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

Author

Fiore, Vito, De Vito, Andrea, Rastrelli, Elena, Manca, Valentina, De Matteis, Giuseppe, Ranieri, Roberto, Pontali, Emanuele, Geremia, Nicholas, Panese, Sandro, Starnini, Giulio, Madeddu, Giordano, and Babudieri, Sergio

Subjects
TREATMENT effectiveness, SEROPREVALENCE, HIV-positive persons, COHORT analysis, PRISONERS
Abstract

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

Published
2023
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3. Facing HCV as a Major Public Healthcare Threat in Italy: Epidemiology and Micro-Elimination Pathways among Underserved Populations.

Author

Fiore, Vito, Manca, Valentina, Colpani, Agnese, De Vito, Andrea, Maida, Ivana, Madeddu, Giordano, and Babudieri, Sergio

Subjects
HEPATITIS C treatment, HEPATITIS C diagnosis, ONLINE information services, NOMADS, SYSTEMATIC reviews, HEPATITIS C, CELLULAR signal transduction, SEARCH engines, DISEASE prevalence, REFUGEES, MEDLINE, GREY literature, COVID-19 pandemic
Abstract

Underserved populations have a wide heterogeneity on healthcare provision and use. They also represent the key populations according to WHO 2030 goals for HCV micro-elimination. Our review evaluated the available literature on HCV diagnosis, staging, and treatment among underserved populations, such as incarcerated people, patients with psychiatric disorders, and migrants. A narrative review of literature was performed using key electronic databases (Scopus, Pubmed—MEDLINE) and search engines (Google Scholar). Peer-reviewed publications, grey literature on HCV, and recent models proposed for micro-elimination in underserved populations were included. An insight into the COVID-19 pandemic and its influence on HCV micro-elimination pathways will be also provided. Regarding prison settings, a progressive reduction in HCV epidemiology among incarcerated people in the last years was found (one-third of the level it had been before). People suffering from psychiatric disorders have a high anti-HCV prevalence, but there is a lack of data on active infections. A bidirectional relationship between HCV and psychiatric disorders was found. Migrants showed a very inconsistent assessment of HCV. Furthermore, available studies recorded data from populations with high heterogeneity of anti-HCV prevalence, Therefore, the reported results need caution in their evaluation. [ABSTRACT FROM AUTHOR]

Published
2023
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4. Women Living with HIV in Italian Prison Settings: Results from the Gender-Specific ROSE Network.

Author

Rastrelli, Elena, Fiore, Vito, Ranieri, Roberto, Pontali, Emanuele, Prestileo, Tullio, Barbarini, Giorgio, Ialungo, Anna Maria, Dell'Isola, Serena, De Vito, Andrea, Bolcato, Matteo, Madeddu, Giordano, Di Mizio, Giulio, Starnini, Giulio, and Babudieri, Sergio

Subjects
HEPATITIS C virus, HIV-positive women, HIV prevention, CHRONIC hepatitis C, HIV infection transmission, SEXUAL intercourse
Abstract

Background: Incarcerated women are a minority in the Italian prison population. The lack of prevention and awareness of HIV infection and the lack of access to treatment make the treatment path difficult. Methods: we conducted a multi-center study including incarcerated women living with HIV (WLWH). Results: The study included 85 WLWH with a mean age of 41.7 ± 8.7 years, and 58.8% (50/85) of them were Italian. Principally, HIV transmission was related to sexual intercourse, 47% of all patients were PWIDs, and 62.5% of them were on opioid substitution therapy (OST). Overall, 56.4% of the included patients had a CD4+ cell count of >500 cells/mmc. Among the participants, 92.9% were on antiretroviral therapy, 87.3% had treatment before incarceration, and 83.5% were virologically suppressed. Among the 13 non-virally-suppressed patients, 53.8% were unaware of their serological status before incarceration and had started HAART but were still not virologically suppressed; 46.2% (6/13) had a lack of compliance or had suspended the treatment before incarceration and restarted it after admission. All patients with chronic hepatitis C underwent treatment with direct-acting antivirals and reached a sustained virological response. Conclusions: the detention of these women could represent an occasion for the patients' healthcare provision and use, and the creation of a gender-specific network can be an effective strategy for reaching this population. [ABSTRACT FROM AUTHOR]

Published
2023
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5. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

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

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

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

Published
2018

6. Correlates of infection and molecular characterization of blood-borne HIV, HCV, and HBV infections in HIV-1 infected inmates in Italy

Author

Sanarico, Nunzia, D’Amato, Stefania, Bruni, Roberto, Rovetto, Claudia, Salvi, Emanuela, Di Zeo, Patrizia, Chionne, Paola, Madonna, Elisabetta, Pisani, Giulio, Costantino, Angela, Equestre, Michele, Tosti, Maria E., Cenci, Alessandra, Maggiorella, Maria T., Sernicola, Leonardo, Pontali, Emanuele, Pansera, Alfredo, Quattrocchi, Rocco, Carbonara, Sergio, Signorile, Fabio, Surace, Lorenzo Antonio, Federzoni, Guido, Garlassi, Elisa, Starnini, Giulio, Monarca, Roberto, Babudieri, Sergio, Rapicetta, Maria, Pompa, Maria G., Caraglia, Anna, Ensoli, Barbara, Ciccaglione, Anna R., and Buttò, Stefano

Subjects
Adult, Male, Hepatitis B virus, inmates, Observational Study, HIV Infections, Hepacivirus, virus variability, HBV, Blood-Borne Pathogens, Prevalence, Humans, Aged, virus diseases, HIV, Middle Aged, Hepatitis B, Hepatitis C, digestive system diseases, Cross-Sectional Studies, Italy, HCV, HIV-1, Female, Research Article
Abstract

Coinfection of blood-borne hepatitis B and hepatitis C viruses (HBV and HCV, respectively) in human immunodeficiency virus type 1 (HIV-1)-positive individuals frequently occurs in inmate population and peculiar viral strains and patterns of virological markers may be observed. Plasma from 69 HIV-1-positive inmates was obtained from 7 clinical centers connected with correctional centers in different towns in Italy. HIV, HBV, and HCV markers were tested by commercial assays. Virus genotyping was carried out by sequencing the protease and reverse transcriptase-encoding region (PR-RT region) for HIV and a region encompassing the NS5B gene for HCV and subsequent phylogenetic analysis. Twelve over 14 HIV-subtyped inmates were infected with HIV-1 subtype B strains. The 2 non-B strains belonged to subtype G and CRF02_AG, in an Italian and a Gambian patient, respectively. Variants carrying the K103N and Y181C resistance mutations to non-nucleoside reverse transcriptase inhibitors (NNRTIs) were found in 2 out of 9 patients naive for combined antiretroviral therapy (cART) (22.2%). Most HIV-positive patients (92.8%) showed evidence of past or present HBV and/or HCV infection. Prevalence of HBV and HCV was 81.2% for both viruses, whereas prevalence of HBV/HCV coinfection was 69.6%. A significantly higher presence of HCV infection was found in Italians [odds ratio (OR) 11.0; interval 1.7–80.9] and in drug users (OR 27.8; interval 4.9–186.0). HCV subtypes were determined in 42 HCV or HBV/HCV-coinfected individuals. HCV subtypes 1a, 3a, 4d, and 1b were found in 42.9%, 40.5%, 14.3%, and 2.4% of inmates, respectively. Low titers of HBV DNA in HBV DNA positive subjects precluded HBV subtyping. The high prevalence of HBV and HCV coinfections in HIV-infected inmates, as well as the heterogeneity of HIV and HCV subtypes suggest the need to adopt systematic controls in prisons to monitor both the burden and the genetic forms of blood-borne viral infections, in order to apply targeted therapeutic interventions.

Published
2016

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

Author

Kondili, Loreta A., Andreoni, Massimo, Alberti, Alfredo, Lobello, Salvatore, Babudieri, Sergio, Roscini, Antonio Saverio, Merolla, Rocco, Marrocco, Walter, and Craxì, Antonio

Abstract

• Italy has had the highest HCV prevalence in Western Europe over the past 20 years, while current HCV estimates are unknown. • Using a probabilistic approach and a Markov liver disease progression modelling to estimate the number of annual historical HCV incident cases, we were able to estimate the number of infected asymptomatic individuals. • High estimated burden of 410,775 individuals with chronic HCV infection of whom 281,809 potentially undiagnosed, yet unlinked to care highlight the need to undertake an active country-based screening strategy to attain HCV elimination goals. The universal treatment of diagnosed patients with chronic HCV infection has been widely conducted in Italy since 2017. However, the pool of individuals diagnosed but yet to be treated in Italy has been estimated to end around 2025, leaving a significant proportion of infected individuals undiagnosed/without care. Estimates of this population are currently unknown. A probabilistic modelling approach was applied to estimate annual historical HCV incident cases by their age-group (0–100 years) distribution from available literature and Italian National database (1952 to October 2019). Viraemic infection rates were modelled on the main infection routes in Italy: people who inject drugs (PWID), tattoos, sexual transmission, glass syringe use, blood transfusion and vertical transmission. Annual liver fibrosis stage transition probabilities were modelled using a Markov model. The number of HCV viraemic asymptomatic (fibrosis stage F0-F3:potentially undiagnosed/unlinked to care) and symptomatic (fibrosis stage F4: potentially linked to care) individuals was estimated. By October 2019, total viraemic HCV individuals in Italy (excluding treated patients since 1992) were estimated to be 410,775 (0.68 % of current population of Italy; 95 % CI: 0.64−0.71%, based on the current Italian population), of which 281,809 (0.47 %; 95 % CI:0.35−0.60%) were fibrosis stage F0-F3. Among different high risk groups in stage F0-F3, the following distribution was estimated: PWID; 52.0 % (95 % CI:37.9–66.6 %), tattoo; 28.8 % (95 % CI:23–32.3 %), sexual transmission; 12.0 % (95 % CI:9.6–13.7 %), glass syringe and transfusion; 6.4 % (95 % CI:2.4–17.8 %), and vertical transmission; 0.7 % (95 % CI:0.4–1.2 %). Under the assumption that most untreated HCV-infected individuals with stage F0-F3 are undiagnosed, more than 280,000 individuals are undiagnosed and/or unlinked to care in Italy. Marked heterogeneity across the major routes of HCV transmission was estimated. This modelling approach may be a useful tool to characterise the HCV epidemic profile also in other countries, based on country specific epidemiology and HCV main transmission routes. [ABSTRACT FROM AUTHOR]

Published
2021
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8. Characteristics of hepatitis C virus resistance in an international cohort after a decade of direct-acting antivirals

Author

Anita Y.M. Howe, Chaturaka Rodrigo, Evan B. Cunningham, Mark W. Douglas, Julia Dietz, Jason Grebely, Stephanie Popping, Javier Alejandro Sfalcin, Milosz Parczewski, Christoph Sarrazin, Adolfo de Salazar, Ana Fuentes, Murat Sayan, Josep Quer, Midori Kjellin, Hege Kileng, Orna Mor, Johan Lennerstrand, Slim Fourati, Velia Chiara Di Maio, Vladimir Chulanov, Jean-Michel Pawlotsky, P. Richard Harrigan, Francesca Ceccherini-Silberstein, Federico Garcia, Marianne Martinello, Gail Matthews, Fay Fabián Fernando, Juan I. Esteban, Beat Müllhaupt, Julian Schulze zur Wiesch, Peter Buggisch, Christoph Neumann-Haefelin, Thomas Berg, Christoph P. Berg, Jörn M. Schattenberg, Christophe Moreno, Rudolf Stauber, Andrew Lloyd, Gregory Dore, Tanya Applegate, Juan Ignacio, Damir Garcia-Cehic, Josep Gregori, Francisco Rodriguez-Frias, Ariadna Rando, Yael Gozlan, Mario Angelico, Massimo Andreoni, Sergio Babudieri, Ada Bertoli, Valeria Cento, Nicola Coppola, Antonio Craxì, Stefania Paolucci, Giustino Parruti, Caterina Pasquazzi, Carlo Federico Perno, Elisabetta Teti, C. Vironet, Anders Lannergård, Ann-Sofi Duberg, Soo Aleman, Tore Gutteberg, Alexandre Soulier, Aurélie Gourgeon, Stephane Chevaliez, Stanislas Pol, Fabrice Carrat, Dominique Salmon, Rolf Kaiser, Elena Knopes, Perpetua Gomes, Rob de Kneght, Bart Rijnders, Mario Poljak, Maja Lunar, Rafael Usubillaga, Carole Seguin_Devaux, Enoch Tay, Caroline Wilson, Dao Sen Wang, Jacob George, Jen Kok, Ana Belén Pérez, Natalia Chueca, Miguel García-Deltoro, Ana María Martínez-Sapiña, María Magdalena Lara-Pérez, Silvia García-Bujalance, Teresa Aldámiz-Echevarría, Francisco Jesús Vera-Méndez, Juan Antonio Pineda, Marta Casado, Juan Manuel Pascasio, Javier Salmerón, Juan Carlos Alados-Arboledas, Antonio Poyato, Francisco Téllez, Antonio Rivero-Juárez, Dolores Merino, María Jesús Vivancos-Gallego, José Miguel Rosales-Zábal, María Dolores Ocete, Miguel Ángel Simón, Pilar Rincón, Sergi Reus, Alberto De la Iglesia, Isabel García-Arata, Miguel Jiménez, Fernando Jiménez, José Hernández-Quero, Carlos Galera, Mohamed Omar Balghata, Joaquín Primo, Mar Masiá, Nuria Espinosa, Marcial Delgado, Miguel Ángel von-Wichmann, Antonio Collado, Jesús Santos, Carlos Mínguez, Felícitas Díaz-Flores, Elisa Fernández, Enrique Bernal, José De Juan, José Joaquín Antón, Mónica Vélez, Antonio Aguilera, Daniel Navarro, Juan Ignacio Arenas, Clotilde Fernández, María Dolores Espinosa, María José Ríos, Roberto Alonso, Carmen Hidalgo, Rosario Hernández, María Jesús Téllez, Francisco Javier Rodríguez, Pedro Antequera, Cristina Delgado, Patricia Martín, Javier Crespo, Berta Becerril, Oscar Pérez, Antonio García-Herola, José Montero, Carolina Freyre, Concepción Grau, Joaquin Cabezas, Miguel Jimenez, Manuel Alberto Macias Rodriguez, Cristina Quilez, Maria Rodriguez Pardo, Leopoldo Muñoz-Medina, Blanca Figueruela, Virology, Internal Medicine, Medical Microbiology & Infectious Diseases, Institut Català de la Salut, [Howe AYM] British Columbia Centre for Disease Control, British Columbia, Canada. [Rodrigo C] School of Medical Sciences, UNSW Sydney, Sydney, Australia. [Cunningham EB, Grebely J] The Kirby Institute, UNSW Sydney, Sydney, Australia. [Douglas MW] Storr Liver Centre, The Westmead Institute for Medical Research, The University of Sydney at Westmead Hospital, Westmead, Australia. [Dietz J] Department of Internal Medicine 1, University Hospital, Goethe University, Frankfurt, Germany. [Quer J] Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. CIBEREHD, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, Howe, Anita Y. M., Rodrigo, Chaturaka, Cunningham, Evan, Douglas, Mark W., Dietz, Julia, Grebely, Jason, Popping, Stephanie, Alejandro Sfalcin, Javier, Parczewski, Milosz, Sarrazin, Christoph, de Salazar, Adolfo, Fuentes, Ana, Sayan, Murat, Quer, Josep, Kjellin, Midori, Kileng, Hege, Mor, Orna, Lennerstrand, Johan, Fourati, Slim, Chiara di Maio, Velia, Chulanov, Vladimir, Pawlotsky, Jean-Michel, Richard Harrigan, P., Ceccherini-Silberstein, Francesca, Garcia, Federico, Martinello, Marianne, Matthews, Gail, Fabi??n Fernando, Fay, Esteban, Juan I., M??llhaupt, Beat, Schulze zur Wiesch, Julian, Buggisch, Peter, Neumann-Haefelin, Christoph, Berg, Thoma, Berg, Christoph P., Schattenberg, J??rn M., Moreno, Christophe, Stauber, Rudolf, Lloyd, Andrew, Dore, Gregory, Applegate, Tanya, Ignacio, Juan, Garcia-Cehic, Damir, Gregori, Josep, Rodriguez-Frias, Francisco, Rando, Ariadna, Angelico, Mario, Andreoni, Massimo, Babudieri, Sergio, Bertoli, Ada, Cento, Valeria, Coppola, Nicola, Crax??, Antonio, Paolucci, Stefania, Parruti, Giustino, Pasquazzi, Caterina, Federico Perno, Carlo, Teti, Elisabetta, Vironet, C., Lannerg??rd, Ander, Duberg, Ann-Sofi, Aleman, Soo, Gutteberg, Tore, Soulier, Alexandre, Gourgeon, Aur??lie, Chevaliez, Stephane, Pol, Stanisla, Carrat, Fabrice, Salmon, Dominique, Kaiser, Rolf, Knopes, Elena, Gomes, Perpetua, de Kneght, Rob, Rijnders, Bart, Poljak, Mario, Lunar, Maja, Usubillaga, Rafael, Seguin, Carole, Tay, Enoch, Wilson, Caroline, Sen Wang, Dao, George, Jacob, Kok, Jen, Bel??n P??rez, Ana, Chueca, Natalia, Garc??a-Deltoro, Miguel, Mar??a Mart??nez-Sapi??a, Ana, Magdalena Lara-P??rez, Mar??a, Garc??a-Bujalance, Silvia, Ald??miz-Echevarr??a, Teresa, Jes??s Vera-M??ndez, Francisco, Antonio Pineda, Juan, Casado, Marta, Manuel Pascasio, Juan, Salmer??n, Javier, Carlos Alados-Arboledas, Juan, Poyato, Antonio, T??llez, Francisco, Rivero-Ju??rez, Antonio, Merino, Dolore, Jes??s Vivancos-Gallego, Mar??a, Miguel Rosales-Z??bal, Jos??, Dolores Ocete, Mar??a, ngel Sim??n, Miguel, Rinc??n, Pilar, Reus, Sergi, De la Iglesia, Alberto, Garc??a-Arata, Isabel, Jim??nez, Miguel, Jim??nez, Fernando, Hern??ndez-Quero, Jos??, Galera, Carlo, Omar Balghata, Mohamed, Primo, Joaqu??n, Masi??, Mar, Espinosa, Nuria, Delgado, Marcial, ngel von-Wichmann, Miguel, Collado, Antonio, Santos, Jes??, M??nguez, Carlo, D??az-Flores, Fel??cita, Fern??ndez, Elisa, Bernal, Enrique, De Juan, Jos??, Joaqu??n Ant??n, Jos??, V??lez, M??nica, Aguilera, Antonio, Navarro, Daniel, Ignacio Arenas, Juan, Fern??ndez, Clotilde, Dolores Espinosa, Mar??a, Jos?? R??os, Mar??a, Alonso, Roberto, Hidalgo, Carmen, Hern??ndez, Rosario, Jes??s T??llez, Mar??a, Javier Rodr??guez, Francisco, Antequera, Pedro, Delgado, Cristina, Mart??n, Patricia, Crespo, Javier, Becerril, Berta, P??rez, Oscar, Garc??a-Herola, Antonio, Montero, Jos??, Freyre, Carolina, Grau, Concepci??n, Cabezas, Joaquin, Jimenez, Miguel, Alberto Macias Rodriguez, Manuel, Quilez, Cristina, Rodriguez Pardo, Maria, Mu??oz-Medina, Leopoldo, and Figueruela, Blanca

Subjects
fenómenos microbiológicos::farmacorresistencia microbiana::farmacorresistencia viral [FENÓMENOS Y PROCESOS], Infectious Medicine, NNI, non-nucleoside, aOR, adjusted odds ratio, viruses, GT, genotype, Infektionsmedicin, Gastroenterology and Hepatology, NS5A, NS5AI, NS5A replication complex inhibitor, LDV, ledipasvir, Settore MED/07, PIB, pibrentasvir, RASs, resistance-associated substitutions, SDG 3 - Good Health and Well-being, SHARED, The Surveillance of Hepatitis C Antiviral Resistance, Epidemiology and methoDologies, Microbiological Phenomena::Drug Resistance, Microbial::Drug Resistance, Viral [PHENOMENA AND PROCESSES], Internal Medicine, Gastroenterologi, virologic failure, Immunology and Allergy, Medicaments antivírics, Resistència als medicaments, DAA, Hepatology, virosis::hepatitis viral humana::hepatitis C [ENFERMEDADES], Gastroenterology, Virus Diseases::Hepatitis, Viral, Human::Hepatitis C [DISEASES], virus diseases, DAA, direct-acting antiviral, DCV, daclatasvir, Hepatitis C, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS], PI, NS3 protease inhibitor, OR, odds ratio, SVR, sustained virologic response, VEL, velpatasvir, DSV, dasabuvir, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS], SOF, sofosbuvir, HCV, sFC, substitution frequency change, NI, nucleoside, RAS
Abstract

Virologic failure; Hepatitis C Fracaso virológico; Hepatitis C Fracàs virològic; Hepatitis C Background & Aims Direct-acting antiviral (DAA) regimens provide a cure in >95% of patients with chronic HCV infection. However, in some patients in whom therapy fails, resistance-associated substitutions (RASs) can develop, limiting retreatment options and risking onward resistant virus transmission. In this study, we evaluated RAS prevalence and distribution, including novel NS5A RASs and clinical factors associated with RAS selection, among patients who experienced DAA treatment failure. Methods SHARED is an international consortium of clinicians and scientists studying HCV drug resistance. HCV sequence linked metadata from 3,355 patients were collected from 22 countries. NS3, NS5A, and NS5B RASs in virologic failures, including novel NS5A substitutions, were examined. Associations of clinical and demographic characteristics with RAS selection were investigated. Results The frequency of RASs increased from its natural prevalence following DAA exposure: 37% to 60% in NS3, 29% to 80% in NS5A, 15% to 22% in NS5B for sofosbuvir, and 24% to 37% in NS5B for dasabuvir. Among 730 virologic failures, most were treated with first-generation DAAs, 94% had drug resistance in ≥1 DAA class: 31% single-class resistance, 42% dual-class resistance (predominantly against protease and NS5A inhibitors), and 21% triple-class resistance. Distinct patterns containing ≥2 highly resistant RASs were common. New potential NS5A RASs and adaptive changes were identified in genotypes 1a, 3, and 4. Following DAA failure, RAS selection was more frequent in older people with cirrhosis and those infected with genotypes 1b and 4. Conclusions Drug resistance in HCV is frequent after DAA treatment failure. Previously unrecognized substitutions continue to emerge and remain uncharacterized. The initial SHARED development was funded in part by Merck and a User Partnership Program grant from Genome British Columbia to P.R.H and A.Y.M.H (UPP029). The Kirby Institute is funded by the Australian Government Department of Health and Ageing. The views expressed in this publication do not necessarily represent the position of the Australian (or any other) Government. C.R. and J.G. are supported by an NHMRC Investigator Grant (nos. 1173666, 1176131). An NHMRC Program Grant supported RAS testing and data collection by M.W.D. (1053206) and small grants from the Australian Centre for HIV and Hepatitis Virology Research, The University of Sydney, Western Sydney Local Health District Research Education Network, and the Robert W. Storr bequest to the Sydney Medical Foundation (University of Sydney). S.P. received personal fees from Gilead Sciences. Regarding the Italian data, the work was supported in part by the Italian Ministry of Instruction, University and Research (MIUR) (Bandiera InterOmics Protocollo PB05 1°), by the Italian Ministry of Health (RF-2016-02362422), and by Aviralia and Vironet C Foundations.

Published
2022

9. Real life experiences in HCV management in 2018

Author

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

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

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

Published
2018

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