title: 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.
abstract: 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.
authors.affiliation: Saint Louis University School of Medicine, St. Louis, MO 63104, USA. dibiscam@slu.edu
authors.forename: A M
authors.initials: AM
authors.lastname: Di Bisceglie
authors.forename: H L
authors.initials: HL
authors.lastname: Bonkovsky
authors.forename: S
authors.initials: S
authors.lastname: Chopra
authors.forename: S
authors.initials: S
authors.lastname: Flamm
authors.forename: R K
authors.initials: RK
authors.lastname: Reddy
authors.forename: N
authors.initials: N
authors.lastname: Grace
authors.forename: P
authors.initials: P
authors.lastname: Killenberg
authors.forename: C
authors.initials: C
authors.lastname: Hunt
authors.forename: C
authors.initials: C
authors.lastname: Tamburro
authors.forename: A S
authors.initials: AS
authors.lastname: Tavill
authors.forename: R
authors.initials: R
authors.lastname: Ferguson
authors.forename: E
authors.initials: E
authors.lastname: Krawitt
authors.forename: B
authors.initials: B
authors.lastname: Banner
authors.forename: B R
authors.initials: BR
authors.lastname: Bacon
mesh_terms: 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
chemical_list: D007372:Interferons; D007501:Iron; D000410:Alanine Transaminase