Effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir in patients with chronic hepatitis C previously treated with DAAs.
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| Abstract | BACKGROUND & 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.
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| Authors | Jordi Llaneras, Mar Riveiro-Barciela, Sabela Lens, Moisés Diago, Alba Cachero, Javier García-Samaniego, Isabel Conde, Ana Arencibia, Juan Arenas, Francisco Gea, Xavier Torras, José Luis Calleja, José Antonio Carrión, 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, Maria Buti |
| Journal | Journal of hepatology (J Hepatol) Vol. 71 Issue 4 Pg. 666-672 (10 2019) ISSN: 1600-0641 [Electronic] Netherlands |
| PMID | 31203153 (Publication Type: Clinical Trial, Journal Article, Multicenter Study) |
| Copyright | Copyright © 2019. Published by Elsevier B.V. |
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