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All Journal The Indonesian Journal of Gastroenterology, Hepatology and Digestive Endoscopy
FX Pridady
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Medicine & Pharmacology

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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 Nurul Akbar; Ali Sulaiman; Rino Alvani Gani; Irsan Hasan; Laurentius Lesmana; Andri Sanityoso; Sjaifoellah Noer; FX Pridady; Soemarno Soemarno
The Indonesian Journal of Gastroenterology, Hepatology, and Digestive Endoscopy VOLUME 10, ISSUE 1, April 2009
Publisher : The Indonesian Society for Digestive Endoscopy

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.24871/10120097-13

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
Co-Authors Ali Sulaiman Ali Sulaiman Andri Sanityoso Andri Sanityoso Irsan Hasan Laurentius Lesmana Laurentius Lesmana Nurul Akbar Nurul Akbar Rino Alvani Gani Rino Alvani Gani Sjaifoellah Noer Soemarno Soemarno Soemarno Soemarno