• Jordi Llaneras, Mar Riveiro-Barciela, Sabela Lens, Moisés Diago, Alba Cachero, Javier García-Samaniego, Isabel Conde, Ana Arencibia, Juan Arenas, Francisco Gea, Xavier Torras, Luis Calleja José J Hospital Universitario Puerta del Hierro, Madrid, Spain., Antonio Carrión José J Liver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autònoma de Barc, Inmaculada Fernández, Rosa María Morillas, José Miguel Rosales, Isabel Carmona, Conrado Fernández-Rodríguez, Manuel Hernández-Guerra, Susana Llerena, Vanesa Bernal, Juan Turnes, Jesús M González-Santiago, Silvia Montoliu, Blanca Figueruela, Ester Badia, Manuel Delgado, Miguel Fernández-Bermejo, Mercedes Iñarrairaegui, Juan Manuel Pascasio, Rafael Esteban, Zoe Mariño, and Maria Buti.
• Hospital Universitari Vall d'Hebron, Department of Medicine of the UAB (Universitat Autònoma de Barcelona), Spain.
• J. Hepatol. 2019 Oct 1; 71 (4): 666-672.

Background & AimsAround 5% of patients with chronic hepatitis C virus (HCV) infection treated with direct-acting antiviral (DAA) agents do not achieve sustained virological response (SVR). The currently approved retreatment regimen for prior DAA failure is a combination of sofosbuvir, velpatasvir, and voxilaprevir (SOF/VEL/VOX), although there is little data on its use in clinical practice. The aim of this study was to analyse the effectiveness and safety of SOF/VEL/VOX in the real-world setting.MethodsThis was a prospective multicentre study assessing the efficacy of retreatment with SOF/VEL/VOX in patients who had experienced a prior DAA treatment failure. The primary endpoint was SVR 12 weeks after the completion of treatment (SVR12). Data on safety and tolerability were also recorded.ResultsA total of 137 patients were included: 75% men, 35% with liver cirrhosis. Most were infected with HCV genotype (GT) 1 or 3. The most common prior DAA combinations were sofosbuvir plus an NS5A inhibitor or ombitasvir/paritaprevir/r+dasabuvir. A total of 136 (99%) patients achieved undetectable HCV RNA at the end of treatment. Overall SVR12 was 95% in the 135 patients reaching this point. SVR12 was lower in patients with cirrhosis (89%, p = 0.05) and those with GT3 infection (80%, p <0.001). Patients with GT3 infection and cirrhosis had the lowest SVR12 rate (69%). Of the patients who did not achieve SVR12, 1 was reinfected and 7 experienced treatment failure (6 GT3, 1 GT1a). The presence of resistance-associated substitutions did not impact SVR12. Adverse effects were mild and non-specific.ConclusionReal-world data show that SOF/VEL/VOX is an effective, safe rescue therapy for patients with prior DAA treatment failure despite the presence of resistance-associated substitutions. However, patients with liver cirrhosis infected by GT3 remain the most-difficult-to-treat group.Lay SummaryTreatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks is the current recommendation for the 5% of patients infected with HCV who do not achieve eradication of the virus under treatment with direct-acting antivirals. In a Spanish cohort of 137 patients who failed a previous combination of direct-acting antivirals, a cure rate of 95% was achieved with SOF/VEL/VOX. Genotypic characteristics of the virus (genotype 3) and the presence of cirrhosis were factors that decreased the rate of cure. Treatment with SOF/VEL/VOX is an effective and safe rescue therapy due to its high efficacy and very good safety profile.Copyright © 2019. Published by Elsevier B.V.

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