Hope-For-HepB Top10 June 2008

Entecavir therapy for lamivudine-refractory chronic hepatitis B: Improved virologic, biochemical, and serology outcomes through 96 weeks.

Sherman M, Yurdaydin C, Simsek H, Silva M, Liaw YF, Rustgi VK, Sette H, Tsai N, Tenney DJ, Vaughan J, Kreter B, Hindes R; AI463026 Benefits of Entecavir for Hepatitis B Liver Disease (BEHoLD) Study Group.

Hepatology. 2008 Jun 8; Epub ahead of print.

Rating & Commentary
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Follow-up study of entecavir in 77 patients with lamivudine resistant chronic hepatitis B and 1 year of therapy. The proportion of patients with HBV DNA <300 copies/ml increased from 21% to 40% in the second year of therapy. Antiviral resistance occurred in 8%.


Tailored regimen of interferon alpha for HBeAg-positive chronic hepatitis B: a prospective controlled study.

Luo K, Mao Q, Karayiannis P, Liu D, Liu Z, Zhou Y, Feng X, Zhu Y, Guo Y, Jiang R, Zhou F, Peng J, Hou J.

J Viral Hepat. 2008 Jun 11; Epub ahead of print.

Rating & Commentary
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Large study in 374 HBeAg positive chronic hepatitis B patients showing that tailored interferon treatment, with continuation of treatment as long as HBV DNA levels are continuously decreasing, resulted in higher rates of sustained response compared to a strategy with predefined 6-month treatment duration (40% vs. 28%, p=0.01).


Tenofovir monotherapy is effective in hepatitis B patients with antiviral treatment failure to adefovir in the absence of adefovir-resistant mutations.

Tan J, Degertekin B, Wong SN, Husain M, Oberhelman K, Lok AS.

J Hepatol. 2008;48(3):391-8.

Rating & Commentary
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Small study in 13 chronic hepatitis B virus infected patients showing that tenofovir monotherapy is effective in non-responders to adefovir therapy, with virological response in 8 of 10 patients receiving tenofovir alone. In patients with adefovir resistance addition of emtricitabine is recommended because of the potential of cross-resistance.


Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: Randomized controlled trial in Japanese patients.

Suzuki F, Toyoda J, Katano Y, Sata M, Moriyama M, Imazeki F, Kage M, Seriu T, Omata M, Kumada H.

J Gastroenterol Hepatol. 2008 Jun 12; Epub ahead of print.

Rating & Commentary
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Study in 84 lamivudine-refractory hepatitis B virus infected patients showing that 90% and 93% of patients receiving 0.5 or 1 mg entecavir, respectively, achieved a reduction in HBV DNA of at least 2 log(10) copies/ml after 52 weeks. The incidence of virological breakthrough was lower than previously reported (in 1 of 84 patients, without evidence of entecavir resistance).


Sequential combination therapy leads to biochemical and histological improvement despite low ongoing intrahepatic hepatitis B virus replication.

Lutgehetmann M, Volzt T, Quaas A, Zankel M, Fischer C, Dandri M, Petersen J.

Antivir Ther. 2008;13(1):57-66.

Rating & Commentary
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Small study in 24 HBV infected patients, who received 48 weeks of peginterferon and adefovir combination therapy followed by 96 weeks of adefovir monotherapy, showing a marked decrease of cccDNA at week 48 but no further decrease between week 48 and week 144. During 2 years of adefovir monotherapy resistance was observed in 10% of patients (2/24).


Analysis of hepatitis B genotype changes in chronic hepatitis B infection: Influence of antiviral therapy.

Jardi R, Rodriguez-Frias F, Schaper M, Giggi E, Tabernero D, Homs M, Esteban R, Buti M.

J Hepatol. 2008 May 6; Epub ahead of print.

Rating & Commentary
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Detailed analysis of hepatitis B virus (HBV) genotypes in 22 patients with chronic HBV infection showing that changes in genotypes could be observed in patients receiving antiviral therapy, particularly the selection of genotype A in patients with genotype A+D infection.


Longitudinal changes in serum HBV DNA levels and predictors of progression during the natural course of HBeAg-negative chronic hepatitis B virus infection.

Papatheodoridis GV, Chrysanthos N, Hadziyannis E, Cholongitas E, Manesis EK.

J Viral Hepat. 2008;15(6):434-41.

Rating & Commentary
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Large study in 150 untreated HBeAg negative chronic hepatitis B virus infected patients (85 inactive carriers and 65 with chronic hepatitis B) confirming that most inactive carriers have HBV DNA <2,000 IU/ml.  The 3-year risk of progression to chronic hepatitis B is about 15%, which is associated with higher baseline ALT and HBV DNA of 2,000-5,000 IU/ml.


A simple noninvasive score predicts gastroesophageal varices in patients with chronic viral hepatitis.

Gentile I, Viola C, Graf M, Liuzzi R, Quarto M, Cerini R, Piazza M, Borgia G.

J Clin Gastroenterol. 2008 Jun 16; Epub ahead of print.

Rating & Commentary
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Study in 254 patients with hepatitis B or C related cirrhosis showing that esophageal varices were associated with age >50 years, platelet count <150,000/mmc, albumin <3.6 g/dL, and AST/ALT-ratio >1. A simple score of <2 of these factors can accurately predict virual absence of varices and thereby reduce the need for upper endoscopic screening by about 50%.


The impact of chronic hepatitis B on quality of life: a multinational study of utilities from infected and uninfected persons.

Levy AR, Kowdley KV, Iloeje U, Tafesse E, Mukherjee J, Gish R, Bzowej N, Briggs AH.

Value Health. 2008;11(3):527-38.

Rating & Commentary
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Large study in 534 chronic hepatitis B infected patients and 600 controls showing that chronic hepatitis and compensated cirrhosis had moderate impact on health related quality of life, while decompensated cirrhosis and hepatocellulair carcinoma significantly diminished quality of life.


Long-term antibody persistence in children primed and boosted with a DTPw-HBV vaccine at 2, 4, 6, 18, months of age.

Poovorawan Y, Hutagalung Y, Chongsrisawat V, Thaemboonlers A, Lefevre I.

Vaccine. 2008;26(12):1535-40.

Rating & Commentary
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Study showing that the combined tetravalent DTPw-HBV vaccines at 2, 4, 6 months and booster dosing at 18 months and 4 years resulted in protective anti-HBs antibody concentrations of >10 mIU/ml in 90.9% of subjects at 7-year follow-up and 60.9% of subjects at 10-year follow-up.

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