Clevudine for the treatment of chronic hepatitis B virus infection

Expert Opinion on Investigational Drugs

Volumn 14, Issue 10, 2005, Pages 1277-1284

  Hui, Chee Kin ^a   Lau, George K K ^a  

^a UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Clevudine; Combination therapy; HBV

Indexed keywords

ADEFOVIR DIPIVOXIL; ALPHA INTERFERON; ALPHA2A INTERFERON; AMDOXOVIR; CLEVUDINE; DNA DIRECTED DNA POLYMERASE GAMMA; DNA POLYMERASE; EMTRICITABINE; ENTECAVIR; FAMCICLOVIR; FIALURIDINE; LAMIVUDINE; MEMBRANE ANTIGEN; PLACEBO; RECOMBINANT GAMMA INTERFERON; TELBIVUDINE; TENOFOVIR; VIRUS DNA; VIRUS RNA;

ANTIBIOTIC RESISTANCE; ANTIGEN EXPRESSION; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG APPROVAL; DRUG CLASSIFICATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG MECHANISM; DRUG STRUCTURE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; MONOTHERAPY; NONHUMAN; SIDE EFFECT; STRUCTURE ANALYSIS; VIRUS LOAD; VIRUS REPLICATION;

EID: 27144497327     PISSN: 13543784     EISSN: None     Source Type: Journal    
DOI: 10.1517/13543784.14.10.1277     Document Type: Article

References (42)

1. LEE WM: Hepatitis B virus infection. N. Engl. J. Med. (1997) 337:1733-1745.
2. CHEN CJ, YANG HI, SU J et al.: Elevated serum level of hepatitis B virus DNA is an independent risk factor for hepatocellular carcinoma: a long-term follow-up study in Taiwan. J. Hepatol. (2005) 42(Suppl. 2):16.
3. YU MW, YEH SH, CHEN PJ et al.: Hepatitis B virus genotype and DNA level and hepatocellular carcinoma: a prospective study in men. J. Natl. Cancer Inst. (2005) 97:265-272.
4. LIAW YF, LEUNG N, GUAN R et al.: Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2005 update. Liver Intl. (2005) 25:472-489.
5. EASL JURY: EASL international consensus statement conference on hepatitis B: consensus statement. J. Hepatol. (2003) 38:533-540.
6. LOK ASF, McMAHON BJ: Chronic hepatitis B: update of recommendation. Hepatology (2004) 39:857-861.
7. BALZARINI J, WEDWOOD O, KRUINING J et al.: Anti-HIV and anti-HBV activity and resistance profile of 2′-3′-dideoxy-3′-thiocynate (3TC) and its arylphosphoramide derivative CF-1109. Biochem. Biophys. Res. Commun. (1996) 2:363-369.
8. ALLEN MI, DESLAURIERS M, ANDREWS CW et al.: Identification and characterization of mutations in hepatitis B virus resistant to lamivudine. Lamivudine Clinical Investigation Group. Hepatology (1998) 27:1670-1677.
9. LEUNG N: Clinical experience with lamivudine. Semin. Liver Dis. (2002) 22(Suppl. 1):15-21.
10. LOCARNINI S, QI X, ARTERBURN S et al.: Incidence and predictors of emergence of adefovir resistant HBV during four years of adefovir dipivoxil therapy for patients with chronic hepatitis B. J. Hepatol. (2005) 42(Suppl. 2):17.
11. CHANG TT, GISH R, DE MAN R et al.: Entecavir is superior to lamivudine for the treatment of HBeAg (+) chronic hepatitis B: results of Phase III study ETV-022 in nucleoside/nucleotide-naive patients. Hepatology (2004) 40(Suppl. 1):193A.
12. - patients with chronic hepatitis B. J. Hepatol. (2005) 42(Suppl. 2):192.
13. HADZIYANNIS SJ, TASSOPOULOS NC, HEATHCOTE EJ et al.: Long-term therapy with adefovir dipivoxil for HBeAg negative chronic hepatitis B. N. Engl. J. Med. (2005) 352:2673-2681.
14. CHU CK, MA TW, SHANMUGANATHAN K et al.: Use of 2′-fluoro-5-methyl-b-L-arabinofuranosyluracil as a novel antiviral agent for hepatitis B virus and Epstein-Barr virus. Antimicrob. Agents Chemother. (1995) 39:979.
15. CHU CK, BOUDINOT FD, PEEK S et al.: Preclinical investigation of L-FMAU as an anti-hepatitis B virus agent.. Antiviral Ther. (1998) 3(Suppl. 3):113.
16. CHENG YC: Potential use of antiviral L (-) nucleoside analogues for the prevention or treatment of viral associated cancers. Cancer Lett. (2001) 162:S33-S37.
17. BALAKRISHNA PS, LIU SH, ZHU YL, CHU CK, CHENG YC: Inhibition of hepatitis B virus by a novel L-nucleoside, 2′-fluoro-5-methyl-β-L-arabinofuranosyl uracil. Antimicrob. Agents Chemother. (1996) 40:380-386.
18. TAO WA, WU L, COOKS RG, WANG F, BEGLEY JA, LAMPERT B: Rapid enantiomeric quantification of an antiviral nucleoside agent by mass spectrometry. J. Med. Chem. (2001) 44:3541-3544.
19. PAI S, LIU S, ZHU Y et al.: Inhibition of hepatitis B virus by a novel L-nucleoside/nucleotide, 2′-fluoro-5-methyl-β-L-arabinofuranosyl uracil. Antimicrob. Agents Chemother. (1996) 40:380-386.
20. SEIGNERES B, PICHOUD C, MARTIN P, FURMAN P, TREPO C, ZOULIM F: Inhibitory activity of dioxolane purine analogs on wild-type and lamivudine-resistant mutants of hepadnaviruses. Hepatology (2002) 36:710-722.
21. ZHU Y, YAMAMOTO T, CULLEN J et al.: Kinetics of hepadnavirus loss from the liver during inhibition of viral DNA synthesis. J. Virol. (2001) 75:311-322.
22. PEEK SF, COTE PJ, JACO JR et al.: Antiviral activity of clevudine [L-FMAU, 1-(2-fluoro-5-methyl-β-L-arabinofuranosyl) uracil] against woodchuck hepatitis B virus replication and gene expression in chronically infected woodchucks. Hepatology (2001) 33:254-266.
23. CHU CK, MA TW, SHANMUGANATHAN K et al.: Use of 2′-fluoro-5-methyl-β-L-arabinosyluracil as a novel antiviral agent for hepatitis B virus and Epstein Barr virus. Antimicrob. Agents Chemother. (1995) 39:979-981.
24. 2a (40 kD) (PEGASYS) monotherapy and in combination with lamivudine is more effective than lamivudine monotherapy in HBeAg positive chronic hepatitis B: results from a large, multinational study. N. Engl. J. Med. (2005) 352:2682-2695.
25. ABDELHAMED AM, KELLEY CM, MILLER TG et al.: Rebound of hepatitis B virus replication in HepG2 cells after cessation of antiviral treatment. J. Virol. (2002) 76:8148-8160.
26. MENNE S, RONEKER CA, TENNANT BC et al.: Immunogeneic effects of woodchuck hepatitis virus surface antigen vaccine in combination with antiviral therapy: breaking of humoral and cellular immune tolerance in chronic woodchuck hepatitis virus infection. Intervirology (2002) 45:237-250.
27. KORBA BE, COTE PJ, MENNE S et al.: Clevudine therapy with vaccine inhibits progression of chronic hepatitis and delays onset of hepatocellular carcinoma in chronic woodchuck hepatitis virus infection. Antivir. Ther. (2004) 9:937-952.
28. JACQUARD AC, NASSAL M, PICHOUD C et al.: Effect of combination of clevudine and emtricitabine with adenovirus mediated delivery of gamma interferon in the woodchuck model of hepatitis B virus infection. Antimicrob. Agent Chemother. (2004) 48:2683-2692.
29. SEIGNERES B, MARTIN P, WERLE B et al.: Effects of pyrimidine and purine analog combinations in the duck hepatitis B virus infection model. Antimicrob. Agents Chemother. (2003) 47:1842-1852.
30. MARCELLIN P, MOMMEJA-MARIN H, SACKS SI et al.: A Phase II dose-escalating trial of clevudine in patients with chronic hepatitis B. Hepatology (2004) 40:140-148.
31. 2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N. Engl. J. Med. (2004) 351:1206.
32. LEE HS, CHUNG YH, LEE KS et al.: A 12-week clevudine therapy showed durable antiviral activity and normalization of alanine transaminase levels for 6 months after discontinuation of treatment in patients with chronic hepatitis B. Hepatology (2004) 40(Suppl. 1):652A.
33. LEE KS, BYUN KS, CHUNG YH et al.: Clevudine therapy for 24 weeks further reduced serum hepatitis B virus DNA levels and increased ALT normalization rates without emergence of viral breakthrough than 12-week clevudine therapy. Hepatology (2004) 40(Suppl. 1):657A.
34. YAMAMATO T, LITWIN S, ZHOU T et al.: Mutations of the woodchuck hepatitis virus polymerase gene that confer resistance to lamivudine and 2′ fluoro-5-methyl-β-L-arabinosyluracil. J. Virol. (2002) 76:1213-1223.
35. ZOULIN F: Combination of nucleoside analogues in the treatment of chronic hepatitis B virus infection: lesson from experimental models. J. Antimicrob. Chemother. (2005) 55:608-611.
36. COLLEDGE D, LOCARNINI S, SHAW T: Synergistic inhibition of hepadnaviral replication by lamivudine in combination with penciclovir in vitro. Hepatology (1997) 26:216-225.
37. COLLEDGE D, CIVITICO G, LOCARNINI S et al.: In vitro antihepadnaviral activities of combinations of penciclovir, lamivudine and adefovir. Antimicrob. Agents Chemother. (2000) 44:551-560.
38. DELANEY WE IV, YANG H, MILLER MD et al.: Combinations of adefovir with nucleoside analogs produces additive antiviral effects against hepatitis B in vitro. Antimicrob. Agents Chemother. (2004) 48:3702-3710.
39. 2b alone or in combination with lamivudine for HBeAg positive chronic hepatitis B: a randomized trial. Lancet (2005) 365:123-129.
40. BONI C, BERTOLETTI A, PENNA A et al.: Lamivudine treatment can restore T cell responsiveness in chronic hepatitis B. J. Clin. Invest. (1998) 102:968-975.
41. BONI C, PENNA A, BERTOLETTI A et al.: Transient restoration of anti-viral T cell responses induced by lamivudine therapy in chronic hepatitis B. J. Hepatol. (2003) 39:595-605.
42. LAU GK, COOKSLEY H, RIBIERO RM et al.: Randomized, double-blind study comparing adefovir dipivoxil (ADV) plus emtricitabine (FTC) combination therapy versus ADV alone in HBeAg (+) chronic hepatitis B: efficacy and mechanisms of treatment response. Hepatology (2004) 40(Suppl. 1):666A.