Iron reduction as an adjuvant to interferon therapy in patients with chronic hepatitis C who have previously not responded to interferon: a multicenter, prospective, randomized, controlled trial.
Hepatic iron concentration has consistently been observed as being directly correlated with the response to interferon therapy in chronic hepatitis C virus (HCV). We therefore conducted a randomized, controlled trial comparing iron reduction by phlebotomy with iron reduction followed by retreatment with interferon in 96 patients with chronic hepatitis C who had previously not responded to a course of interferon. During the initial phase when all patients were undergoing phlebotomy, we found that serum alanine transaminase (ALT) activities decreased but by less than 50% from baseline in 67 patients (89%), decreased by more than 50% in 12 patients (13%) and became normal in 9 patients (9%) with no overall change in HCV-RNA levels. Subsequently no patient in either treatment group achieved a sustained virologic response. Improvements in necroinflammatory changes were noted in liver biopsy specimens in those patients receiving phlebotomy plus interferon (mean index 8.59 vs. 7.37, P <. 05). A slight but not statistically significant decrease in histologic activity index was noted in those subjects treated by phlebotomy alone (mean index 8.4 vs. 7.75, P not significant). We conclude that, although prior phlebotomy therapy does not improve the rate of sustained response to interferon retreatment, it does result in less liver injury manifested by a decrease in serum transaminase activity and a slight improvement in liver histopathology.
Di Bisceglie
A M
AM
Saint Louis University School of Medicine, St. Louis, MO 63104, USA. dibiscam@slu.edu
Bonkovsky
H L
HL
Chopra
S
S
Flamm
S
S
Reddy
R K
RK
Grace
N
N
Killenberg
P
P
Hunt
C
C
Tamburro
C
C
Tavill
A S
AS
Ferguson
R
R
Krawitt
E
E
Banner
B
B
Bacon
B R
BR
D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D005260:Female; D019698:Hepatitis C, Chronic / Q000628:therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D007501:Iron / Q000097:blood*; D008297:Male; D008875:Middle Aged; D018962:Phlebotomy; D011446:Prospective Studies
D007372:Interferons; D007501:Iron; D000410:Alanine Transaminase