title: Interferon-alpha 2b combined with daily ketoprofen administration improves virological response in chronic hepatitis C: a prospective and randomised trial.
abstract: BACKGROUND
  Less than 15% of patients with chronic hepatitis C show a sustained virological response to interferon treatment.
  
  
  OBJECTIVE
  To evaluate the efficacy and safety of different doses of ketoprofen combined with interferon-alpha 2b in the treatment of chronic hepatitis C.
  
  
  METHODS
  Seventy compensated patients with chronic hepatitis C received interferon-alpha 2b 3 million units three times a week for six months. They were randomly assigned to: group 1 (n = 23), interferon-alpha 2b alone; group 2 (n = 23), interferon-alpha 2b plus 200 mg ketoprofen three times a week; group 3 (n = 24), interferon-alpha 2b plus 200 mg ketoprofen twice a day. Complete and sustained responses were defined as normal serum alanine aminotransferase levels and negative serum hepatitis C virus RNA at six and 12 months respectively.
  
  
  RESULTS
  Complete and sustained responses were similar in groups 1 and 2: 10% v 5% and 5% v 0% respectively. In group 3, complete response was 29% (p = 0.13 v group 1 and p = 0.04 v group 2) and sustained response was 26% (p = 0.07 v group 1 and p = 0.01 v group 2). Overall, adverse events were similar in the three groups. However, 'flu-like syndrome was less common in group 2 (30%) and group 3 (37%) than in group 1 (77%) (p = 0.01).
  
  
  CONCLUSIONS
  Twice daily ketoprofen administration combined with interferon-alpha 2b produced an increase in complete and sustained responses. Although the combination of interferon-alpha 2b with ketoprofen was well tolerated and decreased the incidence of 'flu-like syndrome, it is advisable to monitor possible non-steroid anti-inflammatory drug hepatotoxicity.
authors.affiliation: Unidad de Hepatología, Hospital Dr Bonorino Udaondo, School of Medicine, University of Salvador, Buenos Aires, Argentina.
authors.forename: A E
authors.initials: AE
authors.lastname: Muñoz
authors.forename: D
authors.initials: D
authors.lastname: Levi
authors.forename: A
authors.initials: A
authors.lastname: Podestá
authors.forename: J M
authors.initials: JM
authors.lastname: Gorín
authors.forename: J
authors.initials: J
authors.lastname: González
authors.forename: M A
authors.initials: MA
authors.lastname: Bartellini
authors.forename: M S
authors.initials: MS
authors.lastname: Munne
authors.forename: A
authors.initials: A
authors.lastname: Cabanne
authors.forename: D
authors.initials: D
authors.lastname: Flichman
authors.forename: R
authors.initials: R
authors.lastname: Terg
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D019698:Hepatitis C, Chronic / Q000188:drug therapy*; D006801:Humans; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage*; D007660:Ketoprofen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011994:Recombinant Proteins
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D007660:Ketoprofen