A one-year trial of lamivudine for chronic hepatitis B

New England Journal of Medicine

Volumn 339, Issue 2, 1998, Pages 61-68

  Lai, Ching Lung ^a,i   Chien, Rong Nan ^b   Leung, Nancy W Y ^c   Chang, Ting Tsung ^d   Guan, Richard ^e   Tai, Dar In ^b   Ng, Keng Yeen ^f   Wu, Pui Chee ^a   Dent, Julie C ^g   Barber, Judy ^h   Stephenson, Sally L ^h   Gray, D Fraser ^h  

^a QUEEN MARY HOSPITAL   (Hong Kong)

^b CHANG GUNG MEMORIAL HOSPITAL   (Taiwan)

^c CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^d NATIONAL CHENG KUNG UNIVERSITY HOSPITAL   (Taiwan)

^e NATIONAL UNIVERSITY HOSPITAL   (Singapore)

^f SINGAPORE GENERAL HOSPITAL   (Singapore)

^g Glaxo Wellcome   (Hong Kong)

^h GLAXOSMITHKLINE   (United Kingdom)

ⁱ UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PLACEBO; VIRUS DNA;

ABDOMINAL PAIN; ADOLESCENT; ADULT; ARTICLE; CHRONIC HEPATITIS; CLINICAL TRIAL; CONTROLLED STUDY; COUGHING; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; HAIR LOSS; HEADACHE; HEPATITIS B; HISTOLOGY; HUMAN; LIVER BIOPSY; LIVER FIBROSIS; LIVER NECROSIS; MAJOR CLINICAL STUDY; MALAISE; MALE; MULTICENTER STUDY; NAUSEA; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT INFECTION; SEROCONVERSION; VERTIGO; VIRUS MUTATION; VOMITING;

ADOLESCENT; ADULT; AGED; ALANINE TRANSAMINASE; DNA, VIRAL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HEPATITIS B E ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; LAMIVUDINE; LIVER; LIVER CIRRHOSIS; MALE; MIDDLE AGED; MUTATION; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 0032499913     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199807093390201     Document Type: Article

References (30)

1. Maynard JE. Hepatitis B: global importance and need for control. Vaccine 1990;8:Suppl:S18-S20.
2. Liaw YF, Tai DI, Chu CM, Chen TJ. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology 1988;8:493-6.
3. Beasley RP, Hwang LY, Lin CC, Chien CS. Hepatocellular carcinoma and hepatitis B virus: a prospective study of 22 707 men in Taiwan. Lancet 1981;2:1129-33.
4. Stevens CE, Neurath RA, Beasley RP, Szmunes W. HBeAg and anti-HBe detection by radioimmunoassay: correlation with vertical transmission of hepatitis B virus in Taiwan. J Med Virol 1979;3:237-41.
5. Xu ZY, Liu CB, Francis DP, et al. Prevention of perinatal acquisition of hepatitis B virus carriage using vaccine: preliminary report of a randomized, double-blind, placebo-controlled and comparative trial. Pediatrics 1985;76:713-8.
6. Beasley RP, Hwang LY. Postnatal infectivity of hepatitis B surface antigen-carrier mothers. J Infect Dis 1983;147:185-90.
7. de Jongh FE, Jassen HL, de Man RA, Hop WC, Schalm SW, van Blankenstein M. Survival and prognostic indicators of hepatitis B surface antigen-positive cirrhosis of the liver. Gastroenterology 1992;103:1630-5.
8. Wong DKH, Cheung AM, O'Rourke K, Naylor CD, Detsky AS, Heathcote J. Effect of alpha-interferon treatment in patients with hepatitis B e antigen-positive chronic hepatitis B: a meta-analysis. Ann Intern Med 1993;119:312-23.
9. Dusheiko GM. Treatment and prevention of chronic viral hepatitis. Pharmacol Ther 1995;65:47-73.
10. Chung HT, Lok ASF, Lai CL. Re-evaluation of α-interferon treatment of chronic hepatitis B using polymerase chain reaction. J Hepatol 1993;17: 208-14.
11. Liaw YF, Lin SM, Chen TJ, Chien RN, Sheen IS, Chu CM. Beneficial effect of prednisolone withdrawal followed by human lymphoblastoid interferon on the treatment of chronic type B hepatitis in Asians: a randomized controlled trial. J Hepatol 1994;20:175-80.
12. Lok ASF, Wu PC, Lai CL, et al. A controlled trial of interferon with or without prednisone priming for chronic hepatitis B. Gastroenterology 1992;102:2091-7.
13. 2-interferon in Chinese HBsAg-carrier children. Lancet 1987;2:877-80.
14. 2-interferon in Chinese patients with chronic hepatitis B infection. Lancet 1988;2:298-302.
15. 2 interferon with or without prednisone in Chinese HBsAg carrier children. QJM 1991; 78:155-63.
16. Eron JJ, Benoit SL, Jemsek J, et al. Treatment with lamivudine, zidovudine, or both in HIV-positive patients with 200 to 500 CD4+ cells per cubic millimeter. N Engl J Med 1995;333:1662-9.
17. Tyrrell DLJ, Mitchell MC, De Man RA, et al. Phase II trial of lamivudine for chronic hepatitis B. Hepatology 1993;18:Suppl:112A. abstract.
18. Lai CL, Ching CK, Tung AKM, et al. Lamivudine is effective in suppressing hepatitis B virus DNA in Chinese hepatitis B surface antigen carriers: a placebo-controlled trial. Hepatology 1997;25:241-4.
19. Dienstag JL, Perrillo RP, Schiff ER, Bartholomew M, Vicary C, Rubin R. A preliminary trial of lamivudine for chronic hepatitis B infection. N Engl J Med 1995;333:1657-61.
20. Nevens F, Main J, Honkoop P, et al. Lamivudine therapy for chronic hepatitis B: a six-month randomised dose-ranging study. Gastroenterology 1997;113:1258-63.
21. Knodell RG, Ishak KG, Black WC, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981;1:431-5.
22. Wu PC, Lau JYN, Lau TK, Lau SK, Lai CL. Relationship between intrahepatic expression of hepatitis B viral antigens and histology in Chinese patients with chronic hepatitis B virus infection. Am J Clin Pathol 1993;100:648-53.
23. Wu PC, Fang JW, Lai CL, et al. Hepatic expression of hepatitis B virus genome in chronic hepatitis B virus infection. Am J Clin Pathol 1996;105: 87-95.
24. Ling R, Mutimer D, Ahmed M, et al. Selection of mutations in the hepatitis B virus polymerase during therapy of transplant recipients with lamivudine. Hepatology 1996;24:711-3.
25. Bartholomew MM, Jansen RW, Jeffers LJ, et al. Hepatitis-B-virus resistance to lamivudine given for recurrent infection after orthotopic liver transplantation. Lancet 1997;349:20-2.
26. Armitage P, Berry G. Statistical methods in medical research. 2nd ed. Oxford, England: Blackwell Scientific, 1987.
27. Fleiss JL. Statistical methods for rates and proportions. 2nd ed. New York: John Wiley, 1981.
28. Stokes ME, Davis CS, Koch GG. Categorical data analysis using the SAS system. Cary, N.C.: SAS Institute, 1995.
29. Perrillo RP Schiff ER, Davis GL, et al. A randomized, controlled trial of interferon alfa-2b alone and after prednisone withdrawal for the treatment of chronic hepatitis B. N Engl J Med 1990;323:295-301.
30. Niederau C, Heintges T, Lange S, et al. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med 1996;334:1422-7.