title: Pegylated interferon α plus ribavirin for the treatment of chronic hepatitis C: a multicentre independent study supported by the Italian Drug Agency.
abstract: BACKGROUND
  Data on the efficacy of Peg-interferon/ribavirin therapy for chronic hepatitis C are mostly derived from treatment of selected patients enrolled in clinical trials. This study aimed to assess the effectiveness of Peg-interferon/ribavirin therapy in "real world" chronic hepatitis C patients in Italy.
  
  
  METHODS
  Independent observational multicentre study including consecutive patients receiving Peg-interferon/ribavirin in the 18 months before (retrospective phase) and after (prospective phase) the start of the study.
  
  
  RESULTS
  4176 patients were eligible. The final study population consisted of 2051 patients in the retrospective and 2073 in the prospective phase. Sustained virological response was achieved by 1036 patients (50.5%) during the retrospective phase: 325 were genotypes 1/4 (34.1%) and 684 were genotypes 2/3 (67.2%) and by 800 patients (38.6%) during the prospective phase: 300 were genotypes 1/4 (28.4%) and 473 were genotypes 2/3 (51.5%). During multivariate analysis genotypes 2/3 were significantly associated with higher sustained virological response rates; cirrhosis and γ-glutamil-transpeptidase >2 times the normal limit were associated with poorer response.
  
  
  CONCLUSIONS
  The response to Peg-interferon/ribavirin therapy in "real world" clinical practice is distinctly lower than in registration trials. The difference in response rates was more pronounced among easy-to-treat than among difficult-to-treat hepatitis C virus genotypes.
authors.affiliation: Gastroenterology & Hepatology Unit, Gradenigo Hospital, Torino, Italy. Electronic address: floriano.rosina@gradenigo.it.
authors.forename: Floriano
authors.initials: F
authors.lastname: Rosina
authors.affiliation: National Centre for Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health (ISS), Rome, Italy.
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Tosti
authors.affiliation: Gastroenterology & Hepatology Unit, Torino University, Torino, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Borghesio
authors.affiliation: National Centre for Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health (ISS), Rome, Italy.
authors.forename: Maria
authors.initials: M
authors.lastname: Masocco
authors.affiliation: National Centre for Epidemiology, Surveillance and Health Promotion, Italian National Institute of Health (ISS), Rome, Italy.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Mele
authors.affiliation: Hepatology & Interventional Ultrasound Unit, Gragnano Hospital, Gragnano (NA), Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: Coppola
authors.affiliation: Institute of Infectious Diseases, Bari University, Bari, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Milella
authors.affiliation: Infectious and Parasitic Diseases Unit, Federico II University, Napoli, Italy.
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Borgia
authors.affiliation: Department of Medical and Surgical Sciences, Bologna University, Policlinico Sant'Orsola-Malpighi, Bologna, Italy.
authors.forename: Pietro
authors.initials: P
authors.lastname: Andreone
authors.affiliation: Gastroenterology & Hepatology Unit, San Filippo Neri Hospital, Rome, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Koch
authors.affiliation: Department of Experimental and Clinical Medicine, Florence University, Florence, Italy.
authors.forename: Anna Linda
authors.initials: AL
authors.lastname: Zignego
authors.affiliation: Internal Medicine I & Hepatology Unit, S. Pertini Hospital, Rome, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Romano
authors.affiliation: Hepatology Unit - Gastroenterology Unit, Orlandi Hospital, Bussolengo (VR), Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Carrara
authors.affiliation: Gastroenterology & Hepatology Unit, Di.Bi.M.I.S., Palermo University, Palermo, Italy.
authors.forename: Piero Luigi
authors.initials: PL
authors.lastname: Almasio
authors.affiliation: Gastroenterology & Digestive Endoscopy Unit, Santa Corona Hospital, Pietra Ligure (SV), Italy.
authors.forename: Emilio
authors.initials: E
authors.lastname: Azzola
authors.affiliation: Department of Clinical Medicine & Surgery, Gastroenterology Unit, Federico II University, Napoli, Italy.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Nardone
authors.affiliation: Department of Gastroenterology, Marche Polytechnic University, Ancona, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Benedetti
authors.affiliation: Institute of Infectious and Tropical Diseases, Brescia University, Brescia, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Carosi
authors.affiliation: Infectious Diseases Unit, Azienda Sanitaria Firenze, Firenze, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Mazzotta
authors.affiliation: Infectious and Tropical Diseases Unit, S. Anna and S. Sebastiano Hospital, Naples Second University, Caserta, Italy.
authors.forename: Evangelista
authors.initials: E
authors.lastname: Sagnelli
authors.affiliation: Gastroenterology & Hepatology Unit, Torino University, Torino, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Rizzetto
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D005838:Genotype; D019698:Hepatitis C, Chronic / Q000188:drug therapy / Q000821:virology; D006518:Hepatitis Viruses / Q000235:genetics; D016898:Interferon-alpha / Q000627:therapeutic use; D007558:Italy; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries; D012254:Ribavirin / Q000627:therapeutic use; D012367:RNA, Viral / Q000032:analysis; D016896:Treatment Outcome
chemical_list: D000998:Antiviral Agents; D004337:Drug Carriers; D016898:Interferon-alpha; C100416:peginterferon alfa-2a; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D012254:Ribavirin; D012367:RNA, Viral
keywords: Ribavirin; Sustained virological response (SVR); Treatment