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

Author

Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., Fagiuoli S., Soria, A, Fava, M, Bernasconi, D, Lapadula, G, Colella, E, Valsecchi, M, Migliorino, G, D'Ambrosio, R, Landonio, S, Schiavini, M, Spinetti, A, Carriero, C, Degasperi, E, Cologni, G, Gatti, F, Vigano, P, Hasson, H, Uberti-Foppa, C, Pasulo, L, Baiguera, C, Rossotti, R, Vinci, M, Puoti, M, Giorgini, A, Menzaghi, B, Lombardi, A, Pan, A, Aghemo, A, Grossi, P, Boldizzoni, R, Colombo, S, Vigano, M, Rumi, M, Del Poggio, P, Valenti, L, Giglio, O, De Bona, A, d'Arminio Monforte, A, Colombo, A, Spinelli, O, Pigozzi, M, Molteni, C, Bonfanti, P, Terreni, N, Perini, P, Capretti, A, Bella, D, Liani, C, Polo, S, Aimo, G, Pagnucco, L, Bhoori, S, Centenaro, R, Graffeo, M, Ciaccio, A, Dionigi, E, Lazzaroni, S, Carderi, I, Di Marco, M, Rizzardini, G, Noventa, F, Lampertico, P, Fagiuoli, S, Soria A., Fava M., Bernasconi D. P., Lapadula G., Colella E., Valsecchi M. G., Migliorino G. M., D'Ambrosio R., Landonio S., Schiavini M., Spinetti A., Carriero C., Degasperi E., Cologni G., Gatti F., Vigano P., Hasson H., Uberti-Foppa C., Pasulo L., Baiguera C., Rossotti R., Vinci M., Puoti M., Giorgini A., Menzaghi B., Lombardi A., Pan A., Aghemo A., Grossi P. A., Boldizzoni R., Colombo S., Vigano M., Rumi M. G., Del Poggio P., Valenti L., Giglio O., De Bona A., d'Arminio Monforte A., Colombo A., Spinelli O., Pigozzi M. G., Molteni C., Bonfanti P., Terreni N., Perini P., Capretti A., Bella D., Liani C., Polo S., Aimo G., Pagnucco L., Bhoori S., Centenaro R., Graffeo M., Ciaccio A., Dionigi E., Lazzaroni S., Carderi I., Di Marco M., Rizzardini G., Noventa F., Lampertico P., and Fagiuoli S.

Abstract

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

Published
2020

3. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., Fagiuoli S., D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, Fagiuoli, S, D'Ambrosio R., Pasulo L., Giorgini A., Spinetti A., Messina E., Fanetti I., Puoti M., Aghemo A., Vigano P., Vinci M., Menzaghi B., Lombardi A., Pan A., Pigozzi M. G., Grossi P., Lazzaroni S., Spinelli O., Invernizzi P., Maggiolo F., Terreni N., Monforte A. D., Poggio P. D., Taddei M. T., Colombo S., Pozzoni P., Molteni C., Brocchieri A., Bhoori S., Buscarini E., Centenaro R., Mendeni M., Colombo A. E., Di Marco M., Dionigi E., Bella D., Borghi M., Zuin M., Zaltron S., Noventa F., Annalisa D. S., Lampertico P., and Fagiuoli S.

Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020

5. Clinical patterns of hepatocellular carcinoma in nonalcoholic fatty liver disease: A multicenter prospective study

Author

Piscaglia, Fabio, Svegliati Baroni, Gianluca, Barchetti, Andrea, Pecorelli, Anna, Marinelli, Sara, Tiribelli, Claudio, Bellentani, Stefano, Bernardi M, Biselli M, Bernardi M, Biselli M, Caraceni P, Domenicali M, Garuti F, Gramenzi A, Lenzi B, Magalotti D, Cescon M, Ravaioli M, Del Poggio P, Olmi S, Rapaccini GL, Balsamo C, Di Nolfo MA, Vavassori E, Alberti A, Benvegnù L, Gatta A, Giacomin A, Vanin V, Pozzan C, Maddalo G, Giampalma E, Cappelli A, Golfieri R, Mosconi C, Renzulli M, Roselli P, Dell'Isola S, Ialungo AM, Risso D, Marenco S, Sammito G, Bruzzone L, Bosco G, Grieco A, Pompili M, Rinninella E, Siciliano M, Chiaramonte M, Guarino M, Cammà C, Maida M, Costantino A, Barcellona MR, Schiadà L, Gemini S, Lanzi A, Stefanini GF, Dall'Aglio AC, Cappa FM, Suzzi A, Mussetto A, Treossi O, Missale G, Porro E, Mismas V, Vivaldi C, Bolondi L, Zoli M, Granito A, Malagotti D, Tovoli F, Trevisani F, Venerandi L, Brandi G, Cucchetti A, Bugianesi E, Vanni E, Mezzabotta L, Cabibbo G, Petta S, Fracanzani A, Fargion S, Marra F, Fani B, Biasini E, Sacco R, CAPORASO, NICOLA, Colombo M, D'Ambrosio R, Crocè LS, Patti R, Giannini EG, Loria P, Lonardo A, Baldelli E, Miele L, Farinati F, Borzio M, Dionigi E, Soardo G, Caturelli E, Ciccarese F, Virdone R, Affronti A, Foschi FG, Borzio F., MORISCO, FILOMENA, Piscaglia, Fabio, Svegliati Baroni, Gianluca, Barchetti, Andrea, Pecorelli, Anna, Marinelli, Sara, Tiribelli, Claudio, Bellentani, Stefano, Bernardi M, Biselli M, Bernardi, M, Biselli, M, Caraceni, P, Domenicali, M, Garuti, F, Gramenzi, A, Lenzi, B, Magalotti, D, Cescon, M, Ravaioli, M, Del Poggio, P, Olmi, S, Rapaccini, Gl, Balsamo, C, Di Nolfo, Ma, Vavassori, E, Alberti, A, Benvegnù, L, Gatta, A, Giacomin, A, Vanin, V, Pozzan, C, Maddalo, G, Giampalma, E, Cappelli, A, Golfieri, R, Mosconi, C, Renzulli, M, Roselli, P, Dell'Isola, S, Ialungo, Am, Risso, D, Marenco, S, Sammito, G, Bruzzone, L, Bosco, G, Grieco, A, Pompili, M, Rinninella, E, Siciliano, M, Chiaramonte, M, Guarino, M, Cammà, C, Maida, M, Costantino, A, Barcellona, Mr, Schiadà, L, Gemini, S, Lanzi, A, Stefanini, Gf, Dall'Aglio, Ac, Cappa, Fm, Suzzi, A, Mussetto, A, Treossi, O, Missale, G, Porro, E, Mismas, V, Vivaldi, C, Bolondi, L, Zoli, M, Granito, A, Malagotti, D, Tovoli, F, Trevisani, F, Venerandi, L, Brandi, G, Cucchetti, A, Bugianesi, E, Vanni, E, Mezzabotta, L, Cabibbo, G, Petta, S, Fracanzani, A, Fargion, S, Marra, F, Fani, B, Biasini, E, Sacco, R, Morisco, Filomena, Caporaso, Nicola, Colombo, M, D'Ambrosio, R, Crocè, L, Patti, R, Giannini, Eg, Loria, P, Lonardo, A, Baldelli, E, Miele, L, Farinati, F, Borzio, M, Dionigi, E, Soardo, G, Caturelli, E, Ciccarese, F, Virdone, R, Affronti, A, Foschi, Fg, Borzio, F., Fabio Piscagliaxxx, Gianluca Svegliati-Baroni, Andrea Barchetti, Anna Pecorellixxx, Sara Marinellixxx, Claudio Tiribelli, and, Stefano Bellentani, on behalf of the HCC-NAFLD Italian Study Group [, Mauro Bernardi, Maurizio Biselli, Paolo Caraceni, Marco Domenicali, Francesca Garuti, Annagiulia Gramenzi, Barbara Lenzi, Donatella Magalotti, Matteo Cescon, Matteo Ravaioli, Emanuela Giampalma, Rita Golfieri, Cristina Mosconi, Luigi Bolondi, Marco Zoli, Alessandro Granito, Francesco Tovoli, Franco Trevisani, Laura Venerandi, Giovanni Brandi, Alessandro Cucchetti, ], DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE, DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, Facolta' di MEDICINA e CHIRURGIA, AREA MIN. 06 - Scienze mediche, Da definire, Croce', Saveria, and HCC NAFLD Italian Study, Group

Subjects
Male, Cirrhosis, Survival, Chronic liver disease, Gastroenterology, 0302 clinical medicine, Non-alcoholic Fatty Liver Disease, Nonalcoholic fatty liver disease, 80 and over, Prospective Studies, Chronic, Prospective cohort study, Aged, 80 and over, Medicine (all), Liver Neoplasms, hepatocellular carcinoma, Middle Aged, Hepatitis C, Liver Neoplasm, 030220 oncology & carcinogenesis, Hepatocellular carcinoma, Competing risk analysi, 030211 gastroenterology & hepatology, Female, Non Alcoholic SteatoHepatitis=NASH, Human, medicine.medical_specialty, Aged, Carcinoma, Hepatocellular, Hepatitis C, Chronic, Humans, Hepatology, Competing risk analysis, Milan criteria, 03 medical and health sciences, Internal medicine, medicine, Survival rate, business.industry, Settore MED/09 - MEDICINA INTERNA, Carcinoma, nutritional and metabolic diseases, Hepatocellular, medicine.disease, digestive system diseases, Nonalcoholic fatty liver disease, hepatocellular carcinoma, clinical patterns, business, clinical patterns
Abstract

none 31 no Nonalcoholic fatty liver disease (NAFLD) represents the hepatic manifestation of metabolic syndrome and may evolve into hepatocellular carcinoma (HCC). Only scanty clinical information is available on HCC in NAFLD. The aim of this multicenter observational prospective study was to assess the clinical features of patients with NAFLD-related HCC (NAFLD-HCC) and to compare them to those of hepatitis C virus (HCV)-related HCC. A total of 756 patients with either NAFLD (145) or HCV-related chronic liver disease (611) were enrolled in secondary care Italian centers. Survival was modeled according to clinical parameters, lead-time bias, and propensity analysis. Compared to HCV, HCC in NAFLD patients had a larger volume, showed more often an infiltrative pattern, and was detected outside specific surveillance. Cirrhosis was present in only about 50% of NAFLD-HCC patients, in contrast to the near totality of HCV-HCC. Regardless of tumor stage, survival was significantly shorter (P = 0.017) in patients with NAFLD-HCC, 25.5 months (95% confidence interval 21.9-29.1), than in those with HCV-HCC, 33.7 months (95% confidence interval 31.9-35.4). To eliminate possible confounders, a propensity score analysis was performed, which showed no more significant difference between the two groups. Additionally, analysis of patients within Milan criteria submitted to curative treatments did not show any difference in survival between NAFLD-HCC and HCV-HCC (respectively, 38.6 versus 41.0 months, P = nonsignificant) CONCLUSIONS: NAFLD-HCC is more often detected at a later tumor stage and could arise also in the absence of cirrhosis, but after patient matching, it has a similar survival rate compared to HCV infection; a future challenge will be to identify patients with NAFLD who require more stringent surveillance in order to offer the most timely and effective treatment. Fabio Piscagliaxxx; Gianluca Svegliati-Baroni; Andrea Barchetti; Anna Pecorellixxx; Sara Marinellixxx; Claudio Tiribelli; and; Stefano Bellentani; on behalf of the HCC-NAFLD Italian Study Group [;Mauro Bernardi; Maurizio Biselli; Paolo Caraceni; Marco Domenicali; Francesca Garuti; Annagiulia Gramenzi; Barbara Lenzi; Donatella Magalotti; Matteo Cescon; Matteo Ravaioli; Emanuela Giampalma; Rita Golfieri; Cristina Mosconi; Luigi Bolondi; Marco Zoli; Alessandro Granito; Francesco Tovoli; Franco Trevisani; Laura Venerandi; Giovanni Brandi; Alessandro Cucchetti;] Fabio Piscagliaxxx; Gianluca Svegliati-Baroni; Andrea Barchetti; Anna Pecorellixxx; Sara Marinellixxx; Claudio Tiribelli; and; Stefano Bellentani; on behalf of the HCC-NAFLD Italian Study Group [;Mauro Bernardi; Maurizio Biselli; Paolo Caraceni; Marco Domenicali; Francesca Garuti; Annagiulia Gramenzi; Barbara Lenzi; Donatella Magalotti; Matteo Cescon; Matteo Ravaioli; Emanuela Giampalma; Rita Golfieri; Cristina Mosconi; Luigi Bolondi; Marco Zoli; Alessandro Granito; Francesco Tovoli; Franco Trevisani; Laura Venerandi; Giovanni Brandi; Alessandro Cucchetti;]

Published
2016

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

Author

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

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

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

Published
2020

8. Renal safety in 3264 HCV patients treated with DAA-based regimens: Results from a large Italian real-life study

Author

Alessandra Brocchieri, Marta Borghi, Angelo Pan, Mariella Di Marco, Silvia Colombo, Chiara Molteni, Natalia Terreni, Paolo Poggio, Alberto Colombo, De Silvestri Annalisa, Riccardo Centenaro, Luisa Pasulo, Paolo Viganò, Maria Cristina Vinci, Marie Graciella Pigozzi, Stefano Fagiuoli, Pietro Lampertico, Sergio Lazzaroni, Sherrie Bhoori, Massimo Zuin, Franco Noventa, Alessio Aghemo, Barbara Menzaghi, Andrea Lombardi, Franco Maggiolo, I. Fanetti, Alessia Giorgini, Massimo Puoti, Emanuela Messina, Paolo Grossi, Roberta D'Ambrosio, Pietro Invernizzi, Monia Mendeni, Daniele Bella, E. Dionigi, Ombretta Spinelli, Maria Teresa Taddei, Pietro Pozzoni, Antonella d'Arminio Monforte, Elisabetta Buscarini, Angiola Spinetti, Serena Zaltron, D'Ambrosio, R, Pasulo, L, Giorgini, A, Spinetti, A, Messina, E, Fanetti, I, Puoti, M, Aghemo, A, Vigano, P, Vinci, M, Menzaghi, B, Lombardi, A, Pan, A, Pigozzi, M, Grossi, P, Lazzaroni, S, Spinelli, O, Invernizzi, P, Maggiolo, F, Terreni, N, Monforte, A, Poggio, P, Taddei, M, Colombo, S, Pozzoni, P, Molteni, C, Brocchieri, A, Bhoori, S, Buscarini, E, Centenaro, R, Mendeni, M, Colombo, A, Di Marco, M, Dionigi, E, Bella, D, Borghi, M, Zuin, M, Zaltron, S, Noventa, F, Annalisa, D, Lampertico, P, and Fagiuoli, S

Subjects
Male, Sustained Virologic Response, Sofosbuvir, Hepacivirus, Kidney, urologic and male genital diseases, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, MED/12 - GASTROENTEROLOGIA, eGFR, Aged, 80 and over, Hepatitis C, Middle Aged, medicine.anatomical_structure, Italy, 030220 oncology & carcinogenesis, Drug Therapy, Combination, Female, 030211 gastroenterology & hepatology, Glomerular Filtration Rate, Cohort study, medicine.drug, Adult, medicine.medical_specialty, SVR, Genotype, Renal function, CKD, Antiviral Agents, Young Adult, 03 medical and health sciences, Internal medicine, medicine, Humans, Renal Insufficiency, Chronic, Aged, Retrospective Studies, Hepatology, business.industry, Ribavirin, Retrospective cohort study, Hepatitis C, Chronic, medicine.disease, Logistic Models, chemistry, business, Kidney disease
Abstract

Background: Sofosbuvir (SOF)-based regimens have been associated with renal function worsening in HCV patients with estimated glomerular filtration rate (eGFR) ≤ 45 ml/min, but further investigations are lacking. Aim: To assess renal safety in a large cohort of DAA-treated HCV patients with any chronic kidney disease (CKD). Methods: All HCV patients treated with DAA in Lombardy (December 2014–November 2017) with available kidney function tests during and off-treatment were included. Results: Among 3264 patients [65% males, 67% cirrhotics, eGFR 88 (9–264) ml/min], CKD stage was 3 in 9.5% and 4/5 in 0.7%. 79% and 73% patients received SOF and RBV, respectively. During DAA, eGFR declined in CKD-1 (p < 0.0001) and CKD-2 (p = 0.0002) patients, with corresponding rates of CKD stage reduction of 25% and 8%. Conversely, eGFR improved in lower CKD stages (p < 0.0001 in CKD-3a, p = 0.0007 in CKD-3b, p = 0.024 in CKD-4/5), with 33–45% rates of CKD improvement. Changes in eGFR and CKD distribution persisted at SVR. Baseline independent predictors of CKD worsening at EOT and SVR were age (p < 0.0001), higher baseline CKD stages (p < 0.0001) and AH (p = 0.010 and p < 0.0001, respectively). Conclusions: During DAA, eGFR significantly declined in patients with preserved renal function and improved in those with lower CKD stages, without reverting upon drug discontinuation.

Published
2020
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10. Management of hepatocellular carcinoma in the elderly.

Author

Borzio M, Dionigi E, Parisi G, Raguzzi I, and Sacco R

Abstract

Mean age of hepatocellular carcinoma (HCC) patients has been progressively increasing over the last decades and ageing of these patients is becoming a real challenge in every day clinical practice. Unfortunately, international guidelines on HCC management do not address this problem exhaustively and do not provide any specific recommendation. We carried out a literature search in MEDLINE database for studies reporting on epidemiology, clinical characteristics and treatment outcome of HCC in elderly patients. Available data seem to indicate that in elderly patients the outcome of HCC is mostly influenced by liver function and tumor stage rather than by age and the latter should not influence treatment allocation. Age is not a risk for resection and older patients with resectable HCC and good liver function could gain benefit from surgery. Mild comorbidities do not seem a contraindication for surgery in aged patients. Conversely, major resection in elderly, even when performed in experienced high-volume centres, should be avoided. Both percutaneous ablation and transarterial chemoembolization are not contraindicated in aged patients and safety profile of these procedures is acceptable. Sorafenib is a viable option for advanced HCC in elderly provided that a careful evaluation of concomitant comorbidities, particularly cardiovascular ones, is taken into account. Available data seem to suggest that in either elderly and younger, treatment is a main predictor of outcome. Consequently, a nihilistic attitude of physicians towards under- or no-treatment of aged patients should not be longer justified.

Published
2015
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