efficacy and shortens therapy.METHODS: Patients with HCV genotype 2 or 3 infection (n = 151), enrolled at research centers in North America, Europe, or Australia, were assigned randomly to groups given 12 or 16 weeks of daclatasvir (60 mg once daily), or 24 weeks of placebo, each combined with peginterferon alfa-2a and ribavirin. Treatment was extended to 24 weeks for recipients of daclatasvir who did not meet the criteria for early virologic response. The primary end point was SVR at 24 weeks after treatment (SVR24).RESULTS: Baseline characteristics were similar among patients within each HCV genotype group. However, the 80 patients with HCV genotype 3, compared with the 71 patients with HCV genotype 2, were younger (mean age, 45 vs 53 y, respectively), and a larger proportion had cirrhosis (23% vs 1%, respectively). Among patients with HCV genotype 2 infection, an SVR24 was achieved by 83%, 83%, and 63% of those in the daclatasvir 12-week group, the daclatasvir 16-week group, or the placebo group, respectively; among patients with HCV genotype 3 infection, an SVR24 was achieved by 69%, 67%, and 59% of patients in these groups, respectively. Differences between genotypes largely were attributable to the higher frequency of post-treatment relapse among patients infected with HCV genotype 3. In both daclatasvir arms for both HCV genotypes, the lower bound of the 80% confidence interval of the difference in SVR24 rates between the daclatasvir and placebo arms was above -20%, establishing noninferiority. Safety findings were similar among groups, and wer

Published
2015

26. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection:a randomised study

Author

Hézode, Christophe, Hirschfield, Gideon M, Ghesquiere, Wayne, Sievert, William, Rodriguez-Torres, Maribel, Shafran, Stephen D, Thuluvath, Paul J, Tatum, Harvey A, Waked, Imam, Esmat, Gamal, Lawitz, Eric J, Rustgi, Vinod K, Pol, Stanislas, Weis, Nina, Pockros, Paul J, Bourlière, Marc, Serfaty, Lawrence, Vierling, John M, Fried, Michael W, Weiland, Ola, Brunetto, Maurizia R, Everson, Gregory T, Zeuzem, Stefan, Kwo, Paul Y, Sulkowski, Mark, Bräu, Norbert, Hernandez, Dennis, McPhee, Fiona, Wind-Rotolo, Megan, Liu, Zhaohui, Noviello, Stephanie, Hughes, Eric A, Yin, Philip D, Schnittman, Steven, Hézode, Christophe, Hirschfield, Gideon M, Ghesquiere, Wayne, Sievert, William, Rodriguez-Torres, Maribel, Shafran, Stephen D, Thuluvath, Paul J, Tatum, Harvey A, Waked, Imam, Esmat, Gamal, Lawitz, Eric J, Rustgi, Vinod K, Pol, Stanislas, Weis, Nina, Pockros, Paul J, Bourlière, Marc, Serfaty, Lawrence, Vierling, John M, Fried, Michael W, Weiland, Ola, Brunetto, Maurizia R, Everson, Gregory T, Zeuzem, Stefan, Kwo, Paul Y, Sulkowski, Mark, Bräu, Norbert, Hernandez, Dennis, McPhee, Fiona, Wind-Rotolo, Megan, Liu, Zhaohui, Noviello, Stephanie, Hughes, Eric A, Yin, Philip D, and Schnittman, Steven

Abstract

OBJECTIVE: To evaluate the safety and efficacy of daclatasvir, an HCV NS5A inhibitor with pangenotypic activity, administered with peginterferon-alfa-2a/ribavirin.DESIGN: In this Phase 2b double-blind, placebo-controlled study, treatment-naive adults with HCV genotype 1 (N=365) or 4 (N=30) infection were randomly assigned (2:2:1) to daclatasvir 20 mg or 60 mg, or placebo once daily plus weekly peginterferon-alfa-2a and twice-daily ribavirin. Daclatasvir recipients achieving protocol-defined response (PDR; HCV-RNA

Published
2015

27. Daclatasvir Plus Peginterferon and Ribavirin Is Noninferior to Peginterferon and Ribavirin Alone, and Reduces the Duration of Treatment for HCV Genotype 2 or 3 Infection

Author

Dore, Gregory J., primary, Lawitz, Eric, additional, Hézode, Christophe, additional, Shafran, Stephen D., additional, Ramji, Alnoor, additional, Tatum, Harvey A., additional, Taliani, Gloria, additional, Tran, Albert, additional, Brunetto, Maurizia R., additional, Zaltron, Serena, additional, Strasser, Simone I., additional, Weis, Nina, additional, Ghesquiere, Wayne, additional, Lee, Samuel S., additional, Larrey, Dominique, additional, Pol, Stanislas, additional, Harley, Hugh, additional, George, Jacob, additional, Fung, Scott K., additional, de Lédinghen, Victor, additional, Hagens, Peggy, additional, McPhee, Fiona, additional, Hernandez, Dennis, additional, Cohen, David, additional, Cooney, Elizabeth, additional, Noviello, Stephanie, additional, and Hughes, Eric A., additional

Published
2015
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31. T-lymphocyte response to hepatitis C virus in different clinical courses of infection

Author

Botarelli, Patrizia, primary, Brunetto, Maurizia R., additional, Minutello, Maria A., additional, Calvo, Pierluigi, additional, Unutmaz, Derya, additional, Weiner, Amy J., additional, Choo, Qui-lim, additional, Shuster, Jeffrey R., additional, Kuo, George, additional, Bonino, Ferruccio, additional, Houghton, Michael, additional, and Abrignam, Sergio, additional

Published
1993
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32. Eight‐year efficacy and safety of tenofovir alafenamide for treatment of chronic hepatitis B virus infection: Final results from two randomised phase 3 trials.

Author

Buti, Maria, Lim, Young‐Suk, Chan, Henry Lik Yuen, Agarwal, Kosh, Marcellin, Patrick, Brunetto, Maurizia R., Chuang, Wan‐Long, Janssen, Harry L. A., Fung, Scott K., Izumi, Namiki, Jablkowski, Maciej S., Abdurakhmanov, Dzhamal, Abramov, Frida, Wang, Hongyuan, Botros, Irina, Yee, Leland J., Mateo, Roberto, Flaherty, John F., Osinusi, Anu, and Pan, Calvin Q.

Subjects
*HEPATITIS B, *CHRONIC hepatitis B, *HEPATITIS associated antigen, *CLINICAL trials, *REVERSE transcriptase
Abstract

Summary Background Aims Methods Results Conclusion In two phase 3 studies, tenofovir alafenamide (TAF) showed non‐inferior efficacy versus tenofovir disoproxil fumarate (TDF), with more favourable renal and bone safety in patients with chronic hepatitis B (CHB).Here, we report the studies' final 8‐year results.CHB patients (hepatitis B e antigen [HBeAg]‐negative and HBeAg‐positive) were randomised (2:1) to double‐blind TAF 25 mg/day or TDF 300 mg/day for up to 3 years, followed by open‐label (OL) TAF through year 8. Virological, biochemical, serological and fibrosis responses, and safety, including bone and renal parameters, were evaluated. Resistance to TAF was assessed annually by deep sequencing of polymerase/reverse transcriptase and by phenotyping.Among 1298 patients randomised to double‐blind TAF (n = 866) or double‐blind TDF (n = 432), 775 in the TAF group and 382 in the TDF group received OL TAF, including 180 and 202 who switched from TDF to TAF at year 2 (TDF2y → TAF6y) or year 3 (TDF3y → TAF5y), respectively. At year 8, among patients in the TAF8y, TDF2y → TAF6y and TDF3y → TAF5y groups, 69%, 66% and 73% (missing‐equals‐failure analysis) and 95%, 94% and 97% (missing‐equals‐excluded) of patients, respectively, achieved HBV DNA <29 IU/mL. Estimated glomerular filtration rate (Cockcroft‐Gault method; eGFRCG) and hip/spine bone mineral density (BMD) remained stable in patients receiving double‐blind/OL TAF, with only small declines at year 8. Decreases in eGFRCG and hip/spine BMD observed during double‐blind TDF improved after switching to OL TAF. No patients developed resistance to TAF.Long‐term TAF treatment exhibited favourable safety and tolerability with high rates of viral suppression and no development of resistance.ClinicalTrials.gov numbers NCT01940341 and NCT01940471. [ABSTRACT FROM AUTHOR]

Published
2024
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33. Relationship between the intrahepatic expression of 'e' and 'c' epitopes of the nucleocapsid protein of hepatitis B virus and viraemia.

Author

Ballare, M., Lavarini, Carla, Brunetto, Maurizia R., Petruzzelli, Eleonora, Dovis, M., Molino, G., and Bonino, F.

Subjects
HEPATITIS B, LIVER diseases, IMMUNOGLOBULINS, NUCLEIC acid hybridization, MONOCLONAL antibodies, CELL nuclei, PROTEINS
Abstract

The relationship between hepatitis B viraemia and intrahepatic HBV nucleocapsid proteins (HBcAg and HBeAg) was studied in 18 patients with chronic hepatitis B. Monoclonal antibodies (MoABs) were obtained in BALB/c mice primed with recombinant HBV nucleocapsid proteins. Four MoABs reacting with recombinant proteins gave positive results in competitive assays. Two reacted as anti-HBc and two as anti-HBe. One of them showed a strong affinity for the cytoplasmic, membrane bound antigen (P23e) of infected hepatocytes while the latter showed a higher specificity for serum HBeAg than for the intraheptic antigen. Anti-HBeMoA Bs had a staining capacity for liver cell nuclei comparable with that of polyclonal antibodies. Overall the anti-HBc MoABs stained the liver cell nuclei in 86% of cases, while anti-HBc MoABs stained in 58% of cases. The hepatoeytc cytoplasm was stained by anti-HBc MoABs and anti-HBe MoABs in 64% and 72% of cases respectively. Not one of 12 control liver biopsies was stained. Viraemia (HBV-DNA) was measured by dot blot hybridization and was correlated with the number of hepatocytes containing the nucleocapsid antigen. The highest levels of HBV-DNA (>108 genomes/ml) were detected in patients with prevalent nuclear staining while the lowest ones were observed in those with prevalent eytoplasmic expression of this antigen. The application of anti-HBV-nueleocapsid MoABs in diagnostics requires careful scrutiny since some are specific for the circulating antigen while others show a higher afffinity for the intrahepatic antigen. [ABSTRACT FROM AUTHOR]

Published
1989

34. Profiling the risk of hepatocellular carcinoma after long-term HCV eradication in patients with liver cirrhosis in the PITER cohort

Author

Loreta A. Kondili, Maria Giovanna Quaranta, Luisa Cavalletto, Vincenza Calvaruso, Luigina Ferrigno, Roberta D'Ambrosio, Ilaria Simonelli, Giuseppina Brancaccio, Giovanni Raimondo, Maurizia R. Brunetto, Anna Linda Zignego, Carmine Coppola, Andrea Iannone, Elisa Biliotti, Gabriella Verucchi, Marco Massari, Anna Licata, Francesco Barbaro, Marcello Persico, Francesco Paolo Russo, Filomena Morisco, Maurizio Pompili, Mauro Viganò, Massimo Puoti, Teresa Santantonio, Erica Villa, Antonio Craxì, Liliana Chemello, Valentina Panetta, Giovanni Battista Gaeta, Roberto Filomia, Barbara Coco, Monica Monti, Daniela Caterina Amoruso, Salvatore Madonia, Donatella Ieluzzi, Gloria Taliani, Lorenzo Badia, Guglielmo Marco Migliorino, Alessia Giorgini, Mario Masarone, Pierluigi Blanc, Valentina Cossiga, Martina De Siena, Xhimi Tata, Maria Grazia Rumi, Luchino Chessa, Pietro Lampertico, Carlo Ferrari, Ivan Gentile, Giustino Parruti, Leonardo Baiocchi, Alessia Ciancio, Pietro Invernizzi, Alessandro Federico, Carlo Torti, Giulia Morsica, Pietro Andreone, Alessio Aghemo, Patrizia Popoli, Stefano Vella, Kondili, L. A., Quaranta, M. G., Cavalletto, L., Calvaruso, V., Ferrigno, L., D'Ambrosio, R., Simonelli, I., Brancaccio, G., Raimondo, G., Brunetto, M. R., Zignego, A. L., Coppola, C., Iannone, A., Biliotti, E., Verucchi, G., Massari, M., Licata, A., Barbaro, F., Persico, M., Russo, F. P., Morisco, F., Pompili, M., Vigano, M., Puoti, M., Santantonio, T., Villa, E., Craxi, A., Chemello, L., Panetta, V., Gaeta, G. B., Filomia, R., Coco, B., Monti, M., Amoruso, D. C., Madonia, S., Ieluzzi, D., Taliani, G., Badia, L., Migliorino, G. M., Giorgini, A., Masarone, M., Blanc, P., Cossiga, V., De Siena, M., Tata, X., Rumi, M. G., Chessa, L., Lampertico, P., Ferrari, C., Gentile, I., Parruti, G., Baiocchi, L., Ciancio, A., Invernizzi, P., Federico, A., Torti, C., Morsica, G., Andreone, P., Aghemo, A., Popoli, P., Vella, S., Kondili, Loreta A, Quaranta, Maria Giovanna, Cavalletto, Luisa, Calvaruso, Vincenza, Ferrigno, Luigina, D'Ambrosio, Roberta, Simonelli, Ilaria, Brancaccio, Giuseppina, Raimondo, Giovanni, Brunetto, Maurizia R, Zignego, Anna Linda, Coppola, Carmine, Iannone, Andrea, Biliotti, Elisa, Verucchi, Gabriella, Massari, Marco, Licata, Anna, Barbaro, Francesco, Persico, Marcello, Russo, Francesco Paolo, Morisco, Filomena, Pompili, Maurizio, Viganò, Mauro, Puoti, Massimo, Santantonio, Teresa, Villa, Erica, Craxì, Antonio, and Chemello, Liliana

Subjects
Settore MED/12, Real-life cohort, Hepatology, Direct-acting antiviral, HCC, Long term outcomes, Predictive factors, Gastroenterology, Long term outcome, Predictive factor
Abstract

Background and aims: Severe liver disease markers assessed before HCV eradication are acknowledged to usually improve after the SVR. We prospectively evaluated, in the PITER cohort, the long-term HCC risk profile based on predictors monitored after HCV eradication by direct-acting antivirals in patients with cirrhosis. Methods: HCC occurrence was evaluated by Kaplan-Meier analysis. Cox regression analysis identified the post-treatment variables associated with de-novo HCC; their predictive power was presented in a nomogram. Results: After the end of therapy (median follow-up:28.47 months), among 2064 SVR patients, 119 (5.8%) developed de-novo HCC. The HCC incidence was 1.90%, 4.21%, 6.47% at 12-, 24- and 36-months from end-of-therapy, respectively (incidence rate 2.45/100 person-years). Age, genotype 3, diabetes, platelets (PLT)≤120,000/µl and albumin ≤3.5g/dl levels were identified as pre-treatment HCC independent predictors. Adjusting for age, the post-treatment PLT≤120,000/µl (AdjHR 1.92; 95%CI:1.06-3.45) and albumin≤3.5g/dl (AdjHR 4.38; 95%CI 2.48-7.75) values were independently associated with HCC occurrence. Two different risk profiles were identified by combining long-term post-therapy evaluation of PLT ≤ vs. >120,000/µl and albumin ≤ vs. >3.5g/dl showing a significant different HCC incidence rate of 1.35 vs. 3.77/100 p-y, respectively. Conclusions: The nomogram score based on age, PLT and albumin levels after SVR showed an accurate prediction capability and may support the customizing management for early HCC detection.

Published
2023

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

Author

Kondili, La, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, Al, Brunetto, Mr, Raimondo, G, Taliani, G, Iannone, A, Russo, Fp, Santantonio, Ta, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, Em, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, Mg, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, Mg, Montilla, S, Razavi, H, Melazzini, M, Vella, S, Craxì, A, PITER Collaborating, Group., Kondili LA, Robbins S, Blach S, Gamkrelidze I, Zignego AL, Brunetto MR, Raimondo G, Taliani G, Iannone A, Russo FP, Santantonio TA, Zuin M, Chessa L, Blanc P, Puoti M, Vinci M, Erne EM, Strazzabosco M, Massari M, Lampertico P, Rumi MG, Federico A, Orlandini A, Ciancio A, Borgia G, Andreone P, Caporaso N, Persico M, Ieluzzi D, Madonia S, Gori A, Gasbarrini A, Coppola C, Brancaccio G, Andriulli A, Quaranta MG, Montilla S, Razavi H, Melazzini M, Vella S, Craxì Antonio, 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, Kondili, L. A., Robbins, S., Blach, S., Gamkrelidze, I., Zignego, A. L., Brunetto, M. R., Raimondo, G., Taliani, G., Iannone, A., Russo, F. P., Santantonio, T. A., Zuin, M., Chessa, L., Blanc, P., Puoti, M., Vinci, M., Erne, E. M., Strazzabosco, M., Massari, M., Lampertico, P., Rumi, M. G., Federico, A., Orlandini, A., Ciancio, A., Borgia, G., Andreone, P., Caporaso, N., Persico, M., Ieluzzi, D., Madonia, S., Gori, A., Gasbarrini, A., Coppola, C., Brancaccio, G., Andriulli, A., Quaranta, M. G., Montilla, S., Razavi, H., Melazzini, M., Vella, S., Craxi, A., Kondili, L, Robbins, S, Blach, S, Gamkrelidze, I, Zignego, A, Brunetto, M, Raimondo, G, Taliani, G, Iannone, A, Russo, F, Santantonio, T, Zuin, M, Chessa, L, Blanc, P, Puoti, M, Vinci, M, Erne, E, Strazzabosco, M, Massari, M, Lampertico, P, Rumi, M, Federico, A, Orlandini, A, Ciancio, A, Borgia, G, Andreone, P, Caporaso, N, Persico, M, Ieluzzi, D, Madonia, S, Gori, A, Gasbarrini, A, Coppola, C, Brancaccio, G, Andriulli, A, Quaranta, M, Montilla, S, Razavi, H, Melazzini, M, Vella, S, and Craxi, A

Subjects
HCV, WHO, chronic infection, linkage to care, Liver Cirrhosis, medicine.medical_specialty, Carcinoma, Hepatocellular, Sustained Virologic Response, Viral Hepatitis, Settore MED/12 - GASTROENTEROLOGIA, World Health Organization, Antiviral Agents, NO, 03 medical and health sciences, Liver disease, 0302 clinical medicine, Pharmacotherapy, Cost of Illness, Cause of Death, Health care, medicine, Humans, 030212 general & internal medicine, Viremia, chronic infection, HCV, linkage to care, WHO, Disease Eradication, Mortality, Intensive care medicine, Cause of death, Hepatology, business.industry, Public health, Carcinoma, Liver Neoplasms, Hepatocellular, Hepatitis C, medicine.disease, Markov Chains, Italy, 030211 gastroenterology & hepatology, business, Viral hepatitis
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.

Published
2018

36. Predicting de-novo portal vein thrombosis after HCV eradication: A long-term competing risk analysis in the ongoing PITER cohort.

Author

Kondili LA, Zanetto A, Quaranta MG, Ferrigno L, Panetta V, Calvaruso V, Zignego AL, Brunetto MR, Raimondo G, Biliotti E, Ieluzzi D, Iannone A, Madonia S, Chemello L, Cavalletto L, Coppola C, Morisco F, Barbaro F, Licata A, Federico A, Cerini F, Persico M, Pompili M, Ciancio A, Piscaglia F, Chessa L, Giacometti A, Invernizzi P, Brancaccio G, Benedetti A, Baiocchi L, Gentile I, Coppola N, Nardone G, Craxì A, and Russo FP

Subjects
Humans, Antiviral Agents therapeutic use, Portal Vein, Liver Cirrhosis diagnosis, Liver Cirrhosis epidemiology, Liver Cirrhosis complications, Risk Assessment, Albumins therapeutic use, Bilirubin, Esophageal and Gastric Varices complications, Hepatitis C, Chronic complications, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Venous Thrombosis diagnosis, Venous Thrombosis epidemiology, Venous Thrombosis etiology
Abstract

Background & Aims: Sustained virological response (SVR) by direct-acting antivirals (DAAs) may reverse the hypercoagulable state of HCV cirrhosis and the portal vein thrombosis (PVT) risk. We evaluated the incidence and predictive factors of de novo, non-tumoral PVT in patients with cirrhosis after HCV eradication., Methods: Patients with HCV-related cirrhosis, consecutively enrolled in the multi-center ongoing PITER cohort, who achieved the SVR using DAAs, were prospectively evaluated. Kaplan-Meier and competing risk regression analyses were performed., Results: During a median time of 38.3 months (IQR: 25.1-48.7 months) after the end of treatment (EOT), among 1609 SVR patients, 32 (2.0%) developed de novo PVT. A platelet count ≤120,000/μL, albumin levels ≤3.5 mg/dL, bilirubin >1.1 mg/dL, a previous liver decompensation, ALBI, Baveno, FIB-4, and RESIST scores were significantly different (p < 0.001), among patients who developed PVT versus those who did not. Considering death and liver transplantation as competing risk events, esophageal varices (subHR: 10.40; CI 95% 4.33-24.99) and pre-treatment ALBI grade ≥2 (subHR: 4.32; CI 95% 1.36-13.74) were independent predictors of PVT. After HCV eradication, a significant variation in PLT count, albumin, and bilirubin (p < 0.001) versus pre-treatment values was observed in patients who did not develop PVT, whereas no significant differences were observed in those who developed PVT (p > 0.05). After the EOT, esophageal varices and ALBI grade ≥2, remained associated with de novo PVT (subHR: 9.32; CI 95% 3.16-27.53 and subHR: 5.50; CI 95% 1.67-18.13, respectively)., Conclusions: In patients with HCV-related cirrhosis, a more advanced liver disease and significant portal hypertension are independently associated with the de novo PVT risk after SVR., (© 2023 The Authors. United European Gastroenterology Journal published by Wiley Periodicals LLC on behalf of United European Gastroenterology.)

Published
2024
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37. Improved Bone Safety of Tenofovir Alafenamide Compared to Tenofovir Disoproxil Fumarate Over 2 Years in Patients With Chronic HBV Infection.

Author

Seto WK, Asahina Y, Brown TT, Peng CY, Stanciu C, Abdurakhmanov D, Tabak F, Nguyen TT, Chuang WL, Inokuma T, Ikeda F, Santantonio TA, Habersetzer F, Ramji A, Lau AH, Suri V, Flaherty JF, Wang H, Gaggar A, Subramanian GM, Mukewar S, Brunetto MR, Fung S, and Chan HL

Abstract

Background & Aims: Long-term use of tenofovir disoproxil fumarate (TDF) reduces bone mineral density (BMD). Tenofovir alafenamide (TAF), a new prodrug of tenofovir, has shown non-inferior efficacy to TDF in patients with chronic hepatitis B virus (HBV) infection, with improved bone effects at 48 weeks. We performed a randomized trial to evaluate the bone safety of TAF compared with TDF over 2 years, assessing baseline risk factors for bone loss, were evaluated after 2 years of treatment., Methods: In a double-blind study, hepatitis B e antigen (HBeAg)-positive patients (n = 873) and HBeAg-negative patients (n = 425) were randomly assigned (2:1) to groups given TAF (25 mg; n = 866) or TDF (300 mg; n = 432) once daily. We assessed bone safety, including hip and spine BMD, using dual-energy X-ray absorptiometry and measured changes in serum markers of bone turnover over 96 weeks., Results: At baseline, treatment groups were well matched. At week 96, patients receiving TAF had significantly smaller decreases in hip BMD (mean reduction of 0.33%) than patients receiving TDF (mean reduction of 2.51%) (P < .001) and spine BMD (reduction of 0.75% in patients receiving patients receiving TAF vs reduction of 2.57% in patients receiving TDF) (P < .001). For hip BMD, the magnitude of difference in bone loss between the TAF and TDF groups increased at week 96 compared to week 48 (P < .001). The TAF group had minimal changes in markers of bone turnover by 12 weeks of treatment, but the TDF group had significant changes, compared to baseline. Risk factors for bone loss had fewer effects in patients receiving TAF than TDF at week 96., Conclusions: In double-blind randomized trials, we found that after 2 years of treatment, patients receiving TAF had continued improvements in bone safety compared with patients receiving TDF. Clinicaltrial.gov ID NCT01940471 and NCT01940341., (Copyright © 2018 AGA Institute. Published by Elsevier Inc. All rights reserved.)

Published
2018
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