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1. Long-term outcomes of bictegravir/emtricitabine/tenofovir alafenamide as first-line therapy and as switch strategy in virologically suppressed persons with HIV: data from the ICONA cohort

Author

d’Arminio Monforte, A, Tavelli, A, Di Biagio, A, Sarmati, L, Marchetti, G, Bai, F, Cingolani, A, Quiros Roldan, E, Mussini, C, Lichtner, M, Vergori, A, Piconi, S, Orofino, G, Fusco, F, Bandera, A, Nozza, S, Castagna, A, Antinori, A, Antinori, S, Cauda, R, Di Perri, G, Girardi, E, Iardino, R, Lazzarin, A, Quiros-Roldan, E, Suligoi, B, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Gori, A, Lo Caputo, S, Maggiolo, F, Puoti, M, Perno, C, Torti, C, Bonora, S, Calcagno, A, Canetti, D, Cervo, A, Cinque, P, Gagliardini, R, Giacomelli, A, Gianotti, N, Guaraldi, G, Lanini, S, Lapadula, G, Lai, A, Madeddu, G, Malagnino, V, Mondi, A, Mazzotta, V, Pinnetti, C, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Spagnuolo, V, Squillace, N, Svicher, V, Taramasso, L, De Benedittis, S, Fanti, I, Giotta, M, Rodano’, A, Bove, A, Cernuschi, M, Cosmaro, L, Errico, M, Perziano, A, Calvino, V, Augello, M, Carrara, S, Graziano, S, Prota, G, Truffa, S, Vincenti, D, Rovito, R, Giacometti, A, Costantini, A, Barocci, V, Santoro, C, Milano, E, Comi, L, Suardi, C, Badia, L, Cretella, S, Erne, E, Pieri, A, Focà, E, Minardi, C, Menzaghi, B, Abeli, C, Chessa, L, Pes, F, Maggi, P, Alessio, L, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Dal Zoppo, S, Segala, D, Di Pietro, M, Costa, C, Ferrara, S, Bassetti, M, Pontali, E, Blanchi, S, Bobbio, N, Mazzarello, G, Fondaco, L, Molteni, C, Canavesi, G, Nunnari, G, Pellicanò, G, Rizzardini, G, Bono, V, Cossu, M, Lolatto, R, Moioli, M, Pezzati, L, Diotallevi, S, Tincati, C, Puzzolante, C, Bonfanti, P, Sangiovanni, V, Gentile, I, Esposito, V, Coppola, N, Di Filippo, G, Rizzo, V, Sangiovanni, N, Martini, S, Cattelan, A, Leoni, D, Cascio, A, Colomba, C, Francisci, D, Schiaroli, E, Parruti, G, Sozio, F, Blanc, P, Bonelli, S, Lazzaretti, C, Corsini, R, Mastroianni, C, Latini, A, Lamonica, S, Capozzi, M, Rivano Capparuccia, M, Iaiani, G, Stingone, C, Gianserra, L, Paulicelli, J, Plazzi, M, D’Ettore, G, Fusto, M, Coledan, I, De Vito, A, Fabbiani, M, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Pasticci, B, Di Giuli, C, Calleri, G, Accardo, G, Tascini, C, Londero, A, Manfrin, V, Battagin, G, Starnini, G, Farinacci, D, Null, N, d’Arminio Monforte, Antonella, Tavelli, Alessandro, Di Biagio, Antonio, Sarmati, Loredana, Marchetti, Giulia C, Bai, Francesca, Cingolani, Antonella, Quiros Roldan, Eugenio, Mussini, Cristina, Lichtner, Miriam, Vergori, Alessandra, Piconi, Stefania, Orofino, Giancarlo, Fusco, Francesco Maria, Bandera, Alessandra, Nozza, Silvia, Castagna, Antonella, Antinori, Andrea, Marchetti, G C, Perno, C F, Santoro, M M, Erne, E M, Di Pietro, M A, Cossu, M V, Moioli, M C, Fusco, F M, Cattelan, A M, Bonelli, S I, Plazzi, M M, d’Ettore, G, Pasticci, B M, Orofino, G C, null, null, d’Arminio Monforte, A, Tavelli, A, Di Biagio, A, Sarmati, L, Marchetti, G, Bai, F, Cingolani, A, Quiros Roldan, E, Mussini, C, Lichtner, M, Vergori, A, Piconi, S, Orofino, G, Fusco, F, Bandera, A, Nozza, S, Castagna, A, Antinori, A, Antinori, S, Cauda, R, Di Perri, G, Girardi, E, Iardino, R, Lazzarin, A, Quiros-Roldan, E, Suligoi, B, von Schloesser, F, Viale, P, Ceccherini-Silberstein, F, Cozzi-Lepri, A, Gori, A, Lo Caputo, S, Maggiolo, F, Puoti, M, Perno, C, Torti, C, Bonora, S, Calcagno, A, Canetti, D, Cervo, A, Cinque, P, Gagliardini, R, Giacomelli, A, Gianotti, N, Guaraldi, G, Lanini, S, Lapadula, G, Lai, A, Madeddu, G, Malagnino, V, Mondi, A, Mazzotta, V, Pinnetti, C, Rossotti, R, Rusconi, S, Santoro, M, Saracino, A, Spagnuolo, V, Squillace, N, Svicher, V, Taramasso, L, De Benedittis, S, Fanti, I, Giotta, M, Rodano’, A, Bove, A, Cernuschi, M, Cosmaro, L, Errico, M, Perziano, A, Calvino, V, Augello, M, Carrara, S, Graziano, S, Prota, G, Truffa, S, Vincenti, D, Rovito, R, Giacometti, A, Costantini, A, Barocci, V, Santoro, C, Milano, E, Comi, L, Suardi, C, Badia, L, Cretella, S, Erne, E, Pieri, A, Focà, E, Minardi, C, Menzaghi, B, Abeli, C, Chessa, L, Pes, F, Maggi, P, Alessio, L, Cacopardo, B, Celesia, B, Vecchiet, J, Falasca, K, Pan, A, Dal Zoppo, S, Segala, D, Di Pietro, M, Costa, C, Ferrara, S, Bassetti, M, Pontali, E, Blanchi, S, Bobbio, N, Mazzarello, G, Fondaco, L, Molteni, C, Canavesi, G, Nunnari, G, Pellicanò, G, Rizzardini, G, Bono, V, Cossu, M, Lolatto, R, Moioli, M, Pezzati, L, Diotallevi, S, Tincati, C, Puzzolante, C, Bonfanti, P, Sangiovanni, V, Gentile, I, Esposito, V, Coppola, N, Di Filippo, G, Rizzo, V, Sangiovanni, N, Martini, S, Cattelan, A, Leoni, D, Cascio, A, Colomba, C, Francisci, D, Schiaroli, E, Parruti, G, Sozio, F, Blanc, P, Bonelli, S, Lazzaretti, C, Corsini, R, Mastroianni, C, Latini, A, Lamonica, S, Capozzi, M, Rivano Capparuccia, M, Iaiani, G, Stingone, C, Gianserra, L, Paulicelli, J, Plazzi, M, D’Ettore, G, Fusto, M, Coledan, I, De Vito, A, Fabbiani, M, Montagnani, F, Franco, A, Fontana Del Vecchio, R, Pasticci, B, Di Giuli, C, Calleri, G, Accardo, G, Tascini, C, Londero, A, Manfrin, V, Battagin, G, Starnini, G, Farinacci, D, Null, N, d’Arminio Monforte, Antonella, Tavelli, Alessandro, Di Biagio, Antonio, Sarmati, Loredana, Marchetti, Giulia C, Bai, Francesca, Cingolani, Antonella, Quiros Roldan, Eugenio, Mussini, Cristina, Lichtner, Miriam, Vergori, Alessandra, Piconi, Stefania, Orofino, Giancarlo, Fusco, Francesco Maria, Bandera, Alessandra, Nozza, Silvia, Castagna, Antonella, Antinori, Andrea, Marchetti, G C, Perno, C F, Santoro, M M, Erne, E M, Di Pietro, M A, Cossu, M V, Moioli, M C, Fusco, F M, Cattelan, A M, Bonelli, S I, Plazzi, M M, d’Ettore, G, Pasticci, B M, Orofino, G C, and null, null

Abstract

Objectives: To assess the effectiveness of bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) among people poorly represented in clinical trials and potentially at higher risk of suboptimal response to ART. Methods: Observational cohort study on persons with HIV (PWH) enrolled in ICONA who started BIC/FTC/TAF as initial therapy or as switching regimen while virologically suppressed. Primary endpoint was time to treatment failure (TF): new AIDS/death or virological failure (VF) or discontinuation for toxicity/failure. Secondary endpoints were time to treatment discontinuation for toxicity (TDT) and to VF. Groups of interest were those aged >50 years, female sex, and advanced HIV disease at first ART start. Probability of the events overall and according to groups and adjusted HR for every endpoint were calculated by Kaplan–Meier curves and Cox regression models. Results: Nine hundred and thirty-three ART-naive and 1655 ART-experienced PWH initiated BIC/FTC/TAF. Over a median follow-up of 69.8 weeks, 89 (9.6%) PWH at their first regimen experienced TF. PWH aged >50 years had 1.83-fold (95% CI: 1.19–2.83) higher risk of TF; PWH with advanced HIV disease had 2.21-fold (95% CI: 1.53–3.82) higher risk; there were no differences in TF according to sex. Over a median follow-up of 146.3 weeks, 109 (6.6%) out of 1655 switching PWH experienced TF; no differences were found in the risk of TF, TDT and VF according to groups of interest. Conclusions: Overall, BIC/FTC/TAF is well tolerated and virologically effective in the real-world scenario for ART-naive and -experienced PWH. Older ART-naive PWH and those with advanced HIV disease may respond less well as the burden of diseases might compromise treatment efficacy.

Published
2024

2. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V. C., Cento, V., Di Paolo, D., Aragri, M., De Leonardis, F., Tontodonati, M., Micheli, V., Bellocchi, M. C., Antonucci, F. P., Bertoli, A., Lenci, I., Milana, M., Gianserra, L., Melis, M., Di Biagio, A., Sarrecchia, C., Sarmati, L., Landonio, S., Francioso, S., Lambiase, L., Nicolini, L. A., Marenco, S., Nosotti, L., Giannelli, V., Siciliano, M., Romagnoli, D., Pellicelli, A., Vecchiet, J., Magni, C. F., Babudieri, S., Mura, M. S., Taliani, G., Mastroianni, C., Vespasiani-Gentilucci, U., Romano, M., Morisco, F., Gasbarrini, A., Vullo, V., Bruno, S., Baiguera, C., Pasquazzi, C., Tisone, G., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., Perno, C. F., Ceccherini-Silberstein, F., Mariani, R., Paoloni, M., Iapadre, N., Grimaldi, A., Menzaghi, B., Quirino, T., Vecchiet, J., Bruzzone, B., De Maria, A., Di Biagio, A., Marenco, S., Nicolini, L. A., Picciotto, A., Viscoli, C., Casinelli, K., Monache, M. Delle, Lichtner, M., Mastroianni, C., Aghemo, A., Bruno, S., Cerrone, M., Colombo, M., Monforte, A. DʼArminio, Danieli, E., Donato, F., Gubertini, G., Landonio, S., Magni, C. F., Mancon, A., Micheli, V., Monico, S., Niero, F., Puoti, M., Rizzardini, G., Russo, M. L., Alfieri, R., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Romagnoli, D., Brancaccio, G., Caporaso, N., Gaeta, G. B., Lembo, V., Morisco, F., Calvaruso, V., Craxì, A., Di Marco, V., Mazzola, A., Petta, S., DʼAmico, E., Cacciatore, P., Consorte, A., Palitti, V. Pace, Parruti, G., Pieri, A., Polilli, E., Tontodonati, M., Andreoni, M., Angelico, M., Antenucci, F., Antonucci, F. P., Aragri, M., Armenia, D., Baiocchi, L., Bellocchi, M., Bertoli, A., Biliotti, E., Biolato, M., Carioti, L., Ceccherini-Silberstein, F., Cento, V., Cerasari, G., Cerva, C., Ciotti, M., DʼAmbrosio, C., DʼEttorre, G., De Leonardis, F., De Sanctis, A., Di Maio, V. C., Di Paolo, D., Francioso, S., Furlan, C., Gallo, P., Gasbarrini, A., Giannelli, V., Gianserra, L., Grieco, A., Grieco, S., Lambiase, L., Lattanzi, B., Lenci, I., Malagnino, V., Manuelli, M., Merli, M., Miglioresi, L., Milana, M., Nosotti, L., Palazzo, D., Pasquazzi, C., Pellicelli, A., Perno, C. F., Romano, M., Santopaolo, F., Santoro, M. M., Sarmati, L., Sarrecchia, C., Sforza, D., Siciliano, M., Sorbo, M. C., Spaziante, M., Svicher, V., Taliani, G., Teti, E., Tisone, G., Vespasiani-Gentilucci, U., Vullo, V., Mangia, A., Babudieri, S., Maida, I., Melis, M., Mura, M. S., Falconi, L., Di Giammartino, D., and Tarquini, P.

Published
2016
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4. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy

Author

Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., Zazzi M., Bertoli, A, Sorbo, M, Aragri, M, Lenci, I, Teti, E, Polilli, E, Di Maio, V, Gianserra, L, Biliotti, E, Masetti, C, Magni, C, Babudieri, S, Nicolini, L, Milana, M, Cacciatore, P, Sarmati, L, Pellicelli, A, Paolucci, S, Craxi, A, Morisco, F, Palitti, V, Siciliano, M, Coppola, N, Iapadre, N, Puoti, M, Rizzardini, G, Taliani, G, Pasquazzi, C, Andreoni, M, Parruti, G, Angelico, M, Perno, C, Cento, V, Ceccherini-Silberstein, F, Andreone, P, Baldanti, F, Barbarini, G, Boccaccio, V, Boglione, L, Bolis, M, Bonora, S, Borghi, V, Brancaccio, G, Bruno, S, Bruzzone, B, Calvaruso, V, Caporaso, N, Ciaccio, A, Ciancio, A, Colombatto, P, Cozzolongo, R, D'Ambrosio, C, D'Ettorre, G, De Leonardis, F, De Luca, A, Di Biagio, A, Di Perri, G, Francioso, S, Gaeta, G, Gasbarrini, A, Ghisetti, V, Giorgini, A, Grieco, A, Gubertini, G, Gulminetti, R, Lambiase, L, Landonio, S, Lichtner, M, Maida, I, Marenco, S, Marinaro, L, Maserati, R, Melis, M, Menzaghi, B, Meregalli, E, Micheli, V, Niero, F, Paoloni, M, Pieri, A, Rendina, M, Romagnoli, D, Rossetti, B, Ruggiero, T, Sangiovanni, V, Starace, M, Sticchi, L, Tarquini, P, Toniutto, P, Vullo, V, Zazzi, M, Bertoli A., Sorbo M. C., Aragri M., Lenci I., Teti E., Polilli E., Di Maio V. C., Gianserra L., Biliotti E., Masetti C., Magni C. F., Babudieri S., Nicolini L. A., Milana M., Cacciatore P., Sarmati L., Pellicelli A., Paolucci S., Craxi A., Morisco F., Palitti V. P., Siciliano M., Coppola N., Iapadre N., Puoti M., Rizzardini G., Taliani G., Pasquazzi C., Andreoni M., Parruti G., Angelico M., Perno C. F., Cento V., Ceccherini-Silberstein F., Andreone P., Baldanti F., Barbarini G., Boccaccio V., Boglione L., Bolis M., Bonora S., Borghi V., Brancaccio G., Bruno S., Bruzzone B., Calvaruso V., Caporaso N., Ciaccio A., Ciancio A., Colombatto P., Cozzolongo R., D'Ambrosio C., D'Ettorre G., De Leonardis F., De Luca A., Di Biagio A., Di Perri G., Francioso S., Gaeta G. B., Gasbarrini A., Ghisetti V., Giorgini A., Grieco A., Gubertini G., Gulminetti R., Lambiase L., Landonio S., Lichtner M., Maida I., Marenco S., Marinaro L., Maserati R., Melis M., Menzaghi B., Meregalli E., Micheli V., Niero F., Paoloni M., Pieri A., Rendina M., Romagnoli D., Rossetti B., Ruggiero T., Sangiovanni V., Starace M., Sticchi L., Tarquini P., Toniutto P., Vullo V., and Zazzi M.

Abstract

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

Published
2018

5. Features of fragile people with SARS-CoV-2 infection in isolation in a COVID-19 hotel in Rome, Italy.

Author

STINGONE, C., LATINI, A., GIANSERRA, L., SALVI, M., DONÀ, M. G., GIULIANI, E., LA PAROLA, I. LESNONI, MUSSI, A., CAMELI, N., GARELLI, V., GIULIANI, M., BUONOMINI, A. R., VUJOVIC, B., CERIMELE, M., and MORRONE, A.

Abstract

OBJECTIVE: Temporary COVID-19 hotels have been established in Italy to assist the homeless people that test positive for SARSCoV-2 and require isolation. This observational study aimed to investigate the characteristics of the subjects who were isolated at the Casa tra Noi COVID-19 hotel in Rome between October 2020 and May 2021 and to estimate the duration of SARSCoV-2 positivity according to their main socio-demographic, behavioural and clinical features. SUBJECTS AND METHODS: Socio-demographic data, clinical history, and anamnestic data of guests were collected by the clinicians reviewing the medical documentation and face-to-face interviewing. Nasopharyngeal swabs were performed every 7 days and the presence of SARS-CoV-2 was assessed by RT-PCR. Median duration of SARSCoV-2 positivity according to socio-demographic, behavioral factors and clinical condition was calculated. RESULTS: The 196 guests (161 males, 82.1%) had a median age of 41 years (IQR: 30-53), and were mostly African (87, 44.4%). Only asymptomatic/paucisymptomatic infections were observed. Almost half of the individuals (84, 42.9%) were affected by at least one co-morbidity, the frequency of which was higher among women (57.1% vs. 39.8%, p=0.06). The date of the negative SARS-CoV-2 molecular test was known for 144 guests (73.5%). Among these, the median duration of positivity was 21 days (IQR: 14-26) and did not significantly vary with age, country of origin, smoking status, alcohol or drug abuse. Among the co-morbidities, only infectious diseases significantly modified the duration of positivity, which increased from 21 to 34 days (p=0.013). CONCLUSIONS: Hotel guests were frequently affected by physical/mental co-morbidities. Duration of SARS-CoV-2 positivity was significantly prolonged only in individuals affected by an infectious disease. [ABSTRACT FROM AUTHOR]

Published
2022

6. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, Collaborators (129) Mariani R, HCV Italian Resistance Network Study Group., Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio VC, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, Ms, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V C, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M C, Antonucci, F P, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L A, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C F, Babudieri, S, Mura, M S, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C F, Ceccherini-Silberstein, F, HCV Italian Resistance Network Study Group., Collaborators (129) Mariani R, Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Nicolini, La, Viscoli, C, Casinelli, K, Monache, Md, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, Monforte, Ad, Danieli, E, Donato, F, Gubertini, G, Magni, Cf, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, Ml, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, Gb, Lembo, V, Calvaruso, V, Craxì, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Palitti, Vp, Pieri, A, Polilli, E, Antenucci, F, Antonucci, Fp, Armenia, D, Baiocchi, L, Bellocchi, M, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Di Maio, Vc, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Perno, Cf, Santopaolo, F, Santoro, Mm, Sforza, D, Sorbo, Mc, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Mura, M, Falconi, L, Di Giammartino, D, Tarquini, P., Di Maio, V. C, Bellocchi, M. C, Antonucci, F. P, Nicolini, L. A, Magni, C. F, Mura, M. S, Vespasiani Gentilucci, U, Morisco, Filomena, Perno, C. F, Ceccherini Silberstein, F., Caporaso, Nicola, Di Maio, V., Cento, V., Di Paolo, D., Aragri, M., De Leonardis, F., Tontodonati, M., Micheli, V., Bellocchi, M., Antonucci, F., Bertoli, A., Lenci, I., Milana, M., Gianserra, L., Melis, M., Di Biagio, A., Sarrecchia, C., Sarmati, L., Landonio, S., Francioso, S., Lambiase, L., Nicolini, L., Marenco, S., Nosotti, L., Giannelli, V., Siciliano, M., Romagnoli, D., Pellicelli, A., Vecchiet, J., Magni, C., Babudieri, S., Mura, M., Taliani, G., Mastroianni, C., Vespasiani-Gentilucci, U., Romano, M., Morisco, F., Gasbarrini, A., Vullo, V., Bruno, S., Baiguera, C., Pasquazzi, C., Tisone, G., Picciotto, A., Andreoni, M., Parruti, G., Rizzardini, G., Angelico, M., Perno, C., Ceccherini-Silberstein, F., Mariani, R., Paoloni, M., Iapadre, N., Grimaldi, A., Menzaghi, B., Quirino, T., Bruzzone, B., De Maria, A., Viscoli, C., Casinelli, K., Delle Monache, M., Lichtner, M., Aghemo, A., Cerrone, M., Colombo, M., D'Arminio Monforte, A., Danieli, E., Donato, F., Gubertini, G., Mancon, A., Monico, S., Niero, F., Puoti, M., Russo, M., Alfieri, R., Gnocchi, M., Orro, A., Milanesi, L., Baldelli, E., Bertolotti, M., Borghi, V., Mussini, C., Brancaccio, G., Caporaso, N., Gaeta, G., Lembo, V., Calvaruso, V., Craxã­, A., DI MARCO, V., Mazzola, A., Petta, S., D'Amico, E., Cacciatore, P., Consorte, A., Pace Palitti, V., Pieri, A., Polilli, E., Antenucci, F., Armenia, D., Baiocchi, L., Biliotti, E., Biolato, M., Carioti, L., Cerasari, G., Cerva, C., Ciotti, M., D'Ambrosio, C., D'Ettorre, G., De Sanctis, A., Furlan, C., Gallo, P., Grieco, A., Grieco, S., Lattanzi, B., Malagnino, V., Manuelli, M., Merli, M., Miglioresi, L., Palazzo, D., Santopaolo, F., Santoro, M., Sforza, D., Sorbo, M., Spaziante, M., Svicher, V., Teti, E., Mangia, A., Maida, I., Falconi, L., and Di Giammartino, D.

Subjects
0301 basic medicine, ns3, Genotyping Techniques, viruses, Drug Resistance, Hepacivirus, Viral Nonstructural Proteins, medicine.disease_cause, Gastroenterology, Telaprevir, chemistry.chemical_compound, genotype, genotyping techniques, hepacivirus, hepatitis C, humans, RNA viral, retrospective studies, sequence analysis, DNA, viral nonstructural proteins, drug resistance, viral, mutation, pharmacology, infectious diseases, 0302 clinical medicine, Retrospective Studie, Genotype, Pharmacology (medical), Viral, Hepatitis C, Humans, RNA, Viral, Retrospective Studies, Sequence Analysis, DNA, Drug Resistance, Viral, Mutation, Proteolytic enzymes, virus diseases, Settore MED/07 - Microbiologia e Microbiologia Clinica, hcv-rna levels, Infectious Diseases, HCV-RNA, 030211 gastroenterology & hepatology, Sequence Analysis, medicine.drug, Human, Microbiology (medical), medicine.medical_specialty, Hepatitis C virus, Concordance, Settore MED/12 - GASTROENTEROLOGIA, Pharmacology, Biology, 03 medical and health sciences, Boceprevir, Internal medicine, medicine, hcv, Genotyping, Hepaciviru, Viral Nonstructural Protein, Settore MED/09 - MEDICINA INTERNA, Virology, digestive system diseases, 030104 developmental biology, chemistry, Sequence Analysi, RNA, Genotyping Technique
Abstract

OBJECTIVES: This study aims to evaluate the reliability and clinical utility of NS3 sequencing in hepatitis C virus (HCV) 1-infected patients who were candidates to start a PI-containing regimen. METHODS: NS3 protease sequencing was performed by in-house-developed HCV-1 subtype-specific protocols. Phylogenetic analysis was used to test sequencing reliability and concordance with previous genotype/subtype assignment by commercial genotyping assays. RESULTS: Five hundred and sixty-seven HCV plasma samples with quantifiable HCV-RNA from 326 HCV-infected patients were collected between 2011 and 2014. Overall, the success rate of NS3 sequencing was 88.9%. The success rate between the two subtype protocols (HCV-1a/HCV-1b) was similarly high for samples with HCV-RNA >3 log IU/mL (>92% success rate), while it was slightly lower for HCV-1a samples with HCV-RNA ≤3 log IU/mL compared with HCV-1b samples. Phylogenetic analysis confirmed the genotype/subtype given by commercial genotyping assays in 92.9% (303/326) of cases analysed. In the remaining 23 cases (7.1%), 1 was HCV-1g (previously defined as subtype 1a), 1 was HCV-4d (previously defined as genotype 1b) and 1 was HCV-1b (previously defined as genotype 2a/2c). In the other cases, NS3 sequencing precisely resolved the either previous undetermined/discordant subtype 1 or double genotype/subtype assignment by commercial genotyping assays. Resistance-associated variants (RAVs) to PI were detected in 31.0% of samples. This prevalence changed according to PI experience (17.1% in PI-naive patients versus 79.2% in boceprevir/telaprevir/simeprevir-failing patients). Among 96 patients with available virological outcome following boceprevir/telaprevir treatment, a trend of association between baseline NS3 RAVs and virological failure was observed (particularly for HCV-1a-infected patients: 3/21 failing patients versus 0/22 achieving sustained virological response; P = 0.11). CONCLUSIONS: HCV-NS3 sequencing provides reliable results and at the same time gives two clinically relevant pieces of information: a correct subtype/genotype assignment and the detection of variants that may interfere with the efficacy of PI.

Published
2016
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7. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M, Antonucci, F, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C, Babudieri, S, Mura, M, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Mariani, R, Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Viscoli, C, Casinelli, K, Delle Monache, M, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, D'Arminio Monforte, A, Danieli, E, Donato, F, Gubertini, G, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, M, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, G, Lembo, V, Calvaruso, V, Craxi, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Pace Palitti, V, Pieri, A, Polilli, E, Antenucci, F, Armenia, D, Baiocchi, L, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Santopaolo, F, Santoro, M, Sforza, D, Sorbo, M, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Falconi, L, Di Giammartino, D, Tarquini, P, Di Maio V. C., Cento V., Di Paolo D., Aragri M., De Leonardis F., Tontodonati M., Micheli V., Bellocchi M. C., Antonucci F. P., Bertoli A., Lenci I., Milana M., Gianserra L., Melis M., Di Biagio A., Sarrecchia C., Sarmati L., Landonio S., Francioso S., Lambiase L., Nicolini L. A., Marenco S., Nosotti L., Giannelli V., Siciliano M., Romagnoli D., Pellicelli A., Vecchiet J., Magni C. F., Babudieri S., Mura M. S., Taliani G., Mastroianni C., Vespasiani-Gentilucci U., Romano M., Morisco F., Gasbarrini A., Vullo V., Bruno S., Baiguera C., Pasquazzi C., Tisone G., Picciotto A., Andreoni M., Parruti G., Rizzardini G., Angelico M., Perno C. F., Ceccherini-Silberstein F., Mariani R., Paoloni M., Iapadre N., Grimaldi A., Menzaghi B., Quirino T., Bruzzone B., De Maria A., Viscoli C., Casinelli K., Delle Monache M., Lichtner M., Aghemo A., Cerrone M., Colombo M., D'Arminio Monforte A., Danieli E., Donato F., Gubertini G., Mancon A., Monico S., Niero F., Puoti M., Russo M. L., Alfieri R., Gnocchi M., Orro A., Milanesi L., Baldelli E., Bertolotti M., Borghi V., Mussini C., Brancaccio G., Caporaso N., Gaeta G. B., Lembo V., Calvaruso V., Craxi A., Di Marco V., Mazzola A., Petta S., D'Amico E., Cacciatore P., Consorte A., Pace Palitti V., Pieri A., Polilli E., Antenucci F., Armenia D., Baiocchi L., Biliotti E., Biolato M., Carioti L., Cerasari G., Cerva C., Ciotti M., D'Ambrosio C., D'Ettorre G., De Sanctis A., Furlan C., Gallo P., Grieco A., Grieco S., Lattanzi B., Malagnino V., Manuelli M., Merli M., Miglioresi L., Palazzo D., Santopaolo F., Santoro M. M., Sforza D., Sorbo M. C., Spaziante M., Svicher V., Teti E., Mangia A., Maida I., Falconi L., Di Giammartino D., Tarquini P., Di Maio, V, Cento, V, Di Paolo, D, Aragri, M, De Leonardis, F, Tontodonati, M, Micheli, V, Bellocchi, M, Antonucci, F, Bertoli, A, Lenci, I, Milana, M, Gianserra, L, Melis, M, Di Biagio, A, Sarrecchia, C, Sarmati, L, Landonio, S, Francioso, S, Lambiase, L, Nicolini, L, Marenco, S, Nosotti, L, Giannelli, V, Siciliano, M, Romagnoli, D, Pellicelli, A, Vecchiet, J, Magni, C, Babudieri, S, Mura, M, Taliani, G, Mastroianni, C, Vespasiani-Gentilucci, U, Romano, M, Morisco, F, Gasbarrini, A, Vullo, V, Bruno, S, Baiguera, C, Pasquazzi, C, Tisone, G, Picciotto, A, Andreoni, M, Parruti, G, Rizzardini, G, Angelico, M, Perno, C, Ceccherini-Silberstein, F, Mariani, R, Paoloni, M, Iapadre, N, Grimaldi, A, Menzaghi, B, Quirino, T, Bruzzone, B, De Maria, A, Viscoli, C, Casinelli, K, Delle Monache, M, Lichtner, M, Aghemo, A, Cerrone, M, Colombo, M, D'Arminio Monforte, A, Danieli, E, Donato, F, Gubertini, G, Mancon, A, Monico, S, Niero, F, Puoti, M, Russo, M, Alfieri, R, Gnocchi, M, Orro, A, Milanesi, L, Baldelli, E, Bertolotti, M, Borghi, V, Mussini, C, Brancaccio, G, Caporaso, N, Gaeta, G, Lembo, V, Calvaruso, V, Craxi, A, Di Marco, V, Mazzola, A, Petta, S, D'Amico, E, Cacciatore, P, Consorte, A, Pace Palitti, V, Pieri, A, Polilli, E, Antenucci, F, Armenia, D, Baiocchi, L, Biliotti, E, Biolato, M, Carioti, L, Cerasari, G, Cerva, C, Ciotti, M, D'Ambrosio, C, D'Ettorre, G, De Sanctis, A, Furlan, C, Gallo, P, Grieco, A, Grieco, S, Lattanzi, B, Malagnino, V, Manuelli, M, Merli, M, Miglioresi, L, Palazzo, D, Santopaolo, F, Santoro, M, Sforza, D, Sorbo, M, Spaziante, M, Svicher, V, Teti, E, Mangia, A, Maida, I, Falconi, L, Di Giammartino, D, Tarquini, P, Di Maio V. C., Cento V., Di Paolo D., Aragri M., De Leonardis F., Tontodonati M., Micheli V., Bellocchi M. C., Antonucci F. P., Bertoli A., Lenci I., Milana M., Gianserra L., Melis M., Di Biagio A., Sarrecchia C., Sarmati L., Landonio S., Francioso S., Lambiase L., Nicolini L. A., Marenco S., Nosotti L., Giannelli V., Siciliano M., Romagnoli D., Pellicelli A., Vecchiet J., Magni C. F., Babudieri S., Mura M. S., Taliani G., Mastroianni C., Vespasiani-Gentilucci U., Romano M., Morisco F., Gasbarrini A., Vullo V., Bruno S., Baiguera C., Pasquazzi C., Tisone G., Picciotto A., Andreoni M., Parruti G., Rizzardini G., Angelico M., Perno C. F., Ceccherini-Silberstein F., Mariani R., Paoloni M., Iapadre N., Grimaldi A., Menzaghi B., Quirino T., Bruzzone B., De Maria A., Viscoli C., Casinelli K., Delle Monache M., Lichtner M., Aghemo A., Cerrone M., Colombo M., D'Arminio Monforte A., Danieli E., Donato F., Gubertini G., Mancon A., Monico S., Niero F., Puoti M., Russo M. L., Alfieri R., Gnocchi M., Orro A., Milanesi L., Baldelli E., Bertolotti M., Borghi V., Mussini C., Brancaccio G., Caporaso N., Gaeta G. B., Lembo V., Calvaruso V., Craxi A., Di Marco V., Mazzola A., Petta S., D'Amico E., Cacciatore P., Consorte A., Pace Palitti V., Pieri A., Polilli E., Antenucci F., Armenia D., Baiocchi L., Biliotti E., Biolato M., Carioti L., Cerasari G., Cerva C., Ciotti M., D'Ambrosio C., D'Ettorre G., De Sanctis A., Furlan C., Gallo P., Grieco A., Grieco S., Lattanzi B., Malagnino V., Manuelli M., Merli M., Miglioresi L., Palazzo D., Santopaolo F., Santoro M. M., Sforza D., Sorbo M. C., Spaziante M., Svicher V., Teti E., Mangia A., Maida I., Falconi L., Di Giammartino D., and Tarquini P.

Abstract

Objectives: This study aims to evaluate the reliability and clinical utility of NS3 sequencing in hepatitis C virus (HCV) 1-infected patients who were candidates to start a PI-containing regimen. Methods: NS3 protease sequencing was performed by in-house-developed HCV-1 subtype-specific protocols. Phylogenetic analysis was used to test sequencing reliability and concordance with previous genotype/subtype assignment by commercial genotyping assays. Results: Five hundred and sixty-seven HCV plasma samples with quantifiable HCV-RNA from 326 HCV-infected patients were collected between 2011 and 2014. Overall, the success rate of NS3 sequencing was 88.9%. The success rate between the two subtype protocols (HCV-1a/HCV-1b) was similarly high for samples with HCV-RNA > 3 log IU/mL (>92% success rate), while it was slightly lower for HCV-1a samples with HCV-RNA ≤ 3 log IU/mL compared with HCV-1b samples. Phylogenetic analysis confirmed the genotype/subtype given by commercial genotyping assays in 92.9% (303/326) of cases analysed. In the remaining 23 cases (7.1%), 1 was HCV-1g (previously defined as subtype 1a), 1 was HCV-4d (previously defined as genotype 1b) and 1 was HCV-1b (previously defined as genotype 2a/2c). In the other cases, NS3 sequencing precisely resolved the either previous undetermined/discordant subtype 1 or double genotype/subtype assignment by commercial genotyping assays. Resistance-associated variants (RAVs) to PI were detected in 31.0% of samples. This prevalence changed according to PI experience (17.1% in PI-naive patients versus 79.2% in boceprevir/telaprevir/simeprevir-failing patients). Among 96 patients with available virological outcome following boceprevir/telaprevir treatment, a trend of association between baseline NS3 RAVs and virological failure was observed (particularly for HCV-1a-infected patients: 3/21 failing patients versus 0/22 achieving sustained virological response; P = 0.11). Conclusions: HCV-NS3 sequencing provides reliable

Published
2016

8. Compassionate use of tenofovir alafenamide, coformulated with elvitegravir, cobicistat, and emtricitabine, in HIV-infected patients with renal impairment: an Italian experience

Author

Maffongelli, G., Cerva, C., Stingone, C., Plazzi, M. M., Fabbri, G., Vergori, A., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Gazzola, L., D’Arminio, A., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Valentinotti, R., Luzzati, R., Salpietro, S., Carini, E., Castagna, A., Lazzarin, A., Di Biagio, A., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Vittozzi, P., Pavone, P., Dettorre, G., Palmiero, G., Borgia, G., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Marino, R., Sozio, F., Parruti, G., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Marinello, S., Cattelan, A. M., Trentalange, A., Marinaro, L., Bonora, S., Ferrara, S., Santantonio, T., Chirianni, A., Antinori, A., Sarmati, L., and Andreoni, M.

Published
2017

9. Corrigendum to 'Brain and cognitive functions in two groups of naïve HIV patients selected for a different plan of antiretroviral therapy: A qEEG study' [Clin. Neurophysiol. 127 (2016) 3455–3469]((S1388245716305089)(10.1016/j.clinph.2016.09.001))

Author

Babiloni, C, Pennica, A, Capotosto, P, Onorati, P, Muratori, C, Ferracuti, S, Roma, P, Correr, V, Piccinni, E, Noce, G, Del Percio, C, Cordone, S, Limatola, C, Soricelli, A, Di Campli, F, Gianserra, L, Ciullini, L, Aceti, A, Viscione, M, Teti, E, Sarmati, L, and Andreoni, M

Subjects
Settore MED/17 - Malattie Infettive
Published
2017

10. Changes of lipid profile after switching to E/C/F/TAF: data from the Italian Compassionate Use Program

Author

Vergori, A., Fabbri, G., Lorenzini, P., Plazzi, M., Maffongelli, G., Cerva, C., Vitiello, P., Quirino, T., Rossotti, R., Danieli, E., Tau, P., Puoti, M., Lanza, P., Castelli, F., Trizzino, M., Cascio, A., Costenaro, P., Manfrin, V., Ferretto, R., Colafigli, M., Latini, A., Cristaudo, C., Gianserra, L., Pennica, A., Rossetti, B., Modica, S., De Luca, A., Nardini, G., Guaraldi, G., Mussini, C., Schiaroli, E., Baldelli, F., Lapadula, G., Pastore, V., Gori, A., La Monica, S., Cauda, R., Badia, L., Viale, P., Corsini, R., Magnani, G., Carleo, M. A., Pellicano', Giovanni Francesco, Nunnari, Giuseppe, Chirianni, A., Andreoni, M., and Medicina Tropicale, A. Antinori con il patrocinio della Società Italiana di Malattie Infettive e.

Published
2017

11. Corrigendum to 'Abnormal cortical sources of resting state electroencephalographic rhythms in single treatment-naïve HIV individuals: A statistical z-score index' [Clin. Neurophysiol. 127 (2016) 1803–1812] (S138824571501559X) (10.1016/j.clinph.2015.12.007))

Author

Babiloni, C, Pennica, A, Del Percio, C, Noce, G, Cordone, S, Muratori, C, Ferracuti, S, Donato, N, Di Campli, F, Gianserra, L, Teti, E, Aceti, A, Soricelli, A, Viscione, M, Limatola, C, Andreoni, M, and Onorati, P

Subjects
Settore MED/17 - Malattie Infettive
Published
2017

13. 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

14. Effectiveness of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports

Author

Ponziani, Francesca Romana, Siciliano, Massimo, Lionetti, R, Pasquazzi, C, Gianserra, L, D'Offizi, G, Gasbarrini, Antonio, Pompili, Maurizio, Ponziani, Francesca Romana (ORCID:0000-0002-5924-6238), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), Pompili, Maurizio (ORCID:0000-0001-6699-7980), Ponziani, Francesca Romana, Siciliano, Massimo, Lionetti, R, Pasquazzi, C, Gianserra, L, D'Offizi, G, Gasbarrini, Antonio, Pompili, Maurizio, Ponziani, Francesca Romana (ORCID:0000-0002-5924-6238), Gasbarrini, Antonio (ORCID:0000-0002-7278-4823), and Pompili, Maurizio (ORCID:0000-0001-6699-7980)

Abstract

Hepatitis C virus infection is common among patients on hemodialysis therapy and is an important cause of morbidity and mortality. We investigated the safety and effectiveness of a paritaprevir/ritonavir/ombitasvir/dasabuvir regimen in a group of 10 patients on hemodialysis therapy with genotype 1a, 1b, or 4 hepatitis C virus infection who had predictors of unfavorable response, such as compensated cirrhosis (7 patients) or advanced fibrosis and failure of previous therapy (3 patients). The treatment, with or without ribavirin, was administered daily for 12 or 24 weeks. Clinical and virologic assessment was performed every 4 weeks during the treatment and at posttreatment weeks 4 and 12. All patients achieved a sustained virologic response at posttreatment week 12. 80% of patients reported at least one adverse event: fatigue and anemia of mild intensity were the most common; a single episode of moderate liver decompensation was observed. The paritaprevir/ritonavir/ombitasvir/dasabuvir antiviral regimen is effective and well tolerated in genotype 1 or 4 hepatitis C virus-infected patients on hemodialysis therapy with compensated cirrhosis and/or failure of previous treatments.

Published
2017

15. Natural HCV resistance is common in Italy and differently associated to genotypes

Author

Sorbo, M.C., primary, Cento, V., additional, Bertoli, A., additional, Lenci, I., additional, Polilli, E., additional, Masetti, C., additional, Gianserra, L., additional, Teti, E., additional, Biliotti, E., additional, Magni, C.F., additional, Aragri, M., additional, Micheli, V., additional, Melis, M., additional, Nicolini, L.A., additional, Marenco, S., additional, Calvaruso, V., additional, Paolucci, S., additional, Baldanti, F., additional, Morisco, F., additional, Siciliano, M., additional, Pace Palitti, V., additional, Andreone, P., additional, Bruzzone, B., additional, Coppola, N., additional, Ruggiero, T., additional, Lichtner, M., additional, Menzaghi, B., additional, Romagnoli, D., additional, Iapadre, N., additional, Di Maio, V.C., additional, De Leonardis, F., additional, Milana, M., additional, Cacciatore, P., additional, Pieri, A., additional, Sarmati, L., additional, Landonio, S., additional, Gasbarrini, A., additional, Puoti, M., additional, Craxì, A., additional, Vullo, V., additional, Pellicelli, A., additional, Babudieri, S., additional, Rizzardini, G., additional, Taliani, G., additional, Andreoni, M., additional, Pasquazzi, C., additional, Parruti, G., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional

Published
2017
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17. Clinical relevance of accurate HCV genotype and subtype assignment by NS3/NS5A/NS5B direct sequencing in the era of new direct acting antiviral agents

Author

Aragri, M., primary, Di Maio, V.C., additional, Di Paolo, D., additional, Cento, V., additional, De Leonardis, F., additional, Gianserra, L., additional, Tontodonati, M., additional, Micheli, V., additional, Landonio, S., additional, Manunta, A., additional, Bertoli, A., additional, Ciotti, M., additional, Antonucci, F.P., additional, Campoli, R., additional, La Rosa, K. Yu, additional, Deodati, F., additional, Lenci, I., additional, Francioso, S., additional, Nicolini, L.A., additional, Marenco, S., additional, Teti, E., additional, Lambiase, L., additional, Milana, M., additional, Maida, I., additional, Di Biagio, A., additional, Pellicelli, A., additional, Nosotti, L., additional, Grieco, S., additional, Cacciatore, P., additional, Romagnoli, D., additional, Siciliano, M., additional, D’Ettorre, G., additional, Babudieri, S., additional, Lichtner, M., additional, Vespasiani-Gentilucci, U., additional, Romano, M., additional, Sarrecchia, C., additional, Grieco, A., additional, Morisco, F., additional, Mastroianni, C., additional, Vecchiet, J., additional, Puoti, M., additional, D’Amico, E., additional, Caporaso, N., additional, Gasbarrini, A., additional, Bruno, S., additional, Magni, C., additional, Mura, M.S., additional, Taliani, G., additional, Picciotto, A., additional, Rizzardini, G., additional, Andreoni, M., additional, Pasquazzi, C., additional, Parruti, G., additional, Angelico, M., additional, Perno, C.F., additional, and Ceccherini-Silberstein, F., additional

Published
2016
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18. Biphasic Kinetics of HCV-RNA Decay is Accompanied by an even Faster Aminotransferases Normalization in All-Daa Treated Cirrhotic Patients: A Different Scenario from Interferon-Based Therapies

Author

Cento, V., primary, Di Carlo, D., additional, Nguyen, T.H.T., additional, Biliotti, E., additional, Pasquazzi, C., additional, Gianserra, L., additional, Di Paolo, D., additional, Calvaruso, V., additional, Teti, E., additional, Cerrone, M., additional, Romagnoli, D., additional, Melis, M., additional, Danieli, E., additional, Menzaghi, B., additional, Polilli, E., additional, Siciliano, M., additional, Nicolini, L.A., additional, Di Biagio, A., additional, Magni, C.F., additional, Antonucci, F.P., additional, Di Maio, V.C., additional, Alfieri, R., additional, Sarmati, L., additional, Casalino, P., additional, Bernardini, S., additional, Micheli, V., additional, Rizzardini, G., additional, Villa, E., additional, Parruti, G., additional, Quirino, T., additional, Puoti, M., additional, Babudieri, S., additional, Monforte, A. D’A., additional, Andreoni, M., additional, Craxì, A., additional, Lenci, I., additional, Angelico, M., additional, Taliani, G., additional, Guedj, J., additional, Ceccherini-Silberstein, F., additional, and Perno, C.F., additional

Published
2016
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19. In the ERA of New Direct Acting Antiviral Agents HCV Sequencing Allows the Most Accurate Subtype and Genotype Assignment

Author

Aragri, M., primary, Di Maio, V.C., additional, Di Paolo, D., additional, Cento, V., additional, De Leonardis, F., additional, Gianserra, L., additional, Tontodonati, M., additional, Micheli, V., additional, Landonio, S., additional, Manunta, A., additional, Bertoli, A., additional, Ciotti, M., additional, Antonucci, F.P., additional, Lenci, I., additional, Francioso, S., additional, Nicolini, L.A., additional, Marenco, S., additional, Teti, E., additional, Lambiase, L., additional, Milana, M., additional, Maida, I., additional, Di Biagio, A., additional, Pellicelli, A., additional, Nosotti, L., additional, Grieco, S., additional, Cacciatore, P., additional, Romagnoli, D., additional, Siciliano, M., additional, D’Ettorre, G., additional, Babudieri, S., additional, Lichtner, M., additional, Gentilucci, U.V., additional, Romano, M., additional, Sarrecchia, C., additional, Grieco, A., additional, Morisco, F., additional, Mastroianni, C., additional, Vecchiet, J., additional, Puoti, M., additional, D’Amico, E., additional, Gasbarrini, A., additional, Bruno, S., additional, Magni, C., additional, Mura, M.S., additional, Taliani, G., additional, Picciotto, A., additional, Rizzardini, G., additional, Andreoni, M., additional, Pasquazzi, C., additional, Parruti, G., additional, Angelico, M., additional, Perno, C.F., additional, and Silberstein, F.C., additional

Published
2016
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20. Antiretroviral therapy effects on sources of cortical rhythms in HIV subjects: responders vs. mild responders

Author

Babiloni, C, Pennica, A, Vecchio, F, Onorati, P, Muratori, C, Ferracuti, S, Roma, P, Donato, N, Noce, G, Del Percio, C, Bonacci, C, Di Campli, F, Gianserra, L, Teti, E, Aceti, A, Soricelli, A, Viscione, M, Rossini, Paolo Maria, Andreoni, M., Rossini, Paolo Maria (ORCID:0000-0003-2665-534X), Babiloni, C, Pennica, A, Vecchio, F, Onorati, P, Muratori, C, Ferracuti, S, Roma, P, Donato, N, Noce, G, Del Percio, C, Bonacci, C, Di Campli, F, Gianserra, L, Teti, E, Aceti, A, Soricelli, A, Viscione, M, Rossini, Paolo Maria, Andreoni, M., and Rossini, Paolo Maria (ORCID:0000-0003-2665-534X)

Abstract

We tested the hypothesis that 5months of combined anti-retroviral therapy (cART) affect cortical sources of resting state cortical electroencephalographic (EEG) rhythms in naïve HIV subjects.

Published
2015

21. HCV NS3 sequencing as a reliable and clinically useful tool for the assessment of genotype and resistance mutations for clinical samples with different HCV-RNA levels

Author

Di Maio, V. C., primary, Cento, V., additional, Di Paolo, D., additional, Aragri, M., additional, De Leonardis, F., additional, Tontodonati, M., additional, Micheli, V., additional, Bellocchi, M. C., additional, Antonucci, F. P., additional, Bertoli, A., additional, Lenci, I., additional, Milana, M., additional, Gianserra, L., additional, Melis, M., additional, Di Biagio, A., additional, Sarrecchia, C., additional, Sarmati, L., additional, Landonio, S., additional, Francioso, S., additional, Lambiase, L., additional, Nicolini, L. A., additional, Marenco, S., additional, Nosotti, L., additional, Giannelli, V., additional, Siciliano, M., additional, Romagnoli, D., additional, Pellicelli, A., additional, Vecchiet, J., additional, Magni, C. F., additional, Babudieri, S., additional, Mura, M. S., additional, Taliani, G., additional, Mastroianni, C., additional, Vespasiani-Gentilucci, U., additional, Romano, M., additional, Morisco, F., additional, Gasbarrini, A., additional, Vullo, V., additional, Bruno, S., additional, Baiguera, C., additional, Pasquazzi, C., additional, Tisone, G., additional, Picciotto, A., additional, Andreoni, M., additional, Parruti, G., additional, Rizzardini, G., additional, Angelico, M., additional, Perno, C. F., additional, and Ceccherini-Silberstein, F., additional

Published
2015
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23. Cortical sources of resting-state EEG rhythms are abnormal in naïve HIV subjects

Author

Babiloni, C, Vecchio, F, Buffo, P, Onorati, P, Muratori, C, Ferracuti, S, Roma, P, Battuello, M, Donato, N, Pellegrini, P, Di Campli, F, Gianserra, L, Teti, E, Aceti, A, Rossini, Paolo Maria, Pennica, A., Rossini, Paolo Maria (ORCID:0000-0003-2665-534X), Babiloni, C, Vecchio, F, Buffo, P, Onorati, P, Muratori, C, Ferracuti, S, Roma, P, Battuello, M, Donato, N, Pellegrini, P, Di Campli, F, Gianserra, L, Teti, E, Aceti, A, Rossini, Paolo Maria, Pennica, A., and Rossini, Paolo Maria (ORCID:0000-0003-2665-534X)

Abstract

The aim of the study was to test the hypothesis that cortical sources of resting-state electroencephalographic (EEG) rhythms show peculiar frequency/spatial features in naïve human subjects with human immunodeficiency virus (HIV) compared to healthy control subjects.

Published
2012

24. FRI-196 - Biphasic Kinetics of HCV-RNA Decay is Accompanied by an even Faster Aminotransferases Normalization in All-Daa Treated Cirrhotic Patients: A Different Scenario from Interferon-Based Therapies

Author

Cento, V., Di Carlo, D., Nguyen, T.H.T., Biliotti, E., Pasquazzi, C., Gianserra, L., Di Paolo, D., Calvaruso, V., Teti, E., Cerrone, M., Romagnoli, D., Melis, M., Danieli, E., Menzaghi, B., Polilli, E., Siciliano, M., Nicolini, L.A., Di Biagio, A., Magni, C.F., Antonucci, F.P., Di Maio, V.C., Alfieri, R., Sarmati, L., Casalino, P., Bernardini, S., Micheli, V., Rizzardini, G., Villa, E., Parruti, G., Quirino, T., Puoti, M., Babudieri, S., Monforte, A. D’A., Andreoni, M., Craxì, A., Lenci, I., Angelico, M., Taliani, G., Guedj, J., Ceccherini-Silberstein, F., and Perno, C.F.

Published
2016
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25. THU-263 - In the ERA of New Direct Acting Antiviral Agents HCV Sequencing Allows the Most Accurate Subtype and Genotype Assignment

Author

Aragri, M., Di Maio, V.C., Di Paolo, D., Cento, V., De Leonardis, F., Gianserra, L., Tontodonati, M., Micheli, V., Landonio, S., Manunta, A., Bertoli, A., Ciotti, M., Antonucci, F.P., Lenci, I., Francioso, S., Nicolini, L.A., Marenco, S., Teti, E., Lambiase, L., Milana, M., Maida, I., Di Biagio, A., Pellicelli, A., Nosotti, L., Grieco, S., Cacciatore, P., Romagnoli, D., Siciliano, M., D’Ettorre, G., Babudieri, S., Lichtner, M., Gentilucci, U.V., Romano, M., Sarrecchia, C., Grieco, A., Morisco, F., Mastroianni, C., Vecchiet, J., Puoti, M., D’Amico, E., Gasbarrini, A., Bruno, S., Magni, C., Mura, M.S., Taliani, G., Picciotto, A., Rizzardini, G., Andreoni, M., Pasquazzi, C., Parruti, G., Angelico, M., Perno, C.F., and Silberstein, F.C.

Published
2016
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26. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens

Author

Carlo Magni, Barbara Menzaghi, Valeria Cento, Francesca Ceccherini-Silberstein, Giustino Parruti, Antonio Di Biagio, Velia Chiara Di Maio, Sergio Babudieri, Antonella d'Arminio Monforte, Loredana Sarmati, Laura Gianserra, Paolo Casalino, Tiziana Quirino, Elena Danieli, Jeremie Guedj, Dante Romagnoli, Ilaria Lenci, Sergio Bernardini, Laura Ambra Nicolini, Elisa Biliotti, Matteo Bolis, M. Melis, Maddalena Cerrone, Massimo Puoti, Valeria Micheli, Carlo Federico Perno, Vincenza Calvaruso, Thi Huyen Tram Nguyen, Ennio Polilli, Giuliano Rizzardini, Massimo Siciliano, Massimo Andreoni, Mario Angelico, Francesco Paolo Antonucci, Domenico Di Carlo, Caterina Pasquazzi, Antonio Craxì, Daniele Di Paolo, Elisabetta Teti, Gloria Taliani, Roberta Alfieri, Cento, V, Nguyen, T, Di Carlo, D, Biliotti, E, Gianserra, L, Lenci, I, Di Paolo, D, Calvaruso, V, Teti, E, Cerrone, M, Romagnoli, D, Melis, M, Danieli, E, Menzaghi, B, Polilli, E, Siciliano, M, Nicolini, L, Di Biagio, A, Magni, C, Bolis, M, Antonucci, F, Di Maio, V, Alfieri, R, Sarmati, L, Casalino, P, Bernardini, S, Micheli, V, Rizzardini, G, Parruti, G, Quirino, T, Puoti, M, Babudieri, S, Monforte, A, Andreoni, M, Craxì, A, Angelico, M, Pasquazzi, C, Taliani, G, Guedj, J, Perno, C, Ceccherini-Silberstein, F, Cento, V., Nguyen, T., Di Carlo, D., Biliotti, E., Gianserra, L., Lenci, I., Di Paolo, D., Calvaruso, V., Teti, E., Cerrone, M., Romagnoli, D., Melis, M., Danieli, E., Menzaghi, B., Polilli, E., Siciliano, M., Nicolini, L., Di Biagio, A., Magni, C., Bolis, M., Antonucci, F., Di Maio, V., Alfieri, R., Sarmati, L., Casalino, P., Bernardini, S., Micheli, V., Rizzardini, G., Parruti, G., Quirino, T., Puoti, M., Babudieri, S., Monforte, A., Andreoni, M., Craxi, A., Angelico, M., Pasquazzi, C., Taliani, G., Guedj, J., Perno, C., and Ceccherini-Silberstein, F.

Subjects
Genetics and Molecular Biology (all), Simeprevir, Male, Hepacivirus, Pharmacology, Biochemistry, Stiffness, 0302 clinical medicine, Animal Cells, Medicine, Amino Acids, lcsh:Science, Alanine, Organic Compounds, Liver Diseases, 3. Good health, Cirrhosis, Physical Sciences, Administration, Interferon, 030211 gastroenterology & hepatology, Drug Therapy, Combination, Cellular Types, Oligopeptides, Human, Oral, Materials Science, Gastroenterology and Hepatology, Microbiology, Antiviral Agents, 03 medical and health sciences, Drug Therapy, Humans, Aged, Kinetic, Hepaciviru, Biochemistry, Genetics and Molecular Biology (all), Mathematical Modeling, lcsh:R, Chemical Compounds, Biology and Life Sciences, Proteins, medicine.disease, digestive system diseases, Administration, Oral, Alanine Transaminase, Female, Hepatitis C, Interferons, Kinetics, Middle Aged, RNA, Viral, Ribavirin, Sofosbuvir, Treatment Outcome, Viral Nonstructural Proteins, Agricultural and Biological Sciences (all), 030104 developmental biology, chemistry, Aliphatic Amino Acids, lcsh:Q, 0301 basic medicine, lcsh:Medicine, Medicine (all), Telaprevir, chemistry.chemical_compound, Medicine and Health Sciences, Viral, Multidisciplinary, biology, Antimicrobials, Simulation and Modeling, Drugs, Antivirals, Chemistry, Liver, Combination, Oligopeptide, Anatomy, medicine.drug, Research Article, Settore MED/17 - Malattie Infettive, General Science & Technology, Material Properties, Research and Analysis Methods, Microbial Control, Virology, Mechanical Properties, NS5A, Antiviral Agent, business.industry, HCV DAA ALT, Viral Nonstructural Protein, Organic Chemistry, Cell Biology, biology.organism_classification, Alanine transaminase, biology.protein, Hepatocytes, RNA, business
Abstract

Background Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR. Study design Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization. Results HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p

Published
2017

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

Author

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

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

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

Published
2018

30. Effectiveness and safety of risankizumab in HIV patients with psoriasis: A case series.

Author

Orsini D, Maramao FS, Gargiulo L, Ibba L, Piscazzi F, Pacifico A, Latini A, Gianserra L, Cristaudo A, Costanzo A, and Narcisi A

Subjects
Humans, Severity of Illness Index, Antibodies, Monoclonal, Interleukin-23, Treatment Outcome, HIV Infections complications, HIV Infections drug therapy, Psoriasis complications, Psoriasis drug therapy
Abstract

Biological therapies represent the gold-standard treatment of severe forms of plaque psoriasis. However, people living with HIV are often under-treated for psoriasis because very limited data are available on the use of biologics in this population. We report four cases of patients affected by HIV and moderate-to-severe plaque psoriasis, all treated with risankizumab, a monoclonal antibody that selectively targets interleukin-23. After 16 weeks, all patients experienced complete or almost complete skin clearance without any adverse events. Data on the effectiveness and safety of biological therapies in people living with HIV are limited to case reports or small case series, especially for the most recently approved inhibitors of interleukin-23. Our experienced, although limited, supports the role of risankizumab as a safe and effective therapy for psoriasis amongst patients living with HIV., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: L. Gargiulo has been a consultant for Almirall. A. Costanzo has served as an advisory board member, consultant and has received fees and speaker’s honoraria or has participated in clinical trials for Abbvie, Almirall, Biogen, LEO Pharma, Lilly, Janssen, Novartis, Pfizer, Sanofi Genzyme, and UCB-Pharma. A. Narcisi has served on advisory boards, received honoraria for lectures and research grants from Almirall, Abbvie, Leo Pharma, Celgene, Eli Lilly, Janssen, Novartis, Sanofi‐Genzyme, Amgen and Boehringer Ingelheim. The other authors have nothing to declare.

Published
2024
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31. Immunogenicity and Safety of BNT162b2 Homologous Booster Vaccination in People Living with HIV under Effective cART.

Author

Gianserra L, Donà MG, Giuliani E, Stingone C, Pontone M, Buonomini AR, Giuliani M, Pimpinelli F, Morrone A, and Latini A

Abstract

Data on COVID-19 boosting vaccination in people living with HIV (PLWH) are scant. We investigated the immunogenicity and safety of the BNT162b2 homologous boosting vaccination. Anti-SARS-CoV-2 spike antibodies (LIAISON® SARS-CoV-2 S1/S2 IgG test, DiaSorin®), CD4+, CD8+ and viraemia were monitored at T0 (pre-vaccination), T1 (4 weeks after the second dose), T2 (pre-booster) and T3 (4 weeks after the booster dose). Humoral responses were evaluated according to sex, age, BMI, nadir and baseline CD4+ counts, as well as type of cART regimen. Forty-two subjects were included: the median age was 53 years (IQR: 48−61); the median time since HIV was 12.4 years (IQR: 6.5−18.3); the median nadir and baseline CD4+ counts were 165 (IQR: 104−291) and 687 cells/mm3 (IQR: 488−929), respectively. The booster dose was administered at a median of 5.5 months after the second dose. Median anti-SARS-CoV-2 IgG concentration had significantly decreased at T2 compared to T1 (107 vs. 377, p < 0.0001). Antibody levels elicited by the booster dose (median: 1580 AU/mL) were significantly higher compared with those of all the other time points (p < 0.0001). None of the investigated variables significantly affected antibody response induced by the booster dose. Local and systemic side-effects were referred by 23.8% and 14.3% of the subjects, respectively. One patient developed sensorineural hearing loss (SNHL) 24 h after boosting. He recovered auditory function upon endothympanic administration of corticosteroids. The BNT162b2 boosting vaccination in PLWH is safe and greatly increased the immune response with respect to the primary vaccination.

Published
2022
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33. Author Correction: Features of fragile people with SARS-CoV-2 infection in isolation in a COVID-19 hotel in Rome, Italy.

Author

Stingone C, Latini A, Gianserra L, Salvi M, Donà MG, Giuliani E, Lesnoni La Parola I, Mussi A, Cameli N, Garelli V, Giuliani M, Buonomini AR, Vujovic B, Cerimele M, and Morrone A

Abstract

Correction to: European Review for Medical and Pharmacological Sciences 2022; 26 (7): 2631-2638-DOI: 10.26355/eurrev&#95;202204&#95;28501-PMID: 35442479, published online on 15 April 2022. After publication, at the request of the Italian Ministry of Health, the authors asked to insert the following statement in the Acknowledgments section: "This research was funded by the Italian Ministry of Health (RC 2022)". There are amendments to this paper. The Publisher apologizes for any inconvenience this may cause. https://www.europeanreview.org/article/28501.

Published
2022
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35. Prevalence of Single and Multiple Natural NS3, NS5A and NS5B Resistance-Associated Substitutions in Hepatitis C Virus Genotypes 1-4 in Italy.

Author

Bertoli A, Sorbo MC, Aragri M, Lenci I, Teti E, Polilli E, Di Maio VC, Gianserra L, Biliotti E, Masetti C, Magni CF, Babudieri S, Nicolini LA, Milana M, Cacciatore P, Sarmati L, Pellicelli A, Paolucci S, Craxì A, Morisco F, Palitti VP, Siciliano M, Coppola N, Iapadre N, Puoti M, Rizzardini G, Taliani G, Pasquazzi C, Andreoni M, Parruti G, Angelico M, Perno CF, Cento V, and Ceccherini-Silberstein F

Subjects
Adult, Aged, Female, Hepatitis C drug therapy, Hepatitis C epidemiology, Humans, Italy epidemiology, Male, Middle Aged, Prevalence, Drug Resistance, Viral genetics, Genotype, Hepacivirus genetics, Hepatitis C genetics, Viral Nonstructural Proteins genetics
Abstract

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

Published
2018
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36. Cortical sources of resting state electroencephalographic rhythms probe brain function in naïve HIV individuals.

Author

Babiloni C, Noce G, Pennica A, Onorati P, Capotosto P, Del Percio C, Roma P, Correr V, Piccinni E, Toma G, Soricelli A, Di Campli F, Gianserra L, Ciullini L, Aceti A, Teti E, Sarmati L, Crocetti G, Ferri R, Catania V, Pascarelli MT, Andreoni M, and Ferracuti S

Subjects
Adult, Electroencephalography, Female, HIV Infections psychology, Humans, Male, Neuropsychological Tests, Rest physiology, Cerebral Cortex physiopathology, Cognition physiology, HIV Infections physiopathology
Abstract

Objective: Here we evaluated the hypothesis that resting state electroencephalographic (EEG) cortical sources correlated with cognitive functions and discriminated asymptomatic treatment-naïve HIV subjects (no AIDS)., Methods: EEG, clinical, and neuropsychological data were collected in 103 treatment-naïve HIV subjects (88 males; mean age 39.8 years ± 1.1 standard error of the mean, SE). An age-matched group of 70 cognitively normal and HIV-negative (Healthy; 56 males; 39.0 years ± 2.0 SE) subjects, selected from a local university archive, was used for control purposes. LORETA freeware was used for EEG source estimation in fronto-central, temporal, and parieto-occipital regions of interest., Results: Widespread sources of delta (<4 Hz) and alpha (8-12 Hz) rhythms were abnormal in the treatment-naïve HIV group. Fronto-central delta source activity showed a slight but significant (p < 0.05, corrected) negative correlation with verbal and semantic test scores. So did parieto-occipital delta/alpha source ratio with memory and composite cognitive scores. These sources allowed a moderate classification accuracy between HIV and control individuals (area under the ROC curves of 70-75%)., Conclusions: Regional EEG abnormalities in quiet wakefulness characterized treatment-naïve HIV subjects at the individual level., Significance: This EEG approach may contribute to the management of treatment-naïve HIV subjects at risk of cognitive deficits., (Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.)

Published
2018
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37. Effectiveness of Paritaprevir/Ritonavir/Ombitasvir/Dasabuvir in Hemodialysis Patients With Hepatitis C Virus Infection and Advanced Liver Fibrosis: Case Reports.

Author

Ponziani FR, Siciliano M, Lionetti R, Pasquazzi C, Gianserra L, D'Offizi G, Gasbarrini A, and Pompili M

Subjects
2-Naphthylamine, Anilides administration & dosage, Antiviral Agents administration & dosage, Carbamates administration & dosage, Cyclopropanes, Drug Therapy, Combination, Humans, Lactams, Macrocyclic, Macrocyclic Compounds administration & dosage, Male, Middle Aged, Proline analogs & derivatives, Ritonavir administration & dosage, Severity of Illness Index, Sulfonamides administration & dosage, Treatment Outcome, Uracil administration & dosage, Uracil analogs & derivatives, Valine, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Kidney Failure, Chronic complications, Liver Cirrhosis complications, Renal Dialysis
Abstract

Hepatitis C virus infection is common among patients on hemodialysis therapy and is an important cause of morbidity and mortality. We investigated the safety and effectiveness of a paritaprevir/ritonavir/ombitasvir/dasabuvir regimen in a group of 10 patients on hemodialysis therapy with genotype 1a, 1b, or 4 hepatitis C virus infection who had predictors of unfavorable response, such as compensated cirrhosis (7 patients) or advanced fibrosis and failure of previous therapy (3 patients). The treatment, with or without ribavirin, was administered daily for 12 or 24 weeks. Clinical and virologic assessment was performed every 4 weeks during the treatment and at posttreatment weeks 4 and 12. All patients achieved a sustained virologic response at posttreatment week 12. 80% of patients reported at least one adverse event: fatigue and anemia of mild intensity were the most common; a single episode of moderate liver decompensation was observed. The paritaprevir/ritonavir/ombitasvir/dasabuvir antiviral regimen is effective and well tolerated in genotype 1 or 4 hepatitis C virus-infected patients on hemodialysis therapy with compensated cirrhosis and/or failure of previous treatments., (Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.)

Published
2017
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38. Improvement of ALT decay kinetics by all-oral HCV treatment: Role of NS5A inhibitors and differences with IFN-based regimens.

Author

Cento V, Nguyen THT, Di Carlo D, Biliotti E, Gianserra L, Lenci I, Di Paolo D, Calvaruso V, Teti E, Cerrone M, Romagnoli D, Melis M, Danieli E, Menzaghi B, Polilli E, Siciliano M, Nicolini LA, Di Biagio A, Magni CF, Bolis M, Antonucci FP, Di Maio VC, Alfieri R, Sarmati L, Casalino P, Bernardini S, Micheli V, Rizzardini G, Parruti G, Quirino T, Puoti M, Babudieri S, D'Arminio Monforte A, Andreoni M, Craxì A, Angelico M, Pasquazzi C, Taliani G, Guedj J, Perno CF, and Ceccherini-Silberstein F

Subjects
Administration, Oral, Aged, Alanine Transaminase metabolism, Antiviral Agents administration & dosage, Drug Therapy, Combination, Female, Hepacivirus genetics, Humans, Interferons pharmacology, Kinetics, Male, Middle Aged, Oligopeptides administration & dosage, Oligopeptides pharmacology, RNA, Viral blood, Ribavirin administration & dosage, Ribavirin pharmacology, Simeprevir administration & dosage, Simeprevir pharmacology, Sofosbuvir administration & dosage, Sofosbuvir pharmacology, Treatment Outcome, Alanine Transaminase blood, Antiviral Agents pharmacology, Hepatitis C drug therapy, Viral Nonstructural Proteins antagonists & inhibitors
Abstract

Background: Intracellular HCV-RNA reduction is a proposed mechanism of action of direct-acting antivirals (DAAs), alternative to hepatocytes elimination by pegylated-interferon plus ribavirin (PR). We modeled ALT and HCV-RNA kinetics in cirrhotic patients treated with currently-used all-DAA combinations to evaluate their mode of action and cytotoxicity compared with telaprevir (TVR)+PR., Study Design: Mathematical modeling of ALT and HCV-RNA kinetics was performed in 111 HCV-1 cirrhotic patients, 81 treated with all-DAA regimens and 30 with TVR+PR. Kinetic-models and Cox-analysis were used to assess determinants of ALT-decay and normalization., Results: HCV-RNA kinetics was biphasic, reflecting a mean effectiveness in blocking viral production >99.8%. The first-phase of viral-decline was faster in patients receiving NS5A-inhibitors compared to TVR+PR or sofosbuvir+simeprevir (p<0.001), reflecting higher efficacy in blocking assembly/secretion. The second-phase, noted δ and attributed to infected-cell loss, was faster in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.27 vs 0.21 d-1, respectively, p = 0.0012). In contrast the rate of ALT-normalization, noted λ, was slower in patients receiving TVR+PR or sofosbuvir+simeprevir compared to NS5A-inhibitors (0.17 vs 0.27 d-1, respectively, p<0.001). There was no significant association between the second-phase of viral-decline and ALT normalization rate and, for a given level of viral reduction, ALT-normalization was more profound in patients receiving DAA, and NS5A in particular, than TVR+PR., Conclusions: Our data support a process of HCV-clearance by all-DAA regimens potentiated by NS5A-inhibitor, and less relying upon hepatocyte death than IFN-containing regimens. This may underline a process of "cell-cure" by DAAs, leading to a fast improvement of liver homeostasis.

Published
2017
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39. Corrigendum to "Brain and cognitive functions in two groups of naïve HIV patients selected for a different plan of antiretroviral therapy: A qEEG study" [Clin. Neurophysiol. 127 (2016) 3455-3469].

Author

Babiloni C, Pennica A, Capotosto P, Onorati P, Muratori C, Ferracuti S, Roma P, Correr V, Piccinni E, Noce G, Del Percio C, Cordone S, Limatola C, Soricelli A, Di Campli F, Gianserra L, Ciullini L, Aceti A, Viscione M, Teti E, Sarmati L, and Andreoni M

Published
2017
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41. Brain and cognitive functions in two groups of naïve HIV patients selected for a different plan of antiretroviral therapy: A qEEG study.

Author

Babiloni C, Pennica A, Capotosto P, Onorati P, Muratori C, Ferracuti S, Roma P, Correr V, Piccinni E, Noce G, Del Percio C, Cordone S, Limatola C, Soricelli A, Di Campli F, Gianserra L, Ciullini L, Aceti A, Viscione M, Teti E, Sarmati L, and Andreoni M

Subjects
Adult, Anti-Retroviral Agents administration & dosage, Brain drug effects, Electroencephalography drug effects, Female, Follow-Up Studies, HIV Infections diagnosis, Humans, Male, Antiretroviral Therapy, Highly Active methods, Brain physiopathology, Cognition physiology, Electroencephalography methods, HIV Infections drug therapy, HIV Infections physiopathology
Abstract

Objective: Cortical sources of electroencephalographic (EEG) rhythms were investigated in two sub-populations of naïve HIV subjects, grouped based on clinical criteria to receive different combination anti-retroviral therapies (cARTs). These EEG sources were hypothesized to reflect beneficial effects of both regimes., Methods: Eyes-closed resting state EEG data were collected in 19 (Group A) and 39 (Group B) naïve HIV subjects at baseline (i.e. pre-treatment; T0) and after 5months of cART (T5). Compared with the Group A, the Group B was characterized by slightly worse serological parameters and higher cardiovascular risk. At T0, mean viral load (VL) and CD4 count were 87,694copies/ml and 435cells/μl in the Group A and 187,370copies/ml and 331cells/μl in the Group B. The EEG data were also collected in 50 matched control HIV-negative subjects. Cortical EEG sources were assessed by LORETA software., Results: Compared to the Control Group, the HIV Groups showed lower alpha (8-12Hz) source activity at T0 while the Group B also exhibited higher delta source activity. The treatment partially normalized alpha and delta source activity in the Group A and B, respectively, in association with improved VL, CD4, and cognitive functions., Conclusions: Different cART regimens induced diverse beneficial effects in delta or alpha source activity in the two naïve HIV Groups., Significance: These sources might unveil different neurophysiological effects of diverse cART on brain function in naïve HIV Groups as a function of clinical status and/or therapeutic compounds., (Copyright © 2016 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Published
2016
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42. Antiretroviral therapy affects the z-score index of deviant cortical EEG rhythms in naïve HIV individuals.

Author

Babiloni C, Pennica A, Del Percio C, Noce G, Cordone S, Lopez S, Berry K, Muratori C, Ferracuti S, Roma P, Correr V, Di Campli F, Gianserra L, Ciullini L, Aceti A, Soricelli A, Teti E, Viscione M, Limatola C, Onorati P, Capotosto P, and Andreoni M

Subjects
Adult, Alpha Rhythm drug effects, Beta Rhythm drug effects, Delta Rhythm drug effects, Electroencephalography, Humans, Male, Antiretroviral Therapy, Highly Active, Brain Waves drug effects, Cerebral Cortex drug effects, Cerebral Cortex physiopathology, HIV Infections drug therapy, HIV Infections physiopathology
Abstract

Objective: Here we tested the effect of combined antiretroviral therapy (cART) on deviant electroencephalographic (EEG) source activity in treatment-naïve HIV individuals., Methods: Resting state eyes-closed EEG data were recorded before and after 5 months of cART in 48 male HIV subjects, who were naïve at the study start. The EEG data were also recorded in 59 age- and sex-matched healthy subjects as a control group. Frequency bands of interest included delta, theta, alpha1, alpha2 and alpha3, based on alpha frequency peak specific to each individual. They also included beta1 (13-20 Hz) and beta2 (20-30 Hz). Low-resolution brain electromagnetic tomography (LORETA) estimated EEG cortical source activity in frontal, central, temporal, parietal, and occipital regions., Results: Before the therapy, the HIV group showed greater parietal delta source activity and lower spatially diffuse alpha source activity compared to the control group. Thus, the ratio of parietal delta and alpha3 source activity served as an EEG marker. The z-score showed a statistically deviant EEG marker (EEG +) in 50% of the HIV individuals before therapy (p < 0.05). After 5 months of cART, delta source activity decreased, and alpha3 source activity increased in the HIV subjects with EEG + (about 50% of them showed a normalized EEG marker)., Conclusions: This procedure detected a deviant EEG marker before therapy and its post-therapy normalization in naïve HIV single individuals., Significance: The parietal delta/alpha3 EEG marker may be used to monitor cART effects on brain function in such individuals.

Published
2016
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43. Abnormal cortical sources of resting state electroencephalographic rhythms in single treatment-naïve HIV individuals: A statistical z-score index.

Author

Babiloni C, Pennica A, Del Percio C, Noce G, Cordone S, Muratori C, Ferracuti S, Donato N, Di Campli F, Gianserra L, Teti E, Aceti A, Soricelli A, Viscione M, Limatola C, Andreoni M, and Onorati P

Subjects
Adult, Humans, Male, Pilot Projects, Viral Load methods, Cerebral Cortex physiopathology, Electroencephalography methods, Electroencephalography statistics & numerical data, HIV Infections diagnosis, HIV Infections physiopathology, Rest physiology
Abstract

Objective: This study tested a simple statistical procedure to recognize single treatment-naïve HIV individuals having abnormal cortical sources of resting state delta (<4 Hz) and alpha (8-13 Hz) electroencephalographic (EEG) rhythms with reference to a control group of sex-, age-, and education-matched healthy individuals. Compared to the HIV individuals with a statistically normal EEG marker, those with abnormal values were expected to show worse cognitive status., Methods: Resting state eyes-closed EEG data were recorded in 82 treatment-naïve HIV (39.8 ys.±1.2 standard error mean, SE) and 59 age-matched cognitively healthy subjects (39 ys.±2.2 SE). Low-resolution brain electromagnetic tomography (LORETA) estimated delta and alpha sources in frontal, central, temporal, parietal, and occipital cortical regions., Results: Ratio of the activity of parietal delta and high-frequency alpha sources (EEG marker) showed the maximum difference between the healthy and the treatment-naïve HIV group. Z-score of the EEG marker was statistically abnormal in 47.6% of treatment-naïve HIV individuals with reference to the healthy group (p<0.05). Compared to the HIV individuals with a statistically normal EEG marker, those with abnormal values exhibited lower mini mental state evaluation (MMSE) score, higher CD4 count, and lower viral load (p<0.05)., Conclusions: This statistical procedure permitted for the first time to identify single treatment-naïve HIV individuals having abnormal EEG activity., Significance: This procedure might enrich the detection and monitoring of effects of HIV on brain function in single treatment-naïve HIV individuals., (Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Published
2016
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44. Pharmacogenetics as a tool to tailor antiretroviral therapy: A review.

Author

Aceti A, Gianserra L, Lambiase L, Pennica A, and Teti E

Abstract

Highly active antiretroviral therapy (HAART) has substantially changed human immunodeficiency virus (HIV) infection from an inexorably fatal condition into a chronic disease with a longer life expectancy. This means that HIV patients should receive antiretroviral drugs lifelong, and the problems concerning with a chronic treatment (tolerability, side effects, adherence to treatment) have now become dominant. In this context, strategies for the treatment personalization have taken a central role in optimizing the therapeutic response and prevention of adverse drug reactions. In this setting, the study of pharmacogenetics features could be a very useful tool in clinical practice; moreover, nowadays the study of genetic profiles allows optimizations in the therapeutic management of People Living With HIV (PLWH) through the use of test introduced into clinical practice and approved by international guidelines for the adverse effects prevention such as the genetic test HLA-B*5701 to detect hypersensitivity to Abacavir. For other tests further studies are needed: CYP2B6 516 G > T testing may be able to identify patients at higher risk of Central Nervous System side effects following standard dosing of Efavirenz, UGT1A1*28 testing before initiation of antiretroviral therapy containing Atazanavir may aid in identifying individuals at risk of hyperbilirubinaemia. Pharmacogenetics represents a ​​research area with great growth potential which may be useful to guide the rational use of antiretrovirals.

Published
2015
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45. Antiretroviral therapy effects on sources of cortical rhythms in HIV subjects: responders vs. mild responders.

Author

Babiloni C, Pennica A, Vecchio F, Onorati P, Muratori C, Ferracuti S, Roma P, Donato N, Noce G, Del Percio C, Bonacci C, Di Campli F, Gianserra L, Teti E, Aceti A, Soricelli A, Viscione M, Rossini PM, and Andreoni M

Subjects
Adult, Anti-Retroviral Agents therapeutic use, Cerebral Cortex physiopathology, Electroencephalography drug effects, Electroencephalography methods, Female, HIV Infections physiopathology, Humans, Longitudinal Studies, Male, Alpha Rhythm drug effects, Anti-Retroviral Agents pharmacology, Brain Mapping methods, Cerebral Cortex drug effects, Delta Rhythm drug effects, HIV Infections drug therapy
Abstract

Objective: We tested the hypothesis that 5months of combined anti-retroviral therapy (cART) affect cortical sources of resting state cortical electroencephalographic (EEG) rhythms in naïve HIV subjects., Methods: Eyes-closed resting state EEG data were recorded at baseline (i.e. pre-treatment; T0), T1 (after 4weeks of cART), T2 (after 8weeks of cART), and T5 (after 5months of cART) in 38 naïve HIV subjects. EEG data were also recorded in 40 age-matched cognitively normal subjects for control purposes. EEG rhythms of interest were delta (2-4Hz), theta (4-8Hz), alpha 1 (8-10.5Hz), alpha 2 (10.5-13Hz), beta 1 (13-20Hz), and beta 2 (20-30Hz). Cortical EEG sources were estimated by LORETA software., Results: Compared to the control group, the HIV group at T0 showed greater delta sources and lower widespread alpha sources. cART induced a global improvement of biological (viral load, CD4 count) and EEG (delta, alpha) markers, remarkable even after 4weeks. Compared to HIV Responders (>100cells/μl at 5-month follow up), the HIV Mild Responders (<100cells/μl) showed greater parietal delta sources at baseline and lower occipital alpha sources at 5-month follow up., Conclusions: In naïve HIV subjects, 5months of successful cART affect brain synchronization mechanisms at the basis of the generation of delta and alpha rhythms., Significance: The present EEG markers may be useful secondary neurophysiological end points for pharmacological clinical trials in naïve HIV subjects., (Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Published
2015
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46. Cortical sources of resting-state EEG rhythms in "experienced" HIV subjects under antiretroviral therapy.

Author

Babiloni C, Buffo P, Vecchio F, Onorati P, Muratori C, Ferracuti S, Roma P, Battuello M, Donato N, Noce G, Di Campli F, Gianserra L, Teti E, Aceti A, Soricelli A, Viscione M, Andreoni M, Rossini PM, and Pennica A

Subjects
Adult, CD4 Lymphocyte Count, Cerebral Cortex physiopathology, Cross-Sectional Studies, Female, HIV Infections immunology, Humans, Male, Middle Aged, Neuropsychological Tests, Tomography, Viral Load, Antiretroviral Therapy, Highly Active, Electroencephalography, HIV Infections drug therapy, HIV Infections physiopathology
Abstract

Objective: Treatment-naïve patients with human immunodeficiency virus (HIV) are characterized by diffuse abnormalities of resting-state cortical electroencephalographic (EEG) rhythms (Babiloni et al., 2012a). Here, we tested the hypothesis that these EEG rhythms vary as a function of the systemic immune activity and antiretroviral therapy (ART) in HIV patients., Methods: Resting-state eyes-closed EEG data were recorded in 68 ART-HIV patients (mini mental state evaluation (MMSE) of 27.5 ± 0.3 SEM), in 60 treatment-naïve HIV subjects (MMSE of 27.5 ± 0.4 SEM) and in 75 age-matched cognitively normal subjects (MMSE of 29.3 ± 0.1 SEM). Based on the CD4 lymphocytes' count, we divided ART-HIV subjects into two subgroups: those with CD4>500 cells/μl (ART-HIV+) and those with CD4<500 cells/μl (ART-HIV-). EEG rhythms of interest were delta (2-4 Hz), theta (4-8 Hz), alpha 1 (8-10.5 Hz), alpha 2 (10.5-12 Hz), beta 1 (13-20 Hz), and beta 2 (20-30 Hz). Cortical EEG sources were estimated by LORETA software., Results: Widespread theta, alpha, and beta sources were lower in ART-HIV subjects than in control subjects. Furthermore, occipital and temporal alpha 1 sources were lower in treatment-naïve HIV than in ART-HIV subjects. Moreover, the opposite was true for widespread pathological delta sources. Finally, parietal, occipital, and temporal alpha 1 sources were lower in ART-HIV- than in ART-HIV+ subjects., Conclusions: In ART-HIV subjects, cortical sources of resting-state alpha rhythms are related to systemic immune activity and cART., Significance: This EEG procedure may produce biomarkers of treatment response in patients' brain compartments for longitudinal clinical studies., (Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Published
2014
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47. Cortical sources of resting-state EEG rhythms are abnormal in naïve HIV subjects.

Author

Babiloni C, Vecchio F, Buffo P, Onorati P, Muratori C, Ferracuti S, Roma P, Battuello M, Donato N, Pellegrini P, Di Campli F, Gianserra L, Teti E, Aceti A, Rossini PM, and Pennica A

Subjects
Adult, Alpha Rhythm physiology, Beta Rhythm physiology, Case-Control Studies, Cerebral Cortex physiology, Delta Rhythm physiology, Electromagnetic Phenomena, Female, Humans, Male, Neuropsychological Tests, Theta Rhythm physiology, Brain Mapping methods, Cerebral Cortex physiopathology, Electroencephalography methods, HIV Infections physiopathology, Rest physiology
Abstract

Objective: The aim of the study was to test the hypothesis that cortical sources of resting-state electroencephalographic (EEG) rhythms show peculiar frequency/spatial features in naïve human subjects with human immunodeficiency virus (HIV) compared to healthy control subjects., Methods: Resting-state eyes-closed EEG data were recorded in 18 naïve HIV subjects (15 males; mean age 39 years±2.0 standard error of mean, SEM) and in 18 age-matched cognitively normal subjects (15 males; 38.7years±2.2 SEM). EEG rhythms of interest were delta (2-4Hz), theta (4-8Hz), alpha1 (8-10Hz), alpha2 (10-12Hz), beta1 (13-20Hz) and beta2 (20-30Hz). Cortical EEG sources were estimated by normalised, low-resolution electromagnetic tomography (LORETA)., Results: Mini Mental State Evaluation (MMSE) score was lower in HIV (26.5 ± 0.7 SEM) than in healthy (29.2 ± 0.5 SEM) subjects (p<0.05). Central and parietal delta sources showed higher amplitude in the HIV than in control subjects. Furthermore, topographically widespread, cortical sources of resting-state alpha rhythms were lower in amplitude in HIV subjects than in control subjects., Conclusions: The present results suggest that topography and frequency of the cortical sources of resting-state EEG rhythms can distinguish groups of HIV and control subjects., Significance: These results encourage future studies in an enlarged cohort of HIV subjects to test the hypothesis that the present methodological approach provides clinically useful information for an early detection of the effect of HIV infection on brain and cognitive functions., (Copyright © 2012 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.)

Published
2012
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