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A Multicenter Study to Evaluate the Safety and Efficacy of Heberon (Interferon Alfa-2B) in Combination With Ribavirin for the Treatment of Chronic Hepatitis C in Iran



Forootan H1 ; Sharifi A1 ; Mirmomen SH1 ; Daryani N1 ; Ghofrani H1 ; Farahvash M1 ; Nasiri M1 ; Talebi M2 ; Ghavidel A3 ; Vosoghinia H4 ; Mansourghanaei F5 ; Zahedi M6 ; Mirmomen H7 ; Azmi M7 Show All Authors
Authors
  1. Forootan H1
  2. Sharifi A1
  3. Mirmomen SH1
  4. Daryani N1
  5. Ghofrani H1
  6. Farahvash M1
  7. Nasiri M1
  8. Talebi M2
  9. Ghavidel A3
  10. Vosoghinia H4
  11. Mansourghanaei F5
  12. Zahedi M6
  13. Mirmomen H7
  14. Azmi M7
  15. Amirian M8
  16. Gharb S9
Show Affiliations
Authors Affiliations
  1. 1. Digestive Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Tehran, Iran
  2. 2. Department of Gastroenterology and Hepatology, Esfahan University of Medical Sciences, Alzahra Hospital, Esfahan, Iran
  3. 3. Department of Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Imam Khomeini Hospital, Tabriz, Iran
  4. 4. Department of Internal Medicine, Mashhad University of Medical Sciences, Ghaem Hospital, Mashhad, Iran
  5. 5. Digestive Research Center, Gilan University of Medical Sciences, Razi Hospital, Rasht, Iran
  6. 6. Samenolhojaj Therapeutic Center, Kerman, Iran
  7. 7. Department of Internal Medicine, Ahvaz University of Medical Sciences, Sina Hospital, Ahvaz, Iran
  8. 8. Department of Internal Medicine, Zahedan University of Medical Sciences, Emam Khomeini Hospital, Zahedan, Iran
  9. 9. Baharestan St.

Source: Medical Journal of the Islamic Republic of Iran Published:2005

Abstract

Background: Combination therapy with interferon and ribavirin is the most effective treatment for chronic hepatitis C today. The aim of this study was to evaluate the efficacy and safety of thrice-weekly Heberon (interferon alfa-2b) in combination with ribavirin as first-line treatment of chronic hepatitis C. Methods: A total of 97 treatment-naive patients received Heberon three million units thrice-weekly subcutaneously in combination with ribavirin for 12 months. Serum HCV RNA levels were measured before and during therapy and 6 months after the end of therapy. End-of-treatment and sustained virological responses was defined as an undetectable HCV-RNA level at the end of treatment, and 6 months after treatment was completed (end of follow-up), respectively. Results: In an intent-to-treat analysis, HCV-RNA was undetectable at the end of treatment in 49.5% of patients. At the end of follow-up, sustained virological response was 36.1%. Combination treatment was generally well tolerated. Six patients stopped therapy because of side effects: severe cytopenia (n=4), depression (n=1), and hyperthyroidism (n=1). Common side effects of therapy include: Flu-like syndrome (85.6%), generalized alopecia (41.2%), injection site inflammation (37.1%), mood changes (36%), anorexia (34%) and weight loss (32%). Conclusion: Heberon as an IFN product in combination with ribavirin for treatment of patients with chronic hepatitis C is relatively safe, feasible, and potentially efficacious. It has comparable results in achieving end-of-treatment and sustained virological responses in chronic hepatitis C.
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