title: Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection.
abstract: Patients with hepatitis C virus (HCV) genotype 4 infection are poorly represented in clinical trials of second-generation direct-acting antiviral agents (DAAs). More data are needed to help guide treatment decisions. We investigated the effectiveness and safety of DAAs in patients with genotype 4 infection in routine practice. In this cohort study, HCV genotype 4-infected patients treated with ombitasvir/paritaprevir/ritonavir (OMV/PTVr) + ribavirin (RBV) (n=122) or ledipasvir/sofosbuvir (LDV/SOF) ± RBV (n=130) included in a national database were identified and prospectively followed up. Demographic, clinical and virologic data and serious adverse events (SAEs) were analyzed. Differences between treatment groups mean that data cannot be compared directly. Overall sustained virologic response at Week 12 post treatment (SVR12) was 96.2% with OMV/PTVr+RBV and 95.4% with LDV/SOF±RBV. In cirrhotic patients, SVR12 was 91.2% with OMV/PTVr+RBV and 93.2% with LDV/SOF±RBV. There was no significant difference in SVR12 according to degree of fibrosis in either treatment group (P = .243 and P = .244, respectively). On multivariate analysis, baseline albumin <3.5 g/dL (OMV/PTVr) and bilirubin >2 mg/dL (both cohorts) were significantly associated with failure to achieve SVR (P < .05). Rates of SAEs and SAE-associated discontinuation were 5.7% and 2.5%, respectively, in the OMV/PTVr subcohort and 4.6% and 0.8%, respectively, in the LDV/SOF subcohort. DAA-based regimens returned high rates of SVR12, comparable to limited data from clinical trials, in cirrhotic and non-cirrhotic HCV genotype 4 patients managed in a realworld setting. Safety profiles of both regimens were good and comparable to those reported for other HCV genotypes.
authors.affiliation: Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain. Electronic address: javiercrespo1991@gmail.com.
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo
authors.affiliation: Department of Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid and CIBERehd, Madrid, Spain.
authors.forename: Jose Luis
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Department of Gastroenterology, Hospital San Pedro, Logroño, Spain.
authors.forename: Begoña
authors.initials: B
authors.lastname: Sacristan
authors.affiliation: Department of Clinical Pharmacology, Hospital Universitario Puerta de Hierro, Madrid, Spain.
authors.forename: Belén
authors.initials: B
authors.lastname: Ruiz-Antorán
authors.affiliation: Department of Gastroenterology, Hospital Universitario Virgen del Rocío, IBIS and CIBERehd, Sevilla, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Ampuero
authors.affiliation: Department of Gastroenterology, Hospital Universitario Puerta de Hierro, Universidad Autonoma de Madrid and CIBERehd, Madrid, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Hernández-Conde
authors.affiliation: Liver Unit, Hospital Universitario La Paz, CIBERehd, IdiPAZ, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: García-Samaniego
authors.affiliation: Department of Gastroenterology, Hospital Universitario Ramon y Cajal and CIBERehd, Madrid, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Gea
authors.affiliation: Liver Unit, Hospital Universitario Vall D'Hebrón and CIBERehd, Barcelona, Spain.
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.affiliation: Gastroenterology and Hepatology Unit, Hospital Universitario Marqués de Valdecilla, Santander, IDIVAL, Universidad de Cantabria, Santander, Spain.
authors.forename: Joaquin
authors.initials: J
authors.lastname: Cabezas
authors.affiliation: Liver Unit, Hospital Cliníc de Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.
authors.forename: Sabela
authors.initials: S
authors.lastname: Lens
authors.affiliation: Hospital Germans Trias i Pujol and CIBERehd, Badalona, Spain.
authors.forename: Rosa Maria
authors.initials: RM
authors.lastname: Morillas
authors.affiliation: Department of Gastroenterology, Hospital Comarcal Laredo, Laredo, Spain.
authors.forename: Jose Ramon
authors.initials: JR
authors.lastname: Salcines
authors.affiliation: Department of Gastroenterology, Hospital Universitario Virgen del Rocio, Sevilla, Spain.
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Pascasio
authors.affiliation: Department of Gastroenterology, Complejo Hospitalario Universitario de Pontevedra and IISGS, Pontevedra, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Turnes
authors.affiliation: Department of Gastroenterology, Hospital Universitario de Burgos, Burgos, Spain.
authors.forename: Federico
authors.initials: F
authors.lastname: Sáez-Royuela
authors.affiliation: Department of Gastroenterology, Hospital Universitario Donostia, San Sebastian, Spain.
authors.forename: Juan
authors.initials: J
authors.lastname: Arenas
authors.affiliation: Department of Gastroenterology, Hospital General Universitario Gregorio Marañón and CIBERehd, Madrid, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Rincón
authors.affiliation: Servicio de Medicina Digestiva, Unidad de Hepatología, Hospital Universitari i Politècnic La Fe and CIBERehd, Valencia, Spain.
authors.forename: Martin
authors.initials: M
authors.lastname: Prieto
authors.affiliation: Department of Gastroenterology, Complejo Asistencial Universitario León, León, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Jorquera
authors.affiliation: Department of Gastroenterology, Hospital Universitario de Toledo, Toledo, Spain.
authors.forename: Juan Jose
authors.initials: JJ
authors.lastname: Sanchez Ruano
authors.affiliation: Department of Gastroenterology, Hospital Universitario Central de Asturias, Oviedo, Spain.
authors.forename: Carmen A
authors.initials: CA
authors.lastname: Navascués
authors.affiliation: Department of Gastroenterology, Hospital Clínico Universitario Santiago, Santiago de Compostela, Spain.
authors.forename: Esther
authors.initials: E
authors.lastname: Molina
authors.affiliation: Department of Gastroenterology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
authors.forename: Adolfo Gallego
authors.initials: AG
authors.lastname: Moya
authors.affiliation: Department of Gastroenterology, Complejo Hospitalario Universitario de Albacete, Albacete, Spain.
authors.forename: José Maria
authors.initials: JM
authors.lastname: Moreno-Planas
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; 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; D011446:Prospective Studies; D000072230:Sustained Virologic Response; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents
keywords: Cirrhosis; Direct-Acting Antiviral Agents; Genotype 4; Routine Clinical Practice