AND THE CONSENSUS INTERFERON STUDY GROUP 15 tion. Efficacy was assessed by normalization of serum alanine This multicenter, randomized, controlled, double-blind, transaminase (ALT) concentration and decrease in serum hepphase III study in 704 patients with chronic hepatitis C infecatitis C virus (HC
Iron reduction before and during interferon therapy of chronic hepatitis C: Results of a multicenter, randomized, controlled trial
โ Scribed by Robert J. Fontana; Jonathan Israel; Paula LeClair; Barbara F. Banner; Kristina Tortorelli; Norman Grace; Robert A. Levine; Gale Fiarman; Michael Thiim; Anthony S. Tavill; Herbert L. Bonkovsky
- Publisher
- John Wiley and Sons
- Year
- 2000
- Tongue
- English
- Weight
- 126 KB
- Volume
- 31
- Category
- Article
- ISSN
- 0270-9139
No coin nor oath required. For personal study only.
โฆ Synopsis
Patients with chronic hepatitis C and low serum and hepatic iron stores may have an improved response to interferon (IFN). We tested whether iron reduction before and during IFN therapy would lead to an improved sustained biochemical and virological response compared with IFN alone. Eighty-two previously untreated patients with chronic hepatitis C were randomized to either: group A IFN-โฃ2b 3 MU 3 times per week for 6 months, or group B iron reduction before and during IFN-โฃ2b 3 MU 3 times per week for 6 months. Group B patients had lower mean serum alanine transaminase (ALT) levels than group A patients during treatment and follow-up. Group B patients had significantly lower mean hepatitis C virus (HCV)-RNA levels at treatment weeks 4 and 12 (P F .05). Serum HCV RNA was undetectable at the end of treatment in 15 group B patients compared with 7 group A patients (P โซุโฌ .03); 7 group B patients and 3 group A patients had persistently undetectable serum HCV RNA 24 weeks after the end of therapy (P โซุโฌ .20). Paired pre-and posttreatment liver biopsies in 18 group B patients demonstrated significant improvements in 2 of the 3 inflammation scores of the Knodell histological activity index (P F .05). No changes occurred in the paired biopsies from 15 group A patients. We conclude that iron reduction via therapeutic phlebotomy improves the end-of-treatment virological and histo-logical response to short-term IFN therapy. Additional studies are needed to determine if iron reduction in combination with higher doses or longer duration of IFN may be of benefit. (HEPATOLOGY 2000;31:730-736.)
Abbreviations: IFN, interferon; HCV, hepatitis C virus; ALT, alanine transaminase; SVR, sustained virological response; ETVR, end-of-treatment virologic response; ETBR, end-of-treatment biochemical response; SBR, sustained biochemical response; HAI, histological activity index; 8EPGF28, epiprostaglandin F 2โฃ .
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