Timing and Duration of Acute Hepatitis C Treatment

Summary

Spontaneous resolution of acute hepatitis C infection cannot be predicted and the majority of cases persist and become chronic. This randomized trial assesses the efficacy and safety of peginterferon alfa-2b. The investigators hypothesize that therapy strategies could prevent the development of chronic hepatitis.

Timeline

Start

2002-01

Primary completion

—

Completion

2006-01

Publications

• Background Kamal SM, Ismail A, Graham CS, He Q, Rasenack JW, Peters T, Tawil AA, Fehr JJ, Khalifa Kel S, Madwar MM, Koziel MJ. Pegylated interferon alpha therapy in acute hepatitis C: relation to hepatitis C virus-specific T cell response kinetics. Hepatology. 2004 Jun;39(6):1721-31. doi: 10.1002/hep.20266.
• Background Gerlach JT, Diepolder HM, Zachoval R, Gruener NH, Jung MC, Ulsenheimer A, Schraut WW, Schirren CA, Waechtler M, Backmund M, Pape GR. Acute hepatitis C: high rate of both spontaneous and treatment-induced viral clearance. Gastroenterology. 2003 Jul;125(1):80-8. doi: 10.1016/s0016-5085(03)00668-1.
• Background Nomura H, Sou S, Tanimoto H, Nagahama T, Kimura Y, Hayashi J, Ishibashi H, Kashiwagi S. Short-term interferon-alfa therapy for acute hepatitis C: a randomized controlled trial. Hepatology. 2004 May;39(5):1213-9. doi: 10.1002/hep.20196.
• Background Kamal SM, Rasenack JW, Bianchi L, Al Tawil A, El Sayed Khalifa K, Peter T, Mansour H, Ezzat W, Koziel M. Acute hepatitis C without and with schistosomiasis: correlation with hepatitis C-specific CD4(+) T-cell and cytokine response. Gastroenterology. 2001 Sep;121(3):646-56. doi: 10.1053/gast.2001.27024.
• Background Santantonio T, Sinisi E, Guastadisegni A, Casalino C, Mazzola M, Gentile A, Leandro G, Pastore G. Natural course of acute hepatitis C: a long-term prospective study. Dig Liver Dis. 2003 Feb;35(2):104-13. doi: 10.1016/s1590-8658(03)00007-0.
• Background Wiegand J, Jackel E, Cornberg M, Hinrichsen H, Dietrich M, Kroeger J, Fritsch WP, Kubitschke A, Aslan N, Tillmann HL, Manns MP, Wedemeyer H. Long-term follow-up after successful interferon therapy of acute hepatitis C. Hepatology. 2004 Jul;40(1):98-107. doi: 10.1002/hep.20291.
• Background Kamal SM, El Tawil AA, Nakano T, He Q, Rasenack J, Hakam SA, Saleh WA, Ismail A, Aziz AA, Madwar MA. Peginterferon alpha-2b and ribavirin therapy in chronic hepatitis C genotype 4: impact of treatment duration and viral kinetics on sustained virological response. Gut. 2005 Jun;54(6):858-66. doi: 10.1136/gut.2004.057182.
• Background Jaeckel E, Cornberg M, Wedemeyer H, Santantonio T, Mayer J, Zankel M, Pastore G, Dietrich M, Trautwein C, Manns MP; German Acute Hepatitis C Therapy Group. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med. 2001 Nov 15;345(20):1452-7. doi: 10.1056/NEJMoa011232.
• Background Larghi A, Zuin M, Crosignani A, Ribero ML, Pipia C, Battezzati PM, Binelli G, Donato F, Zanetti AR, Podda M, Tagger A. Outcome of an outbreak of acute hepatitis C among healthy volunteers participating in pharmacokinetics studies. Hepatology. 2002 Oct;36(4 Pt 1):993-1000. doi: 10.1053/jhep.2002.36129.

Drugs

Indications