Antioxidant drugs combined with alpha-interferon in chronic hepatitis C not responsive to alpha-interferon alone: a randomized, multicentre study.
OBJECTIVE
After non-response to the initial course of therapy, retreatment with alpha-interferon is not effective. The aim of this study was to ascertain whether the administration of N-acetyl cysteine and vitamin E could increase the response rate to retreatment with alpha-interferon.


METHODS
Prospective, multicentre clinical trial.


METHODS
Twelve hospitals in Lombardy, Italy.


METHODS
120 consecutive patients affected by biopsy-proven chronic hepatitis C who had been non-responders to a previous course of alpha-interferon, administered at the dosage of 3-6 million units (MU) three times a week (tiw) for 6 months.


METHODS
The patients were randomly assigned to one of two groups of treatment: group A, natural interferon-alphaN3, 6 or 9 MU tiw, when the body weight was < 60 kg or > or = 60 kg, respectively; group B, the same dosage of natural interferon-alphaN3 in association with oral administration of N-acetyl cysteine 1200 mg/day and vitamin E 600 mg/day. The period of treatment was 6 months in both groups.


RESULTS
Neither end-therapy biochemical response nor sustained biochemical response rates were improved by the combination treatment, and in no case was clearance of the virus from serum observed.


CONCLUSIONS
In this randomized study carried out on 120 patients with chronic hepatitis C not responsive to alpha-interferon, oral supplementation with N-acetyl cysteine and vitamin E did not improve the poor efficacy of retreatment with alpha-interferon alone.
Idéo
G
G
Department of Hepatology, S. Giuseppe Hospital, Milano, Italy. g.ideo@oh-fbf.it
Bellobuono
A
A
Tempini
S
S
Mondazzi
L
L
Airoldi
A
A
Benetti
G
G
Bissoli
F
F
Cestari
C
C
Colombo
E
E
Del Poggio
P
P
Fracassetti
O
O
Lazzaroni
S
S
Marelli
A
A
Paris
B
B
Prada
A
A
Rainer
E
E
Roffi
L
L
D000111:Acetylcysteine / Q000627:therapeutic use*; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016174:Hepacivirus / Q000302:isolation & purification; D019698:Hepatitis C, Chronic / Q000097:blood / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012367:RNA, Viral / Q000097:blood; D017211:Treatment Failure; D014810:Vitamin E / Q000627:therapeutic use*
D000998:Antiviral Agents; D016898:Interferon-alpha; D012367:RNA, Viral; D014810:Vitamin E; D000410:Alanine Transaminase; D000111:Acetylcysteine