Recombinant Interferon-Beta-1α Plus Ribavirin for the Treatment of Chronic HCV Infection: A Prospective, Randomized, Comparative Pilot Study
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Background/Aims: Interferon beta (IFN-β) has been shown to have antiviral activity, and thus could be useful in treating viral infections. Therefore, we compared the efficacy and safety of recombinant IFN-β (IFN-β-1a) plus oral ribavirin versus interferon alpha (IFN-α) plus ribavirin therapy for the treatment of chronic hepatitis C (HCV). Methods: Twenty treatment- naïve patients were randomized into two equal-sized treatment groups. Both IFN-β-1a (44μg) and IFN-α (3 MIU) were given subcutaneously three times a week, while ribavirin was given orally at 1,000-1,200 mg/day. Patients were treated for 24 weeks and followed for an additional 24 weeks. Results: After 24 weeks of treatment, six (60%) and four patients (40%) in the IFN-β-1a group and IFN-α groups, respectively, achieved viral clearance. The sustained virological response (SVR) at the end of the observation period was similar in both groups (40%). However, the baseline viral load was significantly higher (p=0.034) in the IFN-β-1a group than in the IFN-α group, and there were more HCV genotype 1 patients in the IFN-β-1a group (eight versus seven). The IFN-β-1a group was associated with similar adverse events in terms of frequency and severity. Conclusions: The SVR rate and safety profile were similar for the combination of IFN-β-1a and ribavirin and that of IFN-α and ribavirin.
Abstract
Background/Aims: Interferon beta (IFN-β) has been shown to have antiviral activity, and thus could be useful in treating viral infections. Therefore, we compared the efficacy and safety of recombinant IFN-β (IFN-β-1a) plus oral ribavirin versus interferon alpha (IFN-α) plus ribavirin therapy for the treatment of chronic hepatitis C (HCV). Methods: Twenty treatment- naïve patients were randomized into two equal-sized treatment groups. Both IFN-β-1a (44μg) and IFN-α (3 MIU) were given subcutaneously three times a week, while ribavirin was given orally at 1,000-1,200 mg/day. Patients were treated for 24 weeks and followed for an additional 24 weeks. Results: After 24 weeks of treatment, six (60%) and four patients (40%) in the IFN-β-1a group and IFN-α groups, respectively, achieved viral clearance. The sustained virological response (SVR) at the end of the observation period was similar in both groups (40%). However, the baseline viral load was significantly higher (p=0.034) in the IFN-β-1a group than in the IFN-α group, and there were more HCV genotype 1 patients in the IFN-β-1a group (eight versus seven). The IFN-β-1a group was associated with similar adverse events in terms of frequency and severity. Conclusions: The SVR rate and safety profile were similar for the combination of IFN-β-1a and ribavirin and that of IFN-α and ribavirin.
참고문헌 (32)
- Choo QL, "Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome", Science, 244, pp.359~362 (1989)
- National Institutes of Health, "National Institutes of Health Consensus Development Conference Statement: Management of Hepatitis C: 2002--June 10-12, 2002", Hepatology, 36, pp.S3~20 (2002)
- Davis GL, "Projecting future complications of chronic hepatitis C in the United States", Liver Transpl, 9, pp.331~338 (2003)
- Strader DB, "American Association for the Study of Liver Diseases. in: Diagnosis, management, and treatment of hepatitis C", Hepatology, 39, pp.1147~1171 (2004)
- Myers RP, "Interferon for interferon naive patients with chronic hepatitis C", Cochrane Database Syst Rev, 2, pp.CD000370~ (2002)
- Thévenot T, "Meta-analysis of interferon randomized trials in the treatment of viral hepatitis C in naive patients: 1999 update", J Viral Hepat, 8, pp.48~62 (2001)
- Fried MW, "Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection", N Engl J Med, 347, pp.975~982 (2002)
- Pawlotsky JM, "Hepatitis C: it's a long way to new therapy, it's a long way to go", Gastroenterology, 127, pp.1629~1632 (2004)
- San Miguel R, "Meta-analysis: combination therapy with interferon-alpha 2a", 2b and ribavirin for patients with chronic hepatitis C previously non-responsive to interferon, 2002, pp.16, 1611~1621
- Cammà C, "Retreatment with interferon plus ribavirin of chronic hepatitis C non-responders to interferon monotherapy: a meta-analysis of individual patient data", Gut, 51, pp.864~869 (2002)
- Fried MW, "Side effects of therapy of hepatitis C and their management", Hepatology, 36, pp.S237~244 (2002)
- Samuel CE, "Antiviral actions of interferons", Clin Microbiol Rev, 14, pp.778~809 (2001)
- Goodbourn S, "Interferons: cell signalling, immune modulation, antiviral response and virus countermeasures", J Gen Virol, 81, pp.2341~2364 (2000)
- Kaito M, "Twice-a-day versus once-a-day interferon-beta therapy in chronic hepatitis C", Hepatogastroenterology, 50, pp.775~778 (2003)
- Suzuki F, "Twice-daily administration of interferon-beta for chronic hepatitis C is not superior to a once-daily regimen", J Gastroenterol, 36, pp.242~247 (2001)
- Ikeda K, "Interferon beta prevents recurrence of hepatocellular carcinoma after complete resection or ablation of the primary tumor-A prospective randomized study of hepatitis C virus-related liver cancer", Hepatology, 32, pp.228~232 (2000)
- Kobayashi Y, "Quantitation and typing of serum hepatitis C virus RNA in patients with chronic hepatitis C treated with interferon-beta", Hepatology, 18, pp.1319~1325 (1993)
- Buchwalder PA, "Pharmacokinetics and pharmacodynamics of IFN-beta 1a in healthy volunteers", J Interferon Cytokine Res, 20, pp.857~866 (2000)
- Habersetzer F, "A pilot study of recombinant interferon beta-1a for the treatment of chronic hepatitis C", Liver, 20, pp.437~441 (2000)
- Pellicano R, "Interferon beta-1a alone or in combination with ribavirin: a randomized trial to compare efficacy and safety in chronic hepatitis C", World J Gastroentrol, 11, pp.4484~4489 (2005)
- Cheng PN, "Racial differences in responses to interferon-beta-1a in chronic hepatitis C unresponsive to interferon-alpha: a better response in Chinese patients", J Viral Hepat, 11, pp.418~426 (2004)
- De Francesco R, "Challenges and successes in developing new therapies for hepatitis C", Nature, 436, pp.953~960 (2005)
- Omata M, "Resolution of acute hepatitis C after therapy with natural beta interferon", Lancet, 338, pp.914~915 (1991)
- Barbaro G, "Intravenous recombinant interferon-beta versus interferon-alpha-2b and ribavirin in combination for short-term treatment of chronic hepatitis C patients not responding to interferon-alpha. in: Multicenter Interferon Beta Italian Group Investigators", Scand J Gastroenterol, 34, pp.928~933 (1999)
- Pérez R, "Clinical efficacy of intramuscular human interferon-beta vs interferon-alpha 2b for the treatment of chronic hepatitis C", J Viral Hepat, 2, pp.103~106 (1995)
- Castro A, "Tolerance and efficacy of subcutaneous interferon-beta administered for treatment of chronic hepatitis C", J Interferon Cytokine Res, 17, pp.65~67 (1997)
- Murdoch D, "Spotlight on subcutaneous recombinant interferon-beta-1a (Rebif) in relapsing- remitting multiple sclerosis", BioDrugs, 19, pp.323~325 (2005)
- Hepburn MJ, "Differences in treatment outcome for hepatitis C among ethnic groups", Am J Med, 117, pp.163~168 (2004)
- Chan HL, "Randomized trial of interferon beta-1a with or without ribavirin in Asian patients with chronic hepatitis C", Hepatology, 46, pp.315~323 (2007)
- Festi D, "Safety of interferon beta treatment for chronic HCV hepatitis", World J Gastroenterol, 10, pp.12~16 (2004)
- Bagheri H, "Follow-up of adverse drug reactions from peginterferon alfa-2b-ribavirin therapy", Pharmacotherapy, 24, pp.1546~1553 (2004)
- Mager DE, "Pharmacokinetics and pharmacodynamics of PEGylated IFN-beta 1a following subcutaneous administration in monkeys", Pharm Res, 22, pp.58~61 (2005)