title: [Lead-in period and week 8 as predictive tools for response to boceprevir therapy: a retrospective study of Spanish real clinical practice].
abstract: BACKGROUND
  Most discontinuations due to lack of virological response occur during the first few weeks of hepatitis C virus (HCV) triple therapy. Improved knowledge of baseline factors and their correlation with boceprevir decision points may predict treatment success.
  
  
  METHODS
  An observational, retrospective study was conducted to describe the lead-in period as a clinical decision tool in HCV genotype 1 patients treated with boceprevir. Data were collected from the medical records of 186 consecutive patients distributed across 20 Spanish general hospitals.
  
  
  RESULTS
  This study included 171 patients. A total of 80% had fibrosis F3/F4, 74% were previously treated, and 26% were treatment-naïve. After the lead-in period, 54.5% of the patients had a reduction of ≥1 log10; this reduction occurred in 52.5% of those with advanced fibrosis. Boceprevir therapy was started in 94% of the patients. Discontinuations at week 4 were limited to null responders with cirrhosis. The baseline factors associated with virological response at week 4 were IL28B, previous response, and fibrosis score. At week 8, HCV-RNA was undetectable in 48.8% of the patients. The correlation between responses at weeks 8 and 12 was 88%.
  
  
  CONCLUSIONS
  In the Spanish clinical setting, lead-in was mainly used as a clinical decision point for non-responders with cirrhosis. The good correlation between stopping rules at weeks 8 and 12 could be used to anticipate discontinuation, thus saving adverse events and costs.
authors.affiliation: Departamento de Gastroenterología y Hepatología, Hospital Universitario Marqués de Valdecilla, Santander, España. Electronic address: javiercrespo1991@gmail.com.
authors.forename: Javier
authors.initials: J
authors.lastname: Crespo
authors.affiliation: Departamento de Gastroenterología, Hospital Universitario La Fe, Valencia, España.
authors.forename: Marina
authors.initials: M
authors.lastname: Berenguer
authors.affiliation: Departamento de Aparato Digestivo, Hospital Universitario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, España.
authors.forename: Francisco
authors.initials: F
authors.lastname: Pérez
authors.affiliation: Departamento de Gastroenterología y Hepatología, Hospital Universitario 12 de Octubre, Madrid, España.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Departamento de Aparato Digestivo, Hospital Arnau de Vilanova, Lérida.
authors.forename: Olga
authors.initials: O
authors.lastname: González
authors.affiliation: Departamento de Gastroenterología y Hepatología, Hospital Universitario Ramón y Cajal, Madrid, España.
authors.forename: Rafael
authors.initials: R
authors.lastname: Bárcena
authors.affiliation: Departamento de Medicina Interna, Hospital Universitario Vall d'Hebrón, Barcelona, España.
authors.forename: María
authors.initials: M
authors.lastname: Buti
authors.affiliation: Medical Affairs Department, MSD, Madrid, España.
authors.forename: Jesús
authors.initials: J
authors.lastname: López
authors.affiliation: Departamento de Gastroenterología y Hepatología, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, España.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Calleja
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000066491:Clinical Decision-Making; D016903:Drug Monitoring / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use; D007372:Interferons; D007378:Interleukins / Q000235:genetics; D008103:Liver Cirrhosis / Q000188:drug therapy / Q000209:etiology; D008297:Male; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use; D011392:Proline / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011480:Protease Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use; D012189:Retrospective Studies; D012254:Ribavirin / Q000008:administration & dosage / Q000627:therapeutic use; D012720:Severity of Illness Index; D013030:Spain; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects; D014766:Viremia / Q000188:drug therapy*; D000095022:Interferon Lambda
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D007372:Interferons; D007378:Interleukins; D011092:Polyethylene Glycols; D011392:Proline; D011480:Protease Inhibitors; D012367:RNA, Viral; D011994:Recombinant Proteins; D012254:Ribavirin; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; 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; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: Boceprevir; HCV; Lead-in; Peginterferón; Respuesta virológica sostenida; Ribavirina; SVR; VHC; boceprevir; lead-in; pegylated interferon; ribavirin