« Previous
Next »
Gastroenterology
Volume 134, Issue 2
, Pages 405-415
, February 2008
Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach
References
- . Hepatitis B virus infection. N Engl J Med. 1997;337:1733–1745
- . Hepatitis B virus infection—natural history and clinical consequences. N Engl J Med. 2004;350:1118–1129
- . Mechanism of viral persistence and resistance to nucleoside and nucleotide analogs in chronic hepatitis B virus infection. Antiviral Res. 2004;64:1–15
- . HBV drug resistance: mechanisms, detection and interpretation. J Hepatol. 2006;44:593–606
- Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004;351:1521–1531
- 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
- . Interferon alpha treatment and retreatment of hepatitis B e antigen-negative chronic hepatitis B. Gastroenterology. 2001;121:101–109
- A one-year trial of lamivudine for chronic hepatitis B. N Engl J Med. 1998;339:61–68
- Lamivudine as initial treatment for chronic hepatitis B in the United States. N Engl J Med. 1999;341:1256–1263
- Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis B e antigen seroconversion rates: results after 3 years of therapy. Hepatology. 2001;33:1527–1532
- Peginterferon alpha-2a (40 kDa): an advance in the treatment of hepatitis B e antigen-positive chronic hepatitis B. J Viral Hepat. 2003;10:298–305
- Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B. N Engl J Med. 2005;352:2682–2695
- Peginterferon alfa-2a alone, lamivudine alone, and the two in combination in patients with HBeAg-negative chronic hepatitis B. N Engl J Med. 2004;351:1206–1217
- Two-year results from the GLOBE trial in patients with hepatitis B: greater clinical and antiviral efficacy for telbivudine (LdT) versus lamivudine. Hepatology. 2006;44(Suppl 1):222A
- A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med. 2006;354:1001–1010
- Entecavir is superior to lamivudine for the treatment of HBeAg-positive chronic hepatitis B: results of phase III study ETV-022 in nucleoside-naive patients. Hepatology. 2004;40(Suppl 1):193A
- Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med. 2003;348:808–816
- Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology. 2006;131:1743–1751
- Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med. 2003;348:800–807
- Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006;295:65–73
- Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology. 2006;130:678–686
- Hepatitis B virus genotype and DNA level and hepatocellular carcinoma: a prospective study in men. J Natl Cancer Inst. 2005;97:265–272
- Effect of alpha-interferon treatment in patients with hepatitis B e antigen-positive chronic hepatitis B (A meta-analysis). Ann Intern Med. 1993;119:312–323
- Serum HBV DNA as a marker of efficacy during therapy for chronic HBV infection: analysis and review of the literature. Hepatology. 2003;37:1309–1319
- Histological outcome during long-term lamivudine therapy. Gastroenterology. 2003;124:105–117
- Assessment at three years shows high barrier to resistance is maintained in entecavir-treated nucleoside naive patients while resistance emergence increases over time in lamivudine refractory patients. Hepatology. 2006;44(Suppl 2):229A
- Telbivudine GLOBE trial: maximal early HBV suppression is predictive of optimal two-year efficacy in nucleoside-treated hepatitis B patients. Hepatology. 2006;44(Suppl 1):230A
- Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. Hepatology. 2001;34:785–791
- A real-time quantitative polymerase chain reaction method for hepatitis B virus in patients with chronic hepatitis B treated with lamivudine. Am J Gastroenterol. 2003;98:2048–2051
- Persistence of cccDNA during the natural history of chronic hepatitis B and decline during adefovir dipivoxil therapy. Gastroenterology. 2004;126:1750–1758
- Intrahepatic hepatitis B virus covalently closed circular DNA can be a predictor of sustained response to therapy. Gastroenterology. 2005;128:1890–1897
- Peginterferon alpha-2b plus adefovir induce strong cccDNA decline and HBsAg reduction in patients with chronic hepatitis B. Hepatology. 2006;44:675–684
- Intrahepatic levels and replicative activity of covalently closed circular hepatitis B virus DNA in chronically infected patients. Hepatology. 2006;44:694–702
- . Assessment of treatment efficacy in HBV infection and disease. J Hepatol. 2006;44:S95–S99
- Effect of lamivudine therapy on the serum covalently closed-circular (ccc) DNA of chronic hepatitis B infection. Am J Gastroenterol. 2005;100:1099–1103
- Quantitation of covalently closed circular hepatitis B virus DNA in chronic hepatitis B patients. Hepatology. 2004;40:727–737
- . New insight on hepatitis B virus persistence from the study of intrahepatic viral cccDNA. J Hepatol. 2005;42:302–308
- Clinical significance of intrahepatic hepatitis B virus covalently closed circular DNA in chronic hepatitis B patients who received cytotoxic chemotherapy. Blood. 2005;105:2616–2617
- . Genetic variability in hepatitis B viruses. J Gen Virol. 2002;83:1267–1280
- Genotype H: a new Amerindian genotype of hepatitis B virus revealed in Central America. J Gen Virol. 2002;83:2059–2073
- . Genotype C hepatitis B virus infection is associated with a higher risk of reactivation of hepatitis B and progression to cirrhosis than genotype B: a longitudinal study of hepatitis B e antigen-positive patients with normal aminotransferase levels at baseline. J Hepatol. 2005;43:411–417
- Geographic distribution of hepatitis B virus (HBV) genotype in patients with chronic HBV infection in Japan. Hepatology. 2001;34:590–594
- Rapid detection of genotypes and mutations in the pre-core promoter and the pre-core region of hepatitis B virus genome: correlation with viral persistence and disease severity. J Hepatol. 2000;33:430–439
- . Worldwide epidemiology of HBeAg-negative chronic hepatitis B and associated precore and core promoter variants. J Viral Hepat. 2002;9:52–61
- Hepatitis B virus genotypes in Alaska native people with hepatocellular carcinoma: preponderance of genotype F. J Infect Dis. 2007;195:5–11
- Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet. 2005;365:123–129
- Treatment with peginterferon alpha-2b for HBeAg-positive chronic hepatitis B: HBsAg loss is associated with HBV genotype. Am J Gastroenterol. 2006;101:297–303
- Early detection of viral resistance by determination of hepatitis B virus polymerase mutations in patients treated by lamivudine for chronic hepatitis B. Hepatology. 2000;32:1078–1088
- Evaluation of the MagNA Pure LC used with the Trugene HBV Genotyping Kit. J Clin Virol. 2005;34:155–157
- Detection of hepatitis B virus YMDD variants using mass spectrometric analysis of oligonucleotide fragments. J Hepatol. 2004;40:837–844
- Sensitive line probe assay that simultaneously detects mutations conveying resistance to lamivudine and adefovir. J Clin Microbiol. 2006;44:1094–1097
- Evaluation of methods for monitoring drug resistance in chronic hepatitis B patients during lamivudine therapy based on mass spectrometry and reverse hybridization. Antivir Ther. 2005;10:441–449
- Detection of rtN236T and rtA181V/T mutations associated with resistance to adefovir dipivoxil in samples from patients with chronic hepatitis B virus infection by the INNO-LiPA HBV DR line probe assay (version 2). J Clin Microbiol. 2006;44:1994–1997
- Complex dynamics of hepatitis B virus resistance to adefovir dipivoxil. J Hepatol. 2007;46(Suppl 1):S26
- Comparison of sequence analysis and INNO-LiPA HBV DR line probe assay in patients with chronic hepatitis B. J Chemother. 2005;17:514–520
- Dynamics of hepatitis B virus resistance to lamivudine. J Virol. 2006;80:643–653
- An international collaborative study to establish a World Health Organization international standard for hepatitis B virus DNA nucleic acid amplification techniques. Vox Sang. 2001;80:63–71
- . Hepatitis B virus (HBV) DNA assays (methods and practical use) and viral kinetics. J Hepatol. 2003;39(Suppl 1):S31–S35
- . Molecular diagnosis of viral hepatitis. Gastroenterology. 2002;122:1554–1568
- . Evaluation of the Cobas TaqMan 48 real-time PCR system for quantitation of hepatitis B virus DNA. J Clin Microbiol. 2005;43:3504–3507
- Fully automated quantitation of hepatitis B virus (HBV) DNA in human plasma by the Cobas AmpliPrep/Cobas TaqMan system. J Clin Virol. 2006;35:373–380
- Expertise of laboratories in viral load quantification, genotyping, and precore mutant determination for hepatitis B virus in a multicenter study. J Clin Microbiol. 2006;44:3600–3607
- . Quantitation of hepatitis B virus DNA by real-time PCR using internal amplification control and dual TaqMan MGB probes. J Virol Methods. 2006;135:83–90
- Evaluation of the Cobas AmpliPrep-total nucleic acid isolation-Cobas TaqMan hepatitis B virus (HBV) quantitative test and comparison to the Versant HBV DNA 3.0 assay. J Clin Microbiol. 2006;44:1390–1399
- Comparison of the Cobas TaqMan HBV test with the COBAS Amplicor monitor test for measurement of hepatitis B virus DNA in serum. J Med Virol. 2005;77:486–490
- Quantitation of hepatitis B lamivudine resistant mutants by real-time amplification refractory mutation system PCR. J Hepatol. 2004;40:986–992
- . The concept of hepatitis B virus mutant escape. J Clin Virol. 2005;34(Suppl 1):S125–S129
- Stepwise process for the development of entecavir resistance in a chronic hepatitis B virus infected patient. J Hepatol. 2006;46:531–538
- Selection of a multiple drug-resistant hepatitis B virus strain in a liver-transplanted patient. Gastroenterology. 2006;131:1253–1261
- In vitro susceptibilities of wild-type or drug-resistant hepatitis B virus to (-)-beta-D-2,6-diaminopurine dioxolane and 2′-fluoro-5-methyl-beta-L-arabinofuranosyluracil. Antimicrob Agents Chemother. 2001;45:2495–2501
- Cross-resistance testing of antihepadnaviral compounds using novel recombinant baculoviruses which encode drug-resistant strains of hepatitis B virus. Antimicrob Agents Chemother. 2001;45:1705–1713
- Phenylpropenamide derivatives AT-61 and AT-130 inhibit replication of wild-type and lamivudine-resistant strains of hepatitis B virus in vitro. Antimicrob Agents Chemother. 2002;46:3057–3060
- A new strategy for studying in vitro the drug susceptibility of clinical isolates of human hepatitis B virus. Hepatology. 2004;40:855–864
- Generation of stable cell lines expressing lamivudine-resistant hepatitis B virus for antiviral-compound screening. Antimicrob Agents Chemother. 2003;47:1936–1942
- . Lamivudine, adefovir and tenofovir exhibit long-lasting anti-hepatitis B virus activity in cell culture. J Viral Hepat. 2000;7:79–83
- Large variation in the replication efficiencies of HBV mutants: implications for phenotypic assays for antiviral drug resistance. Hepatology. 2006;44(Suppl 1):252A
- . The natural history and treatment of chronic hepatitis B: a critical evaluation of standard treatment criteria and endpoints. Ann Intern Med. 2007;147:58–61
- . When to start and stop hepatitis B treatment: can one set of criteria apply to all patients regardless of age at infection?. Ann Intern Med. 2007;147:62–64
- Antiviral drug-resistant HBV: standardization of nomenclature and assays and recommendations for management. Hepatology. 2007;46:254–265
- Transient selection of a hepatitis B virus polymerase gene mutant associated with a decreased replication capacity and famciclovir resistance. Hepatology. 1999;29:230–237
- Management of antiviral resistance in patients with chronic hepatitis B. Antivir Ther. 2004;9:679–693
- Intracellular metabolism and in vitro activity of tenofovir against hepatitis B virus. Antimicrob Agents Chemother. 2006;50:2471–2477
- Pharmacogenetics of long-term responses to antiretroviral regimens containing efavirenz and/or nelfinavir: an Adult Aids Clinical Trials Group Study. J Infect Dis. 2005;192:1931–1942
- Novel deoxycytidine kinase gene polymorphisms: a population screening study in Caucasian healthy volunteers. Eur J Clin Pharmacol. 2006;62:681–684
- . The impact of drug resistance on the effectiveness of chemotherapy for chronic hepatitis B. Hepatology. 2000;32:866–867
- Prevalence and clinical correlates of YMDD variants during lamivudine therapy for patients with chronic hepatitis B. Clin Infect Dis. 2003;36:687–696
- Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology. 2003;125:1714–1722
- High barrier to resistance results in no emergence of entecavir resistance in nucleoside-naïve subjects during the first two years of therapy. J Hepatol. 2006;44(Suppl 2):S182
- Clinical emergence of entecavir-resistant hepatitis B virus requires additional substitutions in virus already resistant to lamivudine. Antimicrob Agents Chemother. 2004;48:3498–3507
- Two-year entecavir resistance in lamivudine refractory HBV patients reveals different clinical outcomes depending on the resistance substitutions present. Antimicrob Agents Chemother. 2007;51:902–911
- Analysis of hepatitis B virus quasispecies changes during emergence and reversion of lamivudine resistance in liver transplantation. Antivir Ther. 1999;4:7–14
Supported in part by the VIRGIL European Network of Excellence on Antiviral Drug Resistance, by a grant (LSHM-CT-2004-503359) from the Priority 1 “Life Sciences, Genomics and Biotechnology for Health” program in the 6th Framework Program of the European Union, and by the French National Agency for AIDS and Viral Hepatitis Research (ANRS) (J.M.P. and F.Z.); in part by the Intramural Research Program of the National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health (T.J.L.); and in part by the Extramural Research Program of the National Institutes of Health (RO-1: AIO60449 to S.L.).
Jean-Michel Pawlotsky acted as a consultant/advisor for Roche (Basel, Switzerland), Gilead (Foster City, CA), Bristol-Myers Squibb (Princeton, NJ), Idenix (Cambridge, MA), and Novartis (Basel, Switzerland), and received research support from Roche and Gilead; Geoffrey Dusheiko received consultancy fees from Glaxo SmithKline (London, UK), Roche, Novartis, Schering Plough (Kenilworth, NJ), Idenix, Gilead Sciences, and Bristol-Myers Squibb, and received research support from the same groups; Daryl Lau acted as a consultant/advisor and has received research grants from Roche, Gilead, Bristol-Myers Squibb, and Novartis; George Lau is a Consultant for Roche and Novartis; Stephen Locarnini has received royalties and is a patent holder for Melbourne Health (Parkville, Victoria, Australia), has received consulting fees from Evivar (Melbourne, Victoria, Australia), Gilead, Pharmasset, and Bristol-Myers Squibb, has received research support from Evivar and Gilead, and has ownership interests in Pharmasset (Princeton, NJ); Paul Martin is a consultant and speaker for Bristol-Myers Squibb, Gilead, Idenix, and Roche; Douglas D. Richman is a consultant for Bristol-Myers Squibb, Gilead, Idenix, and Roche; and Fabien Zoulim is a consultant and has received speaker fees from Gilead, Bristol-Myers Squibb, Idenix, and Novartis.
PII: S0016-5085(07)02113-0
doi: 10.1053/j.gastro.2007.11.036
© 2008 AGA Institute. Published by Elsevier Inc. All rights reserved.
« Previous
Next »
Gastroenterology
Volume 134, Issue 2
, Pages 405-415
, February 2008

