Author information
1 Hospital Universitari Vall d'Hebron. Department of Medicine of the UAB (Universitat Autònoma de Barcelona), Spain.
2 Hospital Universitari Vall d'Hebron. Department of Medicine of the UAB (Universitat Autònoma de Barcelona), Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain.
3 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Hospital Clínic, Barcelona. IDIBAPS. Universidad de Barcelona, Spain.
4 Hospital General Universitario de Valencia, Valencia, Spain.
5 Hospital Universitari de Bellvitge, Hospitalet de Llobregat, Spain.
6 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Hospital Universitario La Paz, IdiPAZ, Madrid, Spain.
7 Hospital Universitario y Politécnico La Fe de Valencia, Valencia, Spain.
8 Hospital Universitario Nuestra Señora de La Candelaria, Santa Cruz de Tenerife, Spain.
9 Hospital Universitario Donostia, Donostia, Spain.
10 Hospital Ramón y Cajal, Madrid, Spain.
11 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Hospital Universitari de Santa Creu i Sant Pau, Barcelona, Spain.
12 Hospital Universitario Puerta del Hierro, Madrid, Spain.
13 Liver Section, Gastroenterology Department, Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), UAB (Universitat Autònoma de Barcelona), Barcelona, Spain.
14 Hospital 12 de Octubre, Madrid, Spain.
15 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
16 Hospital Costa del Sol, Málaga, Spain.
17 Hospital Virgen de la Macarena, Seville, Spain.
18 Hospital Universitario Fundación Alcorcon, Madrid, Spain.
19 Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain.
20 Hospital Universitario Marqués de Valdecilla, Santander, Spain.
21 Hospital Miguel Servet, Zaragoza, Spain.
22 Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain.
23 Complejo Asistencial Universitario de Salamanca, Salamanca, Spain.
24 Hospital Joan XXIII, Tarragona, Spain.
25 Hospital Virgen de Valme, Seville, Spain.
26 Hospital Universitario de Burgos, Burgos, Spain.
27 Hospital Universitario A Coruña, la Coruña, Spain.
28 Hospital Universitario San Pedro de Alcántara, Cáceres, Spain.
29 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Clínica Universidad de Navarra. Instituto de Investigación Sanitaria de Navarra (IdiSNA), Navarra, Spain.
30 Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain; Hospital Universitario Virgen del Rocío, Seville, Spain.
31 Hospital Universitari Vall d'Hebron. Department of Medicine of the UAB (Universitat Autònoma de Barcelona), Spain; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Spain. Electronic address: mbuti@vhebron.net.
Abstract
BACKGROUND:
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:
Prospective multicentre study including previously DAA-treated patients who were retreated with SOF/VEL/VOX. The primary endpoint was SVR12. Data on safety and tolerability were also recorded.
RESULTS:
137 patients included: 75% men, 35% with liver cirrhosis. Most were infected by HCV genotype (GT) 1 or 3. Most common prior DAA combinations were sofosbuvir plus an NS5A inhibitor or ombitasvir/paritaprevir/r+dasabuvir. 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). GT3 patients with cirrhosis had the lowest SVR12 rate (69%). Patients who did not achieve SVR12 included 1 with reinfection and 7 with treatment failure (6 GT3, 1 GT1a). Presence of resistance-associated substitutions (RASs) did not impact SVR12. Adverse effects were mild and nonspecific.
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 RASs. However, patients with liver cirrhosis infected by GT3 remain the most-difficult-to-treat group.