Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)

Summary

The aim is to investigate whether Lamivudine 100mg daily is effective in the long term treatment of HBeAg negative chronic HBV infected patients with active liver disease in Asia

Timeline

Start

2000-11

Primary completion

—

Completion

2005-01

Publications

• Background Tassopoulos NC, Volpes R, Pastore G, Heathcote J, Buti M, Goldin RD, Hawley S, Barber J, Condreay L, Gray DF. Efficacy of lamivudine in patients with hepatitis B e antigen-negative/hepatitis B virus DNA-positive (precore mutant) chronic hepatitis B. Lamivudine Precore Mutant Study Group. Hepatology. 1999 Mar;29(3):889-96. doi: 10.1002/hep.510290321.
• Background Maynard JE. Hepatitis B: global importance and need for control. Vaccine. 1990 Mar;8 Suppl:S18-20; discussion S21-3. doi: 10.1016/0264-410x(90)90209-5.
• Background Tu H, Xiong SD, Trepo C, Wen YM. Frequency of hepatitis B virus e-minus mutants varies among patients from different areas of China. J Med Virol. 1997 Feb;51(2):85-9. doi: 10.1002/(sici)1096-9071(199702)51:23.0.co;2-n.
• Background Tu H, Li PY, Wen YM. Anti-HBe titre in patients infected with wild-type and e-minus variant of hepatitis B virus. Res Virol. 1996 Jan-Feb;147(1):39-43. doi: 10.1016/0923-2516(96)80238-x.
• Background ter Borg F, ten Kate FJ, Cuypers HT, Leentvaar-Kuijpers A, Oosting J, Wertheim-van Dillen PM, Honkoop P, Rasch MC, de Man RA, van Hattum J, Chamuleau RA, Reesink HW, Jones EA. Relation between laboratory test results and histological hepatitis activity in individuals positive for hepatitis B surface antigen and antibodies to hepatitis B e antigen. Lancet. 1998 Jun 27;351(9120):1914-8. doi: 10.1016/s0140-6736(97)09391-4.
• Background Brunetto MR, Giarin MM, Oliveri F, Chiaberge E, Baldi M, Alfarano A, Serra A, Saracco G, Verme G, Will H, et al. Wild-type and e antigen-minus hepatitis B viruses and course of chronic hepatitis. Proc Natl Acad Sci U S A. 1991 May 15;88(10):4186-90. doi: 10.1073/pnas.88.10.4186.
• Background Chu CM, Yeh CT, Chiu CT, Sheen IS, Liaw YF. Precore mutant of hepatitis B virus prevails in acute and chronic infections in an area in which hepatitis B is endemic. J Clin Microbiol. 1996 Jul;34(7):1815-8. doi: 10.1128/JCM.34.7.1815-1818.1996.
• Background Chan HLY, Hui Y, Ching JYL, Leung NWY, Chan FKL, Sung JJY. Can we predict disease activity in chronic hepatitis B virus (CHB) infected patients with negative HBeAg. Gastroenterology 1999; 116: A1195
• Background Chan HLY,Ghany MC, Lok ASF. Hepatitis B. In Schiff ER, Sorrell MF, Madrey WC, Eds. Schiff's Deseases of the LIver, 8th ed. Lippincott-Raven Publishers, New York, 1998:757-92
• Background Zaaijer HL, ter Borg F, Cuypers HT, Hermus MC, Lelie PN. Comparison of methods for detection of hepatitis B virus DNA. J Clin Microbiol. 1994 Sep;32(9):2088-91. doi: 10.1128/jcm.32.9.2088-2091.1994.
• Background Laras A, Koskinas J, Avgidis K, Hadziyannis SJ. Incidence and clinical significance of hepatitis B virus precore gene translation initiation mutations in e antigen-negative patients. J Viral Hepat. 1998 Jul;5(4):241-8. doi: 10.1046/j.1365-2893.1998.00109.x.
• Background Chan HL, Hussain M, Lok AS. Different hepatitis B virus genotypes are associated with different mutations in the core promoter and precore regions during hepatitis B e antigen seroconversion. Hepatology. 1999 Mar;29(3):976-84. doi: 10.1002/hep.510290352.
• Background Krajden M, Minor J, Cork L, Comanor L. Multi-measurement method comparison of three commercial hepatitis B virus DNA quantification assays. J Viral Hepat. 1998 Nov;5(6):415-22. doi: 10.1046/j.1365-2893.1998.00129.x.
• Background Lai VC, Guan R, Wood ML, Lo SK, Yuen MF, Lai CL. Nucleic acid-based cross-linking assay for detection and quantification of hepatitis B virus DNA. J Clin Microbiol. 1999 Jan;37(1):161-4. doi: 10.1128/JCM.37.1.161-164.1999.
• Background Chan HLY, Leung NY, Lau TCM, Wong ML, Sung JJY. Comparison of three different hepatitis B virus (HBV) DNA assays in monitoring of anti-viral therapy. Hepatology 1999 (in press)

Drugs

Indications