title: Individualized treatment of genotype 1 naïve patients: an Italian multicenter field practice experience.
abstract: BACKGROUND
  Triple therapy including Telaprevir or Boceprevir still represents in many European countries the standard of care for patients with Hepatitis C Virus genotype 1 infection. The number of patients who received this treatment resulted generally lower than expected. We investigated, among naïve patients, number and characteristics of treatment candidates who were started on triple or dual therapy in comparison to those who were deferred.
  
  
  METHODS
  621 naïve treatment candidates were prospectively evaluated at each center. Factors associated with decision to defer or treat with dual or triple therapy were investigated by univariate and multivariate analyses. Rates of Sustained Virological Response and safety profile were analysed.
  
  
  RESULTS
  Of candidates to treatment, 33% did not received it. It was mostly due to high risk of Interferon-induced decompensation. Of 397 patients who were started on treatment, 266 (67%) received triple, 131 dual. Among patient receiving treatment, unfavorable IL28B, severe liver damage and higher albumin were independently associated with the physician decision to administer triple therapy. Sustained Virological Response after dual therapy was 66.4%, after triple 73.7% (p = 0.14). 142 patients received Telaprevir. The choice of Telaprevir-based therapy was associated with higher Body Mass Index and advanced liver disease. Sustained Virological Response rates were 71.1% after Telaprevir and 76.6% after Boceprevir.
  
  
  CONCLUSIONS
  Individualizing treatment with available regimens allows to maximize Sustained Virological Response and to reduce the number of patients who remain untreated. High proportion of patients with severe liver damage urgently need Interferon free treatment.
authors.affiliation: Hospital IRCCS "Casa Sollievo della Sofferenza", Liver Unit, San Giovanni Rotondo, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Mangia
authors.affiliation: Galliera Hospital, Infectious Diseases, Genova, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cenderello
authors.affiliation: Hospital of Parma, Unit of Infectious Diseases and Hepatology, Parma, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Orlandini
authors.affiliation: Hospital IRCCS "Casa Sollievo della Sofferenza", Liver Unit, San Giovanni Rotondo, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Piazzolla
authors.affiliation: University of Genova, Department of Internal Medicine, Gastroenterology Unit, Genova, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Picciotto
authors.affiliation: "S. Paolo" Hospital, University of Milan, Department of Medicine, Milan, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Zuin
authors.affiliation: AOU "San Giovanni Battista" - Molinette, Department of Medical Sciences, Torino, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Ciancio
authors.affiliation: Second University of Naples, Department of Infectious Diseases, Naples, Italy.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Brancaccio
authors.affiliation: "G. Careggi" Hospital, Department of Gastroenterology, Florence, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Forte
authors.affiliation: Hospital of Venosa, Unit of Medicine, Venosa, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Carretta
authors.affiliation: University of Milan, Department of Experimental and Clinical Medicine, Milan, Italy.
authors.forename: Anna Linda
authors.initials: AL
authors.lastname: Zignego
authors.affiliation: Hospital of Canosa, Department of Internal Medicine, Canosa, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Minerva
authors.affiliation: University of Bari, Clinic of Infectious Diseases, Bari, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Brindicci
authors.affiliation: "S. Andrea" Hospital, Department of Gastroenterology, Rome, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Marignani
authors.affiliation: University of Ancona, Department of Gastroenterology, Ancona, Italy.
authors.forename: Gianluca Svegliati
authors.initials: GS
authors.lastname: Baroni
authors.affiliation: "Vittorio Emanuele" Hospital, Liver Unit, Catania, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Bertino
authors.affiliation: "R. Dimiccoli" Hospital, Department of Gaastroenterology, Barletta, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cuccorese
authors.affiliation: Hospital IRCCS "Casa Sollievo della Sofferenza", Liver Unit, San Giovanni Rotondo, Italy.
authors.forename: Leonardo
authors.initials: L
authors.lastname: Mottola
authors.affiliation: Hospital IRCCS "Casa Sollievo della Sofferenza", Liver Unit, San Giovanni Rotondo, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Ripoli
authors.affiliation: Università degli Studi del Piemonte Orientale, Department of Internal Medicine, Novara, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Pirisi
mesh_terms: D003657:Decision Making; D004359:Drug Therapy, Combination; D005260:Female; D056726:Genetic Association Studies; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000235:genetics* / Q000821:virology; D006801:Humans; D007372:Interferons; D007378:Interleukins / Q000235:genetics; D007558:Italy; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use; D057285:Precision Medicine; D011392:Proline / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D000095022:Interferon Lambda
chemical_list: D007372:Interferons; D007378:Interleukins; D009842:Oligopeptides; D011392:Proline; C000624353:interferon-lambda, human; D000095022:Interferon Lambda; 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