Pegasys and Copegus for Asian Patients With Treatment-naive Hepatitis C Genotypes 6, 7, 8, 9

Summary

The purpose of this research study is to test the safety, tolerability, and effectiveness of the drugs Pegasys and Copegus when used for hepatitis C genotypes 6, 7, 8, and 9. Patients are randomly assigned (by chance) to either Treatment Group A (Pegasys and Copegus for 24 weeks) or Treatment Group B (Pegasys and Copegus for 48 weeks).

Timeline

Start

2004-10

Primary completion

2009-09

Completion

2009-09

Publications

• Background Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
• Background Adams NJ, Chamberlain RW, Taylor LA, Davidson F, Lin CK, Elliott RM, Simmonds P. Complete coding sequence of hepatitis C virus genotype 6a. Biochem Biophys Res Commun. 1997 May 19;234(2):393-6. doi: 10.1006/bbrc.1997.6627.
• Background Nguyen MH, Keeffe EB. Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6. Clin Gastroenterol Hepatol. 2005 Oct;3(10 Suppl 2):S97-S101. doi: 10.1016/s1542-3565(05)00711-1.
• Background Mizokami M, Gojobori T, Ohba K, Ikeo K, Ge XM, Ohno T, Orito E, Lau JY. Hepatitis C virus types 7, 8 and 9 should be classified as type 6 subtypes. J Hepatol. 1996 May;24(5):622-4. doi: 10.1016/s0168-8278(96)80149-8.
• Background Nguyen MH, Keeffe EB. Chronic hepatitis C: genotypes 4 to 9. Clin Liver Dis. 2005 Aug;9(3):411-26, vi. doi: 10.1016/j.cld.2005.05.010.
• Background Lu L, Nakano T, He Y, Fu Y, Hagedorn CH, Robertson BH. Hepatitis C virus genotype distribution in China: predominance of closely related subtype 1b isolates and existence of new genotype 6 variants. J Med Virol. 2005 Apr;75(4):538-49. doi: 10.1002/jmv.20307.
• Background Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Goncales FL Jr, Haussinger D, Diago M, Carosi G, Dhumeaux D, Craxi A, Lin A, Hoffman J, Yu J. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med. 2002 Sep 26;347(13):975-82. doi: 10.1056/NEJMoa020047.
• Background Lindsay KL. Introduction to therapy of hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S114-20. doi: 10.1053/jhep.2002.36226.
• Background Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet. 2001 Sep 22;358(9286):958-65. doi: 10.1016/s0140-6736(01)06102-5.
• Background Kinzie JL, Naylor PH, Nathani MG, Peleman RR, Ehrinpreis MN, Lybik M, Turner JR, Janisse JJ, Massanari M, Mutchnick MG. African Americans with genotype 1 treated with interferon for chronic hepatitis C have a lower end of treatment response than Caucasians. J Viral Hepat. 2001 Jul;8(4):264-9. doi: 10.1046/j.1365-2893.2001.00292.x.
• Background Muir A, Rockey DC. Treatment of acute hepatitis C with interferon alfa-2b. N Engl J Med. 2002 Apr 4;346(14):1091-2. No abstract available.
• Background Reddy KR, Hoofnagle JH, Tong MJ, Lee WM, Pockros P, Heathcote EJ, Albert D, Joh T. Racial differences in responses to therapy with interferon in chronic hepatitis C. Consensus Interferon Study Group. Hepatology. 1999 Sep;30(3):787-93. doi: 10.1002/hep.510300319.
• Background Wiley TE. Hepatitis C: does race really matter? Am J Gastroenterol. 2001 Aug;96(8):2292-4. doi: 10.1111/j.1572-0241.2001.04030.x. No abstract available.
• Background Hui CK, Yuen MF, Sablon E, Chan AO, Wong BC, Lai CL. Interferon and ribavirin therapy for chronic hepatitis C virus genotype 6: a comparison with genotype 1. J Infect Dis. 2003 Apr 1;187(7):1071-4. doi: 10.1086/368217. Epub 2003 Mar 7.
• Background Dev AT, McCaw R, Sundararajan V, Bowden S, Sievert W. Southeast Asian patients with chronic hepatitis C: the impact of novel genotypes and race on treatment outcome. Hepatology. 2002 Nov;36(5):1259-65. doi: 10.1053/jhep.2002.36781.
• Background McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, Ling MH, Cort S, Albrecht JK. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med. 1998 Nov 19;339(21):1485-92. doi: 10.1056/NEJM199811193392101.

Drugs

Indications