BACKGROUND: Less than 15% of patients with chronic hepatitis C show a sustained virological response to interferon treatment. AIM: To evaluate the efficacy and safety of different doses of ketoprofen combined with interferon-alpha 2b in the treatment of chronic hepatitis C. PATIENTS/ METHODS: Seventy compensated patients with chronic hepatitis C receivedinterferon-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.
RCT Entities:
BACKGROUND: Less than 15% of patients with chronic hepatitis C show a sustained virological response to interferon treatment. AIM: To evaluate the efficacy and safety of different doses of ketoprofen combined with interferon-alpha 2b in the treatment of chronic hepatitis C. PATIENTS/ 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: A M Di Bisceglie; P Martin; C Kassianides; M Lisker-Melman; L Murray; J Waggoner; Z Goodman; S M Banks; J H Hoofnagle Journal: N Engl J Med Date: 1989-11-30 Impact factor: 91.245
Authors: L Stuyver; R Rossau; A Wyseur; M Duhamel; B Vanderborght; H Van Heuverswyn; G Maertens Journal: J Gen Virol Date: 1993-06 Impact factor: 3.891