Llaneras, JordiRiveiro-Barciela, MarLens, SabelaDiago, MoisésCachero, AlbaGarcía-Samaniego, JavierConde, IsabelArencibia, AnaArenas, JuanGea, FranciscoTorras, XavierLuis Calleja, JoséAntonio Carrión, JoséFernández, InmaculadaMaría Morillas, RosaRosales, José MiguelCarmona, IsabelFernández-Rodríguez, ConradoHernández-Guerra, ManuelLlerena, SusanaBernal, VanesaTurnes, JuanGonzález-Santiago, Jesús MMontoliu, SilviaFigueruela, BlancaBadia, EsterDelgado, ManuelFernández-Bermejo, MiguelIñarrairaegui, MercedesPascasio, Juan ManuelEsteban, RafaelMariño, ZoeButi, Maria2023-01-252023-01-252019-06-14http://hdl.handle.net/10668/14121Around 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. 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. 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  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. 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.enHCV genotype 3Hepatitis CSofosbuvirTreatment failuresVelpatasvirVoxilaprevirAdultAminoisobutyric AcidsAntiviral AgentsCarbamatesCyclopropanesDrug CombinationsDrug MonitoringDrug Resistance, ViralFemaleHepacivirusHepatitis C, ChronicHeterocyclic Compounds, 4 or More RingsHumansLactams, MacrocyclicLeucineLiver CirrhosisMacrocyclic CompoundsMaleMiddle AgedProlineQuinoxalinesSofosbuvirSpainSulfonamidesSustained Virologic ResponseTreatment Outcomeresearch article31203153open access10.1016/j.jhep.2019.06.0021600-0641http://repositori.upf.edu/bitstream/10230/43566/1/llaneras-joh-effe.pdf