Lamivudine: In children and adolescents with chronic hepatitis B virus infection

Pediatric Drugs

Volumn 4, Issue 10, 2002, Pages 687-694

  Keam, Susan J ^a   Scott, Lesley J ^a  

^a ADIS INTERNATIONAL INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALPHA INTERFERON; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; VIRUS DNA; ZALCITABINE;

ABDOMINAL DISCOMFORT; ABDOMINAL PAIN; ADOLESCENT DISEASE; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ALOPECIA; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; CHILDHOOD DISEASE; CLINICAL TRIAL; COUGHING; DEPRESSION; DOSE KIDNEY FUNCTION RELATION; DOSE RESPONSE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG INDICATION; DRUG MECHANISM; DRUG METABOLISM; DRUG RESPONSE; DRUG TOLERABILITY; FEVER; FLU LIKE SYNDROME; HEADACHE; HEPATITIS B; HUMAN; INFECTION; NEUTROPENIA; PRIORITY JOURNAL; REVIEW; SORE THROAT;

EID: 0036396361     PISSN: 11745878     EISSN: None     Source Type: Journal    
DOI: 10.2165/00128072-200204100-00005     Document Type: Review

References (43)

1. Dusheiko G. Lamivudine therapy for hepatitis B infection. Scand J Gastroenterol 1999; 34 Suppl. 230: 76-81
2. Johnson MA, Moore KHP, Yuen GJ, et al. Clinical pharmacokinetics of lamivudine. Clin Pharmacokinet 1999 Jan; 36 (1): 41-66
3. Sokal EM, Roberts EA, Mieli-Vergani G, et al. A dose ranging study of the pharmacokinetics, safety, and preliminary efficacy of lamivudine in children and adolescents with chronic hepatitis B. Antimicrob Agents Chemother 2000 Mar; 44 (3): 590-7
4. Leung N. Management of chronic hepatitis B: nucleoside analogues in the treatment of chronic hepatitis B. J Gastroenterol Hepatol 2000; 15 Suppl.: E53-60
5. Jarvis B, Faulds D. Lamivudine: a review of its therapeutic potential in chronic hepatitis B. Drugs 1999 Jul; 58: 101-41
6. Perry CM, Faulds D. Lamivudine: a review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV infection. Drugs 1997 Apr; 53 (4): 657-80
7. Santantonio T, Niro GA, Sinisi E, et al. Lamivudine/interferon combination therapy in anti-HBe positive chronic hepatitis B patients: a controlled pilot study. J Hepatol 2002; 36: 799-804
8. Barbaro G, Zechini F, Pellichelli AM, et al. Long-term efficacy of interferon alpha-2b and lamivudine in combination compared to lamivudine monotherapy in patients with chronic hepatitis B: an Italian multicenter, randomized trial. J Hepatol 2001; 35: 406-11
9. Schalm SW, Heathcote J, Cianciara J, et al. Lamivudine and alpha interferon combination treatment of patients with chronic hepatitis B infection: a randomised trial. Gut 2000; 46: 562-8
10. Tatulli I, Francavilla R, Rizzo GL, et al. Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B. J Hepatol 2001; 35: 805-10
11. Jarvis B, Perry CM. Management of chronic hepatitis B: defining the role of lamivudine. Dis Manage Health Outcomes 2001; 9 (4): 215-34
12. Sokal E. Drug treatment of pediatric chronic hepatitis B. Pediatric Drugs 2002; 4 (6): 361-9
13. World Health Organisation. Vaccines, immunization and biologicals: hepatitis B vaccine [online]. Available from URL: http://www.who.int/vaccines/en/hepatitisb.shtml [Accessed 2002 Jul 19]
14. Gust ID. Epidemiology of hepatitis B infection in the Western Pacific and South East Asia. Gut 1996; 38 Suppl. 2: S18-23
15. Mahoney FJ. Update on diagnosis, management, and prevention of hepatitis B infection. Clin Microbiol Rev 1999; 12: 351-66
16. Jara P, Bortolotti F. Interferon-alpha treatment of chronic hepatitis B in childhood: a consensus advice based on experience in European children. J Pediatr Gastroenterol Nutr 1999 Aug; 29: 163-70
17. Merican I. Treatment of chronic hepatitis B virus infection in special groups of patients: decompensated cirrhosis, immunosuppressed and paediatric patients. J Gastroenterol Hepatol 2000 May; 15 Suppl.: E71-8
18. Lok ASF, McMahon BJ. AASLD practice guidelines: chronic hepatitis B. Hepatology 2001; 34 (6): 1225-41
19. FDA. Drug approvals for August 2001 [online]. Available from URL: www.fda.gov/cder/da/da0801.htm [Accessed 2002 May 20]
20. FDA. Pediatric exclusivity labeling changes [online]. Available from URL: http://www.fda.gov/cder/pediatric/labelchange.htm [Accessed 2002 May 20]
21. Locarnini S, Birch C. Antiviral chemotherapy for chronic hepatitis B infection: lessons learned from treating HIV-infected patients. J Hepatol 1999 Mar; 30: 536-50
22. Conjeevaram HS. Therapy for chronic hepatitis B: nucleoside analogues in adult and pediatric patients. Acta Gastroenterol Belg 1998 Apr; 61 (2): 224-7
23. Hoofnagle JH, Dushieko GM, Seeff LB, et al. Seroconversion from hepatitis B e antigen to antibody in chronic type B hepatitis. Ann Intern Med 1981; 94: 744-8
24. Lok AS, Hadziyannis S, Weller IV, et al. Contribution of low level HBV replication to continuing inflammatory activity in patients with anti-HBe positive chronic hepatitis B virus infection. Gut 1984; 25: 1283-7
25. Center for Drug Evaluation and Research. Medical officer's review: supplemental new drug application NDA's 21-003 and 21-004 (SE01-002) [online]. Available from URL: http://www.fda.gov/cder/foi/nda/2001/21-003SE1002_Epivir-HBV_medr.pdf [Accessed 2002 Jun 5]
26. Nevens F, Main J, Honkoop P, et al. Lamivudine therapy for chronic hepatitis B: a six-month randomized dose-ranging study. Gatroenterology 1997; 113: 1258-63
27. Dienstag JL, Perrillo RP, Schiff ER, et al. A preliminary trial of lamivudine for chronic hepatitis B infection. N Engl J Med 1995; 333 (25): 1657-61
28. Boni C, Penna A, Ogg GS, et al. Lamivudine treatment can overcome cytotoxic T-cell hyporesponsiveness in chronic hepatitis B: new perspectives for immune therapy. Hepatology 2001; 33: 963-71
29. Boni C, Bertoletti A, Penna A, et al. Lamivudine treatment can restore T cell responsiveness in chronic hepatitis B. J Clin Invest 1998; 102: 968-75
30. GlaxoSmithKline. Product information: Epivir-HBV® (lamivudine) tablets and Epivir-HBV® (lamivudine) oral solution [online]. Available from URL: http//us.gsk.com [Accessed 2002 May 23]
31. Jonas MM, Kelly DA, Mizerski J, et al. Clinical trial of lamivudine in children with chronic hepatitis B. N Engl J Med 2002 May 30; 346 (22): 1706-13
32. Jonas MM, Kelly DA, Mizerski J, et al. A follow-on study in children with chronic hepatitis B (CHB) who completed a placebo-controlled lamivudine study: a 6-month interim analysis [abstract no. 707]. Hepatology 2001; 34 (4 Pt 2): 349
33. Zuccotti GV, Cucchi C, Gracchi V, et al. A 1-year trial of lamivudine for chronic hepatitis B in children. J Int Med Res 2002 Mar; 30: 200-2
34. Elkabes B, Suoglu OC, Sokucu S, et al. Lamivudine and alpha interferon combination treatment versus alpha interferon treatment in children with chronic hepatitis B infection [abstract]. J Hepatol 2001 Apr; 34 Suppl. 1: 161
35. Dikici B, Bosnak M, Kara IH, et al. Lamivudine and interferon-alpha combination treatment of childhood patients with chronic hepatitis B infection. Pediatr Infect Dis J 2001 Oct; 20 (10): 988-92
36. Gurakan F, Kocak N, Ozen H, et al. Lamivudine (LMV) versus LMV plus IFN for children with chronic hepatitis B who were non-responders to IFN (first year results) [abstract]. J Hepatol 2001 Apr; 34 Suppl. 1: 176
37. Gurakan F, Kocak N, Ozen H, et al. Lamivudine versus LMV plus interferon (IFN) alpha as initial therapy for children with chronic hepatitis B (first year results) [abstract]. J Hepatol 2001 Apr; 34 Suppl. 1: 176
38. Selimoglu MA, Aydogdu S, Unal F, et al. Alpha interferon and lamivudine combination therapy for chronic hepatitis B in children. Pediatr Int 2002 Aug; 44 (4): 404-8
39. Dikici B, Bosnak M, Bosnak V, et al. Combination therapy for children with chronic hepatitis B virus infection. J Gastroenterol Hepatol 2002 Oct; 17 (10): 1087-91
40. Liaw Y-F, Leung NWY, Chang T-T, et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Gastroenterology 2000; 119: 172-80
41. Guan R, Lai CL, Liaw YF. et al. Efficacy and safety of 5 years lamivudine treatment of Chinese patients with chronic hepatitis B [abstract no. 187]. J Gastroenterol Hepatol 2001; 16 Suppl.: A60-1
42. Jonas MM, Kelly DA, Mizerski J, et al. Epivir HBV effective and well-tolerated in children with chronic hepatitis B virus (HBV) infection [abstract no. 16]. The American Association for the Study of Liver Diseases 52nd Annual Meeting: selected highlights; 2001 Nov 9-13; Dallas
43. GlaxoSmithKline. Product development pipeline [online]. Available from URL: http://science.gsk.com/pipeline/Pipeline2002new.pdf [Accessed 2002 Aug 7]