title: An a priori prediction model of response to peginterferon plus ribavirin dual therapy in naïve patients with genotype 1 chronic hepatitis C.
abstract: BACKGROUND
  Aim was to select naïve patients with genotype 1 chronic hepatitis C having a high probability of response to Peg-interferon+ribavirin therapy.
  
  
  METHODS
  In 1073 patients (derivation cohort), predictors of rapid and sustained virological response were identified by logistic analysis; regression coefficients were used to generate prediction models for sustained virological response. Probabilities at baseline and treatment week 4 were utilized to develop a decision rule to select patients with high likelihood of response. The model was then validated in 423 patients (validation cohort).
  
  
  RESULTS
  In the derivation cohort, 257 achieved rapid virological response and 818 did not, with sustained virological response rates of 80.2% and 25.4%, respectively; interleukin-28B polymorphisms, fibrosis staging, gamma-glutamyl transferase, and viral load predicted sustained virological response. Assuming a <30% sustained virological response probability for not recommending Peg-interferon+ribavirin, 100 patients (25.6%) in the validation cohort were predicted a priori to fail this regimen. Assuming a ≥80% sustained virological response probability as a threshold to continue with Peg-interferon+ribavirin, 61 patients were predicted to obtain sustained virological response, and 55 of them (90.2%) eventually did.
  
  
  CONCLUSIONS
  This model uses easily determined variables for a personalized estimate of the probability of sustained virological response with Peg-interferon+ribavirin, allowing to identify patients who may benefit from conventional therapy.
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, Italy.
authors: Angelo
authors: A
authors: Andriulli
authors: Department of Mathematics, Tor Vergata University, Roma, Italy.
authors: Alessandra
authors: A
authors: Nardi
authors: Unit of Gastroenterology, Di.B.I.S., University of Palermo, Italy.
authors: Vito
authors: V
authors: Di Marco
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, Italy. Electronic address: antonio.ippolito@me.com.
authors: Antonio Massimo
authors: AM
authors: Ippolito
authors: Department of Mathematics, Tor Vergata University, Roma, Italy.
authors: Caius
authors: C
authors: Gavrila
authors: Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
authors: Alessio
authors: A
authors: Aghemo
authors: Hepatology and Liver Transplantation Unit, University of Tor Vergata, Roma, Italy.
authors: Daniele
authors: D
authors: Di Paolo
authors: Division of Clinical and Molecular Hepatology, University of Messina, Italy.
authors: Giovanni
authors: G
authors: Squadrito
authors: Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy.
authors: Eleonora
authors: E
authors: Grassi
authors: Unit of Gastroenterology, Di.B.I.S., University of Palermo, Italy.
authors: Vincenza
authors: V
authors: Calvaruso
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, Italy.
authors: Maria Rosa
authors: MR
authors: Valvano
authors: Clinic of Infectious Diseases, Second University of Napoli, Italy.
authors: Giuseppina
authors: G
authors: Brancaccio
authors: Unit of Gastroenterology, Di.B.I.S., University of Palermo, Italy.
authors: Antonio
authors: A
authors: Craxi
authors: Hepatology and Liver Transplantation Unit, University of Tor Vergata, Roma, Italy.
authors: Mario
authors: M
authors: Angelico
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics*; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011379:Prognosis; D012367:RNA, Viral / Q000235:genetics*; D060888:Real-Time Polymerase Chain Reaction; D011994:Recombinant Proteins / Q000627:therapeutic use; D012254:Ribavirin / Q000627:therapeutic use*; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a
keywords: Chronic hepatitis; HCV infection; Peg-interferon and ribavirin treatment; Predictors of sustained virological response, Rapid virological response