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Review

Emerging treatments in chronic hepatitis B

&
Pages 207-221 | Published online: 24 Feb 2005

Bibliography

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  • •A review on the goals, indications and efficacy of therapeutic options for HBeAg-negative chronic hepatitis B in early 2003.
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  • •The largest study of standard interferon therapy in HBeAg-negative chronic hepatitis B.
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  • ••An important study showing the effect oflamivudine-resistant HBV mutants on the liver histology of patients with HBeAg-positive chronic hepatitis B under long-term lamivudine therapy.
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  • ••This randomised, multi-centre, placebo-controlled trial demonstrated the safety and efficacy of a 48-week course with adefovir dipivoxil in patients with HBeAg-positive chronic hepatitis B.
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  • HADZIYANNIS SJ,TASSOPOULOS NC, HEATHCOTE EJ et al.: Adefovir dipivoxil for the treatment of hepatitis B antigen-negative chronic hepatitis B. N Engl. J. Med. (2003) 348:800–807.
  • ••This randomised, multi-centre, double-blind, placebo-controlled trial demonstrated the safety and efficacy of a 48-week course with adefovir dipivoxil in patients with HBeAg-negative chronic hepatitis B.
  • HADZIYANNIS SJ, TASSOPOULOS N, HEATHCOTE E 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.
  • HADZIYANNIS SJ, 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 (LTES). Hepatol (2004) 40\(Suppl. 1):17.
  • •This study, recently presented as an abstract, showed the safety and sustained efficacy of 3 years therapy with adefovir dipvoxil in patients with HBeAg-negative chronic hepatitis B.
  • XIONG S, YANG H, WESTLAND CE et al.: Resistance surveillance of HBeAg-chronic hepatitis B (CHB) patients treated for two years with adefovir dipivoxil (ADV).Hepatol (2003) 38\(Suppl. 2):182.
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  • 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.
  • •The first study describing in detail the HBV mutations associated with resistance to adefovir dipivoxil.
  • ZOULIM F, TREPO C, POYNARD T et al.: Adefovir dipivoxil (ADV) for the treatment of patients with chronic hepatitis B (CHB) failing lamivudine (LAM) therapy. Hepatol (2003) 38\(Suppl. 2):184.
  • PETERS MG, HANN HH, MARTIN P et al.: Adefovir dipivoxil alone or in combination with lamivudine in patientswith lamivudine-resistant chronic hepatitis B. Gastroenterology (2004) 126:91–101.
  • •A study showing that adefovir dipivoxil monotherapy may have the same efficacy with the combination of adefovir dipivoxil and lamivudine in the treatment of lamivudine-resistant patients with HBeAg-positive chronic hepatitis B.
  • WESTLAND CE, YANG H, NAMIMI H et al.: Comparison of anti-HBV activity of adefovir against different lamivudine-resistant HBV strains in vitro and in liver transplant patients. Hepatology (2001) 34:446A.
  • LEBRAY P, VALLET-PICHARD A, MICHEL ML et al.: Immunomodulatory drugs and therapeutic vaccine in chronic hepatitis B infection. Hepatol (2003) 39\(Suppl. 1):5151–5159.
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  • ••An important study showing the effect ofthe IFN therapy and particularly of the type of response to IFN therapy on the long-term outcome of patients with HBeAg-negative chronic hepatitis B.
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  • •An important Phase II study evaluating for the first time the efficacy of PEG-INF-a2. in HBeAg-positive chronic hepatitis B.
  • SUNG JJY, CHAN HLY, HUT AY et al.: Combination of pegylated interferon and lamivudine is superior to lamivudine monotherapy in the treatment of chronic hepatitis B - a randomized trial. Hepatol (2003) 38\(Suppl. 2):33.
  • MARCELLIN P, LAU GK, BONINO F et al.: Peginterferon-alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Eng. I Med. (2004) 351:1206–1217.
  • ••An important study showing that, in thetreatment of HBeAg-negative chronic hepatitis B, the efficacy of PEG-INF-a2. alone is similar to that of the combination of PEG-INF-a2. and lamivudine, both being superior than lamivudine alone.
  • TORRESI J, LOCARNINI S: Antiviral chemotherapy for the treatment of hepatitis B virus infections. Gastroenterology (2000) 118(Suppl.):S83–S103.
  • HART GJ, ORR DC, PENN CR et al.: Effects of ( ) 2' deoxy 3' thiacytidine (3TC) Y-triphosphate on human immunodeficiency virus reverse transcriptase and mammalian DNA polymerases alpha, beta, and gamma. Antimicrob. Agents Chemother (1992) 36:1688–1694.
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  • SHAW T, BOWDEN S, LOCARNINI S: Rescue therapy for drug resistant hepatitis B: another argument for combination chemotherapy? Gastroenterology (2004) 126:343–347.
  • NATIONAL INSTITUTE OF HEALTH CONSENSUS DEVELOPMENTCONFERENCE STATEMENT: Management of hepatitis C: 2002 - June 10–12, 2002. Hepatology (2002)36\(Suppl. 1):53–520.This review provides the summary of the consensus statement on the management of hepatitis C sponsored by the NIH and held in 2002.
  • VAN ZONNEVELD M, VAN NUNEN AB, DE MAN RA, SCHALM SW, JANSSEN HLA: Chronic HBV treatment with one year of pegylated-interferon alpha-2b (PEG-IFN) has a comparable safety profile to short term conventional interferon alpha-2b.Hepatal (2003) 38\(Suppl. 2):179.
  • VAN ZONNEVELD M, ZONDERVAN P, DE MAN RA, SCHALM SW, JANSSEN HLA: Liver histology in chronic hepatitis B patients after 1 year of treatment with pegylated interferon interferon alpha-2b in combination with lamivudine or placebo. J. Hepatal (2004) 40\(Suppl. 0:132.
  • YAMANAKA G, WILSON T, INNAIMO S et al.: Metabolic studies on BMS-200475, a new antiviral compound active against hepatitis B virus. Antimicrob. Agents Chemother. (1999) 43:190–193.
  • NEVENS F, DE MAN RA, CHUA D et al.: Effectiveness of a low dose of entecavir in treating recurrent viremia in chronic hepatitis B. Hepatology (2000) 32(Suppl.):377A.
  • LAI C-L, ROSMAWATI M, LAO J et al.:Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B. Gastroenterology (2002) 123:1831–1838.
  • •An interesting study on the antiviral efficacy of entecavir.
  • DE MAN RA, WOLTERS L, NEVENS F et al.: A study of oral entecavir given for 28 days in both treatment-naive and pre-treated subjects with chronic hepatitis. Hepatology (2000) 32(Suppl.):376A.
  • TASSOPOULOS N, HADZIYANNIS S, CIANCIARA J et al.: Entecavir is effective in treating patients with chronic hepatitis B who have failed lamivudine therapy. Hepatology (2001) 34:340A.
  • CHANG T-T, HADZIYANNIS S, CIANCIARA J et al.: Sustained viral load and ALT reduction following 48 weeks of entecavir treatment in subjects with chronic hepatitis B who have failed lamivudine. Hepatology (2002) 36:300A.
  • COLONNO R, ROSE R: Genotypic analysis following 48 week entecavir treatment of chronic HBV subjects failing lamivudine suggests sustained susceptibility and lack of resistance development. Hepatology (2002) 36:644A.
  • GISH R, CHANG TT, HADZIYANNIS S et al.: Sustained viral load and ALT reduction following 48 weeks of entecavir treatment in HBeAg-negative and -positive patients with chronic hepatitis B who have failed prior lamivudine therapy. J. Hepatal (2003) 38\(Suppl. 2):32–33.
  • KORBA BE, SCHINAZI RE COTE P, TENNANT BC, GERIN JL: Effect of oral administration of emtricitabine on woodchuck hepatitis virus replication in chronically infected woodchucks. Antimicrob. Agents Chemother: (2000) 44:1757–1760.
  • LADNER SK, MILLER TJ, OTTO MJ, KING RW: The hepatitis B virus M539V polymerase variation responsible for 3TC resistance also confers cross-resistance to other nucleoside analogues. Antivir: Chem. Chemothei: (1998) 9:65–72.
  • WANG C, CORREY L, LEUNG N et al.: Antiviral activitry of 48 weeks of emtricitabine (FTC) treatment in patients with HBeAg negative/HBV DNA positive chronic hepatitis B (CHB). Hepatology (2001) 34:323A.
  • CHU CK, MAT, SHANMUGANATHAN K et al.: Use of 2'-fluoro-5-methyl-beta-L-arabinofuranosyluracil as a novel antiviral agent for hepatitis B virus and Epstein-Barr virus. Antimicrob. Agents Chemother. (1995) 39:979–981.
  • CHU CK, BOUDINOT FD, PEEK SF et al.: Preclinical investigation of L-FMAU as an anti-hepatitis B virus agent. Alava: Thei: (1998) 3\(Suppl. 3):113–121.
  • PEEK SF, COTE PJ, JACOB JR et al.: Antiviral activity of clevudine [L-FMAU, (1-(2-fluoro-5-methyl-beta, 1-arabinofuranosyl) uracil) I against woodchuck hepatitis virus replication and gene expression in chronically infected woodchucks (Marmara monax Hepatology (2001) 33:254–266.
  • ABDELHAMED AM, KELLEY CM, MILLER TG, FURMAN PA, CABLE EE, ISOM HC: Comparison of anti-hepatitis B virus activities of lamivudine and clevudine by a quantitative assay. Antimicrob. Agents Chemother. (2003) 47:324–336.
  • MARCELLIN P, MOMMEJA-MARIN H, SACKS SL et al.: A Phase II dose-escalating trial of clevudine in patients with chronic hepatitis B. Hepatology (2004) 40: 140–148.
  • •An interesting Phase II study on the antiviral efficacy of clevudine.
  • STANDRING DN, BRIDGES EG, PLACIDI L et al.: Antiviral beta-L-nucleosides specific for hepatitis B virus infection. Antivic Chem. Chemother: (2003) 12\(Suppl. 0:119–129.
  • •A review focusing on the L-nucleosides as new anti-HBV agents.
  • BRYANT ML, BRIDGES EG, PLACIDI L et al.: Antiviral L-nucleosides specific for hepatitis B virus infection. Antimicrob. Agents Chemother: (2001) 45:229–235.
  • DELANEY W, YANG H, MILLER M, GIBBS C, XIONG S: Lamivudine-resistant HBV is cross-resistant to L-dT and L-dC in vitro. J. Hepatal (2002) 36\(Suppl. 1):89.
  • HOD GE RA: Telbivudinehorcitabine Idenix/Novartis. CLIFF. Opin. Investig. Drugs (2004) 5:232–241.
  • LAI C-L, MYERS MW, POW DM et al.: Safe and potent suppression of hepatitis B virus (HBV) with L-deoxythymidine (LDT): results of a dose-escalation trial. Hepatology (2001) 34:321A.
  • LAI C-L, LEUNG N, TEO EK et al.: International multicenter trial of LdT (telbivudine), alone and in combination with lamivudine, for chronic hepatitis B: an interim analysis. Hepatology (2002) 36:301A.
  • LAI C-L, LEUNG NWY, TEO E-K et al.: Results of a one-year international Phase IIb comparative trial of telbivudine,lamivudine, and the combination, in patients with chronic hepatitis B. Hepatology (2003) 38\(Suppl. 1):262A.
  • BENHAMOU Y, POYNARD T: Treatment of chronic hepatitis B virus infection in patients co-infected with human immunodeficiency virus. J. Hepatal (2003) 39\(Suppl. 1):5194–5199.
  • LESSELLS R, LEEN C: Management of hepatitis B in patients coinfected with the human immunodeficiency virus. Eui: Clin. Microbial Infect. Dis. (2004) 23:366–374.
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