Llaneras, JordiFernández Vázquez, María InmaculadaButi, Maria2026-01-082026-01-082019-10-01Llaneras J, Riveiro-Barciela M, Lens S, Diago M, Cachero A, García-Samaniego J, Conde I, Arencibia A, Arenas J, Gea F, Torras X, Calleja JL, Carrión JA, Fernández I, Morillas R M, Rosales J M, Carmona I, Fernández-Rodríguez C, Hernández-Guerra M, Llerena S, Bernal V, Turnes J, González-Santiago JM, Montoliu S, Figueruela B, Badia E, Delgado M, Fernández-Bermejo M, Iñarrairaegui M, Pascasio JM, Esteban R, Mariño Z, Buti M. Effectiveness and Safety of Sofosbuvir/Velpatasvir/ Voxilaprevir in Patients with Chronic Hepatitis C Previously Treated with DAAs. Journal of Hepatology. 2019 Oct;71(4):666-672.10.1016/j.jhep.2019.06.002https://hdl.handle.net/20.500.14352/129575Background & aims: Around 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. Methods: This 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. Results: A 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. Conclusion: Real-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 summary: Treatment 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.engjournal articlehttps://doi.org/10.1016/j.jhep.2019.06.002https://www.journal-of-hepatology.eu/article/S0168-8278(19)30345-9/fulltextrestricted access615HCV genotype 3Hepatitis CSofosbuvirTreatment failuresVelpatasvirVoxilaprevirGastroenterología y hepatologíaEnfermedades infecciosasFarmacología (Medicina)3205.03 Gastroenterología3209 Farmacología