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 comparin g 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 transamina se (ALT) activities decreased but by less than 50% from baseline in 67 pati ents (89%), decreased by more than 50% in 12 patients (13%) and became norm al in 9 patients (9%) with no overall change in HCV-RNA levels. Subsequentl y no patient in either treatment group achieved a sustained virologic respo nse, Improvements in necroinflammatory changes were noted in liver biopsy s pecimens in those patients receiving phlebotomy plus interferon (mean index 8.59 vs. 7.37, P < .05). A slight but not statistically significant decrea se in histologic activity index was noted in those subjects treated by phle botomy 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 man ifested by a decrease in serum transaminase activity and a slight improveme nt in liver histopathology.