Adefovir dipivoxil in chronic hepatitis B infection

Expert Opinion on Pharmacotherapy

Volumn 5, Issue 11, 2004, Pages 2361-2367

  Yuen, Man Fung ^a   Lai, Ching Lung ^a  

^a UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Adefovir; Adefovir dipivoxil; HBV DNA; Nucleotide analogue; Treatment

Indexed keywords

ACYCLIC NUCLEOSIDE; ADEFOVIR DIPIVOXIL; ALANINE AMINOTRANSFERASE; ALPHA INTERFERON; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PLACEBO; VIRUS DNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DNA SYNTHESIS INHIBITION; DOSE CALCULATION; DOSE KIDNEY FUNCTION RELATION; DRUG ACCUMULATION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CHOICE; DRUG DISTRIBUTION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG MONITORING; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG URINE LEVEL; FOOD DRUG INTERACTION; GENE MUTATION; HEPATITIS B; HEPATITIS B VIRUS; HISTOLOGY; HUMAN; LIVER TRANSPLANTATION; MAINTENANCE THERAPY; MONOTHERAPY; NEPHROTOXICITY; NONHUMAN; RISK ASSESSMENT; SEROCONVERSION; STRUCTURE ACTIVITY RELATION; TREATMENT FAILURE; VIRUS RESISTANCE; VIRUS STRAIN;

ADENINE; ANIMALS; ANTIVIRAL AGENTS; CLINICAL TRIALS; DRUG RESISTANCE, VIRAL; HEPATITIS B E ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; LAMIVUDINE; PHOSPHONIC ACIDS;

EID: 8544261146     PISSN: 14656566     EISSN: None     Source Type: Journal    
DOI: 10.1517/14656566.5.11.2361     Document Type: Article

References (41)

1. KRAMATA P, VOTRUBA I, OTOVA B, HOLY A: Different inhibitory potencies of acyclic phosphonomethoxyalkyl nucleotide analogs toward DNA polymerases alpha, delta, and epsilon. Mol. Pharmacol. (1996) 49 1005-1011.
2. CUNDY KC: Clinical pharmacokinetics of the antiviral nucleotide analogues cidofovir and adefovir. Clin. Pharmacokinet. (1999) 36:127-143.
3. Gilead Sciences, Inc.: Hepsera® (adefovir dipivoxil) full prescribing information. Foster City, CA, USA (2002).
4. KEARNEY B, KNIGHT W, CURRIE G et al.: Adeofivr dipivoxil safety and pharmacokinetics in subjects with hepatitis B virus infection and in healthy subjects. J. Hepatol. (2002) 36 Suppl. 1):100.
5. KNIGHT W, HAYASHI S, BENHAMOU Y et al.: Dosing guidelines for adefovir dipivoxil in the treatment of HBV infected patients with renal or hepatic impairment. J. Hepatol. (2002) 36 Suppl. 1):136.
6. FISHER EJ, CHALONER K, COHN DL et al.: The safety and efficacy of adefovir dipivoxil in patients with advanced HIV disease: a randomized, placebo-controlled trial. AIDS (2001) 15 1695-1700.
7. RAY AS, VELA JE, OLSON L, FRIDLAND A: Effective metabolism and long intracellular half life of the anti-hepatitis B agent adefovir in hepatic cells. Biochem. Pharmacol. (2004) 68(9 ):1825-1831.
8. TORRESI J, LOCARNINI SA: New therapeutic strategies in the treatment of hepatitis B virus infection. Expert Opin. Invest. Drugs (1999) 8:289-305.
9. TORRESI J, LOCARNINI S: Antiviral chemotherapy for the treatment of hepatitis B virus infections. Gastroenterology (2000) 118(2 Suppl. 1):S83-S103.
10. CALIO R, VILLANI N, BALESTRA E et al.: Enhancement of natural killer activity and interferon induction by different acyclic nucleoside phosphonates. Antivir. Res. (1994) 23:77-89.
11. COOKSLEY H, CHOKSHI S, WEDEMEYER H et al.: Hepatitis B virus-specific T-cell reactivity during adefovir dipivoxil (ADV) treatment: a multicenter, controlled study. Hepatology (2002) 36 4 Pt 2):633A.
12. MAILLIARD ME, GOLLAN JL: Suppressing hepatitis B without resistance - so far, so good. N. Engl. J. Med. (2003) 348 848-850.
13. YOKOTA T, KONNE K, SHIGETA S et al.: Inhibitory effects of acyclic nucleoside phosphonate analogues on hepatitis B virus DNA synthesis in HBG 11 cells. Antiviral Chem. Chemother. (1994) 5 57-63.
14. HEIJTINK RA, DE WILDE GA, KRUINING J et al.: Inhibitory effect of 9-(2-phosphonylemthoxyethyl)-adenine (PMEA) on human and duck hepatitis B virus infection. Antivir. Res. (1993) 21141-153.
15. HEIJTINK RA, KRUINING J, DE WILDE GA et al.: Inhibitory effects of acyclic nucleoside phosphonates on human hepatitis B virus and duck hepatitis B virus infections in tissue culture. Antimicrob. Agents Chemother. (1994) 38:2180-2182.
16. KRUINING J, HEIJTINK RA, SCHALM SW: Antiviral agents in hepatitis B virus transfected cell lines: inhibitory and cytotoxic effect related to time of treatment. J. Hepatol. (1995) 22:263-267.
17. YOKOTA T, MOCHIZUKI S, KONNO K et al.: Inhibitory effects of selected antiviral compounds on human hepatitis B virus DNA synthesis. Antimicrob. Agents Chemother. (1991) 35:394-397.
18. NAESENS L, SNOECK R, ANDREI G et al.: HPMPC (cidofovir), PMEA (adefovir), and related acyclic nucleoside phosphonate analogues: a review of their pharmacology and clinical potential in the treatment of viral infections. Antivir. Chem. Chemother. (1997) 8:1-23.
19. NICOLL A, COLLEDGE D, TOOLE J et al.: Inhibition of duck hepatitis B virus replication by 9-[2-phosphonyl-methoxyethyl] adenine, an acyclic phosphonate nucleoside analogue. Antimicrob. Agents Chemother. (1998) 42:3130-3135.
20. CULLEN JM, LI DH, BROWN C et al.: Antiviral efficacy and pharmacokinetics of oral adefovir dipivoxil in chronically woodchuck hepatitis virus-infected woodchucks. Antimicrob. Agents Chemother. (2001) 45:2740-2745.
21. GILSON RJ, CHOPRA KB, NEWELL AM et al.: A placebo-controlled Phase I/II study of adefovir dipivoxil in patients with chronic hepatitis B virus infection. J. Viral Hepat.) (1999) 6 387-395.
22. JEFFERS L, HEATHCOTE E, WRIGHT T et al.: A Phase II dose-ranging, placebo-controlled trial of adefovir dipivoxil for the treatment of chronic hepatitis B virus infection. Antiviral Res. (1998) 37:A197.
23. MARCELLIN P, CHANG TT, LIM SG et al.: Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N. Engl. J. Med. (2003) 348:808-816.
24. HADZIYANNIS SJ, TASSOPOULOS NC, HEATHCOTE et al.: Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N. Engl. J. Med. (2003) 348:800-807.
25. WAI CT, CHU CJ, HUSSAIN M, LOK AS: HBV genotype B is associated with better response to interferon therapy in HBeAg (+) chronic hepatitis than genotype C. Hepatology (2002) 36 1425-1430.
26. KAO JH, WU NH, CHEN PJ, LAI MY, CHEN DS: Hepatitis B genotypes and the response to interferon therapy. J. Hepatol. (2000) 33:998-1002.
27. YUEN MF, WONG DKH, SABLON E et al.: Hepatitis B virus genotypes B and C do not affect the antiviral response to lamivudine. Antivir. Ther. (2003) 8:531-534.
28. WESTLAND C, DLANEY W IV, YANG H et al.: Hepatitis B virus genotypes and virologic response in 694 patients in Phase III studies of adefovir dipivoxil. Gastroenterology (2003) 125 107-116.
29. MARCELLIN P, CHANG TT, LIM SG et al.: Adefovir dipivoxil (ADV) 10 mg for the treatment of patients with HBeAg+ chronic hepatitis B: continued efficacy beyond 48 weeks. Hepatology (2002) 36(Pt 2):373A.
30. HADZIYANNIS S, TASSOPOULOS N, HEATHCOTE J et al.: Two year results from a double-blind, randomized, placebo-controlled study of adefovir dipivoxil (ADV) for presumed precore mutant chronic hepatitis B. J. Hepatol. (2003) 38(Suppl. 2):143.
31. HADZIYANNIS S, TASSOPOULOS N, CHANG TT et al.: Three year study of adefovir dipivoxil (ADV) demonstrates sustained efficacy in presumed precore mutant chronic hepatitis B (CHB) patients in a long term safety and efficacy study (LTSES). J. Hepatol. (2004) 40 Suppl. 1):17.
32. CHANG TT, SHIFFMAN M, TONG M et al.: Durability of HBeAg seroconversion after adefovir dipivoxil treatment for chronic hepatitis B (CHB). J. Hepatol. (2004) 40(Suppl. 1):126.
33. SHIFFMAN M, MARCELLIN P, JEFFERS L et al.: HBsAg seroconversion in adefovir dipivoxil (ADV) treated chronic hepatitis B (CHB) patients. J. Hepatol. (2004) 40 (Suppl. 1): 17.
34. ANGUS P, VAUGHAN R, XIONG S et al.: Resistance to adefovir dipivoxil therapy associated with the selection of a novel mutation in the HBV polymerase. Gastroenterology (2003) 125 292-297.
35. WESTLAND CE, YANG H, DELANEY WE IV et al.: Week 48 resistance surveillance in two Phase III clinical studies of adefovir dipivoxil for chronic hepatitis B. Hepatology (2003) 38 96-103.
36. SUNG JJY, LAI JY, ZEUZEM S et al.: A randomized double-blind phse II study of lamivudine (LAM) compared to lamivudine plus adefovir dipivoxil (ADV) for treatment naïve patients with chronic hepatitis B (CHB): week 52 analysis. J. Hepatol. (2003) 38(Suppl. 2):25.
37. PERRILLO R, HANN HW, MUTIMER D et al.: Adefovir dipivoxil added to ongoing lamivudine in chronic hepatitis B with YMDD mutant hepatitis B virus. Gastroenterology (2004) 126:81-90.
38. PETERS MG, HANN HW, MARTIN P et al.: Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology (2004) 126:91-101.
39. SCHIFF ER, LAI CL, HADZIYANNIS S et al.: Adefovir dipivoxil therapy for lamivudine-resistant hepatitis B in pre- and post-liver transplantation patients. Hepatology (2003) 38 1419-1427.
40. WERLE-LAPOSTOLLE B, BOWDEN S, LOCARNINI S et al.: Persistence of cccDNA during the natural history of chronic hepatitis B and decline during adefovir dipivoxil therapy. Gastroenterology (2004) 126:1750-1758.
41. BENHAMOU Y, THIBAULT V, VIG P et al.: Long term treatment with adefovir dipivoxil (ADV) for three years in patients with lamivudine-resistant (LAM-R) HBV and HIV co-infection results in significant and sustained clinical improvement. Hepatology (2003) 38(4 Suppl. 1):714A.