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

Autor: Degasperi E; CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy. Electronic address: elisabetta.degasperi@unimi.it., Spinetti A; Infectious Diseases, ASST Spedali Civili Brescia, Brescia, Italy., Lombardi A; Infectious Diseases, Fondazione IRCCS Policlinico San Matteo, University of Pavia, Pavia, Italy., Landonio S; Infectious Diseases, Sacco Hospital, Milan, Italy., Rossi MC; Infectious Diseases, Treviso Hospital, Treviso, Italy., Pasulo L; Bergamo HCV Network, ASST Papa Giovanni XXIII, Italy., Pozzoni P; Internal Medicine, ASST Lecco Hospital (LC), Italy., Giorgini A; Gastroenterology and Hepatology, ASST Santi Paolo e Carlo, Milan, Italy., Fabris P; Infectious Diseases, Santorso Hospital, Vicenza, Italy., Romano A; Internal Medicine and Hepatology, Department of Medicine, University of Padova, Padova, Italy., Lomonaco L; Gastroenterology, Bussolengo Hospital, Verona, Italy., Puoti M; Infectious Diseases, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., Vinci M; Gastroenterology and Hepatology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy., Gatti F; Hospital Pharmacy, ASST Ovest Milanese, Legnano (MI), Italy., Carolo G; Infectious Diseases, University of Verona, Verona, Italy., Zoncada A; Infectious Diseases, ASST Cremona, Cremona (CR), Italy., Bonfanti P; Infectious Diseases, ASST Lecco Hospital (LC), Italy., Russo FP; Gastroenterology and Multivisceral Transplant, University Hospital Padua, Padova, Italy., Aghemo A; Internal Medicine and Hepatology, IRCCS Humanitas Research Hospital, Humanitas University, Pieve Emanuele (MI), Italy., Soria A; Infectious Diseases, San Gerardo Hospital, ASST Monza, Monza (MB), Italy., Centenaro R; Internal Medicine, ASST Melegnano Martesana, Vizzolo Predabissi (MI), Italy., Maggiolo F; Bergamo HCV Network, ASST Papa Giovanni XXIII, Italy., Rovere P; Infectious Diseases, Legnago Hospital, Verona, Italy., Pasin F; Department of Molecular Medicine, University of Padova, Padova, Italy., Paon V; Internal Medicine, University of Verona, Verona, Italy., Faggiano G; Infectious Diseases, Rovigo Hospital, Italy., Vario A; Hepatology, ULSS 17 Veneto Hospital, Este (PD), Italy., Grossi G; Internal Medicine, ASST Ovest Milanese, Magenta Hospital (MI), Italy., Soffredini R; CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy., Carriero C; Infectious Diseases, ASST Spedali Civili Brescia, Brescia, Italy., Paolucci S; Molecular Virology Unit, Microbiology and Virology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Noventa F; QUOVADIS no profit Association., Alberti A; Department of Molecular Medicine, University of Padova, Padova, Italy., Lampertico P; CRC A.M. e A. Migliavacca Center for Liver Diseases, Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano, Milan, Italy., Fagiuoli S; Bergamo HCV Network, ASST Papa Giovanni XXIII, Italy.
Jazyk: angličtina
Zdroj: Journal of hepatology [J Hepatol] 2019 Dec; Vol. 71 (6), pp. 1106-1115. Date of Electronic Publication: 2019 Aug 06.
DOI: 10.1016/j.jhep.2019.07.020
Abstrakt: 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.)
Databáze: MEDLINE
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