WGO Graded Evidence: Hepatitis B

Level: Clinical Trials: 32 Abstracts

Legend:   : Special Mention  : Important  : Very Important  : Key Development
 
  Impact of adefovir dipivoxil on liver fibrosis and activity assessed with biochemical markers (FibroTest-ActiTest) in patients infected by hepatitis B virus.
Poynard T, Ngo Y, Marcellin P, Hadziyannis S, Ratziu V, Benhamou Y, Adefovir Dipivoxil 437 and 438 Study Groups, J Viral Hepat. 2009 Mar;16(3):203-13
  Lamivudine in late pregnancy to prevent perinatal transmission of hepatitis B virus infection: a multicentre, randomized, double-blind, placebo-controlled study.
Xu WM, Cui YT, Wang L, Yang H, Liang ZQ, Li XM, Zhang SL, Qiao FY, Campbell F, Chang CN, Gardner S, Atkins M, J Viral Hepat. 2009 Feb;16(2):94-103
  A randomized trial of combination hepatitis B therapy in HIV/HBV coinfected antiretroviral naļve individuals in Thailand.
Matthews GV, Avihingsanon A, Lewin SR, Amin J, Rerknimitr R, Petcharapirat P, Marks P, Sasadeusz J, Cooper DA, Bowden S, Locarnini S, Ruxrungtham K, Dore GJ, Hepatology. 2008 Oct;48(4):1062-9
  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 Jul;48(1):99-108
  A randomized study of adefovir dipivoxil in place of HBIG in combination with lamivudine as post-liver transplantation hepatitis B prophylaxis.
Angus PW, Patterson SJ, Strasser SI, McCaughan GW, Gane E, Hepatology. 2008 Nov;48(5):1460-6
  Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B.
Marcellin P, Chang TT, Lim SG, Sievert W, Tong M, Arterburn S, Borroto-Esoda K, Frederick D, Rousseau F, Hepatology. 2008 Sep;48(3):750-8
  Efficacy and safety of entecavir in patients with chronic hepatitis B and advanced hepatic fibrosis or cirrhosis.
Schiff E, Simsek H, Lee WM, Chao YC, Sette H Jr, Janssen HL, Han SH, Goodman Z, Yang J, Brett-Smith H, Tamez R, Am J Gastroenterol. 2008 Nov;103(11):2776-83
Supplementary evidence:
  18-year follow-up study of a prospective randomized trial of hepatitis B vaccinations without booster doses in children.
MF Yuen, WL Lim, AO Chan, DK Wong, SS Sum, CL Lai, Clin Gastroenterol Hepatol. 2004 Oct:941-5
  A phase I study of the safety and immunogenicity of recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide adjuvant.
SA Halperin, G Van Nest, B Smith, S Abtahi, H Whiley, JJ Eiden, Vaccine. 2003 Jun 2:2461-7
  A randomized control trial on interruption of HBV transmission in uterus.
Q Zhu, G Yu, H Yu, Q Lu, X Gu, Z Dong, X Zhang, Chin Med J (Engl). 2003 May:685-7
  A randomized controlled trial of monetary incentives vs. outreach to enhance adherence to the hepatitis B vaccine series among injection drug users.
KH Seal, AH Kral, J Lorvick, A McNees, L Gee, BR Edlin, Drug Alcohol Depend. 2003 Aug 20:127-31
  A two-dose schedule for combined hepatitis A and B vaccination in children aged 6-15 years.
Z Kurug&oeig;l, F Mutluba_, T Ozacar, Vaccine. 2005 Apr 22:2876-80
  Comparison of immunogenicity and safety of Engerix B and Twinrix vaccine
A GaBaj, G Grze[k, D Borys, A Durmowicz, E Grze[k, L Szadujkis-Szadurski, Wiad Lek. 2004:217-20
  Comparison of the accelerated and classic vaccination schedules against Hepatitis B: three-week Hepatitis B vaccination schedule provides immediate and protective immunity.
N Salto.lu, AS Inal, Y Tasova, O Kandemir, Ann Clin Microbiol Antimicrob. 2003 Nov 17:10
  Comparison of two different vaccination schemes against Hepatitis A and B in Mexican children and adolescents.
MS González-Huezo, F Sánchez-Avila, M García Mayol, G Castro Narro, S Sixtos, M Lisker-Melman, D Kershenobich, Rev Gastroenterol Mex. 2003 Oct-Dec:271-6
  Efficacy and immune memory of plasma-derived hepatitis B vaccine 11 years after primary immunization
H Xu, G Zhuang, X Wang, Q Chen, Z Chen, Zhonghua Yu Fang Yi Xue Za Zhi. 2000 Mar:113-5
  Efficacy of GM-CSF as an adjuvant to hepatitis B vaccination in patients with chronic renal failure--results of a prospective, randomized trial.
NP Singh, SK Mandal, A Thakur, D Kapoor, S Anuradha, A Prakash, R Kohli, SK Agarwal, Ren Fail. 2003 Mar:255-66
  Efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF) as a vaccine adjuvant for hepatitis B virus in patients with HIV infection.
MG Sasaki, R Foccacia, IJ de Messias-Reason, Vaccine. 2003 Nov 7:4545-9
  Efficacy of low dose intradermal hepatitis B vaccine: results of a randomized trial among health care workers.
HS Das, P Sawant, RG Shirhatti, K Vyas, S Vispute, S Dhadphale, V Patrawalla, N Desai, Trop Gastroenterol. 2002 Jul-Sep:120-1
  Hepatitis B vaccination in prison with a 3-week schedule is more efficient than the standard 6-month schedule.
PB Christensen, N Fisker, HB Krarup, E Liebert, N Jaroslavtsev, K Christensen, J Georgsen, Vaccine. 2004 Sep 28:3897-901
  Immune response to an indigenously developed r-hepatitis B vaccine in mixed population: study of an accelerated vaccination schedule.
A Chowdhury, A Santra, CM Habibullah, AA Khan, J Karunakaramaiah, TS Kishore, AV Raju, S Lahiri, World J Gastroenterol. 2005 Feb 21:1037-9
  Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and
M Avdicová, V Prikazskż, H Hudecková, L Schuerman, P Willems, Eur J Pediatr. 2002 Nov:581-7
  Immunogenicity in humans of an edible vaccine for hepatitis B.
Y Thanavala, M Mahoney, S Pal, A Scott, L Richter, N Natarajan, P Goodwin, CJ Arntzen, HS Mason, Proc Natl Acad Sci U S A. 2005 Mar 1:3378-82
  Immunogenicity of low dose intradermal hepatitis B vaccine and its comparison with standard dose intramuscular vaccination.
S Gomber, R Sharma, VG Ramachandran, Indian Pediatr. 2004 Sep:922-6
  Multicenter study on the immunogenicity and safety of two recombinant vaccines against hepatitis B.
RM Martins, G Bensabath, LC Arraes, Mde L Oliveira, JC Miguel, GG Barbosa, LA Camacho, Mem Inst Oswaldo Cruz. 2004 Dec:865-71
  Randomized trial of recombinant hepatitis B vaccine in HIV-infected adult patients comparing a standard dose to a double dose.
MO Fonseca, LW Pang, N de Paula Cavalheiro, AA Barone, M Heloisa Lopes, Vaccine. 2005 Apr 22:2902-8
  Rapid seroprotection against hepatitis B following the first dose of a Pre-S1/Pre-S2/S vaccine.
MY Shapira, E Zeira, R Adler, D Shouval, J Hepatol. 2001 Jan:123-7
  Simultaneous vaccination against hepatitis A and B: results of an open, randomized study from the occupational health point of view.
MA Rieger, F Hofmann, M Michaelis, Int J Occup Med Environ Health. 2004:379-91
  Specific hepatitis B vaccine therapy in inactive HBsAg carriers: a randomized controlled trial.
K Yalcin, M Acar, H Degertekin, Infection. 2003 Aug:221-5
  The efficacy of a two-dose hepatitis B vaccination scheme.
GJ Boland, T van Bommel, A Rulos-van den Berg, JP van den Berg, AM van Loon, J van Hattum, Adv Exp Med Biol. 2003:185-90
  Therapeutic vaccination in chronic hepatitis B.
H Senturk, F Tabak, M Akdogan, L Erdem, A Mert, R Ozaras, E Sander, G Ozbay, S Badur, J Gastroenterol Hepatol. 2002 Jan:72-6
  Therapeutic vaccination in the immunotolerant phase of children with chronic hepatitis B infection.
B Dikici, AG Kalayci, F Ozgenc, M Bosnak, M Davutoglu, A Ece, T Ozkan, T Ozeke, RV Yagci, K Haspolat, Pediatr Infect Dis J. 2003 Apr:345-9