title: Identification of naïve HCV-1 patients with chronic hepatitis who may benefit from dual therapy with peg-interferon and ribavirin.
abstract: OBJECTIVE
  The pool of HCV genotype 1 patients likely to be cured by peg-interferon and ribavirin remains to be quantified.
  
  
  METHODS
  In 1045 patients treated with peg-interferon and ribavirin, two therapeutic strategies were confronted: the first one evaluated only baseline variables associated with sustained virological response (SVR), and the second one included the rapid virologic response (RVR) in addition to baseline predictors. An 80% SVR rate was the threshold to retain a strategy as clinically relevant.
  
  
  RESULTS
  Overall, 414 patients (39.6%) attained SVR. In the first strategy, the hierarchy of features independently associated with SVR was IL28B CC genotype (OR 5.082; CI 3.637-7.101), low (<400,000 IU) viremia (OR 2.907; CI 2.111-4.004), F0-F2 fibrosis (OR 1.631; CI 1.122-2.372) and type 2 diabetes (OR 0.528; CI 0.286-0.972). In the alternative strategy, SVR was associated with RVR (OR 6.273; CI 4.274-9.208), IL28B CC genotype (OR 3.306; CI 2.301-4.751), low viremia (OR 2.175; CI 1.542-3.070), and F0-F2 fibrosis (OR 1.506; CI 1.012-2.242). Combining the favorable baseline variables, the rates of SVR ranged from 42.4% to 83.3%, but only 66 patients (6.3%, overall) with all predictors could be anticipated to reach the >80% SVR threshold. Only 26.6% of no-RVR patients attained SVR. Among the 255 RVR patients, the likelihood of SVR was 61.8% in those with unfavorable predictors, 80% in the presence of a single predictor, and 100% when both predictors were present. By using this model, 200 patients (19.1%) were predicted to have an 80% chance of being cured with dual therapy.
  
  
  CONCLUSIONS
  A consistent subset of naïve HCV-1 patients, identified by some baseline characteristics and RVR, may benefit from dual treatment with peg-interferon and ribavirin.
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy. Electronic address: a.andriulli@operapadrepio.it.
authors: Angelo
authors: A
authors: Andriulli
authors: Clinic of Gastroenterology, University of Palermo, Italy.
authors: Vito
authors: V
authors: Di Marco
authors: Department of Clinical and Experimental Medicine, University of Foggia, Italy.
authors: Maurizio
authors: M
authors: Margaglione
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
authors: Antonio Massimo
authors: AM
authors: Ippolito
authors: Clinic of Gastroenterology, Department of Medicine, University of Verona, Italy.
authors: Giovanna
authors: G
authors: Fattovich
authors: Department of Medical Sciences, University of Torino and Department of Gastroenterology and Hepatology, Azienda Ospedaliera Città della Salute e della Scienza, Torino, Italy.
authors: Antonina
authors: A
authors: Smedile
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
authors: Maria Rosa
authors: MR
authors: Valvano
authors: Clinic of Gastroenterology, University of Palermo, Italy.
authors: Vincenza
authors: V
authors: Calvaruso
authors: Division of Gastroenterology, Casa Sollievo Sofferenza Hospital, IRCCS, San Giovanni Rotondo, Italy.
authors: Domenica
authors: D
authors: Gioffreda
authors: Clinic of Infectious Diseases, University of Bari, Italy.
authors: Michele
authors: M
authors: Milella
authors: Gastroenterology, Department of Clinical Medicine and Surgery, Federico II University of Napoli, Italy.
authors: Filomena
authors: F
authors: Morisco
authors: Division of Gastroenterology, Central Hospital, Bolzano, Italy.
authors: Martina
authors: M
authors: Felder
authors: Infectious Diseases, Second University of Napoli, Italy.
authors: Giuseppina
authors: G
authors: Brancaccio
authors: Clinic of Infectious Diseases, University of Foggia, Italy.
authors: Massimo
authors: M
authors: Fasano
authors: DIMO Medical Oncology, University of Bari, Italy.
authors: Pietro
authors: P
authors: Gatti
authors: Division of Infectious Diseases, S. Caterina Novella Hospital, Galatina, Italy.
authors: Paolo
authors: P
authors: Tundo
authors: Division of Gastroenterology, University of Bari, Italy.
authors: Michele
authors: M
authors: Barone
authors: Division of Gastroenterology, "S. de Bellis" Hospital, IRCCS, Castellana Grotte, Italy.
authors: Raffaele
authors: R
authors: Cozzolongo
authors: Hepatology and Liver Transplantation Unit, Tor Vergata University, Roma, Italy.
authors: Mario
authors: M
authors: Angelico
authors: Department of Clinical and Experimental Medicine, University of Foggia, Italy.
authors: Giovanna
authors: G
authors: D'Andrea
authors: Department of Chemical Pharmaceutics, University La Sapienza, Rome, Italy.
authors: Nicola
authors: N
authors: Andriulli
authors: Department of Medical Sciences, University of Torino and Department of Gastroenterology and Hepatology, Azienda Ospedaliera Città della Salute e della Scienza, Torino, Italy.
authors: Maria Lorena
authors: ML
authors: Abate
authors: Division of Gastroenterology, University of Bologna, Italy.
authors: Giuseppe
authors: G
authors: Mazzella
authors: Infectious Diseases, Second University of Napoli, Italy.
authors: Giovanni Battista
authors: GB
authors: Gaeta
authors: Clinic of Gastroenterology, University of Palermo, Italy.
authors: Antonio
authors: A
authors: Craxi
authors: Clinic of Infectious Diseases, University of Foggia, Italy.
authors: Teresa
authors: T
authors: Santantonio
mesh_terms: D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D005838:Genotype; D016174:Hepacivirus / Q000145:classification* / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D012367:RNA, Viral / Q000097:blood; D011994:Recombinant Proteins / Q000008:administration & dosage; D012254:Ribavirin / Q000008:administration & dosage*
chemical_list: D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D012367:RNA, Viral; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D012254:Ribavirin; C417083:peginterferon alfa-2b; C100416:peginterferon alfa-2a
keywords: Chronic HCV liver disease; HCV; Peg-interferon; Predictors of response; Ribavirin