Interferon-alpha 2b combined with daily ketoprofen administration improves virological response in chronic hepatitis C: a prospective and randomised trial.
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.
Muñoz
A E
AE
Unidad de Hepatología, Hospital Dr Bonorino Udaondo, School of Medicine, University of Salvador, Buenos Aires, Argentina.
Levi
D
D
Podestá
A
A
Gorín
J M
JM
González
J
J
Bartellini
M A
MA
Munne
M S
MS
Cabanne
A
A
Flichman
D
D
Terg
R
R
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
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000998:Antiviral Agents; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D007660:Ketoprofen