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1. Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C

Author: Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio V. C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C. F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A. P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M. A., Gaeta G. B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., Zazzi M., Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio V. C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C. F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A. P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M. A., Gaeta G. B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., and Zazzi M.
Abstract: Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3). Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols. Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SOF)/daclatasvir (DCV) or velpatasvir (VEL)±ribavirin (RBV) (N = 91/15) and glecaprevir (G)/pibrentasvir (P) (N = 9). Moreover, 14.8% of patients were treated with suboptimal regimens for GT3: 3D ± RBV (Paritaprevir/r + Ombitasvir+Dasabuvir, N = 15), SOF + Simeprevir (SIM) (N = 1) or SOF/Ledipasvir (LDV) ± RBV (N = 4). RAS prevalence was 15.8% in DAA-naïve patients. At failure, 81.5% patients showed at least one RAS: 11/25 (44.0%) in NS3, 109/135 (80.7%) in NS5A, 7/111 (6.3%) in NS5B SOF-failures. In NS5A-failures, Y93H RAS was the most prevalent (68.5% vs 5.1% DAA-naïve, P <.001) followed by A30K (12.7% vs 2.8% in DAA-naïve, P <.001). Analysing baseline samples, a higher prevalence of NS5A-RASs was observed before treatment in DAA-failures (5/13, 38.5%) vs DAA-naïves (61/393, 15.5%, P =.04). Regarding 228 DAA-naïve patients with an available outcome, 93.9% achieved a SVR. Interestingly, patients with baseline Y93H and/or A30K had SVR rate of 72.2% vs 95.7% for patients without NS5A-RASs (P =.002). Conclusions: In this real-life GT3 cohort, the majority of failures harboured resistant variants carrying NS5A-RASs, the most frequent being Y93H. The presence of natu
Published: 2021

2. Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C

Author: Di Maio, V. C., Barbaliscia, S., Teti, E., Fiorentino, G., Milana, M., Paolucci, S., Pollicino, T., Morsica, G., Starace, M., Bruzzone, B., Gennari, W., Micheli, V., Yu La Rosa, K., Foroghi, L., Calvaruso, V., Lenci, I., Polilli, E., Babudieri, S., Aghemo, A., Raimondo, G., Sarmati, L., Coppola, N., Pasquazzi, C., Baldanti, F., Parruti, G., Perno, C. F., Angelico, M., Craxi, A., Andreoni, M., Ceccherini-Silberstein, F., Andreone, P., Aragri, M., Bertoli, A., Boeri, E., Brancaccio, G., Brunetto, M., Callegaro, A. P., Cenderello, G., Cento, V., Ciaccio, A., Ciancio, A., Cuomo, N., De Santis, A., Di Biagio, A., Di Marco, V., Di Perri, G., Di Stefano, M. A., Gaeta, G. B., Ghisetti, V., Gulminetti, R., Lampertico, P., Landonio, S., Lichtner, M., Lleo, A., Maida, I., Marenco, S., Masetti, C., Mastroianni, C., Minichini, C., Milano, E., Monno, L., Novati, S., Pace Palitti, V., Paternoster, C., Pellicelli, A., Pieri, A., Puoti, M., Rizzardini, G., Ruggiero, T., Rossetti, B., Sangiovanni, V., Santantonio, T., Taliani, G., Toniutto, P., Vullo, V., Zazzi, M., Di Maio, V, Barbaliscia, S, Teti, E, Fiorentino, G, Milana, M, Paolucci, S, Pollicino, T, Morsica, G, Starace, M, Bruzzone, B, Gennari, W, Micheli, V, Yu La Rosa, K, Foroghi, L, Calvaruso, V, Lenci, I, Polilli, E, Babudieri, S, Aghemo, A, Raimondo, G, Sarmati, L, Coppola, N, Pasquazzi, C, Baldanti, F, Parruti, G, Perno, C, Angelico, M, Craxi, A, Andreoni, M, Ceccherini-Silberstein, F, Andreone, P, Aragri, M, Bertoli, A, Boeri, E, Brancaccio, G, Brunetto, M, Callegaro, A, Cenderello, G, Cento, V, Ciaccio, A, Ciancio, A, Cuomo, N, De Santis, A, Di Biagio, A, Di Marco, V, Di Perri, G, Di Stefano, M, Gaeta, G, Ghisetti, V, Gulminetti, R, Lampertico, P, Landonio, S, Lichtner, M, Lleo, A, Maida, I, Marenco, S, Masetti, C, Mastroianni, C, Minichini, C, Milano, E, Monno, L, Novati, S, Pace Palitti, V, Paternoster, C, Pellicelli, A, Pieri, A, Puoti, M, Rizzardini, G, Ruggiero, T, Rossetti, B, Sangiovanni, V, Santantonio, T, Taliani, G, Toniutto, P, Vullo, V, Zazzi, M, Di Maio, Vc, Perno, Cf, Craxì, A, Di Maio V.C., Barbaliscia S., Teti E., Fiorentino G., Milana M., Paolucci S., Pollicino T., Morsica G., Starace M., Bruzzone B., Gennari W., Micheli V., Yu La Rosa K., Foroghi L., Calvaruso V., Lenci I., Polilli E., Babudieri S., Aghemo A., Raimondo G., Sarmati L., Coppola N., Pasquazzi C., Baldanti F., Parruti G., Perno C.F., Angelico M., Craxi A., Andreoni M., Ceccherini-Silberstein F., Andreone P., Aragri M., Bertoli A., Boeri E., Brancaccio G., Brunetto M., Callegaro A.P., Cenderello G., Cento V., Ciaccio A., Ciancio A., Cuomo N., De Santis A., Di Biagio A., Di Marco V., Di Perri G., Di Stefano M.A., Gaeta G.B., Ghisetti V., Gulminetti R., Lampertico P., Landonio S., Lichtner M., Lleo A., Maida I., Marenco S., Masetti C., Mastroianni C., Minichini C., Milano E., Monno L., Novati S., Pace Palitti V., Paternoster C., Pellicelli A., Pieri A., Puoti M., Rizzardini G., Ruggiero T., Rossetti B., Sangiovanni V., Santantonio T., Taliani G., Toniutto P., Vullo V., and Zazzi M.
Subjects: Male, Sofosbuvir, Sustained Virologic Response, Drug Resistance, Hepacivirus, Viral Nonstructural Proteins, Gastroenterology, Settore MED/06, direct-acting antivirals, failure, genotype 3, HCV, resistance, chemistry.chemical_compound, 0302 clinical medicine, Medicine, Viral, Chronic, Phylogeny, Dasabuvir, hcv, virus diseases, Hepatitis C, Pibrentasvir, Italy, 030220 oncology & carcinogenesis, Combination, Drug Therapy, Combination, 030211 gastroenterology & hepatology, Female, medicine.drug, Ledipasvir, medicine.medical_specialty, Daclatasvir, Genotype, Antiviral Agents, Drug Resistance, Viral, Humans, Hepatitis C, Chronic, 03 medical and health sciences, Drug Therapy, Internal medicine, Antiviral Agent, direct-acting antiviral, Hepaciviru, Hepatology, business.industry, Viral Nonstructural Protein, Glecaprevir, direct acting antivirals, Regimen, chemistry, Paritaprevir, business
Abstract: Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3). Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols. Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SOF)/daclatasvir (DCV) or velpatasvir (VEL)±ribavirin (RBV) (N=91/15) and glecaprevir (G)/pibrentasvir (P) (N=9). Moreover, 14.8% of patients were treated with suboptimal regimens for GT3: 3D±RBV (Paritaprevir/r+Ombitasvir+Dasabuvir, N=15), SOF+Simeprevir (SIM) (N=1) or SOF/Ledipasvir (LDV)±RBV (N=4). RAS prevalence was 15.8% in DAA-naïve patients. At failure, 81.5% patients showed at least one RAS: 11/25 (44.0%) in NS3, 109/135 (80.7%) in NS5A, 7/111 (6.3%) in NS5B SOF-failures. In NS5A-failures, Y93H RAS was the most prevalent (68.5% vs 5.1% DAA-naïve, P&nbsp
Published: 2021

3. Genetic Determinants in a Critical Domain of NS5A Correlate with Hepatocellular Carcinoma in Cirrhotic Patients Infected with HCV Genotype 1b

Author: Alkhatib M, Di Maio VC, De Murtas V, Polilli E, Milana M, Teti E, Fiorentino G, Calvaruso V, Barbaliscia S, Bertoli A, Scutari R, Carioti L, Cento V, Santoro MM, Orro A, Maida I, Lenci I, Sarmati L, Craxi A, Pasquazzi C, Parruti G, Babudieri S, Milanesi L, Andreoni M, Angelico M, Perno CF, Ceccherini-Silberstein F, Svicher V, Salpini R, On Behalf Of Hirma Hepatocarcinoma Innovative Research MArkers And Fondazione Vironet C Hcv Virology Italian Resistance., and Alkhatib M, Di Maio VC, De Murtas V, Polilli E, Milana M, Teti E, Fiorentino G, Calvaruso V, Barbaliscia S, Bertoli A, Scutari R, Carioti L, Cento V, Santoro MM, Orro A, Maida I, Lenci I, Sarmati L, Craxi A, Pasquazzi C, Parruti G, Babudieri S, Milanesi L, Andreoni M, Angelico M, Perno CF, Ceccherini-Silberstein F, Svicher V, Salpini R, On Behalf Of Hirma Hepatocarcinoma Innovative Research MArkers And Fondazione Vironet C Hcv Virology Italian Resistance.
Subjects: hepatitis C virus, Liver Cirrhosis, Male, Cirrhosis, viruses, Hepacivirus, Viral Nonstructural Proteins, NS5A, medicine.disease_cause, Severity of Illness Index, genetic variability, Medicine, Liver Neoplasms, virus diseases, hepatocellular carcinoma, Middle Aged, Hepatitis C, QR1-502, Infectious Diseases, Hepatocellular carcinoma, HCV, Host-Pathogen Interactions, Female, Disease Susceptibility, Carcinoma, Hepatocellular, Genotype, Hepatitis C virus, Viremia, Microbiology, Article, Structure-Activity Relationship, Virology, Genetic variation, Humans, Genetic variability, neoplasms, Aged, business.industry, cirrhosis, Sequence Analysis, DNA, biochemical phenomena, metabolism, and nutrition, genotype 1b, medicine.disease, Settore MED/17, digestive system diseases, Mutation, Cancer research, business, Carcinogenesis, Biomarkers
Abstract: HCV is an important cause of hepatocellular carcinoma (HCC). HCV NS5A domain-1 interacts with cellular proteins inducing pro-oncogenic pathways. Thus, we explore genetic variations in NS5A domain-1 and their association with HCC, by analyzing 188 NS5A sequences from HCV genotype-1b infected DAA-naïve cirrhotic patients: 34 with HCC and 154 without HCC. Specific NS5A mutations significantly correlate with HCC: S3T (8.8% vs. 1.3%, p = 0.01), T122M (8.8% vs. 0.0%, p &lt, 0.001), M133I (20.6% vs. 3.9%, p &lt, 0.001), and Q181E (11.8% vs. 0.6%, p &lt, 0.001). By multivariable analysis, the presence of &gt, 1 of them independently correlates with HCC (OR (95%CI): 21.8 (5.7–82.3), p &lt, 0.001). Focusing on HCC-group, the presence of these mutations correlates with higher viremia (median (IQR): 5.7 (5.4–6.2) log IU/mL vs. 5.3 (4.4–5.6) log IU/mL, p = 0.02) and lower ALT (35 (30–71) vs. 83 (48–108) U/L, p = 0.004), suggesting a role in enhancing viral fitness without affecting necroinflammation. Notably, these mutations reside in NS5A regions known to interact with cellular proteins crucial for cell-cycle regulation (p53, p85-PIK3, and β-catenin), and introduce additional phosphorylation sites, a phenomenon known to ameliorate NS5A interaction with cellular proteins. Overall, these results provide a focus for further investigations on molecular bases of HCV-mediated oncogenesis. The role of theseNS5A domain-1 mutations in triggering pro-oncogenic stimuli that can persist also despite achievement of sustained virological response deserves further investigation.
Published: 2021
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4. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author: Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Di Maio, V, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxi, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, L, Palitti, V, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, M, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Di Maio V. C., Cento V., Aragri M., Paolucci S., Pollicino T., Coppola N., Bruzzone B., Ghisetti V., Zazzi M., Brunetto M., Bertoli A., Barbaliscia S., Galli S., Gennari W., Baldanti F., Raimondo G., Perno C. F., Ceccherini-Silberstein F., Andreone P., Andreoni M., Angelico M., Babudieri S., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Cacciatore P., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., Craxi A., D'Ambrosio C., D'Ettorre G., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Lenci I., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Masetti C., Melis M., Meregalli E., Micheli V., Morisco F., Niero F., Nicolini L. A., Palitti V. P., Paoloni M., Parruti G., Pasquazzi C., Pellicelli A., Polilli E., Ponti M. L., Puoti M., Rendina M., Rizzardini G., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., and Vullo V.
Published: 2018

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

Author: 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, Di Maio, V. C. a, Cento V. a, Lenci I. b, Aragri, M. a, Rossi P. b, Barbaliscia S. a, Melis M. c, Verucchi G. d, Magni, C. F. e, Teti E. f, Bertoli A, Bellocchi, MC, Pellicelli, AM, Mastroianni, CM, Perno, CF, 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, Di Maio, V. C. a, Cento V. a, Lenci I. b, Aragri, M. a, Rossi P. b, Barbaliscia S. a, Melis M. c, Verucchi G. d, Magni, C. F. e, Teti E. f, Bertoli A, Bellocchi, MC, Pellicelli, AM, Mastroianni, CM, and Perno, CF
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<.001). Interestingly, 57.1% of DAA IFN-free non-responders had a misclassified genotype, and 3/4 sofosbuvir breakthroughs showed the major-RAS-S282T, while RAS-L159F was frequently found in sofosbuvir relapsers (18.2%). Notably, 9.0% of patients showed also extra target RASs, and 47.4% of patients treated with ≥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 HC
Published: 2017

7. DECLINE OF PREVALENCE OF RESISTANCE ASSOCIATED SUBSTITUTIONS TO NS3 AND NS5A INHIBITORS AT DAA- FAILURE IN HEPATITIS C VIRUS IN ITALY OVER THE YEARS 2015 TO 2018

Author: Redi, D., Rossetti, B., Di Maio, V. C., Aragri, M., Paolucci, S., Masetti, C., Paglicci, L., Bruzzone, B., Minichini, C., FRANCESCA MONTAGNANI, Micheli, V., Landonio, S., Degasperi, E., Giacomo Zanelli, Maserati, R., Maida, I., Callegaro, A. P., Barbaliscia, S., Bertoli, A., Paternoster, C., Marenco, S., Morisco, F., Calvaruso, V., Taliani, G., Puoti, M., Cenderello, G., Santis, A., Lichtner, M., Coppola, N., Gulminetti, R., Cento, V., Rendina, M., Teti, E., Parruti, G., Ruggiero, T., Ghisetti, V., Pasquazzi, C., Nicolini, L. A., Vullo, V., Pellicelli, A., Prestileo, T., Cozzolongo, R., Sangiovanni, V., Biolato, M., Lenci, I., Licata, A., Ciaccio, A., Pace Palitti, V., Giorgini, A., Cariti, G., Ciancio, A., Aghemo, A., Borghi, V., Andreone, P., Brunetto, M., Pollicino, T., Santantonio, T., Cuomo, N., Caudai, C., Babudieri, S., Lampertico, P., Gaeta, G. B., Raimondo, G., Andreoni, M., Rizzardini, G., Angelico, M., Perno, C. F., Craxì, A., Maurizio Zazzi, Ceccherini- Silberstein, F., and on behalf of HCV Virology Italian Resistance Network (Vironet C)
Published: 2019

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

Author: Barbaliscia, S., primary, Di Maio, V.C., additional, Fabeni, L., additional, Teti, E., additional, Paolucci, S., additional, Minichini, C., additional, Aragri, M., additional, Rosa, K. Yu La, additional, Carioti, L., additional, Pasquazzi, C., additional, Milana, M., additional, Foroghi, L., additional, Pollicino, T., additional, Licata, A., additional, Pieri, A., additional, Palitti, V. Pace, additional, Bruzzone, B., additional, Micheli, V., additional, Bertoli, A., additional, Baiocchi, L., additional, Callegaro, A.P., additional, Pellicelli, A., additional, Morisco, F., additional, Gulminetti, R., additional, Novati, S., additional, Lichtner, M., additional, Mastroianni, C., additional, Di Lorenzo, F., additional, Andreone, P., additional, Rossetti, B., additional, Marenco, S., additional, Taliani, G., additional, Boeri, E., additional, Hasson, H., additional, Monno, L., additional, Nicolini, L.A., additional, Landonio, S., additional, Paternoster, C., additional, Puoti, M., additional, Babudieri, S., additional, Quartini, M., additional, Iapadre, N., additional, Cozzolongo, R., additional, Sangiovanni, V., additional, Parruti, G., additional, Sarmati, L., additional, Coppola, N., additional, Baldanti, F., additional, Marco, V. Di, additional, Zazzi, M., additional, Raimondo, G., additional, Angelico, M., additional, Perno, C.F., additional, Andreoni, M., additional, Craxì, A., additional, and Ceccherini-Silberstein, F., additional
Published: 2020
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9. VIRONET-C real life experience of resistance-guided retreatment in HCV infected patients who previously failed a NS5A inhibitor-containing regimen

Author: Di Maio, V.C., primary, Aragri, M., additional, Masetti, C., additional, Paolucci, S., additional, Bruzzone, B., additional, Degasperi, E., additional, Barbaliscia, S., additional, Pollicino, T., additional, Minichini, C., additional, Calvaruso, V., additional, Rendina, M., additional, Cento, V., additional, Teti, E., additional, Micheli, V., additional, Allice, T., additional, Polilli, E., additional, Palitti, V. Pace, additional, Landonio, S., additional, Lenci, I., additional, Francioso, S., additional, Donnarumma, L., additional, Nicolini, L.A., additional, Bertoli, A., additional, Starace, M., additional, Pasquazzi, C., additional, Callegaro, A.P., additional, Morisco, F., additional, Cenderello, G., additional, Marenco, S., additional, Gulminetti, R., additional, Novati, S., additional, Scuteri, A., additional, Andreone, P., additional, Galli, S., additional, Ciancio, A., additional, Sangiovanni, V., additional, Cuomo, N., additional, Raddi, A., additional, Gennari, W., additional, Boeri, E., additional, Morsica, G., additional, Hasson, H., additional, Borghi, V., additional, Maida, I., additional, Brunetto, M., additional, Colombatto, P., additional, Cozzolongo, R., additional, De Santis, A., additional, Lichtner, M., additional, Babudieri, S., additional, Biliotti, E., additional, Taliani, G., additional, Santantonio, T., additional, Di Stefano, M., additional, Paternoster, C., additional, Ganga, R., additional, Merli, M., additional, Rizzardini, G., additional, Pellicelli, A., additional, Giannelli, V., additional, Milano, E., additional, Mastroianni, C., additional, Licata, A., additional, Di Lorenzo, F., additional, Giorgini, A., additional, Sighinolfi, L., additional, Dentone, C., additional, Lleo, A., additional, Rossetti, B., additional, Beretta, I., additional, Cariti, G., additional, Ghisetti, V., additional, Lampertico, P., additional, Parruti, G., additional, Coppola, N., additional, Baldanti, F., additional, Gaeta, G.B., additional, Raimondo, G., additional, Puoti, M., additional, Zazzi, M., additional, Andreoni, M., additional, Angelico, M., additional, Perno, C.F., additional, Craxì, A., additional, and Ceccherini-Silberstein, F., additional
Published: 2020
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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: Di Maio, V.C., primary, Aragri, M., additional, Masetti, C., additional, Paolucci, S., additional, Bruzzone, B., additional, Degasperi, E., additional, Barbaliscia, S., additional, Pollicino, T., additional, Minichini, C., additional, Calvaruso, V., additional, Rendina, M., additional, Cento, V., additional, Teti, E., additional, Micheli, V., additional, Ghisetti, V., additional, Polilli, E., additional, Palitti, V. Pace, additional, Landonio, S., additional, Lenci, I., additional, Donnarumma, L., additional, Nicolini, L.A., additional, Bertoli, A., additional, Starace, M., additional, Pasquazzi, C., additional, Callegaro, A.P., additional, Morisco, F., additional, Cenderello, G., additional, Marenco, S., additional, Gulminetti, R., additional, Novati, S., additional, Guarneri, V., additional, Andreone, P., additional, Galli, S., additional, Ciancio, A., additional, Sangiovanni, V., additional, Cuomo, N., additional, Raddi, A., additional, Morsica, G., additional, Borghi, V., additional, Maida, I., additional, Brunetto, M., additional, Colombatto, P., additional, Cozzolongo, R., additional, De Santis, A., additional, Lichtner, M., additional, Babudieri, S., additional, Taliani, G., additional, Santantonio, T., additional, Di Stefano, M., additional, Paternoster, C., additional, Ganga, R., additional, Puoti, M., additional, Rizzardini, G., additional, Pellicelli, A., additional, Milano, E., additional, Mastroianni, C., additional, Licata, A., additional, Di Lorenzo, F., additional, Giorgini, A., additional, Lampertico, P., additional, Parruti, G., additional, Coppola, N., additional, Zazzi, M., additional, Raimondo, G., additional, Andreoni, M., additional, Craxì, A., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2019
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11. Characterization of baseline factors associated with treatment outcome in HCV-infected patients naive to direct acting antivirals: particular focus on natural resistance

Author: Barbaliscia, S., primary, Di Maio, V.C., additional, Teti, E., additional, Aragri, M., additional, Paolucci, S., additional, Masetti, C., additional, D’Ambrosio, R., additional, Degasperi, E., additional, Polilli, E., additional, Palitti, V. Pace, additional, Fiorentino, G., additional, Foroghi, L., additional, Cento, V., additional, Scutari, R., additional, Bruzzone, B., additional, Calvaruso, V., additional, Coppola, N., additional, Gaeta, G.B., additional, Morsica, G., additional, Ghisetti, V., additional, Bertoli, A., additional, Milana, M., additional, Nicolini, L.A., additional, Gennari, W., additional, Campoli, R., additional, Galli, S., additional, Magni, C.F., additional, Micheli, V., additional, Boccaccio, V., additional, Maserati, R., additional, Bonora, S., additional, Iapadre, N., additional, Morisco, F., additional, Siciliano, M., additional, Guarneri, V., additional, Lichtner, M., additional, Borghi, V., additional, Paba, P., additional, Sarmati, L., additional, Puoti, M., additional, Pellicelli, A., additional, Babudieri, S., additional, Rizzardini, G., additional, Taliani, G., additional, Parruti, G., additional, Lampertico, P., additional, Pasquazzi, C., additional, Angelico, M., additional, Baldanti, F., additional, Craxì, A., additional, Andreoni, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2019
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12. Comparison of resistance profiles among DAA-naive and DAA-experienced patients infected with HCV non-1 genotype in Italy

Author: Maio, V.C.D., primary, Barbaliscia, S., additional, Teti, E., additional, Lenci, I., additional, Aragri, M., additional, Polilli, E., additional, Fiorentino, G., additional, Palitti, V.P., additional, Bruzzone, B., additional, Paolucci, S., additional, Nicola, C., additional, Ruggiero, T., additional, Pollicino, T., additional, Niero, F., additional, Micheli, V., additional, Nicolini, L.A., additional, Marenco, S., additional, Bertoli, A., additional, Maida, I.R., additional, Francioso, S., additional, Foroghi, L., additional, Calvaruso, V., additional, Morisco, F., additional, Lleo, A., additional, Boccaccio, V., additional, Ciancio, A., additional, Maserati, R., additional, Puoti, M., additional, Zazzi, M., additional, Rossetti, B., additional, Vullo, V., additional, D'ambrosio, R., additional, Boglione, L., additional, Bonora, S., additional, Babudieri, S., additional, Gubertini, G.A., additional, Rendina, M.G., additional, Pellicelli, A., additional, Sangiovanni, V., additional, Ciaccio, A., additional, Taliani, G., additional, Raimondo, G., additional, Gaeta, G.B., additional, Craxi, A., additional, Pasquazzi, C., additional, Sarmati, L., additional, Parruti, G., additional, Angelico, M., additional, Andreoni, M., additional, Cento, V., additional, Perno, C.F., additional, and Silberstein, F.C., additional
Published: 2018
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13. Characterization of resistance profiles in HCV 2-3-4 DAA-naïve and DAA-experienced infected patients in Italy

Author: Barbaliscia, S., primary, Di Maio, V.C., additional, Teti, E., additional, Lenci, I., additional, Aragri, M., additional, Polilli, E., additional, Fiorentino, G., additional, Pace Palitti, V., additional, Bruzzone, B., additional, Paolucci, S., additional, Coppola, N., additional, Ruggiero, T., additional, Pollicino, T., additional, Niero, F., additional, Micheli, V., additional, Nicolini, L.A., additional, Marenco, S., additional, Bertoli, A., additional, Maida, I., additional, Francioso, S., additional, Foroghi, L., additional, Calvaruso, V., additional, Morisco, F., additional, Lleo, A., additional, Boccaccio, V., additional, Ciancio, A., additional, Maserati, R., additional, Puoti, M., additional, Zazzi, M., additional, Rossetti, B., additional, Vullo, V., additional, D’Ambrosio, A.R., additional, Boglione, L., additional, Bonora, S., additional, Babudieri, S., additional, Gubertini, G., additional, Rendina, M., additional, Pellicelli, A., additional, Sangiovanni, V., additional, Ciaccio, A., additional, Taliani, G., additional, Raimondo, G., additional, Gaeta, G.B., additional, Craxì, A., additional, Pasquazzi, C., additional, Sarmati, L., additional, Parruti, G., additional, Angelico, M., additional, Andreoni, M., additional, Cento, V., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2018
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14. Optimal efficacy of interferon-free HCV retreatment after protease inhibitor failure in real life

Author: Cento, V., primary, Barbaliscia, S., additional, Lenci, I., additional, Ruggiero, T., additional, Magni, C.F., additional, Paolucci, S., additional, Babudieri, S., additional, Siciliano, M., additional, Pasquazzi, C., additional, Ciancio, A., additional, Perno, C.F., additional, Ceccherini-Silberstein, F., additional, Micheli, V., additional, Troshina, Y., additional, Biliotti, E., additional, Milana, M., additional, Melis, M., additional, Teti, E., additional, Lambiase, L., additional, Menzaghi, B., additional, Nicolini, L.A., additional, Marenco, S., additional, Di Maio, V.C., additional, Aragri, M., additional, Pecchioli, A., additional, Bertoli, A., additional, Sarrecchia, C., additional, Macera, M., additional, Coppola, N., additional, Puoti, M., additional, Romagnoli, D., additional, Pellicelli, A., additional, Bonora, S., additional, Novati, S., additional, Baldanti, F., additional, Ghisetti, V., additional, Andreoni, M., additional, Taliani, G., additional, Rizzardini, G., additional, and Angelico, M., additional
Published: 2017
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15. HCV resistance test guided retreatments after protease inhibitors failures can induce maximal efficacy rate in real-life

Author: Cento, V., primary, Barbaliscia, S., additional, Lenci, I., additional, Ruggiero, T., additional, Masetti, C., additional, Magni, C.F., additional, Micheli, V., additional, Paolucci, S., additional, Troshina, Y., additional, Biliotti, E., additional, Milana, M., additional, Melis, M., additional, Teti, E., additional, Lambiase, L., additional, Menzaghi, B., additional, Nicolini, L.A., additional, Marenco, S., additional, Di Maio, V.C., additional, Aragri, M., additional, Pecchioli, A., additional, Bertoli, A., additional, Antonucci, F.P., additional, Sarmati, L., additional, Sarrecchia, C., additional, Macera, M., additional, Coppola, N., additional, Danieli, E., additional, Romagnoli, D., additional, Pellicelli, A., additional, Bonora, S., additional, Babudieri, S., additional, Di Biagio, A., additional, Picciotto, A., additional, Novati, S., additional, Siciliano, M., additional, Messina, V., additional, Claar, E., additional, Baldanti, F., additional, Pasquazzi, C., additional, Ciancio, A., additional, Puoti, M., additional, Ghisetti, V., additional, Andreoni, M., additional, Taliani, G., additional, Rizzardini, G., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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16. Prevalence and characteristics of resistance associated substitutions in DAA-naive and DAA-failed HCV-3 patients in Italy

Author: Di Maio, V.C., primary, Barbaliscia, S., additional, Lenci, I., additional, Teti, E., additional, Antonucci, F.P., additional, Cento, V., additional, Aragri, M., additional, Paolucci, S., additional, Bruzzone, B., additional, Coppola, N., additional, Ruggiero, T., additional, Pollicino, T., additional, Polilli, E., additional, Pasquazzi, C., additional, Pace Palitti, V., additional, Magni, C.F., additional, Micheli, V., additional, Di Biagio, A., additional, Sticchi, L., additional, Melis, M., additional, Francioso, S., additional, Masetti, C., additional, Foroghi, L., additional, Sarrecchia, C., additional, Baiocchi, L., additional, Landonio, S., additional, Bertoli, A., additional, Calvaruso, V., additional, Morisco, F., additional, Maida, I., additional, Marenco, S., additional, Leo, A., additional, Ghisetti, V., additional, Ciancio, A., additional, Sacchi, P., additional, Novati, S., additional, Brancaccio, G., additional, Pieri, A., additional, Puoti, M., additional, Toniutto, P., additional, Vullo, V., additional, Aghemo, A., additional, Di Perri, G., additional, Babudieri, S., additional, Rizzardini, G., additional, Bruno, S., additional, Pellicelli, A., additional, Taliani, G., additional, Raimondo, G., additional, Baldanti, F., additional, Gaeta, G.B., additional, Craxì, A., additional, Parruti, G., additional, Andreoni, M., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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17. The challenge of HCV-retreatment after DAA-failure: Italian real-life from VIRONET-C network

Author: Cento, V., primary, Barbaliscia, S., additional, Di Maio, V.C., additional, Masetti, C., additional, Minichini, C., additional, Magni, C.F., additional, Micheli, V., additional, Marenco, S., additional, Nicolini, L.A., additional, Bruzzone, B., additional, Troshina, Y., additional, Baiguera, C., additional, Dentone, C., additional, Calvaruso, V., additional, Paolucci, S., additional, Melis, M., additional, Aragri, M., additional, Bertoli, A., additional, Lenci, I., additional, Landonio, S., additional, Schiavini, M., additional, Sticchi, L., additional, Ruggiero, T., additional, Polilli, E., additional, Messina, V., additional, Pellicelli, A., additional, Boglione, L., additional, Cozzolongo, R., additional, Biolato, M., additional, Morisco, F., additional, Siciliano, M., additional, Parruti, G., additional, Barbarini, G., additional, Craxì, A., additional, Babudieri, S., additional, Puoti, M., additional, Ciancio, A., additional, Rizzardini, G., additional, Coppola, N., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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18. Multiclass HCV resistance to interferon-free direct acting antivirals regimens in real life failures advocates for tailored second-line therapies

Author: Di Maio, V.C., primary, Cento, V., additional, Lenci, I., additional, Aragri, M., additional, Barbaliscia, S., additional, Francioso, S., additional, Paolucci, S., additional, Melis, M., additional, Verucchi, G., additional, Masetti, C., additional, Coppola, N., additional, Magni, C.F., additional, Micheli, V., additional, Pollicino, T., additional, Ruggiero, T., additional, Landonio, S., additional, Mancon, A., additional, Starace, M., additional, De Leonardis, F., additional, Santopaolo, F., additional, Bertoli, A., additional, Antonucci, F.P., additional, D’Ambrosio, C., additional, Calvaruso, V., additional, Sorbo, M.C., additional, Morisco, F., additional, Pasquazzi, C., additional, Maida, I., additional, Picciotto, A., additional, Di Biagio, A., additional, Bruzzone, B., additional, Sticchi, L., additional, Ghisetti, V., additional, Cozzolongo, R., additional, Romagnoli, D., additional, Boccaccio, V., additional, Grieco, A., additional, Vecchiet, J., additional, D’Ettorre, G., additional, Merli, M., additional, Gaeta, G.B., additional, Ciancio, A., additional, Marinaro, L., additional, Polilli, E., additional, Cacciatore, P., additional, Andreone, P., additional, Barbarini, G., additional, Gulminetti, R., additional, Novati, S., additional, Pace Palitti, V., additional, Tarquini, P., additional, Puoti, M., additional, Sangiovanni, V., additional, De Stefano, G., additional, Giorgini, A., additional, Paoloni, M., additional, Caporaso, N., additional, Babudieri, S., additional, Gubertini, G., additional, Bruno, S., additional, Andreoni, M., additional, Pellicelli, A., additional, Parruti, G., additional, Raimondo, G., additional, Baldanti, F., additional, Rizzardini, G., additional, Craxì, A., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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19. The challenge of HCV-retreatment after DAA-failure: real-life experience advocates for caution

Author: Cento, V., primary, Barbaliscia, S., additional, Di Maio, V.C., additional, Masetti, C., additional, Minichini, C., additional, Magni, C.F., additional, Micheli, V., additional, Marenco, S., additional, Nicolini, L.A., additional, Bruzzone, B., additional, Troshina, Y., additional, Baiguera, C., additional, Dentone, C., additional, Calvaruso, V., additional, Paolucci, S., additional, Melis, M., additional, Aragri, M., additional, Bertoli, A., additional, Lenci, I., additional, Landonio, S., additional, Schiavini, M., additional, Sticchi, L., additional, Ruggiero, T., additional, Polilli, E., additional, Messina, V., additional, Pellicelli, A., additional, Boglione, L., additional, Cozzolongo, R., additional, Biolato, M., additional, Morisco, F., additional, Siciliano, M., additional, Parruti, G., additional, Barbarini, G., additional, Craxì, A., additional, Babudieri, S., additional, Puoti, M., additional, Ciancio, A., additional, Rizzardini, G., additional, Coppola, N., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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20. Multiclass hepatitis C virus resistance to direct acting antivirals in real life interferon-free regimens failures advocates for tailored second-line therapies

Author: Di Maio, V.C., primary, Cento, V., additional, Lenci, I., additional, Aragri, M., additional, Barbaliscia, S., additional, Francioso, S., additional, Paolucci, S., additional, Melis, M., additional, Verucchi, G., additional, Coppola, N., additional, Magni, C.F., additional, Micheli, V., additional, Pollicino, T., additional, Ruggiero, T., additional, Santopaolo, F., additional, Landonio, S., additional, Mancon, A., additional, Starace, M., additional, Bertoli, A., additional, Antonucci, F.P., additional, D’Ambrosio, C., additional, Calvaruso, V., additional, Morisco, F., additional, Pasquazzi, C., additional, Maida, I., additional, Picciotto, A., additional, Biagio, A.D., additional, Bruzzone, B., additional, Sticchi, L., additional, Ghisetti, V., additional, Cozzolongo, R., additional, Romagnoli, D., additional, Boccaccio, V., additional, Grieco, A., additional, Vecchiet, J., additional, D’Ettorre, G., additional, Merli, M., additional, Gaeta, G.B., additional, Ciancio, A., additional, Marinaro, L., additional, Andreone, P., additional, Barbarini, G., additional, Gulminetti, R., additional, Palitti, V.P., additional, Tarquini, P., additional, Puoti, M., additional, Sangiovanni, V., additional, Stefano, G.D., additional, Giorgini, A., additional, Paoloni, M., additional, Caporaso, N., additional, Babudieri, S., additional, Gubertini, G., additional, Bruno, S., additional, Andreoni, M., additional, Pellicelli, A., additional, Parruti, G., additional, Raimondo, G., additional, Baldanti, F., additional, Craxì, A., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional
Published: 2017
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21. THU-297 - Comparison of resistance profiles among DAA-naive and DAA-experienced patients infected with HCV non-1 genotype in Italy

Author: Maio, V.C.D., Barbaliscia, S., Teti, E., Lenci, I., Aragri, M., Polilli, E., Fiorentino, G., Palitti, V.P., Bruzzone, B., Paolucci, S., Nicola, C., Ruggiero, T., Pollicino, T., Niero, F., Micheli, V., Nicolini, L.A., Marenco, S., Bertoli, A., Maida, I.R., Francioso, S., Foroghi, L., Calvaruso, V., Morisco, F., Lleo, A., Boccaccio, V., Ciancio, A., Maserati, R., Puoti, M., Zazzi, M., Rossetti, B., Vullo, V., D'ambrosio, R., Boglione, L., Bonora, S., Babudieri, S., Gubertini, G.A., Rendina, M.G., Pellicelli, A., Sangiovanni, V., Ciaccio, A., Taliani, G., Raimondo, G., Gaeta, G.B., Craxi, A., Pasquazzi, C., Sarmati, L., Parruti, G., Angelico, M., Andreoni, M., Cento, V., Perno, C.F., and Silberstein, F.C.
Published: 2018
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22. Optimal efficacy of interferon-free HCV retreatment after protease inhibitor failure in real life

Author: Micheli, V., Troshina, Y., Biliotti, E., Milana, M., Melis, M., Teti, E., Lambiase, L., Menzaghi, B., Nicolini, L.A., Marenco, S., Di Maio, V.C., Aragri, M., Pecchioli, A., Bertoli, A., Sarrecchia, C., Macera, M., Coppola, N., Puoti, M., Romagnoli, D., Pellicelli, A., Bonora, S., Novati, S., Baldanti, F., Ghisetti, V., Andreoni, M., Taliani, G., Rizzardini, G., Angelico, M., Cento, V., Barbaliscia, S., Lenci, I., Ruggiero, T., Magni, C.F., Paolucci, S., Babudieri, S., Siciliano, M., Pasquazzi, C., Ciancio, A., Perno, C.F., and Ceccherini-Silberstein, F.
Published: 2017
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23. SAT-288 - The challenge of HCV-retreatment after DAA-failure: real-life experience advocates for caution

Author: Cento, V., Barbaliscia, S., Di Maio, V.C., Masetti, C., Minichini, C., Magni, C.F., Micheli, V., Marenco, S., Nicolini, L.A., Bruzzone, B., Troshina, Y., Baiguera, C., Dentone, C., Calvaruso, V., Paolucci, S., Melis, M., Aragri, M., Bertoli, A., Lenci, I., Landonio, S., Schiavini, M., Sticchi, L., Ruggiero, T., Polilli, E., Messina, V., Pellicelli, A., Boglione, L., Cozzolongo, R., Biolato, M., Morisco, F., Siciliano, M., Parruti, G., Barbarini, G., Craxì, A., Babudieri, S., Puoti, M., Ciancio, A., Rizzardini, G., Coppola, N., Angelico, M., Perno, C.F., and Ceccherini-Silberstein, F.
Published: 2017
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24. PS-154 - Multiclass hepatitis C virus resistance to direct acting antivirals in real life interferon-free regimens failures advocates for tailored second-line therapies

Author: Di Maio, V.C., Cento, V., Lenci, I., Aragri, M., Barbaliscia, S., Francioso, S., Paolucci, S., Melis, M., Verucchi, G., Coppola, N., Magni, C.F., Micheli, V., Pollicino, T., Ruggiero, T., Santopaolo, F., Landonio, S., Mancon, A., Starace, M., Bertoli, A., Antonucci, F.P., D’Ambrosio, C., Calvaruso, V., Morisco, F., Pasquazzi, C., Maida, I., Picciotto, A., Biagio, A.D., Bruzzone, B., Sticchi, L., Ghisetti, V., Cozzolongo, R., Romagnoli, D., Boccaccio, V., Grieco, A., Vecchiet, J., D’Ettorre, G., Merli, M., Gaeta, G.B., Ciancio, A., Marinaro, L., Andreone, P., Barbarini, G., Gulminetti, R., Palitti, V.P., Tarquini, P., Puoti, M., Sangiovanni, V., Stefano, G.D., Giorgini, A., Paoloni, M., Caporaso, N., Babudieri, S., Gubertini, G., Bruno, S., Andreoni, M., Pellicelli, A., Parruti, G., Raimondo, G., Baldanti, F., Craxì, A., Angelico, M., Perno, C.F., and Ceccherini-Silberstein, F.
Published: 2017
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25. Biotech innovations in the prevention of respiratory infectious diseases

Author: Jv, Cento, Barbaliscia S, and CARLO FEDERICO PERNO

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

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

27. Prevalence of resistance-associated substitutions to ns3, ns5a and ns5b inhibitors at daa-failure in hepatitis c virus in Italy from 2015 to 2019

Author: Rossetti, B., Paglicci, L., Velia Chiara Di Maio, Cassol, C., Barbaliscia, S., Paolucci, S., Bruzzone, B., Coppola, N., Montagnani, F., Micheli, V., Monno, L., Zanelli, G., Santantonio, T., Cuomo, N., Caudai, C., Zazzi, M., and Ceccherini-Silberstein, F.

28. Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy

Author: Ada Bertoli, Michael P. Manns, M. Katja Deterding, Vanni Borghi, Silvia Barbaliscia, Elisabetta Degasperi, Julian Schulze zur Wiesch, Velia Chiara Di Maio, Ansgar W. Lohse, Wolfgang Schmidt, Markus Cornberg, Christophe Moreno, Tomas Beyer, Federico García, Johannes Vermehren, Pietro Lampertico, Andreas E. Kremer, Laura Sighinolfi, Felix Piecha, Magdalena Lara, Pier Luigi Toniutto, Christoph Sarrazin, Antonio Craxì, Francesca Ceccherini-Silberstein, Jonas Schreiber, Jesús Santos, Ana Belén Pérez, Alessio Aghemo, William Gennari, Lorenzo Magenta, Manuel Alberto Macias Rodriguez, Heiner Wedermeyer, Ana Fuentes, Stephan Grunwald, Jose Miguel Rosales Zabal, Francisco Téllez, Dolores Merino, Burkhard Jäger, Miguel García Deltoro, Juan Manuel Pascasio-Acevedo, Blanca Figueruela, Andreas Stallmach, Renate Heyne, Valeria Ghisetti, Christoph P. Berg, Carlo Federico Perno, Elisa Fernández-Fuertes, Nikolaus Kordecki, Ana María Martinez Sapiña, Natalia Chueca, Andreas Herrmann, Eva Jägel-Guedes, Vincenza Calvaruso, Maurizio Zazzi, Massimo Andreoni, Lucio Boglione, Mario Angelico, Simona Francioso, Giuseppe Cariti, Cristina Quilez, Tiziano Allice, Christiana Graf, Leopoldo Muñoz-Medina, Fausto Baldanti, Rudolf E. Stauber, Jürgen Siebler, Julia Dietz, Maria Josefa Rodriguez Pardo, Kerstin Port, Heinz Zoller, Juan Carlos Alados, Stefan Zeuzem, Juan Ignacio Arenas Ruiz-Tapiador, Joaquín Cabezas, Stefania Paolucci, Axels Baumgarten, Kai-Henrik Peiffer, Adolfo de Salazar, Pietro Pozzoni, Miguel Jimenez, Hjördis Möller, Dietz J., Di Maio V.C., de Salazar A., Merino D., Vermehren J., Paolucci S., Kremer A.E., Lara M., Pardo M.R., Zoller H., Degasperi E., Peiffer K.-H., Sighinolfi L., Tellez F., Graf C., Ghisetti V., Schreiber J., Fernandez-Fuertes E., Boglione L., Munoz-Medina L., Stauber R., Gennari W., Figueruela B., Santos J., Lampertico P., Zeuzem S., Ceccherini-Silberstein F., Garcia F., Sarrazin C., Aghemo A., Allice T., Andreoni M., Angelico M., Baldanti F., Barbaliscia S., Bertoli A., Borghi V., Calvaruso V., Cariti G., Craxi A., Francioso S., Perno C.F., Pozzoni P., Toniutto P.L., Zazzi M., Perez A.B., Quilez C., Alados J.C., Cabezas J., Ruiz-Tapiador J.I.A., Jimenez M., Pascasio-Acevedo J.M., Rodriguez M.A.M., Zabal J.M.R., Deltoro M.G., Sapina A.M.M., Fuentes A., Chueca N., Berg C.P., Herrmann A., Stallmach A., Port K., Katja Deterding M., Wedermeyer H., Cornberg M., Manns M.P., Moreno C., Wiesch J.S.Z., Piecha F., Lohse A., Siebler J., Kordecki N., Magenta L., Jager B., Moller H., Heyne R., Beyer T., Grunwald S., Baumgarten A., Jagel-Guedes E., and Schmidt W.
Subjects: 0301 basic medicine, Hepatitis C Virus, medicine.medical_specialty, Sofosbuvir, Voxilaprevir, Population, resistance-associated substitutions, Direct-acting antiviral, Voxilaprevir/velpatasvir/sofosbuvir, Gastroenterology, Settore MED/07, Telaprevir, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Voxilaprevir/Velpatasvir/Sofosbuvir, Internal medicine, Boceprevir, Rescue therapy, medicine, Resistance-associated substitution, education, direct-acting antivirals, DAA, education.field_of_study, Hepatology, business.industry, virus diseases, Glecaprevir, HCV, rescue therapy, digestive system diseases, Pibrentasvir, Regimen, 030104 developmental biology, chemistry, 030211 gastroenterology & hepatology, Hepatitis C viru, business, medicine.drug
Abstract: Background & Aims There are limited data on patients with chronic HCV infection in whom combination voxilaprevir (VOX), velpatasvir (VEL), sofosbuvir (SOF) retreatment fails. Thus, we aimed to assess treatment failure and rescue treatment options in these patients. Methods Samples from 40 patients with HCV genotypes (GT) 1-4 in whom VOX/VEL/SOF retreatment failed were collected within the European Resistance Study Group. Population-based resistance analyses were conducted and clinical parameters and retreatment efficacies were evaluated retrospectively in 22 patients. Results Most VOX/VEL/SOF failure patients were infected with HCV GT3a (n = 18, 45%) or GT1a (n = 11, 28%) and had cirrhosis (n = 28, 70%). Previous treatments included an NS3-inhibitor (30%), an NS5A-inhibitor (100%) and SOF (85%). Baseline RAS data from a subgroup of patients before VOX/VEL/SOF retreatment (78%) showed few NS3 RASs apart from Q80K in GT1a (40%), typical NS5A RAS patterns in most patients (74%) and no S282T in NS5B. Sequencing after VOX/VEL/SOF failure was available in 98% of patients and showed only minor changes for NS3 and NS5A RASs. In 22 patients, rescue treatment was initiated with glecaprevir, pibrentasvir alone (n = 2) or with SOF±ribavirin (n = 15), VOX/VEL/SOF±ribavirin (n = 4) or VEL/SOF and ribavirin (n = 1) for 12 to 24 weeks. Sustained virologic response was achieved in 17/21 (81%) patients with a final treatment outcome. Of these, 2 GT3a-infected patients had virologic failure after rescue treatment with VEL/SOF or glecaprevir/pibrentasvir+SOF+ribavirin, and 2 patients with cirrhosis died during treatment or before reaching SVR12. Conclusions VOX/VEL/SOF failure was mainly observed in HCV GT3- and GT1a-infected patients with cirrhosis and was not associated with specific RAS patterns within NS3, NS5A or NS5B target regions. Rescue treatment with multiple targeted therapies was effective in most patients. Lay summary The advent of direct-acting antivirals has enabled the effective cure of chronic hepatitis C in most patients. However, treatment failure occurs in some patients, who are often retreated with a combination regimen called VOX/VEL/SOF, which is associated with very high rates of cure. However, VOX/VEL/SOF retreatment also fails in some patients. Herein, we analysed samples from patients in whom VOX/VEL/SOF retreatment failed and we assessed the efficacy of different rescue therapies, showing that rescue treatment is effective in most patients (81%).
Published: 2021
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29. Impact of analytical treatment interruption on burden and diversification of HIV peripheral reservoir: a pilot study

Author: Vincenzo Spagnuolo, Francesca Ceccherini-Silberstein, Rossana Scutari, Valentino Costabile, A Castagna, L. Galli, Silvia Barbaliscia, L. Carioti, Carlo Federico Perno, Maria Concetta Bellocchi, Andrea Poli, Maria Mercedes Santoro, Claudia Alteri, Andrea Galli, Scutari, R., Costabile, V., Galli, L., Bellocchi, M. C., Carioti, L., Barbaliscia, S., Poli, A., Galli, A., Perno, C. F., Santoro, M. M., Castagna, A., Ceccherini-Silberstein, F., Alteri, C., and Spagnuolo, V.
Subjects: 0301 basic medicine, Adult, Male, Human immunodeficiency virus (HIV), Antiretroviral Therapy, Viremia, HIV Infections, Pilot Projects, Biology, Diversification (marketing strategy), medicine.disease_cause, Microbiology, Article, Virus, Medication Adherence, Settore MED/07, 03 medical and health sciences, 0302 clinical medicine, HIV-1 reservoir, Virology, Antiretroviral Therapy, Highly Active, HIV-1, HIV-1 diversification, analytical treatment interruption, Anti-Retroviral Agents, DNA, Viral, Disease Reservoirs, Female, Humans, Middle Aged, Mutation, Viral Load, medicine, Highly Active, 030212 general & internal medicine, Viral, Genetic diversification, Analytical treatment interruption, DNA, medicine.disease, QR1-502, Peripheral, 030104 developmental biology, Infectious Diseases, Treatment interruption, Viral evolution, Immunology
Abstract: Background: If analytical antiretroviral-treatment (ART) interruption (ATI) might significantly impact quantitative or qualitative peripheral-total HIV-DNA is still debated. Methods: Six chronically HIV-1 infected patients enrolled in APACHE-study were analysed for peripheral-total HIV-DNA and residual viremia, major-resistance-mutations (MRMs) and C2-V3-C3 evolution at pre-ATI (T1), during ATI (T2) and at achievement of virological success after ART-resumption (post-ATI, T3). These data were obtained at three comparable time-points in five chronically HIV-1 infected patients on suppressive ART for ≥1 year, enrolled in MODAt-study. Results: At T1, APACHE and MODAt individuals had similar peripheral-total HIV-DNA and residual viremia (p = 0.792 and 0.662, respectively), and no significant changes for these parameters were observed between T1 and T3 in both groups. At T1, 4/6 APACHE and 2/5 MODAt carried HIV-DNA MRMs. MRMs disappeared at T3 in 3/4 APACHE. All disappearing MRMs were characterized by T1 intra-patient prevalence &lt, 80%, and mainly occurred in APOBEC3-related sites. All MRMs persisted over-time in the 2 MODAt. C2-V3-C3 genetic-distance significantly changed from T1 to T3 in APACHE individuals (+0.36[0.11–0.41], p = 0.04), while no significant changes were found in MODAt. Accordingly, maximum likelihood trees (bootstrap &gt, 70%) and genealogical sorting indices (GSI &gt, 0.50 with p-value &lt, 0.05) showed that T1 C2-V3-C3 DNA sequences were distinct from T2 and T3 viruses in 4/6 APACHE. Virus populations at all three time-points were highly interspersed in MODAt. Conclusions: This pilot study indicates that short ATI does not alter peripheral-total HIV-DNA burden and residual viremia, but in some cases could cause a genetic diversification of peripheral viral reservoir in term of both MRMs rearrangement and viral evolution.
Published: 2021

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

Author: Velia Chiara Di Maio, Valeria Cento, Marianna Aragri, Stefania Paolucci, Teresa Pollicino, Nicola Coppola, Bianca Bruzzone, Valeria Ghisetti, Maurizio Zazzi, Maurizia Brunetto, Ada Bertoli, Silvia Barbaliscia, Silvia Galli, William Gennari, Fausto Baldanti, Giovanni Raimondo, Carlo Federico Perno, Francesca Ceccherini-Silberstein, Pietro Andreone, Massimo Andreoni, Mario Angelico, Sergio Babudieri, Giorgio Barbarini, Vincenzo Boccaccio, Lucio Boglione, Matteo Bolis, Stefano Bonora, Vanni Borghi, Giuseppina Brancaccio, Savino Bruno, Pierluigi Cacciatore, Vincenza Calvaruso, Nicola Caporaso, Antonio Ciaccio, Alessia Ciancio, Piero Colombatto, Raffaele Cozzolongo, Antonio Craxì, Cecilia D'Ambrosio, Gabriella D'Ettorre, Andrea De Luca, Antonio Di Biagio, Giovanni Di Perri, Simona Francioso, Giovanni Battista Gaeta, Alessia Giorgini, Antonio Grieco, Guido Gubertini, Roberto Gulminetti, Lara Lambiase, Ilaria Lenci, Miriam Lichtner, Ivana Maida, Simona Marenco, Letizia Marinaro, Renato Maserati, Chiara Masetti, Michela Melis, Elisa Meregalli, Valeria Micheli, Filomena Morisco, Fosca Niero, Laura Ambra Nicolini, Valeria Pace Palitti, Maurizio Paoloni, Giustino Parruti, Caterina Pasquazzi, Adriano Pellicelli, Ennio Polilli, Maria Laura Ponti, Massimo Puoti, Maria Rendina, Giuliano Rizzardini, Barbara Rossetti, Tina Ruggiero, Vincenzo Sangiovanni, Mario Starace, Laura Sticchi, Pierluigi Tarquini, Pierluigi Toniutto, Vincenzo Vullo, Di Maio VC, Cento V, Aragri M, Paolucci S, Pollicino T3, Coppola N4, Bruzzone B5, Ghisetti V6, Zazzi M7, Brunetto M8, Bertoli A1, Barbaliscia S1, Galli S9, Gennari W10, Baldanti F2, Raimondo G3, Perno CF1, Ceccherini-Silberstein F11, Andreone P, Andreoni M, Angelico M, Babudieri S, Barbarini G, Boccaccio V, Boglione L, Bolis M, Bonora S, Borghi V, Brancaccio G, Bruno S, Cacciatore P, Calvaruso Vincenza, Caporaso N, Ciaccio A, Ciancio A, Colombatto P, Cozzolongo R, Craxì Antonio, D'Ambrosio C, D'Ettorre G, De Luca A, Di Biagio A, Di Perri G, Francioso S, Gaeta GB, Giorgini A, Grieco A, Gubertini G, Gulminetti R, Lambiase L, Lenci I, Lichtner M, Maida I, Marenco S, Marinaro L, Maserati R, Masetti C, Melis M, Meregalli E, Micheli V, Morisco F, Niero F, Nicolini LA, Palitti VP, Paoloni M, Parruti G, Pasquazzi C, Pellicelli A, Polilli E, Ponti ML, Puoti M, Rendina M, Rizzardini G, Rossetti B, Ruggiero T, Sangiovanni V, Starace M, Sticchi L, Tarquini P, Toniutto P, Vullo V., Di Maio, Vc, Cento, V, Aragri, M, Paolucci, S, Pollicino, T, Coppola, N, Bruzzone, B, Ghisetti, V, Zazzi, M, Brunetto, M, Bertoli, A, Barbaliscia, S, Galli, S, Gennari, W, Baldanti, F, Raimondo, G, Perno, Cf, Ceccherini-Silberstein, F., Andreone P, Andreoni, M, Angelico, M, Babudieri, S, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Cacciatore, P, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, Craxì, A, D'Ambrosio, C, D'Ettorre, G, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, Gb, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Lenci, I, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Masetti, C, Melis, M, Meregalli, E, Micheli, V, Morisco, F, Niero, F, Nicolini, La, Palitti, Vp, Paoloni, M, Parruti, G, Pasquazzi, C, Pellicelli, A, Polilli, E, Ponti, Ml, Puoti, M, Rendina, M, Rizzardini, G, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V., Di Maio, V, Perno, C, Ceccherini-Silberstein, F, Andreone, P, Craxi, A, Gaeta, G, Nicolini, L, Palitti, V, Ponti, M, and Vullo, V
Subjects: 0301 basic medicine, medicine.medical_specialty, hepacivirus, HCV RAS, Treatment outcome, Drug Resistance, HCV genotypes, Drug resistance, Biology, NS5A, 03 medical and health sciences, 0302 clinical medicine, Second line, drug resistance viral, humans, retreatment, treatment outcome, antiviral agents, hepatitis c chronic, Internal medicine, Drug Resistance, Viral, Humans, Retreatment, Treatment Outcome, Antiviral Agents, Hepacivirus, Hepatitis C, Chronic, medicine, Viral, Chronic, Hepatology, Hepatitis C, Settore MED/07 - Microbiologia e Microbiologia Clinica, medicine.disease, Virology, Hepatology, HCV, NS5A, 030104 developmental biology, HCV, 030211 gastroenterology & hepatology
Published: 2018

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

Author: L. Lambiase, Anna Claudia Pellicelli, Gloria Taliani, Barbara Menzaghi, Stefania Paolucci, Giuliano Rizzardini, Valeria Cento, Cesare Sarrecchia, Marianna Aragri, Francesca Ceccherini-Silberstein, M. Melis, M. Andreoni, Stefano Novati, Carlo Magni, Silvia Barbaliscia, Ilaria Lenci, V.C. Di Maio, Martina Milana, Elisabetta Teti, Mario Angelico, Caterina Pasquazzi, Aldo Bertoli, M. Puoti, A. Pecchioli, Valeria Micheli, Margherita Macera, Sergio Babudieri, Dante Romagnoli, Valeria Ghisetti, Laura Ambra Nicolini, Elisa Biliotti, Y. Troshina, Carlo Federico Perno, Fausto Baldanti, Simona Marenco, Nicola Coppola, T. Ruggiero, Manuele Koci Siciliano, Stefano Bonora, Alessia Ciancio, Cento, V, Barbaliscia, S, Lenci, I, Ruggiero, T, Magni, C, Paolucci, S, Babudieri, S, Siciliano, M, Pasquazzi, C, Ciancio, A, Perno, C, Ceccherini-Silberstein, F, Micheli, V, Troshina, Y, Biliotti, E, Milana, M, Melis, M, Teti, E, Lambiase, L, Menzaghi, B, Nicolini, L, Marenco, S, Di Maio, V, Aragri, M, Pecchioli, A, Bertoli, A, Sarrecchia, C, Macera, M, Coppola, N, Puoti, M, Romagnoli, D, Pellicelli, A, Bonora, S, Novati, S, Baldanti, F, Ghisetti, V, Andreoni, M, Taliani, G, Rizzardini, G, Angelico, M, Barbaliscia, I, and Ceccherini Silberstein, F
Subjects: 0301 basic medicine, Male, Cirrhosis, Genotyping Techniques, Sustained Virologic Response, Hepacivirus, Treatment failure, chemistry.chemical_compound, Liver disease, 0302 clinical medicine, NS5A-inhibitors, Genotypic resistance testing, Treatment Failure, Chronic, HCV resistance, biology, Direct acting antivirals, HCV failure, Protease-inhibitors, Retreatment, Adult, Aged, Antiviral Agents, Female, Hepatitis C, Chronic, Humans, Microbial Sensitivity Tests, Middle Aged, Protease Inhibitors, Sequence Analysis, DNA, General Medicine, Settore MED/07 - Microbiologia e Microbiologia Clinica, Protease-inhibitor, Hepatitis C, humanities, Infectious Diseases, DIrect acting antivirals, HCVFailure, hcv-resistance, 030211 gastroenterology & hepatology, Sequence Analysis, Microbiology (medical), medicine.medical_specialty, 03 medical and health sciences, Internal medicine, medicine, In real life, Protease inhibitor (pharmacology), Cirrhosi, business.industry, Ribavirin, DNA, biology.organism_classification, medicine.disease, Surgery, Regimen, 030104 developmental biology, chemistry, NS5A-inhibitor, Direct acting antiviral, business
Abstract: Objectives First-generation protease-inhibitors (PIs) have suboptimal efficacy in GT-1 patients with advanced liver disease, and patients experiencing treatment failure may require urgent retreatment. Our objective was to analyse the real-life efficacy of interferon (IFN)-free retreatment after PI-failure, and the role of genotypic-resistance-testing (GRT) in guiding retreatment choice. Methods In this multi-centre observational study, patients retreated with IFN-free regimens after first-generation PI-failure (telaprevir-boceprevir-simeprevir) were included. Sustained-virological-response (SVR) was evaluated at week 12 of follow-up. GRT was performed by population-sequencing. Results After PI-failure, 121 patients (cirrhotic = 86.8%) were retreated following three different strategies: A) with ‘GRT-guided’ regimens (N = 18); B) with ‘AASLD/EASL recommended, not GRT-guided’ regimens (N = 72); C) with ‘not recommended, not GRT-guided’ regimens (N = 31). Overall SVR rate was 91%, but all 18 patients treated with ‘GRT-guided’ regimens reached SVR (100%), despite heterogeneity in treatment duration, use of PI and ribavirin, versus 68/72 patients (94.4%) receiving ‘AASLD/EASL recommended, not GRT-guided’ regimens. SVR was strongly reduced (77.4%) among the 31 patients who received a ‘not recommended, not GRT-guided regimen’ (p
Published: 2017

32. Resistance analysis and treatment outcomes in hepatitis C virus genotype 3-infected patients within the Italian network VIRONET-C.

Author: Di Maio VC, Barbaliscia S, Teti E, Fiorentino G, Milana M, Paolucci S, Pollicino T, Morsica G, Starace M, Bruzzone B, Gennari W, Micheli V, Yu La Rosa K, Foroghi L, Calvaruso V, Lenci I, Polilli E, Babudieri S, Aghemo A, Raimondo G, Sarmati L, Coppola N, Pasquazzi C, Baldanti F, Parruti G, Perno CF, Angelico M, Craxì A, Andreoni M, and Ceccherini-Silberstein F
Subjects: Antiviral Agents pharmacology, Antiviral Agents therapeutic use, Drug Resistance, Viral genetics, Drug Therapy, Combination, Female, Genotype, Humans, Italy epidemiology, Male, Phylogeny, Sofosbuvir therapeutic use, Sustained Virologic Response, Viral Nonstructural Proteins genetics, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic epidemiology
Abstract: Aim: This study aimed to investigate the role of resistance-associated substitutions (RASs) to direct-acting-antivirals (DAAs) in HCV genotype 3 (GT3)., Methods: Within the Italian VIRONET-C network, a total of 539 GT3-infected patients (417 DAA-naïve and 135 DAA-failures, of them, 13 at both baseline and failure) were analysed. Sanger sequencing of NS3/NS5A/NS5B was performed following home-made protocols., Results: The majority of patients were male (79.4%), 91.4% were injection drug users, 49.3% were cirrhotic and 13.9% were HIV co-infected. Phylogenetic analysis classified sequences as GT3a-b-g-h (98%-0.4%-0.2%-1.2%) respectively. Overall, 135 patients failed a DAA regimen: sofosbuvir (SOF)/daclatasvir (DCV) or velpatasvir (VEL)±ribavirin (RBV) (N = 91/15) and glecaprevir (G)/pibrentasvir (P) (N = 9). Moreover, 14.8% of patients were treated with suboptimal regimens for GT3: 3D ± RBV (Paritaprevir/r + Ombitasvir+Dasabuvir, N = 15), SOF + Simeprevir (SIM) (N = 1) or SOF/Ledipasvir (LDV) ± RBV (N = 4). RAS prevalence was 15.8% in DAA-naïve patients. At failure, 81.5% patients showed at least one RAS: 11/25 (44.0%) in NS3, 109/135 (80.7%) in NS5A, 7/111 (6.3%) in NS5B SOF-failures. In NS5A-failures, Y93H RAS was the most prevalent (68.5% vs 5.1% DAA-naïve, P < .001) followed by A30K (12.7% vs 2.8% in DAA-naïve, P < .001). Analysing baseline samples, a higher prevalence of NS5A-RASs was observed before treatment in DAA-failures (5/13, 38.5%) vs DAA-naïves (61/393, 15.5%, P = .04). Regarding 228 DAA-naïve patients with an available outcome, 93.9% achieved a SVR. Interestingly, patients with baseline Y93H and/or A30K had SVR rate of 72.2% vs 95.7% for patients without NS5A-RASs (P = .002)., Conclusions: In this real-life GT3 cohort, the majority of failures harboured resistant variants carrying NS5A-RASs, the most frequent being Y93H. The presence of natural NS5A-RASs before treatment was associated with failure. Further analyses are needed to confirm this observation, particularly for the new current regimens., (© 2021 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
Published: 2021
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33. Impact of Analytical Treatment Interruption on Burden and Diversification of HIV Peripheral Reservoir: A Pilot Study.

Author: Scutari R, Costabile V, Galli L, Bellocchi MC, Carioti L, Barbaliscia S, Poli A, Galli A, Perno CF, Santoro MM, Castagna A, Ceccherini-Silberstein F, Alteri C, and Spagnuolo V
Subjects: Adult, Antiretroviral Therapy, Highly Active, DNA, Viral genetics, Female, HIV Infections drug therapy, HIV Infections virology, Humans, Male, Medication Adherence, Middle Aged, Mutation, Pilot Projects, Anti-Retroviral Agents therapeutic use, DNA, Viral analysis, Disease Reservoirs virology, HIV-1 drug effects, Viral Load drug effects, Viremia drug therapy
Abstract: Background: If analytical antiretroviral-treatment (ART) interruption (ATI) might significantly impact quantitative or qualitative peripheral-total HIV-DNA is still debated., Methods: Six chronically HIV-1 infected patients enrolled in APACHE-study were analysed for peripheral-total HIV-DNA and residual viremia, major-resistance-mutations (MRMs) and C2-V3-C3 evolution at pre-ATI (T1), during ATI (T2) and at achievement of virological success after ART-resumption (post-ATI, T3). These data were obtained at three comparable time-points in five chronically HIV-1 infected patients on suppressive ART for ≥1 year, enrolled in MODAt-study., Results: At T1, APACHE and MODAt individuals had similar peripheral-total HIV-DNA and residual viremia ( p = 0.792 and 0.662, respectively), and no significant changes for these parameters were observed between T1 and T3 in both groups. At T1, 4/6 APACHE and 2/5 MODAt carried HIV-DNA MRMs. MRMs disappeared at T3 in 3/4 APACHE. All disappearing MRMs were characterized by T1 intra-patient prevalence <80%, and mainly occurred in APOBEC3-related sites. All MRMs persisted over-time in the 2 MODAt. C2-V3-C3 genetic-distance significantly changed from T1 to T3 in APACHE individuals (+0.36[0.11-0.41], p = 0.04), while no significant changes were found in MODAt. Accordingly, maximum likelihood trees (bootstrap > 70%) and genealogical sorting indices (GSI > 0.50 with p -value < 0.05) showed that T1 C2-V3-C3 DNA sequences were distinct from T2 and T3 viruses in 4/6 APACHE. Virus populations at all three time-points were highly interspersed in MODAt., Conclusions: This pilot study indicates that short ATI does not alter peripheral-total HIV-DNA burden and residual viremia, but in some cases could cause a genetic diversification of peripheral viral reservoir in term of both MRMs rearrangement and viral evolution.
Published: 2021
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34. Prevalence of resistance-associated substitutions to NS3, NS5A and NS5B inhibitors at DAA-failure in hepatitis C virus in Italy from 2015 to 2019.

Author: Rossetti B, Paglicci L, Di Maio VC, Cassol C, Barbaliscia S, Paolucci S, Bruzzone B, Coppola N, Montagnani F, Micheli V, Monno L, Zanelli G, Santantonio T, Cuomo N, Caudai C, Zazzi M, Ceccherini-Silberstein F, and On Behalf Of The Hcv Virology Italian Resistance Network Vironet C
Subjects: Benzimidazoles therapeutic use, Carbamates therapeutic use, Drug Combinations, Fluorenes therapeutic use, Genotype, Hepacivirus genetics, Heterocyclic Compounds, 4 or More Rings therapeutic use, Humans, Italy, Macrocyclic Compounds therapeutic use, Prevalence, Retrospective Studies, Ribavirin therapeutic use, Sofosbuvir therapeutic use, Sulfonamides therapeutic use, Antiviral Agents therapeutic use, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic genetics
Abstract: Despite the high efficacy of direct-acting antivirals (DAAs), the selection of resistance-associated substitutions (RASs) after virological failure of hepatitis C virus (HCV) DAAs can impair the cure of chronic HCV. The aim of the study was to characterize RASs after virological failure of DAAs in Italy over the years. Within the Italian network VIRONET-C, the change in prevalence of NS3/4A-NS5A-NS5B RASs was retrospectively evaluated in patients who failed a DAA regimen over the years 2015-2019. NS3, NS5A and NS5B Sanger sequencing was performed using homemade protocols and the geno2pheno system was used to define HCV-genotype/subtype and predict drug resistance. The changes in the prevalence of RASs over time were evaluated using the chi-square test for trend. Predictors of RASs at failure were analysed by logistic regression. Among 468 HCV-infected patients, HCV genotype 1 was the most prevalent (1b in 154, 33% and 1a in 109, 23%). DAA regimens were: ledipasvir (LDV)/sofosbuvir (SOF) in 131 patients (28%), daclatasvir (DCV)/SOF in 109 (23%), ombitasvir/paritaprevir/ritonavir+dasabuvir (3D) in 89 (19%), elbasvir (EBR)/grazoprevir (GRZ) in 52 (10.5%), velpatasvir (VEL)/SOF in 53 (11%), glecaprevir (GLE)/pibrentasvir (PIB) in 27 (6%) and ombitasvir/paritaprevir/ritonavir (2D) in 7 (1.5%); ribavirin was administered in 133 (28%). The NS5A fasta sequence was available for all patients, NS5B and NS3/4A both for 93%. The prevalence of NS5A and NS3/4A RASs significantly declined from 2015 to 2019; NS5B RAS remained stable. Independent predictors of any RASs included older age and genotype 1a (vs G2 and vs G4). Notably, at least partial susceptibility to all the agents included in the GLE/PIB and VEL/SOF/Voxilaprevir (VOX) combinations was predicted in >95% of cases. As RASs remain common at the failure of DAAs, their identification could play a crucial role in optimizing re-treatment strategies. In Italy RAS prevalence has been decreasing over the years and susceptibility to the latest developed drug combinations is maintained in most cases.
Published: 2021

35. NS5A Gene Analysis by Next Generation Sequencing in HCV Nosocomial Transmission Clusters of HCV Genotype 1b Infected Patients.

Author: Bellocchi MC, Aragri M, Carioti L, Fabeni L, Pipitone RM, Brancaccio G, Sorbo MC, Barbaliscia S, Di Maio VC, Bronte F, Grimaudo S, Mazzucco W, Frigeri F, Cantone M, Pinto A, Perno CF, Craxì A, Gaeta GB, Di Marco V, and Ceccherini-Silberstein F
Subjects: Acute Disease, Adult, Amino Acid Substitution, Antiviral Agents pharmacology, Antiviral Agents therapeutic use, Blood Transfusion, Chronic Disease, Cross Infection drug therapy, Cross Infection transmission, Drug Resistance, Viral genetics, Female, Genotype, Hepacivirus pathogenicity, Hepatitis C drug therapy, Hepatitis C transmission, High-Throughput Nucleotide Sequencing, Host-Pathogen Interactions genetics, Host-Pathogen Interactions immunology, Humans, Interferons genetics, Interferons immunology, Male, Middle Aged, Phylogeny, Polymorphism, Single Nucleotide, beta-Thalassemia genetics, beta-Thalassemia immunology, Cross Infection virology, Hepacivirus genetics, Hepatitis C virology, Viral Nonstructural Proteins genetics, beta-Thalassemia therapy
Abstract: Background : The aim of the study was to investigate the intra-host variability through next-generation-sequencing (NGS) of the NS5A-gene in nosocomial transmission-clusters observed in two Italian hospitals among hepatitis C virus (HCV)-genotype-1b infected patients. Methods : HCV-sequencing was performed by Sanger-sequencing (NS3 + NS5A + NS5B) and by NGS (NS5A, MiSeq-Illumina) in 15 HCV-1b infected patients [five acute with onco-hematologic-disease and 10 (4/6 acute/chronic) with β-thalassemia]. Resistance-associated-substitutions (RAS) were analysed by Geno2pheno-algorithm. Nucleotide-sequence-variability (NSV, at 1%, 2%, 5%, 10% and 15% NGS-cutoffs) and Shannon entropy were estimated. Phylogenetic analysis was performed by Mega6-software and Bayesian-analysis. Results : Phylogenetic analysis showed five transmission-clusters: one involving four HCV-acute onco-hematologic-patients; one involving three HCV-chronic β-thalassemia-patients and three involving both HCV-acute and chronic β-thalassemia-patients. The NS5A-RAS Y93H was found in seven patients, distributed differently among chronic/acute patients involved in the same transmission-clusters, independently from the host-genetic IL-28-polymorphism. The intra-host NSV was higher in chronic-patients versus acute-patients, at all cutoffs analyzed (p < 0.05). Even though Shannon-entropy was higher in chronic-patients, significantly higher values were observed only in chronic β-thalassemia-patients versus acute β-thalassemia-patients (p = 0.01). Conclusions : In nosocomial HCV transmission-clusters, the intra-host HCV quasispecies divergence in patients with acute-infection was very low in comparison to that in chronic-infection. The NS5A-RAS Y93H was often transmitted and distributed differently within the same transmission-clusters, independently from the IL-28-polymorphism.
Published: 2019
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36. Frequent NS5A and multiclass resistance in almost all HCV genotypes at DAA failures: What are the chances for second-line regimens?

Author: Di Maio VC, Cento V, Aragri M, Paolucci S, Pollicino T, Coppola N, Bruzzone B, Ghisetti V, Zazzi M, Brunetto M, Bertoli A, Barbaliscia S, Galli S, Gennari W, Baldanti F, Raimondo G, Perno CF, and Ceccherini-Silberstein F
Subjects: Drug Resistance, Viral, Humans, Treatment Outcome, Antiviral Agents classification, Antiviral Agents pharmacology, Hepacivirus drug effects, Hepacivirus genetics, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic virology, Retreatment methods
Published: 2018
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37. Optimal cure rate by personalized HCV regimens in real-life: a proof-of-concept study.

Author: Cento V, Aragri M, Teti E, Polilli E, Bertoli A, Foroghi L, Barbaliscia S, Di Maio VC, Pieri A, Pace Palitti V, Sarmati L, Parruti G, Andreoni M, Perno CF, and Ceccherini-Silberstein F
Subjects: Administration, Oral, Antiviral Agents pharmacology, Genotype, Hepacivirus drug effects, Hepacivirus genetics, Humans, Microbial Sensitivity Tests, Proof of Concept Study, RNA, Viral blood, Sequence Analysis, DNA, Sustained Virologic Response, Treatment Outcome, Antiviral Agents administration & dosage, Hepatitis C, Chronic drug therapy, Precision Medicine methods
Abstract: Background: Pretreatment evaluation of HCV-infected patients is a complex interplay between multiple clinical and viral parameters, leading to a tailored approach that may bring real-life sustained virological response (SVR) rates close to 98%-99%., Objectives: As proof-of-concept, we evaluated the efficacy of all-oral direct-acting antiviral (DAA) regimens in patients whose personalization included pre-therapy evaluation of natural resistance-associated substitutions (RASs), in addition to international guideline recommendations., Methods: One hundred and thirty-one patients who started a first-line all-oral DAA regimen between April 2015 and December 2016 were tested for baseline NS3 and NS5A RASs by Sanger sequencing. SVR12 was defined as HCV-RNA undetectability 12 weeks after treatment discontinuation., Results: Compatibly with a real-life context, 74.0% (97 of 131) of patients presented ≥2 pretreatment risk factors for failure to achieve SVR12 (infection by GT-1a/GT-3a; cirrhosis; previous treatment experience; HCV-RNA ≥800 000 IU/mL) and 33.6% had ≥3 risk factors. Natural RASs were frequently detected (32.1% prevalence), with substantial prevalence of NS5A RASs (15.3%), mostly represented by Y93H in GT-1b (3 of 36, 8.3%) and GT-3a (3 of 25, 12.0%) and F28C in GT-2c (2 of 11, 18.2%). Overall, personalized treatment led to 100% SVR12, even in those patients for whom treatment strategy was either strengthened (by ribavirin inclusion and/or duration increase) or simplified (by ribavirin exclusion and/or duration reduction), thanks to baseline RAS evaluation., Conclusions: Even with newer DAA regimens, an integrated interpretation of clinical and virological pretreatment parameters, including natural RASs, may play a relevant role in bringing SVR rates close to the highest achievable. Treatment tailoring can be foreseen in 'hard-to-treat' patients, but also in 'easy' patients with favourable indicators, whereby a simplification/shortening of recommended regimens can be indicated., (© The Author 2017. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)
Published: 2017
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38. Biotech innovations in the prevention of respiratory infectious diseases.

Author: Cento JV, Barbaliscia S, and Perno CF
Subjects: Biotechnology trends, Community-Acquired Infections prevention & control, Cost of Illness, Cross Infection prevention & control, Gels, Humans, Occupational Diseases prevention & control, Respiratory Tract Infections economics, Silver, Biotechnology methods, Filtration instrumentation, Metal Nanoparticles therapeutic use, Personal Protective Equipment classification, Respiratory Tract Infections prevention & control
Abstract: Acute respiratory infections place a huge burden on society in terms of disability, premature mortality, and also direct health service costs (drugs prescriptions) and the indirect costs related to lost production. Therefore, prevention of respiratory infections is an important goal for public health interventions. In this context, silver nanoparticles (AgNPs) represent an interesting perspective for research and development by virtue of their favorable antimicrobial activity against many respiratory pathogens. One of the latest innovations in the biotech field discussed in this review is the creation of a biocompatible, biogel-based nasal filter enriched with AgNPs. Compared to traditional personal protective equipment (PPE), this type of nasal filter has the advantage of combining the antibacterial and antiviral activity of AgNPs with the common filtration capacity shared by other PPEs. This dual mechanism means that AgNP-enriched nasal filters serve to reduce the infecting microbial-load and protect the lower airways, without interfering with the normal respiratory capacity (airflow-resistance <5%). Given their antimicrobial characteristics and performance, AgNP-enriched nasal filters can meet many community and occupational currently unmet needs in the prevention of airborne infectious diseases, by ensuring an excellent respiratory-comfort and a continuous day-use.
Published: 2017

39. Incomplete APOBEC3G/F Neutralization by HIV-1 Vif Mutants Facilitates the Genetic Evolution from CCR5 to CXCR4 Usage.

Author: Alteri C, Surdo M, Bellocchi MC, Saccomandi P, Continenza F, Armenia D, Parrotta L, Carioti L, Costa G, Fourati S, Di Santo F, Scutari R, Barbaliscia S, Fedele V, Carta S, Balestra E, Alcaro S, Marcelin AG, Calvez V, Ceccherini-Silberstein F, Artese A, Perno CF, and Svicher V
Subjects: APOBEC Deaminases, Amino Acid Sequence, Amino Acid Substitution genetics, Base Sequence, Cell Line, Cytidine Deaminase, Evolution, Molecular, HEK293 Cells, HIV Infections virology, Humans, Leukocytes, Mononuclear virology, Cytosine Deaminase genetics, HIV Infections genetics, HIV-1 genetics, Mutation genetics, Receptors, CCR5 genetics, Receptors, CXCR4 genetics
Abstract: Incomplete APOBEC3G/F neutralization by a defective HIV-1Vif protein can promote genetic diversification by inducing G-to-A mutations in the HIV-1 genome. The HIV-1 Env V3 loop, critical for coreceptor usage, contains several putative APOBEC3G/F target sites. Here, we determined if APOBEC3G/F, in the presence of Vif-defective HIV-1 virus, can induce G-to-A mutations at V3 positions critical to modulation of CXCR4 usage. Peripheral blood mononuclear cells (PBMC) and monocyte-derived macrophages (MDM) from 2 HIV-1-negative donors were infected with CCR5-using 81.A-VifWT virus (i.e., with wild-type [WT] Vif protein), 81.A-VifE45G, or 81.A-VifK22E (known to incompletely/partially neutralize APOBEC3G/F). The rate of G-toA mutations was zero or extremely low in 81.A-VifWT- and 81.A-VifE45G-infected PBMC from both donors. Conversely, G-to-A enrichment was detected in 81.A-VifK22E-infected PBMC (prevalence ranging from 2.18% at 7 days postinfection [dpi] to 3.07% at 21 dpi in donor 1 and from 10.49% at 7 dpi to 8.69% at 21 dpi in donor 2). A similar scenario was found in MDM. G-to-A mutations occurred at 8 V3 positions, resulting in nonsynonymous amino acid substitutions. Of them, G24E and E25K strongly correlated with phenotypically/genotypically defined CXCR4-using viruses (P = 0.04 and 5.5e-7, respectively) and increased the CXCR4 N-terminal binding affinity for V3 (WT, -40.1 kcal/mol; G24E, -510 kcal/mol; E25K, -522 kcal/mol). The analysis of paired V3 and Vif DNA sequences from 84 HIV-1-infected patients showed that the presence of a Vif-defective virus correlated with CXCR4 usage in proviral DNA (P = 0.04). In conclusion, incomplete APOBEC3G/F neutralization by a single Vif amino acid substitution seeds a CXCR4-using proviral reservoir. This can have implications for the success of CCR5 antagonist-based therapy, as well as for the risk of disease progression., (Copyright © 2015, American Society for Microbiology. All Rights Reserved.)
Published: 2015
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