Efficacy and Safety of In-Asia-manufactured Interferon alpha-2b in Combination with Ribavirin for Therapy of Naïve Chronic Hepatitis C Patients: A Multicenter, Prospective, Open-Label Trial
), Ali Sulaiman(2), Rino Alvani Gani(3), Irsan Hasan(4), Laurentius Lesmana(5), Andri Sanityoso(6), Sjaifoellah Noer(7), FX Pridady(8), Soemarno Soemarno(9),
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Corresponding Author
Abstract
Background: An open-label, multi center and non-comparative study was conducted to evaluate the efficacy and safety of a more affordable in-Asia-manufactured interferon á-2b product in combination with ribavirin to treat naïve chronic hepatitis C patients.
Method: Thirty chronic naïve hepatitis C patients were treated with in-Asia-manufactured interferon a-2b subcutaneously 3 MIU thrice weekly and ribavirin 800-1,200 mg daily for 48 weeks. Follow-up was done until 24 weeks after the end of treatment. Efficacy was assessed by examining serologic and biochemical parameters at pre and post-treatment. Safety was assessed by evaluating clinical symptoms and laboratory parameters.
Results: The virological response and sustained virological response rates of all Hepatitis C Virus (HCV) genotypes were 83.3% and 76.7% respectively. Post-treatment, 80% patients had significant alanine transaminase (ALT) decreased into normal level and remained normal in 76.7% patients at 24th week follow up period. At that time, the ALT level and sustained virological response were lower in HCV genotypes 1 and 4 than in non-1 and non-4 genotypes. The most frequent adverse event was flu-like syndrome.
Conclusion: The efficacy and safety study on combination therapy of in-Asia-manufactured interferon a-2b and ribavirin has shown a good result based on the current standard of interferon alpha and ribavirin combination therapy.
Keywords: interferons, combination drug therapy, chronic hepatitis C, treatment efficacy, safety
Method: Thirty chronic naïve hepatitis C patients were treated with in-Asia-manufactured interferon a-2b subcutaneously 3 MIU thrice weekly and ribavirin 800-1,200 mg daily for 48 weeks. Follow-up was done until 24 weeks after the end of treatment. Efficacy was assessed by examining serologic and biochemical parameters at pre and post-treatment. Safety was assessed by evaluating clinical symptoms and laboratory parameters.
Results: The virological response and sustained virological response rates of all Hepatitis C Virus (HCV) genotypes were 83.3% and 76.7% respectively. Post-treatment, 80% patients had significant alanine transaminase (ALT) decreased into normal level and remained normal in 76.7% patients at 24th week follow up period. At that time, the ALT level and sustained virological response were lower in HCV genotypes 1 and 4 than in non-1 and non-4 genotypes. The most frequent adverse event was flu-like syndrome.
Conclusion: The efficacy and safety study on combination therapy of in-Asia-manufactured interferon a-2b and ribavirin has shown a good result based on the current standard of interferon alpha and ribavirin combination therapy.
Keywords: interferons, combination drug therapy, chronic hepatitis C, treatment efficacy, safety
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DOI: 10.24871/10120097-13
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