title: Effectiveness and safety of ombitasvir, paritaprevir, ritonavir ± dasabuvir ± ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection.
abstract: Over the last 5 years, therapies for hepatitis C virus (HCV) infection have improved significantly, achieving sustained virologic response (SVR) rates of up to 100% in clinical trials in patients with HCV genotype 1. We investigated the effectiveness and safety of ombitasvir/paritaprevir/ritonavir±dasabuvir in an early access programme. This was a retrospective, multicentre, national study that included 291 treatment-naïve and treatment-experienced patients with genotype 1 or 4 HCV infection. Most patients (65.3%) were male, and the mean age was 57.5 years. The mean baseline viral load was 6.1 log, 69.8% had HCV 1b genotype, 72.9% had cirrhosis and 34.7% were treatment-naïve. SVR at 12 weeks posttreatment was 96.2%. Four patients had virological failure (1.4%), one leading to discontinuation. There were no statistical differences in virological response according to genotype or liver fibrosis. Thirty patients experienced serious adverse events (SAEs) (10.3%), leading to discontinuation in six cases. Hepatic decompensation was observed in five patients. Four patients died during treatment or follow-up, three of them directly related to liver failure. Multivariate analyses showed a decreased probability of achieving SVR associated with baseline albumin, bilirubin and Child-Pugh score B, and a greater probability of developing SAEs related to age and albumin. This combined therapy was highly effective in clinical practice with an acceptable safety profile and low rates of treatment discontinuation.
authors.affiliation: Hospital Universitario Puerta de Hierro Majadahonda, IDIPHIM, Madrid, Spain.|CIBERehd, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Perelló
authors.affiliation: Hospital del Mar, IMIM (Hospital del Mar Medical Research Institute), Barcelona, Spain.|Universitat Autonoma de Barcelona, Barcelona, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Carrión
authors.affiliation: Hospital Universitario Puerta de Hierro Majadahonda, IDIPHIM, Madrid, Spain.
authors.forename: B
authors.initials: B
authors.lastname: Ruiz-Antorán
authors.affiliation: Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.|Facultad de Medicina, Universidad de Cantabria, Santander, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Crespo
authors.affiliation: Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Turnes
authors.affiliation: Hospital Universitario Vall D'Hebrón, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Llaneras
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital Clinic, IDIBAPS, Barcelona, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Lens
authors.affiliation: Hospital Universitario A Coruña, A Coruña, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Delgado
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital Universitario La Paz, Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: García-Samaniego
authors.affiliation: Hospital Universitario Río Hortega, Valladolid, Spain.
authors.forename: F
authors.initials: F
authors.lastname: García-Paredes
authors.affiliation: Hospital Universitario Doce de Octubre, Madrid, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Fernández
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital Universitario Germans Trias i Pujol, Badalona, Spain.
authors.forename: R M
authors.initials: RM
authors.lastname: Morillas
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Rincón
authors.affiliation: Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: J C
authors.initials: JC
authors.lastname: Porres
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital Universitari i Politècnic La Fe, Valencia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Prieto
authors.affiliation: Hospital Universitario Miguel Servet, Zaragoza, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Lázaro Ríos
authors.affiliation: Hospital Universitario Alcorcón, Universidad Rey Juan Carlos, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Fernández-Rodríguez
authors.affiliation: Hospital Álvaro Cunqueiro, Vigo, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Hermo
authors.affiliation: Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Rodríguez
authors.affiliation: CIBERehd, Madrid, Spain.|Clínica Universidad de Navarra, Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.
authors.forename: J I
authors.initials: JI
authors.lastname: Herrero
authors.affiliation: Hospital Universitario Basurto, Bilbao, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Ruiz
authors.affiliation: Hospital Universitario de Cruces, Bilbao, Spain.
authors.forename: J R
authors.initials: JR
authors.lastname: Fernández
authors.affiliation: Hospital Universitario Puerta del Mar, Cádiz, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Macías
authors.affiliation: CIBERehd, Madrid, Spain.|Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Pascasio
authors.affiliation: Complejo Hospitalario Albacete, Albacete, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Moreno
authors.affiliation: Hospital Universitario Clínico Valencia, INCLIVA, Valencia, Spain.|University of Valencia, Valencia, Spain.
authors.forename: M Á
authors.initials: MÁ
authors.lastname: Serra
authors.affiliation: Hospital Universitario Donostia, Donostia, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Arenas
authors.affiliation: Hospital Universitario La Princesa, Madrid, Spain.
authors.forename: Y
authors.initials: Y
authors.lastname: Real
authors.affiliation: CIBERehd, Madrid, Spain.|Complejo Asistencial de León, IBIOMED, León, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Jorquera
authors.affiliation: Hospital Universitario Puerta de Hierro Majadahonda, IDIPHIM, Madrid, Spain.|CIBERehd, Madrid, Spain.|Universidad Autónoma de Madrid, Madrid, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Calleja
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013030:Spain; D000072230:Sustained Virologic Response; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents
keywords: compassionate use; dasabuvir; hepatitis C; ombitasvir; paritaprevir; severe fibrosis