title: Durability of the response to peginterferon-α2b and ribavirin in patients with chronic hepatitis C: a cohort study in the routine clinical setting.
abstract: OBJECTIVE
  To evaluate whether, in chronic hepatitis C-positive naive patients recruited in the routine clinical setting and treated with pegylated-interferon-α2b (Peg-IFN) and ribavirin (RBV), the sustained virologic response (SVR) is durable over the long term and whether it is associated with a decrease in liver complications and incidence of glucose abnormalities.
  
  
  METHODS
  This was a prospective long-term follow-up study of 182 naive patients enrolled in 2001-2002 and treated with Peg-IFN and RBV and followed up to December 2010, with clinical, biochemical, and virological evaluations every 6-12 months.
  
  
  RESULTS
  None of the 115 (63.2%) sustained responders showed late viremic relapse during the follow-up. SVR was better defined at 24 weeks (16/16 relapsers, 100%) than at 12 weeks after the end of therapy (14/16 relapsers, 87.5%). On multivariable analysis, viral genotype (odds ratio 0.16, 95% confidence interval 0.07-0.36, P=0.0001) and a greater than 20% RBV reduction (odds ratio 5.21, 95% confidence interval 1.54-17.67, P=0.008) predicted long-term response (LTR) independently. The incidence of cirrhosis was significantly higher among nonresponders (21.3%) compared with long-term responders (0.9%, P≤0.0001), but the risk of developing glucose abnormalities was not significantly reduced in long-term responders (hazard ratio 1.36, P=0.363). Hepatocellular carcinoma occurred only in three cases.
  
  
  CONCLUSIONS
  SVR achieved in patients treated in the routine clinical setting with Peg-IFN and RBV is durable over the long term and LTR significantly reduces the risk of progression to cirrhosis; however, in a population with mild liver fibrosis, the clinical impact of LTR on the risk of glucose abnormalities seems negligible.
authors.affiliation: aDepartment of Oncology, Division of Gastroenterology bDepartment of Internal Medicine, Division of Hepatogastroenterology cDepartment of Infectious Diseases, Amedeo di Savoia Hospital dUnit of Cancer Epidemiology, Molinette Hospital and CPO Piemonte, University of Turin, Turin eDepartment of Internal Medicine, Division of Gastroenterology, University of Genoa, Genoa fDivision of Gastroenterology, San Paolo Hospital, Savona gDepartment of Translational Medicine, Università del Piemonte Orientale 'A. Avogadro', Novara hDivision of Internal Medicine, Ospedale Madonna del Popolo, Omegna iDivision of Infectious Diseases, Ospedale Umberto Parini, Aosta jDivision of Gastroenterology, Ospedale degli Infermi, Rivoli, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Giordanino
authors.forename: Marco
authors.initials: M
authors.lastname: Sacco
authors.forename: Simone
authors.initials: S
authors.lastname: Ceretto
authors.forename: Antonina
authors.initials: A
authors.lastname: Smedile
authors.forename: Alessia
authors.initials: A
authors.lastname: Ciancio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cariti
authors.forename: Tiziano
authors.initials: T
authors.lastname: De Blasi
authors.forename: Antonio
authors.initials: A
authors.lastname: Picciotto
authors.forename: Simona
authors.initials: S
authors.lastname: Marenco
authors.forename: Alessandro
authors.initials: A
authors.lastname: Grasso
authors.forename: Mario
authors.initials: M
authors.lastname: Pirisi
authors.forename: Carlo
authors.initials: C
authors.lastname: Smirne
authors.forename: Cosimo
authors.initials: C
authors.lastname: Colletta
authors.forename: Antonio
authors.initials: A
authors.lastname: Traverso
authors.forename: Dario
authors.initials: D
authors.lastname: Mazzucco
authors.forename: Giovannino
authors.initials: G
authors.lastname: Ciccone
authors.forename: Daniele
authors.initials: D
authors.lastname: Simondi
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
authors.forename: Giorgio
authors.initials: G
authors.lastname: Saracco
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D044882:Glucose Metabolism Disorders / Q000517:prevention & control / Q000821:virology; D016174:Hepacivirus / Q000187:drug effects / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D016898:Interferon-alpha / Q000009:adverse effects / Q000627:therapeutic use*; D053208:Kaplan-Meier Estimate; D008103:Liver Cirrhosis / Q000517:prevention & control / Q000821:virology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012008:Recurrence; D012254:Ribavirin / Q000009:adverse effects / Q000627:therapeutic use*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C100416:peginterferon alfa-2a