BACKGROUND/AIMS: Interferon a (IFN) is the only agent currently approved by the FDA for the treatment of chronic viral hepatitis due to hepatitis C (HCV). Unfortunately, less than half the patients with HCV treated with IFN respond. Worse yet, half or more of those who do respond relapse when the agent is withdrawn. MATERIALS AND METHODS: In this prospective randomized study, 30 individuals who had failed to respond to a standard course of IFN therapy consisting of 3 MU IFN administered 3 x week for 6 months were randomized to receive a second 6 month course of either 5 MU IFN daily or 5 MU IFN plus regular phlebotomies at weekly intervals to achieve a hemoglobin level of between 10-11 g/dl. The response rates defined as HCV-RNA negativity after 6 months of therapy and after 6 months of follow-up without IFN were determined. RESULTS: Both groups experienced a significant reduction in their serum ALT levels (p < 0.01) and Knodell scores with treatment. A greater number of responders were found in the phlebotomy plus IFN group than in the IFN alone group whether the response was defined by the serum ALT level or presence or absence of HCV-RNA in serum at the end of treatment and follow-up. CONCLUSIONS: The results of this study suggest that both an increased IFN dose coupled with more frequent dosing of IFN alone and combined with phlebotomy treatment are effective at obtaining a response to IFN in individuals with HCV disease who previously have failed to respond to a standard treatment regimen.
RCT Entities:
BACKGROUND/AIMS: Interferon a (IFN) is the only agent currently approved by the FDA for the treatment of chronic viral hepatitis due to hepatitis C (HCV). Unfortunately, less than half the patients with HCV treated with IFN respond. Worse yet, half or more of those who do respond relapse when the agent is withdrawn. MATERIALS AND METHODS: In this prospective randomized study, 30 individuals who had failed to respond to a standard course of IFN therapy consisting of 3 MU IFN administered 3 x week for 6 months were randomized to receive a second 6 month course of either 5 MU IFN daily or 5 MU IFN plus regular phlebotomies at weekly intervals to achieve a hemoglobin level of between 10-11 g/dl. The response rates defined as HCV-RNA negativity after 6 months of therapy and after 6 months of follow-up without IFN were determined. RESULTS: Both groups experienced a significant reduction in their serum ALT levels (p < 0.01) and Knodell scores with treatment. A greater number of responders were found in the phlebotomy plus IFN group than in the IFN alone group whether the response was defined by the serum ALT level or presence or absence of HCV-RNA in serum at the end of treatment and follow-up. CONCLUSIONS: The results of this study suggest that both an increased IFN dose coupled with more frequent dosing of IFN alone and combined with phlebotomy treatment are effective at obtaining a response to IFN in individuals with HCV disease who previously have failed to respond to a standard treatment regimen.
Authors: Massimo Franchini; Giovanni Targher; Franco Capra; Martina Montagnana; Giuseppe Lippi Journal: Hepatol Int Date: 2008-05-08 Impact factor: 6.047