Interferon alpha plus ketoprofen or interferon alpha plus ribavirin in chronic hepatitis C non-responder to interferon alpha alone: results of a pilot study.
BACKGROUND
Recently, in vitro and in vivo studies demonstrated that non-steroidal anti-inflammatory drugs are able to enhance the activity of interferon alpha.


OBJECTIVE
To evaluate the efficacy and tolerability of ketoprofen (a non-steroidal anti-inflammatory drug) plus interferon alpha (group B) compared to interferon alpha plus ribavirin (group C) and interferon alpha alone (group A) in chronic hepatitis C non-responders after a 5-month course with interferon alpha.


METHODS
Without stopping interferon alpha, 49 patients were randomized to receive one of the three treatment regimens for 4 months.


RESULTS
Three patients discontinued the therapy. One out of 16 patients in group A, 6/16 in group B and 5/14 in group C, alanine aminotransferase returned to normal at the end of the therapies (B vs A: p=0.04); serum hepatitis C virus-RNA became negative in 1 patient in group A and in 4 patients in both group B and group C. Six months after treatment, normal alanine transferase and negative hepatitis C virus-RNA were observed in 3 patients in group B and 2 in group C. In these patients, liver histology significantly improved.


CONCLUSIONS
These results indicate that a certain number of non-responder patients to interferon alpha can benefit from a combination therapy of interferon alpha plus ketoprofen that is at least as effective as the combination interferon alpha plus ribavirin.
Andreone
P
P
Department of Internal Medicine, Cardioangiology and Hepatology, University of Bologna, Italy. andreone@med.unibo.it
Cursaro
C
C
Gramenzi
A
A
Fiorino
S
S
Di Giammarino
L
L
Miniero
R
R
D'Errico
A
A
Grigioni
W F
WF
Gasbarrini
G
G
Bernardi
M
M
D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D000998:Antiviral Agents / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage*; D007660:Ketoprofen / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012367:RNA, Viral / Q000097:blood; D012254:Ribavirin / Q000008:administration & dosage*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D012254:Ribavirin; D007660:Ketoprofen; D000410:Alanine Transaminase