Iron reduction before and during interferon therapy of chronic hepatitis C: Results of a multicenter, randomized, controlled trial

Patients with chronic hepatitis C and low serum and hepatic iron stores may have an improved response to interferon (IFN), We tested whether iron redu ction before and during IFN therapy would lead to an improved sustained bio chemical and virological response compared with IFN alone, Eighty-two previ ously untreated patients with chronic hepatitis C were randomized to either : group A IFN-alpha 2b 3 MU 3 times per week for 6 months, or group B iron reduction before and during IFN-alpha 2b 3 MU 3 times per week for 6 months . Group B patients had lower mean serum alanine transaminase (ALT) levels t han group A patients during treatment and follow-up. Group B patients had s ignificantly lower mean hepatitis C virus (HCV)-RNA levels at treatment wee ks 4 and 12 (P < .05). Serum HCV RNA was undetectable at the end of treatme nt in 15 group B patients compared with 7 group A patients (P = .03); 7 gro up B patients and 3 group A patients had persistently undetectable serum HC V RNA 24 weeks after the end of therapy (P = .20), Paired pre- and posttrea tment liver biopsies in 18 group B patients demonstrated significant improv ements in 2 of the 3 inflammation scores of the Knodell histological activi ty index (P < .05), No changes occurred in the paired biopsies from 15 grou p A patients. We conclude that iron reduction via therapeutic phlebotomy im proves the end-of-treatment virological and histological response to short- term IFN therapy. Additional studies are needed to determine if iron reduct ion in combination with higher doses or longer duration of IFN may be of be nefit.