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1. Traditional Cultures versus Next Generation Sequencing for Suspected Orthopedic Infection: Experience Gained from a Reference Centre

Author

Sara Giordana Rimoldi, Davide Brioschi, Daniele Curreli, Federica Salari, Cristina Pagani, Alessandro Tamoni, Concetta Longobardi, Raffaella Bosari, Alberto Rizzo, Simona Landonio, Massimo Coen, Matteo Passerini, Maria Rita Gismondo, Andrea Gori, and Alfonso Manzotti

Subjects
prosthetic joint infection, next-generation sequencing, bone infections, Therapeutics. Pharmacology, RM1-950
Abstract

(Background) The diagnosis and the antimicrobial treatment of orthopedic infection are challenging, especially in cases with culture-negative results. New molecular methods, such as next-generation sequencing (NGS), promise to overcome some limitations of the standard culture, such as the detection of difficult-to-grow bacteria. However, data are scarce regarding the impact of molecular techniques in real-life scenarios. (Methods) We included cases of suspected orthopedic infection treated with surgery from May 2021 to September 2023. We combined traditional cultures with NGS. For NGS, we performed a metagenomic analysis of ribosomal 16s, and we queried dedicated taxonomic libraries to identify the species. To avoid false positive results, we set a cut-off of 1000 counts of the percentage of frequency of reads. (Results) We included 49 patients in our study. Our results show the presence of bacteria in 36/49 (73%) and 29/49 (59%) cases studied with NGS and traditional cultures, respectively. The concordance rate was 61%. Among the 19/49 discordant cases, in 11/19 cases, cultures were negative and NGS positive; in 4/19, cultures were positive and NGS negative; and in the remaining 4/19, different species were detected by traditional cultures and NGS. (Conclusions) Difficult-to-grow microorganisms, such as slow-growing anaerobic bacteria, were better detected by NGS compared to traditional culture in our study. However, more data to distinguish between true pathogens and contaminants are needed. NGS can be an additional tool to be used for the diagnosis of orthopedic infections and the choice of appropriate antimicrobial therapy.

Published
2023
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2. Are direct-acting antivirals safe and effective in hepatitis C virus-cryoglobulinemia? virological, immunological, and clinical data from a real-life experience

Author

Matteo Bolis, Giuliano Rizzardini, Matteo Passerini, Carlo Magni, Simona Landonio, Guido Gubertini, Alessandro Luciano Croci, Monica Schiavini, Simone Passerini, Valentina Scalzi, Elena Ricci, Massimo Galli, and Fosca Niero

Subjects
Male, medicine.medical_specialty, Sustained Virologic Response, Hepatitis C virus, medicine.disease_cause, Antiviral Agents, Gastroenterology, Asymptomatic, Cryoglobulins, Persistence (computer science), 03 medical and health sciences, 0302 clinical medicine, Immune system, Internal medicine, Humans, Medicine, Risk factor, Adverse effect, Aged, Hepatology, business.industry, Complement C4, Complement C3, Hepatitis C, Chronic, Middle Aged, medicine.disease, Cryoglobulinemia, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, medicine.symptom, business
Abstract

OBJECTIVES Hepatitis C virus (HCV) is the major cause of cryoglobulinemia. Direct-acting antivirals (DAAs) have markedly changed the therapeutic outcomes in the treatment of patients with HCV. We evaluate the efficacy, safety, immunological, and clinical response of different DAA regimens in HCV-cryoglobulinemia. PATIENTS AND METHODS Ninety-three cryoglobulinemic patients, divided into symptomatic [symptomatic cryoglobulinemic patients (SCP; n=35)] and asymptomatic [nonsymptomatic cryoglobulinemic patients (NSCP; n=60)], underwent DAAs. Eighty-nine comparable noncryoglobulinemic patients were selected as a control group. We evaluated the sustained virological response (SVR), the adverse effects, and the immune and symptomatic response. RESULTS Percentages of patients who achieved SVR and experienced adverse effects were not statistically different between the three groups (100, 95, 93.3% and 57.1, 53.3, 48.3%). In 68.5% of SCP and in 76.7% of NSCP, cryoglobulins disappeared at SVR. No risk factor was associated with the persistence of cryoglobulins. An increase was observed both in C4 (P=0.002; P=0.018) and in C3 (P=0.0037; P=0.031) in SCP and NSCP. About 70% of symptomatic patients showed a complete or partial symptomatic remission: persistence of symptoms is correlated to the type of clinical picture. CONCLUSION DAA regimens are safe and effective in patients with HCV-cryoglobulinemia. The achievement of SVR is necessary, but not sufficient, to achieve a complete immunological and clinical response.

Published
2018
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3. Comparison of three therapeutic regimens for genotype-3 hepatitis C virus infection in a large real-life multicentre cohort

Author

Sergio Lazzaroni, Paolo Grossi, Chiara Molteni, Maria Grazia Valsecchi, Pietro Lampertico, Luca Valenti, Alessio Aghemo, Alessia Giorgini, Antonella d'Arminio Monforte, Roberta D'Ambrosio, Federico Gatti, Omar Giglio, Daniele Bella, Davide Paolo Bernasconi, Giuseppe Lapadula, Sherrie Bhoori, Hamid Hasson, Monica Schiavini, Elisa Colella, Roberto Boldizzoni, A. Ciaccio, Simona Landonio, Andrea Capretti, Maria Cristina Vinci, Giuliano Rizzardini, Barbara Menzaghi, Elisabetta Degasperi, Caterina Uberti-Foppa, Chiara Baiguera, Andrea Lombardi, Gianpiero Aimo, Layla Pagnucco, Paolo Perini, Giuliana Cologni, Natalia Terreni, Paolo Bonfanti, Mauro Viganò, Paolo Viganò, Alessandro Soria, Roberto Rossotti, Massimo Puoti, Ombretta Spinelli, Canio Carriero, Silvia Polo, Guglielmo Marco Migliorino, Silvia Colombo, Riccardo Centenaro, Luisa Pasulo, Anna De Bona, E. Dionigi, Paolo Poggio, Franco Noventa, Isabella Carderi, Angelo Pan, Angiola Spinetti, Mariella Di Marco, Cecilia Liani, Stefano Fagiuoli, Marie Graciella Pigozzi, Marco Fava, Massimo Graffeo, Maria Grazia Rumi, Alberto Colombo, Soria, A., Fava, M., Bernasconi, D. P., Lapadula, G., Colella, E., Valsecchi, M. G., Migliorino, G. M., D'Ambrosio, R., Landonio, S., Schiavini, M., Spinetti, A., Carriero, C., Degasperi, E., Cologni, G., Gatti, F., Vigano, P., Hasson, H., Uberti-Foppa, C., Pasulo, L., Baiguera, C., Rossotti, R., Vinci, M., Puoti, M., Giorgini, A., Menzaghi, B., Lombardi, A., Pan, A., Aghemo, A., Grossi, P. A., Boldizzoni, R., Colombo, S., Vigano, M., Rumi, M. G., Del Poggio, P., Valenti, L., Giglio, O., De Bona, A., d'Arminio Monforte, A., Colombo, A., Spinelli, O., Pigozzi, M. G., Molteni, C., Bonfanti, P., Terreni, N., Perini, P., Capretti, A., Bella, D., Liani, C., Polo, S., Aimo, G., Pagnucco, L., Bhoori, S., Centenaro, R., Graffeo, M., Ciaccio, A., Dionigi, E., Lazzaroni, S., Carderi, I., Di Marco, M., Rizzardini, G., Noventa, F., Lampertico, P., Fagiuoli, S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, and Fagiuoli, S

Subjects
Male, medicine.medical_specialty, Daclatasvir, Genotype, Sofosbuvir, ribavirin, pibrentasvir, daclatasvir, genotype 3, glecaprevir, Hepatitis C, sofosbuvir, sustained virological response, velpatasvir, Hepacivirus, Antiviral Agents, Gastroenterology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Ribavirin, medicine, Humans, Univariate analysis, Hepatology, business.industry, Glecaprevir, Hepatitis C, Chronic, medicine.disease, Pibrentasvir, Regimen, Treatment Outcome, chemistry, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, business, medicine.drug
Abstract

Background & Aims: In the direct-acting antiviral era, treatment of genotype-3 HCV (HCV-GT3) is still challenging. Real-life comparisons between recommended regimens, sofosbuvir (SOF)+daclatasvir (DAC), SOF/velpatasvir (VEL), glecaprevir/pibrentasvir (GLE/PIB), are scarce. We aimed at filling this data gap. Methods: Sustained virological response 12weeks after treatment completion (SVR12) was assessed for all HCV-GT3 patients consecutively treated within the Lombardia web-based Navigatore HCV-Network; differences in SVR12 across regimens were evaluated by logistic regression. Results: Of the 2082 subjects with HCV-GT3, 1544 were evaluable for comparisons between regimens: SOF+DAC (1023, 66.2%), SOF/VEL (369, 23.9%), GLE/PIB (152, 9.8%). Patients treated with former regimens were more frequently male, cirrhotic, HIV-positive, pretreated, used ribavirin in their regimen, and had lower baseline HCV-RNA. SVR12 was similar across groups: 94.8% in SOF+DAC, 97.6% in SOF/VEL, 96.7% in GLE/PIB (P=.065). At univariate analysis, SVR12 was associated with female gender (97.9% vs 94.8%, P=.007) and lower median pretreatment Log10HCV-RNA (5.87 vs 6.20, P=.001). At multivariate logistic regression analysis, treatment with SOF/VEL was associated with a higher likelihood of SVR12 than SOF+DAC, but only in the absence of ribavirin (98% vs 90.3%). Female gender and lower pretreatment HCV-RNA were independently associated with SVR12. Conclusions: In a large real-life setting of HCV-GT3-infected patients with a high proportion of cirrhosis, the success rate was remarkable. The slight advantage of SOF/VEL on SOF+DAC was significant only without ribavirin. The current prescription shift towards novel regimens (ie SOF/VEL and GLE/PIB) in easier-to-treat patients allows ribavirin-free and shorter schedules without mining SVR12 in this <> genotype.

Published
2020

4. Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure

Author

Elisabetta, Degasperi, Angiola, Spinetti, Andrea, Lombardi, Simona, Landonio, Maria Cristina, Rossi, Luisa, Pasulo, Pietro, Pozzoni, Alessia, Giorgini, Paolo, Fabris, Antonietta, Romano, Lorenzo, Lomonaco, Massimo, Puoti, Maria, Vinci, Federico, Gatti, Giada, Carolo, Alessia, Zoncada, Paolo, Bonfanti, Russo, FRANCESCO PAOLO, Alessio, Aghemo, Alessandro, Soria, Riccardo, Centenaro, Franco, Maggiolo, Pierangelo, Rovere, Francesca, Pasin, Veronica, Paon, Giovanni, Faggiano, Alessandro, Vario, Glenda, Grossi, Roberta, Soffredini, Canio, Carriero, Stefania, Paolucci, Franco, Noventa, Alfredo, Alberti, Pietro, Lampertico, Stefano, Fagiuoli, NAVIGATORE-Lombardia and Veneto Study Groups, Degasperi, E, Spinetti, A, Lombardi, A, Landonio, S, Rossi, M, Pasulo, L, Pozzoni, P, Giorgini, A, Fabris, P, Romano, A, Lomonaco, L, Puoti, M, Vinci, M, Gatti, F, Carolo, G, Zoncada, A, Bonfanti, P, Russo, F, Aghemo, A, Soria, A, Centenaro, R, Maggiolo, F, Rovere, P, Pasin, F, Paon, V, Faggiano, G, Vario, A, Grossi, G, Soffredini, R, Carriero, C, Paolucci, S, Noventa, F, Alberti, A, Lampertico, P, and Fagiuoli, S

Subjects
0301 basic medicine, Liver Cirrhosis, Male, Sofosbuvir, Sustained Virologic Response, Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Direct-acting antiviral, Direct-acting antivirals, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Sulfonamides, Liver Neoplasms, Hepatitis C, Middle Aged, Drug Combinations, Treatment Outcome, Italy, Hepatocellular carcinoma, HCV, RAS, Retreatment, RNA, Viral, 030211 gastroenterology & hepatology, Female, medicine.drug, medicine.medical_specialty, Carcinoma, Hepatocellular, Macrocyclic Compounds, Anemia, Voxilaprevir, Hepatitis C virus, Antiviral Agents, Heterocyclic Compounds, 4 or More Rings, 03 medical and health sciences, Internal medicine, Drug Resistance, Viral, medicine, Humans, Intention-to-treat analysis, Hepatology, business.industry, Ribavirin, Hepatitis C, Chronic, medicine.disease, 030104 developmental biology, chemistry, Carbamates, business
Abstract

Background & Aims Sofosbuvir/velpatasivr/voxilaprevir (SOF/VEL/VOX) is approved for retreatment of patients with HCV and a previous failure on direct-acting antivirals (DAAs), however real-life data are limited. The aim of this study was to assess the effectiveness and safety of SOF/VEL/VOX in a real-life setting. Methods All consecutive patients with HCV receiving SOF/VEL/VOX between May-October 2018 in 27 centers in Northern Italy were enrolled. Bridging fibrosis (F3) and cirrhosis (F4) were diagnosed by liver stiffness measurement: >10 and >13 kPa respectively. Sustained virological response (SVR) was defined as undetectable HCV-RNA 4 (SVR4) or 12 (SVR12) weeks after the end-of-treatment. Results A total of 179 patients were included: median age 57 (18–88) years, 74% males, median HCV-RNA 1,081,817 (482–25,590,000) IU/ml. Fibrosis stage was F0-F2 in 32%, F3 in 21%, F4 in 44%. HCV genotype was 1 in 58% (1b 33%, 1a 24%, 1nc 1%), 2 in 10%, 3 in 23% and 4 in 9%; 82% of patients carried resistance-associated substitutions in the NS3, NS5A or NS5B regions. Patients received SOF/VEL/VOX for 12 weeks, ribavirin was added in 22% of treatment schedules. Undetectable HCV-RNA was achieved by 74% of patients at week 4 and by 99% at week 12. Overall, 162/179 (91%) patients by intention to treat analysis and 162/169 (96%) by per protocol analysis achieved SVR12, respectively; treatment failures included 6 relapsers and 1 virological non-responder. Cirrhosis (p = 0.005) and hepatocellular carcinoma (p = 0.02) were the only predictors of treatment failure. Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%). Conclusions SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting. Lay summary This is the largest European real-life study evaluating effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in a large cohort of consecutive patients with hepatitis C virus infection and a prior direct-acting antiviral failure, who were treated within the NAVIGATORE Lombardia and Veneto Networks, in Italy. This study demonstrated excellent effectiveness (98% and 96% sustained virological response rates at week 4 and 12, respectively) and an optimal safety profile of SOF/VEL/VOX. Cirrhosis and hepatocellular carcinoma onset were the only features associated with treatment failure.

Published
2019

5. Analysis of resistance and phylogenetic clusters in HCV-2c infected patients within the Italian network Vironet C

Author

Anna Claudia Pellicelli, Alessandro Pieri, Enzo Boeri, V. Pace Palitti, Roberto Gulminetti, V. Di Marco, Stefania Paolucci, Simona Landonio, F. Di Lorenzo, Laura Monno, L. Sarmati, Stefano Novati, Annapaola Callegaro, Simona Marenco, G. Raimondo, Lavinia Fabeni, Maurizio Zazzi, Silvia Barbaliscia, Nicola Coppola, P. Andreone, L. Carioti, Claudio Maria Mastroianni, Anna Licata, Fausto Baldanti, M. Andreoni, M. Quartini, M. Lichtner, Gloria Taliani, Laura Ambra Nicolini, Francesca Ceccherini-Silberstein, C.F. Perno, Luca Foroghi, Giustino Parruti, Bianca Bruzzone, Caterina Pasquazzi, C. Paternoster, Martina Milana, Sergio Babudieri, K. Yu La Rosa, M. Puoti, Hamid Hasson, Teresa Pollicino, N. Iapadre, C. Minichini, Raffaele Cozzolongo, Valeria Micheli, Barbara Rossetti, Aldo Bertoli, Elisabetta Teti, Marianna Aragri, Antonio Craxì, Filomena Morisco, V.C. Di Maio, Vincenzo Sangiovanni, Leonardo Baiocchi, and Mario Angelico

Subjects
Genetics, Hepatology, Resistance (ecology), Phylogenetic tree, business.industry, Gastroenterology, Medicine, business
Published
2020
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6. VIRONET-C real life experience of resistance-guided retreatment in HCV infected patients who previously failed a NS5A inhibitor-containing regimen

Author

Mario Starace, Valerio Giannelli, Nunzia Cuomo, Vanni Borghi, Aldo Bertoli, Anna Licata, Anna Claudia Pellicelli, C. Minichini, M. Andreoni, M. Di Stefano, Giuseppe Cariti, Enzo Boeri, Raffaele Cozzolongo, Roberto Gulminetti, E. Milano, Valeria Cento, Elisabetta Degasperi, Laura Sighinolfi, A. Raddi, Ivana Maida, Barbara Rossetti, Teresa Santantonio, Valeria Micheli, C. Masetti, P. Andreone, Giustino Parruti, F. Di Lorenzo, Ilaria Lenci, Tiziano Allice, Annapaola Callegaro, Elisa Biliotti, M. Lichtner, Teresa Pollicino, Pietro Lampertico, Gloria Taliani, Caterina Pasquazzi, Piero Colombatto, Alessia Giorgini, G. Raimondo, Antonio Craxì, Francesca Ceccherini-Silberstein, Filomena Morisco, Valeria Ghisetti, V.C. Di Maio, Giuliano Rizzardini, Silvia Galli, Stefania Paolucci, A. De Santis, A. Lleo, Vincenzo Sangiovanni, A. Ciancio, Maurizio Zazzi, Elisabetta Teti, Simona Marenco, William Gennari, Stefano Novati, Giovanni Cenderello, Simona Landonio, Manuela Merli, A. Scuteri, Nicola Coppola, C.F. Perno, Giulia Morsica, I. Beretta, Claudio Maria Mastroianni, Simona Francioso, Mario Angelico, Laura Ambra Nicolini, Chiara Dentone, Silvia Barbaliscia, G.B. Gaeta, Marianna Aragri, Ennio Polilli, L. Donnarumma, Vincenza Calvaruso, Bianca Bruzzone, Fausto Baldanti, V. Pace Palitti, Roberto Ganga, Maurizia Rossana Brunetto, C. Paternoster, Sergio Babudieri, M. Puoti, Hamid Hasson, and M. Rendina

Subjects
medicine.medical_specialty, Regimen, Hepatology, business.industry, Internal medicine, Gastroenterology, medicine, business, NS5A
Published
2020
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7. THU-141-Efficacy and safety of elbasvir/grazoprevir in a large real-life cohort of HCV-infected patients

Author

Alberto Colombo, Sandro Panese, Mauro Viganò, Simona Landonio, Agostino Colli, Barbara Menzaghi, Caterina Uberti-Foppa, Veronica Paon, Paolo Sacchi, Maria Cristina Rossi, Francesca Cattelan, Andrea Capretti, Maria Cristina Vinci, Luisa Pasulo, Valter Vincenzi, S. Lobello, Giada Carolo, Liliana Chemello, Ombretta Spinelli, Roberta D'Ambrosio, Monia Mendeni, Franco Capra, Alessandro Soria, Roberta Soffredini, Maurizio Carrara, M. Colpani, Massimo Puoti, Giancarlo Spinzi, Alfredo Alberti, Pietro Lampertico, Luisa Cavalletto, Angiola Spinetti, Elisabetta Degasperi, Massimo Zuin, Alessio Aghemo, Laura Comi, Giovanna Cardaci, Valentina Zuccaro, Massimo Memoli, Paolo Poggio, Angelo Pan, Vinicio Manfrin, Alessia Giorgini, Marie Graciella Pigozzi, Serena Zaltron, Francesco Castelli, Franco Noventa, Paolo Grossi, Monica Schiavini, Clara Dibenedetto, Antonella d'Arminio Monforte, Roberto Gulminetti, Elisabetta Buscarini, Piergiorgio Scotton, Stefano Fagiuoli, Martina Gambato, Francesco Russo, Andrea Gori, Paolo Fabris, Caterina Pozzan, and Maria Grazia Rumi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, medicine, Elbasvir, Grazoprevir, business
Published
2019
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8. THU-133-Resistance-guided retreatment of HCV infected patients with a previous failure to an NS5A inhibitor-containing regimen: Italian real life experience

Author

Ada Bertoli, Gloria Taliani, Ilaria Lenci, Stefano Novati, Teresa Santantonio, Raffaele Cozzolongo, C. Masetti, Nunzia Cuomo, Laura Donnarumma, Giovanni Cenderrello, Silvia Barbaliscia, Adriano De Santis, Bianca Bruzzone, Giovanni Raimondo, Massimo Puoti, Carlo Federico Perno, Simona Landonio, Roberto Gulminetti, Elisabetta Degasperi, Giustino Parruti, Vincenza Calvaruso, Marianna Aragri, Teresa Pollicino, Pietro Lampertico, Laura Ambra Nicolini, Velia Chiara Di Maio, Valeria Ghisetti, Adriano M. Pellicelli, Ivana Maida, Caterina Pasquazzi, Valeria Cento, Roberto Ganga, Coppola Nicola, C. Paternoster, Maurizia Rossana Brunetto, Alessia Ciancio, Sergio Babudieri, Massimo Andreoni, Silberstein Francesca Ceccherini, Maurizio Zazzi, Maria Rendina, Miriam Lichtner, Angelico Mario, Ennio Polilli, Giuliano Rizzardini, Vanni Borghi, Maria Paola Callegaro, Valeria Pace Palitti, Stefania Paolucci, Carmine Minichini, Simona Marenco, Antonio Craxì, Filomena Morisco, Vincenzo Sangiovanni, Giulia Morsica, Valeria Micheli, Elisabetta Teti, and Pietro Andreone

Subjects
medicine.medical_specialty, Regimen, Hepatology, business.industry, Internal medicine, medicine, NS5A, business
Published
2019
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9. THU-175-Eligibility and feasibility of hepatitis C treatment in the era of direct-acting antiviral agents: Our experience in real-world practice

Author

Matteo Passerini, Monica Schiavini, Stefania Vimercati, Riccardo Giorgi, Simona Landonio, Carlo Alberto Magni, Simone Passerini, Giuliano Rizzardini, Alessandro Luciano Croci, Elena Angeli, Fosca Niero, Annalisa Mainini, Matteo Bolis, and Guido Gubertini

Subjects
medicine.medical_specialty, Hepatology, business.industry, Medicine, Hepatitis C, business, medicine.disease, Intensive care medicine, Direct acting
Published
2019
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10. Resistance test guided retreatment of HCV infected patients with a previous failure to a NS5A inhibitor-containing regimen: the Italian Vironet C real life experience

Author

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

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

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

Published
2019
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11. Efficacy and safety of Elbasvir/Grazoprevir in a large real-life cohort of HCV-infected patients

Author

Paolo Grossi, Sandro Panese, G. Cardaci, Barbara Menzaghi, Piergiorgio Scotton, Simona Landonio, Agostino Colli, Massimo Zuin, Caterina Uberti-Foppa, Francesco Russo, M. Colpani, Mauro Viganò, Alessia Giorgini, Maria Cristina Rossi, Elisabetta Degasperi, Serena Zaltron, Francesco Castelli, Massimo Memoli, Andrea Gori, Roberta Soffredini, Franco Noventa, S. Lobello, Ombretta Spinelli, Alessandro Soria, A d'Arminio Monforte, Luisa Pasulo, Vinicio Manfrin, Elisabetta Buscarini, Angelo Pan, Monica Schiavini, Maria Grazia Rumi, P. Del Poggio, Alberto Colombo, Valter Vincenzi, Giancarlo Spinzi, Franco Capra, Massimo Puoti, Roberto Gulminetti, Valentina Zuccaro, Stefano Fagiuoli, Alfredo Alberti, Martina Gambato, Luisa Cavalletto, F. Cattelan, Pietro Lampertico, I. Franceschet, Alessio Aghemo, Marie Graciella Pigozzi, L. Comi, Giada Carolo, Liliana Chemello, Veronica Paon, Paolo Sacchi, Andrea Capretti, Maria Cristina Vinci, Roberta D'Ambrosio, Monia Mendeni, Maurizio Carrara, Paolo Fabris, Angiola Spinetti, and Clara Dibenedetto

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Cohort, Gastroenterology, Medicine, Elbasvir, Grazoprevir, business
Published
2019
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12. THU-131-Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir for retreatment of chronic hepatitis C patients with a previous failure to direct-acting antivirals: A real-life study from the NAVIGATORE Lombardia and Veneto Networks

Author

Sara Piovesan, Franco Noventa, Pietro Lampertico, Antonio Carlotto, Paolo Bonfanti, Alessio Aghemo, Canio Carriero, Alessandro Soria, Simona Landonio, Pierangelo Rovere, Filippo Viviani, Angiola Spinetti, Alessia Giorgini, Roberta Soffredini, Maurizio Carrara, Alessia Zoncada, Lorenzo Morini, Pietro Pozzoni, Federico Gatti, Giada Carolo, Franco Capra, Elisabetta Degasperi, Pier Giorgio Scotton, Maria Cristina Vinci, Andrea Lombardi, Paolo Angeli, Riccardo Centenaro, Luisa Pasulo, Alfredo Alberti, Franco Maggiolo, Massimo Puoti, Stefano Fagiuoli, Francesco Russo, and Stefania Paolucci

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Medicine, business, Intensive care medicine, DIRECT ACTING ANTIVIRALS, Life study, Sofosbuvir / velpatasvir / voxilaprevir
Published
2019
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13. THU-180-Treatment of genotype 3 HCV infection in the large real-life 'Navigatore Lombardia' multicentre cohort: Results from three different regimens

Author

Maria Grazia Rumi, Mauro Viganò, Alberto Colombo, Sherrie Bhoori, Antonella d'Arminio Monforte, Riccardo Centenaro, Luisa Pasulo, Sergio Lazzaroni, Alessandro Soria, Andrea Capretti, Maria Cristina Vinci, Pietro Lampertico, Gianpiero Aimo, Chiara Molteni, Andrea Lombardi, Alessio Aghemo, Silvia Polo, Alessia Giorgini, Federico Gatti, Paola Brambilla, Elisabetta Degasperi, E. Dionigi, Anna Spolti, Paolo Bonfanti, Anna De Bona, Luca Valenti, Stefania Salpietro, Marta Borghi, Esther Merlini, Natalia Terreni, Giuliano Rizzardini, Valentina Grasso, Paolo Viganò, Sara Gritti, Paolo Grossi, Roberta D'Ambrosio, Simona Landonio, Alessandra Gambaro, Daniele Bella, Massimo Puoti, Ombretta Spinelli, Caterina Uberti-Foppa, Angelo Pan, Monica Schiavini, Mariella Di Marco, Paolo Poggio, Barbara Menzaghi, Canio Carriero, Hamid Hasson, Elisa Colella, Roberto Boldizzoni, Nunzia Bottalico, Stefano Fagiuoli, Angiola Spinetti, Cecilia Liani, Giuseppe Lapadula, Guido Colloredo Mels, Massimo Graffeo, Franco Noventa, Luciana Scabeni, Roberta Soffredini, Roberto Gulminetti, Marie Graciella Pigozzi, and Isabella Carderi

Subjects
medicine.medical_specialty, Hepatology, business.industry, Internal medicine, Diabetes mellitus, Cohort, Genotype, Medicine, business, medicine.disease
Published
2019
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14. Durability of Boosted Atazanavir (ATV) or Darunavir (DRV) Plus Maraviroc (MVC) Dual rescue Therapy in Poorly Adherent Subjects in View of Long-Acting Drugs

Author

Amedeo Capetti, Simona Landonio, Gianfranco Dedivitiis, Noemi Astuti, Fosca Niero, Giuliano Rizzardini, and Stefania Vimercati

Subjects
medicine.medical_specialty, business.industry, virus diseases, Pharmacology, Atazanavir, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Infectious Diseases, Long acting, General satisfaction, chemistry, Rescue therapy, 030220 oncology & carcinogenesis, Virology, Internal medicine, Dolutegravir, medicine, Ritonavir, business, 030217 neurology & neurosurgery, Darunavir, medicine.drug, Maraviroc
Abstract

In poorly adherent HIV-infected subjects strategic approaches may avoid resistance to long-acting compounds. This study means to assess the safety of a strategy which was being carried out in our Division in several nonadherent subjects with general satisfaction. All subjects who had been switched to boosted protease inhibitors plus maraviroc for treatment failure between June 2014, and April 2015, were retrospectively evaluated. Eighteen were taking darunavir/ritonavir and 26 atazanavir/ritonavir plus maraviroc 300 mg once daily. All had a follow-up of 104 weeks and 27 exceeded 156 weeks. One patient, who was INSTI-experienced and still had >500 HIV-1 RNA copies/mL at week 60, switched to dolutegravir plus darunavir/ritonavir and rapidly failed, selecting for INSTI cross resistance-associated mutations (97A, 140S and 148H). At week 96 and 140, 81.8% and 85.2% had

Published
2017
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15. Viremia residua e SVR in due pazienti con coinfezione da HIV-HCV

Author

Guido Gubertini, Giuliano Rizzardini, Fosca Niero, Simona Landonio, Carlo Magni, Monica Schiavini, Valeria Micheli, and Matteo Bolis

Subjects
business.industry, Medicine, Viremia, business, medicine.disease, Virology
Abstract

Introduzione L’introduzione dei nuovi farmaci antivirali (DAAs) nell’armamentario terapeutico ha rappresentato una svolta epocale nel campo dell’infezione da HCV, e cio ha forse un significato ancora maggiore nei pazienti affetti da concomitante infezione da HIV, i quali presentano una piu rapida progressione della malattia epatica e che, a fronte della stabilizzazione della malattia da HIV con le terapie antiretrovirali croniche (HAART), hanno visto la loro prognosi a lungo termine inficiata dalla concomitante infezione con HCV (1,2). L’efficacia dei DAAs si esprime non solo negli evidenti e altissimi tassi virologici di risposta (sustained virological response, SVR), ma anche nell’ottenimento della stessa persino in casi in cui HCV-RNA al termine del trattamento e ancora rilevabile, come nei due casi che qui descriviamo.

Published
2016
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16. Effectiveness and safety of Sofosbuvir/Velpatasvir/Voxilaprevir for retreatment of chronic hepatitis C patients with a previous failure to direct-acting antivirals: a real-life study from the Navigatore Lombardia and Veneto Networks

Author

Pietro Pozzoni, Maria Cristina Vinci, Andrea Lombardi, Pietro Lampertico, Paolo Angeli, Alessio Aghemo, M. Puoti, F. Maggiolo, A. Carlotto, Simona Landonio, Sara Piovesan, Francesca Gatti, P. Scotton, Francesco Russo, Angiola Spinetti, Stefania Paolucci, Giada Carolo, Franco Noventa, Franco Capra, Stefano Fagiuoli, P.A. Rovere, Lorenzo Morini, Alessia Giorgini, P. Bonfanti, C. Carriero, F. Viviani, Elisabetta Degasperi, A. Zoncada, Roberta Soffredini, Riccardo Centenaro, Luisa Pasulo, Alfredo Alberti, Alessandro Soria, and Maurizio Carrara

Subjects
medicine.medical_specialty, Hepatology, Chronic hepatitis, business.industry, Gastroenterology, Medicine, business, Intensive care medicine, Life study, DIRECT ACTING ANTIVIRALS, Sofosbuvir / velpatasvir / voxilaprevir
Published
2019
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17. What impact do the new direct acting antiviral drugs have on the patients’ quality of life?

Author

Emilio Clementi, E. Cesari, Fosca Niero, Sonia Radice, Monica Schiavini, V. Scalzi, Carlo Magni, Marta Gentili, Stefania Vimercati, Simona Landonio, Dario Cattaneo, Giuliano Rizzardini, and Carla Carnovale

Subjects
medicine.medical_specialty, Quality of life (healthcare), Hepatology, business.industry, Medicine, business, Intensive care medicine, Direct acting
Published
2018
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18. In the ERA of New Direct Acting Antiviral Agents HCV Sequencing Allows the Most Accurate Subtype and Genotype Assignment

Author

A. Manunta, A. Grieco, Lorenzo Nosotti, D. Di Paolo, Gloria Taliani, Umberto Vespasiani Gentilucci, Carlo Magni, L. Lambiase, Simona Landonio, M. Tontodonati, A. Di Biagio, C.F. Perno, F.P. Antonucci, Gabriella d'Ettorre, Valeria Cento, S. Grieco, Maria Stella Mura, Francesca Ceccherini Silberstein, Cesare Sarrecchia, Dante Romagnoli, Elisabetta Teti, Laura Gianserra, Miriam Lichtner, Giustino Parruti, Aldo Bertoli, F. De Leonardis, Adriano M. Pellicelli, P. Cacciatore, Claudio Maria Mastroianni, Laura Ambra Nicolini, M. Andreoni, Antonio Gasbarrini, Simona Francioso, Sergio Babudieri, Simona Marenco, J. Vecchiet, Martina Milana, Mario Angelico, Caterina Pasquazzi, Ivana Maida, Ilaria Lenci, Valeria Micheli, Antonio Picciotto, Marianna Aragri, Marco Romano, E. D’Amico, Giuliano Rizzardini, Filomena Morisco, V.C. Di Maio, M. Siciliano, Savino Bruno, Marco Ciotti, and M. Puoti

Subjects
Genetics, 03 medical and health sciences, PRECLINICAL CHARACTERISATION OF JNJ-54257099 – A POTENT URIDINE-BASED NUCLEOTIDE POLYMERASE INHIBITOR IN PHASE I CLINICAL DEVELOPMENT FOR THE TREATMENT OF CHRONIC HEPATITIS C, 0302 clinical medicine, Hepatology, 030220 oncology & carcinogenesis, Genotype, 030211 gastroenterology & hepatology, Biology, Direct acting
Published
2016

19. ITPA and SLC29A1 Genotyping for the Prediction of Ribavirin Dose Reduction in Anti-HCV Triple Therapy with Protease Inhibitors

Author

Andrea, Lombardi, Simona, Landonio, Carlo, Magni, Stefania, Cheli, Cristina, Mazzali, Mario U, Mondelli, Giuliano, Rizzardini, Emilio, Clementi, and Felicia Stefania, Falvella

Subjects
Adult, Male, Genotype, Proline, Anemia, Hepacivirus, Middle Aged, Antiviral Agents, Hepatitis C, Polymorphism, Single Nucleotide, Equilibrative Nucleoside Transporter 1, Hemoglobins, Ribavirin, Humans, Drug Therapy, Combination, Female, Protease Inhibitors, Pyrophosphatases, Aged
Abstract

Chronic hepatitis C is one of the most important causes of liver disease, leading to cirrhosis, hepatic decompensation and hepatocellular carcinoma. Recently some important advances in therapy have been achieved with the introduction of first wave, first generation direct acting antiviral agents (DAAs) such as boceprevir (BOC), in combination with pegylated interferon (Peg-IFN) and ribavirin (RBV). The superior rate of sustained virological response with this treatment is accompanied by an elevated frequency of anaemia. Several studies have evidenced the importance of single nucleotide polymorphisms (SNPs) in inosine triphosphatase (ITPA) and solute carrier family 29, member 1 (SLC29A1) genes in the development of this adverse event. Here, we investigated haemoglobin levels and the best-known functional SNPs in ITPA and SLC29A1 genes in 22 patients treated with triple therapy with BOC/Peg-IFN/RBV. The identification of ITPA protective and SLC29A1 risk genotypes still appears to be a current methodology in RBV dosing during hepatitis C virus therapy with DAAs.

Published
2015

20. Multiclass HCV resistance to interferon-free direct acting antivirals regimens in real life failures advocates for tailored second-line therapies

Author

Ilaria Lenci, A. Di Biagio, Giuliano Rizzardini, L. Marinaro, C. D'Ambrosio, Fausto Baldanti, Ivana Maida, G.B. Gaeta, M. Puoti, T. Ruggiero, Mario Angelico, Vincenza Calvaruso, Laura Sticchi, Mario Starace, Giustino Parruti, P. Cacciatore, Nicola Caporaso, Caterina Pasquazzi, Stefania Paolucci, Anna Claudia Pellicelli, M. Andreoni, C. Masetti, Sergio Babudieri, Gabriella d'Ettorre, Francesco Santopaolo, Raffaele Cozzolongo, P. Andreone, Carlo Magni, Valeria Cento, Guido Gubertini, J. Vecchiet, Stefano Novati, Nicola Coppola, C.F. Perno, Bianca Bruzzone, F. De Leonardis, V. Pace Palitti, Marianna Aragri, A. Grieco, Pierluigi Tarquini, G. De Stefano, G. Raimondo, Teresa Pollicino, Alessia Giorgini, Giorgio Barbarini, Valeria Ghisetti, G. Verucchi, M.C. Sorbo, Savino Bruno, M. Paoloni, F. Ceccherini-Silberstein, Roberto Gulminetti, Antonio Craxì, Filomena Morisco, Manuela Merli, V.C. Di Maio, Vincenzo Sangiovanni, A. Ciancio, Simona Francioso, Simona Landonio, Aldo Bertoli, A. Mancon, Valeria Micheli, Antonio Picciotto, V. Boccaccio, M. Melis, Ennio Polilli, F.P. Antonucci, Dante Romagnoli, and Silvia Barbaliscia

Subjects
Oncology, medicine.medical_specialty, Hepatology, business.industry, Interferon free, Gastroenterology, DIRECT ACTING ANTIVIRALS, 03 medical and health sciences, 0302 clinical medicine, Second line, 030220 oncology & carcinogenesis, Internal medicine, Medicine, In real life, 030211 gastroenterology & hepatology, business
Published
2017
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21. The challenge of HCV-retreatment after DAA-failure: real-life experience advocates for caution

Author

Vincenza Calvaruso, C. Masetti, Silvia Barbaliscia, Bianca Bruzzone, Giustino Parruti, Sergio Babudieri, Marco Biolato, Marianna Aragri, C.F. Perno, Vincenzo Messina, Valeria Cento, Simona Landonio, M. Melis, Carmine Minichini, Valeria Micheli, F. Ceccherini-Silberstein, Lucio Boglione, Giorgio Barbarini, Mario Angelico, Aldo Bertoli, Monica Schiavini, Laura Ambra Nicolini, Ennio Polilli, Raffaele Cozzolongo, Carlo Magni, Chiara Baiguera, C. Dentone, Giuliano Rizzardini, Anna Claudia Pellicelli, M. Siciliano, Y. Troshina, Antonio Craxì, Filomena Morisco, M. Puoti, V.C. Di Maio, A. Ciancio, Ilaria Lenci, Laura Sticchi, Stefania Paolucci, T. Ruggiero, Simona Marenco, and Nicola Coppola

Subjects
0301 basic medicine, 03 medical and health sciences, medicine.medical_specialty, 030104 developmental biology, 0302 clinical medicine, Hepatology, business.industry, Immunology, medicine, 030211 gastroenterology & hepatology, Intensive care medicine, business
Published
2017
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22. Multiclass hepatitis C virus resistance to direct acting antivirals in real life interferon-free regimens failures advocates for tailored second-line therapies

Author

A. Grieco, Valeria Cento, Savino Bruno, M. Paoloni, Anna Claudia Pellicelli, Gabriella d'Ettorre, Raffaele Cozzolongo, G.D. Stefano, Carlo Magni, V. Boccaccio, M. Andreoni, Fausto Baldanti, Silvia Barbaliscia, J. Vecchiet, Valeria Micheli, Antonio Picciotto, Giustino Parruti, Guido Gubertini, M. Melis, Pierluigi Tarquini, Francesca Ceccherini-Silberstein, Bianca Bruzzone, Sergio Babudieri, Antonio Di Biagio, M. Puoti, Manuela Merli, L. Marinaro, Mario Starace, Caterina Pasquazzi, Marianna Aragri, Antonio Craxì, Teresa Pollicino, Filomena Morisco, V.C. Di Maio, Alessia Giorgini, Vincenzo Sangiovanni, Giorgio Barbarini, Valeria Ghisetti, G. Verucchi, T. Ruggiero, Ivana Maida, P. Andreone, Vincenza Calvaruso, Giovanni Raimondo, C. D'Ambrosio, Simona Francioso, F.P. Antonucci, Dante Romagnoli, C.F. Perno, Mario Angelico, Ilaria Lenci, Alessia Ciancio, Roberto Gulminetti, G.B. Gaeta, Simona Landonio, Nicola Caporaso, Francesco Santopaolo, Nicola Coppola, Laura Sticchi, Valeria Pace Palitti, Stefania Paolucci, Aldo Bertoli, and A. Mancon

Subjects
0301 basic medicine, Hepatology, business.industry, Hepatitis C virus, Interferon free, medicine.disease_cause, DIRECT ACTING ANTIVIRALS, Virology, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Second line, medicine, In real life, 030211 gastroenterology & hepatology, business
Published
2017
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23. Breast Hypertrophy Induced by Ombitasvir/Paritaprevir/Ritonavir and Ribavirina

Author

Emilio Clementi, Stefania Antoniazzi, Marta Gentili, Simona Landonio, Carla Carnovale, Carlo Magni, Sonia Radice, Matteo Bolis, and Fosca Niero

Subjects
medicine.medical_specialty, business.industry, Ribavirin, Breast hypertrophy, Hepatitis C, medicine.disease, Gastroenterology, Muscle hypertrophy, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Oncology, chemistry, 030220 oncology & carcinogenesis, Ombitasvir/paritaprevir/ritonavir, Internal medicine, Internal Medicine, medicine, Surgery, Ritonavir, business, 030217 neurology & neurosurgery, medicine.drug
Published
2016
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24. Clinical relevance of accurate HCV genotype and subtype assignment by NS3/NS5A/NS5B direct sequencing in the era of new direct acting antiviral agents

Author

Carlo Magni, Francesca Ceccherini-Silberstein, M. Puoti, Claudio Maria Mastroianni, A. Di Biagio, Marco Romano, Filomena Morisco, Giustino Parruti, Antonio Gasbarrini, Gloria Taliani, M. Siciliano, Simona Landonio, V.C. Di Maio, Martina Milana, Laura Gianserra, F. Deodati, Caterina Pasquazzi, M. Andreoni, J. Vecchiet, Valeria Cento, L. Lambiase, Marianna Aragri, Simona Francioso, E. D’Amico, Gabriella d'Ettorre, Giuliano Rizzardini, D. Di Paolo, Antonio Grieco, F. De Leonardis, A. Manunta, Ivana Maida, Anna Claudia Pellicelli, Mario Angelico, K. Yu La Rosa, Miriam Lichtner, P. Cacciatore, Cesare Sarrecchia, F.P. Antonucci, Aldo Bertoli, Valeria Micheli, Antonio Picciotto, Dante Romagnoli, Savino Bruno, Laura Ambra Nicolini, Ilaria Lenci, C.F. Perno, Marco Ciotti, Lorenzo Nosotti, Simona Marenco, Elisabetta Teti, M. Tontodonati, Maria Stella Mura, R. Campoli, Nicola Caporaso, S. Grieco, Sergio Babudieri, and Umberto Vespasiani-Gentilucci

Subjects
Genetics, chemistry.chemical_compound, NS3, Hepatology, chemistry, Direct sequencing, Genotype, Gastroenterology, Clinical significance, Biology, NS5A, NS5B, Direct acting
Published
2016
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25. Natural HCV resistance is common in Italy and differently associated to genotypes

Author

Simona Landonio, Barbara Menzaghi, Giustino Parruti, T. Ruggiero, Valeria Cento, Francesca Ceccherini-Silberstein, Ilaria Lenci, M. Melis, Giuliano Rizzardini, Antonio Gasbarrini, P. Cacciatore, V. Pace Palitti, M.C. Sorbo, Ennio Polilli, Martina Milana, Alessandro Pieri, Laura Gianserra, Anna Claudia Pellicelli, P. Andreone, C. Masetti, Bianca Bruzzone, Simona Marenco, Elisabetta Teti, M. Andreoni, Gloria Taliani, Aldo Bertoli, Elisa Biliotti, Miriam Lichtner, Nicola Coppola, Vincenza Calvaruso, Fausto Baldanti, Stefania Paolucci, C.F. Perno, Carlo Magni, Sergio Babudieri, Valeria Micheli, Antonio Craxì, Filomena Morisco, V.C. Di Maio, Dante Romagnoli, Laura Ambra Nicolini, Mario Angelico, Loredana Sarmati, M. Siciliano, M. Puoti, N. Iapadre, Marianna Aragri, Vincenzo Vullo, Caterina Pasquazzi, and F. De Leonardis

Subjects
0301 basic medicine, Genetics, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Hepatology, Resistance (ecology), business.industry, Genotype, Gastroenterology, Medicine, 030211 gastroenterology & hepatology, business
Published
2017
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26. Strategic use of dual regimens of boosted protease inhibitors plus maraviroc in poorly adherent subjects in view of long-acting drugs

Author

Fosca Niero, Amedeo Capetti, Gianfranco Dedivitiis, Giuliano Rizzardini, Mariangela Micale, Laura Carenzi, Stefania Vimercati, and Simona Landonio

Subjects
0301 basic medicine, Creatinine, medicine.medical_specialty, business.industry, 030106 microbiology, RNA, Viremia, General Medicine, medicine.disease, Gastroenterology, Virology, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, chemistry, Internal medicine, medicine, Ritonavir, 030212 general & internal medicine, Adverse effect, business, HIV drug resistance, Darunavir, Maraviroc, medicine.drug
Abstract

In view of the forthcoming long-acting antiretrovirals, measures should be taken to prevent the selection of HIV drug resistance mutations. All subjects who had been switched to boosted protease inhibitors plus maraviroc (bPIs/MVC) with baseline HIV-1 RNA >50 copies/mL between June, 2014, and April, 2015, were retrospectively evaluated. HIV-1 RNA, CD4+ T-cells, serum glucose, creatinine, ALT, and adverse events were controlled every 3 to 4 months. We retrospectively analyzed 44 patients: 18 were taking darunavir/ritonavir (DRV/r) and 26 atazanavir/ritonavir (ATV/r) once daily, plus MVC 300 mg once daily. Seven subjects were in CDC stage C. All had a follow-up of at least 24 weeks, 28 exceeded 48 weeks, and 21 exceeded 72 weeks. All had experienced at least 1 viral failure and had selected at least 1 resistance-associated mutation (RAM). At baseline, 38 had plasma HIV-1 RNA 50-499 copies/mL and 6 had ≥500. At week 24, none had viremia >500 and 30 (68.2%) had suppressed HIV-1 RNA below 50 copies/mL. Of the subgroup with 48 weeks' follow-up, 23 had HIV-1 RNA 50-499 copies/mL, 5 had ≥500, and 20/28 suppressed to

Published
2017
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28. Multiclass HCV resistance to direct-acting antiviral failure in real-life patients advocates for tailored second-line therapies

Author

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

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

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

Published
2017
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