title: Therapy with ombitasvir/paritaprevir/ritonavir plus dasabuvir is effective and safe for the treatment of genotypes 1 and 4 hepatitis C virus (HCV) infection in patients with severe renal impairment: A multicentre experience.
abstract: Limited data are available on direct-acting antivirals for treating hepatitis C virus (HCV) infection in patients with severe renal impairment. The aim of this study was to evaluate the effectiveness and safety of ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± ribavirin (RBV) in patients with stage 4 or 5 chronic kidney disease (CKD) and HCV genotype 1 or 4 infection in real clinical practice, and to investigate pharmacological interactions. This retrospective study included patients treated with OBV/PTV/r+DSV±RBV or OBV/PTV/r+RBV with CKD stage 4 (eGFR: 15-29 mL/min/1.73m2) or 5 (eGFR<15 mL/min/1.73m2or requiring dialysis) and HCV infection by genotypes 1 and 4 between April 2015 and October 2015 in nine Spanish centres. Sustained virological response at 12 weeks (SVR12) was assessed, and clinical and laboratory data, fibrosis stage, adverse events and pharmacological interactions were reported. Forty-six patients were included: 10 (21.7%) had CKD stage 4 and 36 (78.2%) CKD stage 5. Seventeen (36.9%) had cirrhosis. SVR12 rate in the intention-to-treat population was 95.7%. Twenty-one (45.6%) received RBV, which was discontinued in two (9.5%) patients. Anaemia (haemoglobin <10 g/dl) occurred in 12 patients (57.1%) with RBV vs 10 (40.0%) without RBV (P=.246). Renal function remained stable during antiviral therapy. Nine patients (19.5%) experienced serious adverse events unrelated to antiviral therapy. Concomitant medication was discontinued or modified in 41.3% of patients. In conclusion, the effectiveness of OBV/PTV/r±DSV±RBV in patients with CKD 4-5 was similar to that observed in those with normal renal function and was not associated with severe adverse events.
authors.affiliation: Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: R
authors.initials: R
authors.lastname: Muñoz-Gómez
authors.affiliation: Unit of Hepatology, Hospital Universitario Gregorio Marañón, CIBERehd , Madrid, Spain.
authors.forename: D
authors.initials: D
authors.lastname: Rincón
authors.affiliation: Unit of Hepatology, Hospital Universitario Gregorio Marañón, CIBERehd , Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Ahumada
authors.affiliation: Department of Nephrology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Hernández
authors.affiliation: Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Devesa
authors.affiliation: Department of Gastroenterology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Izquierdo
authors.affiliation: Department of Gastroenterology, Hospital Universitario Infanta Cristina, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Ortiz
authors.affiliation: Department of Gastroenterology, Hospital General Universitario de Ciudad Real, Ciudad Real, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Hernández-Albujar
authors.affiliation: Department of Gastroenterology, Hospital Universitario Fundación Alcorcón, Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Fernández-Rodríguez
authors.affiliation: Department of Gastroenterology, Complejo Asistencial de Segovia, Segovia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Calvo
authors.affiliation: Department of Gastroenterology, Hospital Universitario del Sureste, Madrid, Spain.
authors.forename: R
authors.initials: R
authors.lastname: González
authors.affiliation: Department of Gastroenterology, Hospital Universitario Infanta Leonor, Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Lozano
authors.affiliation: Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Castellano
authors.affiliation: Department of Gastroenterology, Hospital Universitario 12 de Octubre, Madrid, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Fernández-Vázquez
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004347:Drug Interactions; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051437:Renal Insufficiency / Q000150:complications* / Q000628:therapy*; D012189:Retrospective Studies; D013030:Spain; D000072230:Sustained Virologic Response; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents
keywords: chronic kidney disease; direct-acting antivirals; end-stage renal disease; hepatitis C infection; ombitasvir paritaprevir dasabuvir; ribavirin