title: [Incidence, management and costs of adverse effects in chronic hepatitis C patients on triple therapy with telaprevir or boceprevir: first 12 weeks of treatment].
abstract: BACKGROUND
  The aim of the study was to analyze the incidence, management and cost associated to hematological and dermatological adverse effects (AE) in chronic hepatitis C patients on triple therapy (TT) with telaprevir (TVR) or boceprevir (BOC).
  
  
  METHODS
  An analysis was made on the data recorded on patients who started treatment with TVR or BOC associated with peginterferon alfa and ribavirin in a 12-week follow-up period.
  
  
  RESULTS
  Fifty-three patients were included (TVR n=36; BOC n=17). Thrombocytopenia (83% TVR vs. 88% BOC) followed by neutropenia (89% TVR vs. 82% BOC) were the most common AE. Dermatological AE were observed in 32% of patients. Eleven patients required treatment discontinuation (all of them received TVR), and toxicity was the main reason for discontinuation (64%). The percentage of patients who required supportive treatment for management of AE was 66%. The most used supportive treatment was erythropoietin. Eight patients required emergency health care, and 2 were hospitalized due to AE. Total cost of additional supportive resources was 32,522€ (625 [SD=876]€/patient) (TVR 759 [SD=1,022]€/patient vs. BOC 349 [SD=327]€/patient; P>.05). Patients with gradeiii-iv toxicity required greater supportive care with higher costs, compared to patients with gradei-ii toxicity (849 [SD=1,143]€/patient vs. 387 [SD=397]€/patient; P=.053).
  
  
  CONCLUSIONS
  The addition of new protease inhibitors to conventional treatment leads to a higher incidence of hematological AE in our study, compared to data described in clinical trials. The elevated incidence of AE involves the use of supportive care, increasing total costs of therapy.
authors.affiliation: Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia, España. Electronic address: guglieri_bea@gva.es.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Guglieri-López
authors.affiliation: Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia, España.
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Ventura-Cerdá
authors.affiliation: Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia, España.
authors.forename: Sandra
authors.initials: S
authors.lastname: Gómez-Álvarez
authors.affiliation: Servicio de Farmacia, Hospital Universitario Doctor Peset, Valencia, España.
authors.forename: Mónica
authors.initials: M
authors.lastname: Climente-Martí
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage* / Q000191:economics*; D003362:Cost-Benefit Analysis; D004359:Drug Therapy, Combination; D064420:Drug-Related Side Effects and Adverse Reactions / Q000191:economics / Q000453:epidemiology / Q000628:therapy; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics*; D006801:Humans; D015994:Incidence; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000191:economics; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000008:administration & dosage* / Q000191:economics*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000191:economics; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000191:economics; D013997:Time Factors
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D009842:Oligopeptides; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C486464:telaprevir; C512204:N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide; D011392:Proline; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: Adverse effects; Análisis de costes; Boceprevir; Chronic hepatitis C; Cost analysis; Efectos adversos; Hepatitis C crónica; Telaprevir