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.
Degasperi, E., Spinetti, A., Lombardi, A., Landonio, S., Rossi, M., Pasulo, L., et al. (2019). Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure. JOURNAL OF HEPATOLOGY, 71(6), 1106-1115 [10.1016/j.jhep.2019.07.020].
|Citazione:||Degasperi, E., Spinetti, A., Lombardi, A., Landonio, S., Rossi, M., Pasulo, L., et al. (2019). Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure. JOURNAL OF HEPATOLOGY, 71(6), 1106-1115 [10.1016/j.jhep.2019.07.020].|
|Tipo:||Articolo in rivista - Articolo scientifico|
|Carattere della pubblicazione:||Scientifica|
|Presenza di un coautore afferente ad Istituzioni straniere:||No|
|Titolo:||Real-life effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in hepatitis C patients with previous DAA failure|
|Autori:||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; Fagiuoli, S|
|Data di pubblicazione:||2019|
|Rivista:||JOURNAL OF HEPATOLOGY|
|Digital Object Identifier (DOI):||http://dx.doi.org/10.1016/j.jhep.2019.07.020|
|Appare nelle tipologie:||01 - Articolo su rivista|