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

Author

Degasperi E, Spinetti A, Lombardi A, Landonio S, Rossi MC, Pasulo L, Pozzoni P, Giorgini A, Fabris P, Romano A, Lomonaco L, Puoti M, Vinci M, Gatti F, Carolo G, Zoncada A, Bonfanti P, Russo FP, Aghemo A, Soria A, Centenaro R, Maggiolo F, Rovere P, Pasin F, Paon V, Faggiano G, Vario A, Grossi G, Soffredini R, Carriero C, Paolucci S, Noventa F, Alberti A, Lampertico P, and Fagiuoli S

Subjects
Antiviral Agents administration & dosage, Antiviral Agents adverse effects, Drug Combinations, Drug Resistance, Viral, Female, Humans, Italy epidemiology, Male, Middle Aged, RNA, Viral isolation & purification, Retreatment methods, Risk Factors, Sustained Virologic Response, Treatment Outcome, Viral Nonstructural Proteins, Carbamates administration & dosage, Carbamates adverse effects, Carcinoma, Hepatocellular epidemiology, Carcinoma, Hepatocellular etiology, Carcinoma, Hepatocellular pathology, Hepacivirus drug effects, Hepacivirus genetics, Hepatitis C, Chronic complications, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic epidemiology, Hepatitis C, Chronic virology, Heterocyclic Compounds, 4 or More Rings administration & dosage, Heterocyclic Compounds, 4 or More Rings adverse effects, Liver Cirrhosis diagnosis, Liver Cirrhosis epidemiology, Liver Neoplasms epidemiology, Liver Neoplasms etiology, Liver Neoplasms pathology, Macrocyclic Compounds administration & dosage, Macrocyclic Compounds adverse effects, Sofosbuvir administration & dosage, Sofosbuvir adverse effects, Sulfonamides administration & dosage, Sulfonamides adverse effects
Abstract

Background & Aims: Sofosbuvir/velpatasivr/voxilaprevir (SOF/VEL/VOX) is approved for retreatment of patients with HCV and a previous failure on direct-acting antivirals (DAAs), however real-life data are limited. The aim of this study was to assess the effectiveness and safety of SOF/VEL/VOX in a real-life setting., Methods: All consecutive patients with HCV receiving SOF/VEL/VOX between May-October 2018 in 27 centers in Northern Italy were enrolled. Bridging fibrosis (F3) and cirrhosis (F4) were diagnosed by liver stiffness measurement: >10 and >13 kPa respectively. Sustained virological response (SVR) was defined as undetectable HCV-RNA 4 (SVR4) or 12 (SVR12) weeks after the end-of-treatment., Results: A total of 179 patients were included: median age 57 (18-88) years, 74% males, median HCV-RNA 1,081,817 (482-25,590,000) IU/ml. Fibrosis stage was F0-F2 in 32%, F3 in 21%, F4 in 44%. HCV genotype was 1 in 58% (1b 33%, 1a 24%, 1nc 1%), 2 in 10%, 3 in 23% and 4 in 9%; 82% of patients carried resistance-associated substitutions in the NS3, NS5A or NS5B regions. Patients received SOF/VEL/VOX for 12 weeks, ribavirin was added in 22% of treatment schedules. Undetectable HCV-RNA was achieved by 74% of patients at week 4 and by 99% at week 12. Overall, 162/179 (91%) patients by intention to treat analysis and 162/169 (96%) by per protocol analysis achieved SVR12, respectively; treatment failures included 6 relapsers and 1 virological non-responder. Cirrhosis (p = 0.005) and hepatocellular carcinoma (p = 0.02) were the only predictors of treatment failure. Most frequent adverse events included fatigue (6%), hyperbilirubinemia (6%) and anemia (4%)., Conclusions: SOF/VEL/VOX is an effective and safe retreatment for patients with HCV who have failed on a previous DAA course in a real-life setting., Lay Summary: This is the largest European real-life study evaluating effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in a large cohort of consecutive patients with hepatitis C virus infection and a prior direct-acting antiviral failure, who were treated within the NAVIGATORE Lombardia and Veneto Networks, in Italy. This study demonstrated excellent effectiveness (98% and 96% sustained virological response rates at week 4 and 12, respectively) and an optimal safety profile of SOF/VEL/VOX. Cirrhosis and hepatocellular carcinoma onset were the only features associated with treatment failure., (Copyright © 2019 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.)

Published
2019
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2. Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure

Author

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

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

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

Published
2019

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