Tenofovir monotherapy versus tenofovir and entecavir combination therapy in adefovir-resistant chronic hepatitis B patients with multiple drug failure: Results of a randomised trial

Gut

Volumn 65, Issue 6, 2016, Pages 1042-1051

  Lim, Young Suk ^a   Yoo, Byung Chul ^b   Byun, Kwan Soo ^c   Kwon, So Young ^b   Kim, Yoon Jun ^d   An, Jihyun ^a   Lee, Han Chu ^a   Lee, Yung Sang ^a  

^a University of Ulsan College of Medicine   (South Korea)

^b Konkuk University School of Medicine   (South Korea)

^c Korea University College of Medicine   (South Korea)

^d Seoul National University College of Medicine   (South Korea)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; CREATININE; ENTECAVIR; PHOSPHATE; TENOFOVIR DISOPROXIL; VIRUS DNA; VIRUS PROTEIN; ADEFOVIR; ADENINE; ANTIVIRUS AGENT; GUANINE; PHOSPHONIC ACID DERIVATIVE; TENOFOVIR;

ADULT; ADVERSE OUTCOME; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL RESISTANCE; ARTICLE; CHRONIC HEPATITIS B; COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; EPIGASTRIC PAIN; FEMALE; FRACTURE; GENOTYPE; HEADACHE; HEPATITIS B VIRUS; HUMAN; LIVER CELL CARCINOMA; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MIDDLE AGED; MONOTHERAPY; MULTICENTER STUDY; NONHUMAN; OSTEOPENIA; OSTEOPOROSIS; PATIENT COMPLIANCE; PHOSPHATE BLOOD LEVEL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT DURATION; VIRUS GENE; VIRUS LOAD; VIRUS MUTATION; VIRUS RESISTANCE; ANALOGS AND DERIVATIVES; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; ENZYMOLOGY; GENETICS; HEPATITIS B, CHRONIC; SOUTH KOREA; TREATMENT OUTCOME;

ADENINE; ADULT; AGED; ANTIVIRAL AGENTS; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; GUANINE; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; MALE; MIDDLE AGED; ORGANOPHOSPHONATES; REPUBLIC OF KOREA; TENOFOVIR; TREATMENT OUTCOME;

EID: 84929603251     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2014-308435     Document Type: Article

References (49)

1. Chen CJ, Yang HI, Su J, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73.
2. Iloeje UH, Yang HI, Su J, et al. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-86.
3. Liaw YF, Sung JJ, Chow WC, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521-31.
4. Gordon SC, Lamerato LE, Rupp LB, et al. Antiviral therapy for chronic hepatitis B virus infection and development of hepatocellular carcinoma in a US population. Clin Gastroenterol Hepatol 2014;12:885-93.
5. Eun JR, Lee HJ, Kim TN, et al. Risk assessment for the development of hepatocellular carcinoma: according to on-treatment viral response during long-term lamivudine therapy in hepatitis B virus-related liver disease. J Hepatol 2010;53:118-25.
6. Papatheodoridis GV, Dimou E, Dimakopoulos K, et al. Outcome of hepatitis B e antigen-negative chronic hepatitis B on long-term nucleos(t)ide analog therapy starting with lamivudine. Hepatology 2005;42:121-9.
7. Yuen MF, Seto WK, Chow DH, et al. Long-term lamivudine therapy reduces the risk of long-term complications of chronic hepatitis B infection even in patients without advanced disease. Antivir Ther 2007;12:1295-303.
8. Hosaka T, Suzuki F, Kobayashi M, et al. Long-term entecavir treatment reduces hepatocellular carcinoma incidence in patients with hepatitis B virus infection. Hepatology 2013;58:98-107.
9. Wong GL, Chan HL, Mak CW, et al. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients With liver cirrhosis. Hepatology 2013;58:1537-47.
10. Lim YS, Han S, Heo NY, et al. Mortality, liver transplantation, and hepatocellular carcinoma among patients with chronic hepatitis B treated with entecavir vs lamivudine. Gastroenterology 2014;147:152-61.
11. Wu CY, Lin JT, Ho HJ, et al. Association of nucleos(t)ide analogue therapy with reduced risk of hepatocellular carcinoma in patients with chronic hepatitis B-A nationwide cohort study. Gastroenterology 2014;147:143-51.
12. Chang TT, Lai CL, Yoon SK, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010;51:422-30.
13. Kitrinos KM, Corsa A, Liu Y, et al. No detectable resistance to tenofovir disoproxil fumarate after 6 years of therapy in patients with chronic hepatitis B. Hepatology 2014;59:434-42.
14. European Association for the Study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B virus infection. J Hepatol 2012;57:167-85.
15. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009;50:661-2.
16. Korean Association for the Study of the Liver. KASL Clinical Practice Guidelines: Management of chronic hepatitis B. Clin Mol Hepatol 2012;18:109-62.
17. Liaw YF, Kao JH, Piratvisuth T, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatology International 2012;6:531-61.
18. Berg T, Marcellin P, Zoulim F, et al. Tenofovir is effective alone or with emtricitabine in adefovir-treated patients with chronic-hepatitis B virus infection. Gastroenterology 2010;139:1207-17.
19. Berg T, Zoulim F, Moeller B, et al. Long-term efficacy and safety of emtricitabine plus tenofovir DF vs. tenofovir DF monotherapy in adefovir-experienced chronic hepatitis B patients. J Hepatol 2014;60:715-22.
20. Fung S, Kwan P, Fabri M, et al. Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2014;146:980-8.
21. Patterson SJ, George J, Strasser SI, et al. Tenofovir disoproxil fumarate rescue therapy following failure of both lamivudine and adefovir dipivoxil in chronic hepatitis B. Gut 2011;60:247-54.
22. Lim YS, Byun KS, Yoo BC, et al. Tenofovir monotherapy versus tenofovir and entecavir combination therapy in patients with entecavir-resistant chronic hepatitis B with multiple drug failure: results of a randomised trial. Gut 2016;65:852-60.
23. Zoulim F, Locarnini S. Management of treatment failure in chronic hepatitis B. J Hepatol 2012;56:S112-22.
24. Gish R, Jia JD, Locarnini S, et al. Selection of chronic hepatitis B therapy with high barrier to resistance. Lancet Infect Dis 2012;12:341-53.
25. Qi X, Xiong S, Yang H, et al. In vitro susceptibility of adefovir-associated hepatitis B virus polymerase mutations to other antiviral agents. Antivir Ther 2007; 12:355-62.
26. Villet S, Pichoud C, Billioud G, et al. Impact of hepatitis B virus rtA181V/T mutants on hepatitis B treatment failure. J Hepatol 2008;48:747-55.
27. Levey AS, Coresh J, Greene T, et al. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med 2006;145:247-54.
28. Han KH, Hong SP, Choi SH, et al. Comparison of multiplex restriction fragment mass polymorphism and sequencing analyses for detecting entecavir resistance in chronic hepatitis B. Antivir Ther 2011;16:77-87.
29. Brunelle MN, Jacquard AC, Pichoud C, et al. Susceptibility to antivirals of a human HBV strain with mutations conferring resistance to both lamivudine and adefovir. Hepatology 2005;41:1391-8.
30. Yim HJ, Hussain M, Liu Y, et al. Evolution of multi-drug resistant hepatitis B virus during sequential therapy. Hepatology 2006;44:703-12.
31. Villet S, Pichoud C, Villeneuve JP, et al. Selection of a multiple drug-resistant hepatitis B virus strain in a liver-transplanted patient. Gastroenterology 2006;131:1253-61.
32. Warner N, Locarnini S. The antiviral drug selected hepatitis B virus rtA181T/sW172∗ mutant has a dominant negative secretion defect and alters the typical profile of viral rebound. Hepatology 2008;48:88-98.
33. Villeneuve J-P, Durantel D, Durantel S, et al. Selection of a hepatitis B virus strain resistant to adefovir in a liver transplantation patient. J Hepatol 2003;39:1085-9.
34. 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;125:292-7.
35. Heo NY, Lim YS, Lee HC, et al. Lamivudine plus adefovir or entecavir for patients with chronic hepatitis B resistant to lamivudine and adefovir. J Hepatol 2010;53:449-54.
36. Shim JH, Suh DJ, Kim KM, et al. Efficacy of entecavir in patients with chronic hepatitis B resistant to both lamivudine and adefovir or to lamivudine alone. Hepatology 2009;50:1064-71.
37. Marcellin P, Heathcote EJ, Buti M, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008;359:2442-55.
38. van Bommel F, de Man RA, et al Long-term efficacy of tenofovir monotherapy for hepatitis B virus-monoinfected patients after failure of nucleoside/nucleotide analogues. Hepatology 2010;51:73-80.
39. Petersen J, Ratziu V, Buti M, et al. Entecavir plus tenofovir combination as rescue therapy in pre-treated chronic hepatitis B patients: an international multicenter cohort study. J Hepatol 2012;56:520-6.
40. Lim YS, Lee JY, Lee D, et al. Randomized trial of entecavir plus adefovir in patients with lamivudine-resistant chronic hepatitis B who show suboptimal response to lamivudine plus adefovir. Antimicrob Agents Chemother 2012;56:2941-7.
41. Lim YS, Lee JY, Lee D, et al. Randomized trial of the virologic response during up to two years of entecavir-adefovir combination therapy in multiple-drug-refractory chronic hepatitis B virus patients. Antimicrob Agents Chemother 2013;57:3369-74.
42. Lim YS, Lee TH, Heo NY, et al. Entecavir plus adefovir combination treatment for chronic hepatitis B patients after failure of nucleoside/nucleotide analogues. Antivir Ther 2012;17:53-60.
43. Zoulim F, Jablkowski MS, Diculescu M, et al. The safety and efficacy of entecavir and tenofovir combination therapy for chronic hepatitis B in patients with previous nucleos(t)ide treatment failure: week 96 results of the ENTEBE study. Hepatology 2014;60:314A.
44. Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-10.
45. Lok AS, Trinh H, Carosi G, et al. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology 2012;143:619-28.
46. Mallet V, Schwarzinger M, Vallet-Pichard A, et al. Effect of Nucleoside and Nucleotide Analogues on Renal Function in Patients With Chronic Hepatitis B Virus Monoinfection. Clin Gastroenterol Hepatol Published Online First: 21 Nov 2014. doi:10.1016/j.cgh.2014.11.021
47. Qi X, Wang JY, Mao RC, et al. Impact of nucleos(t)ide analogues on the estimated glomerular filtration rate in patients with chronic hepatitis B: a prospective cohort study in China. J Viral Hepat 2015;22:46-54.
48. Pageaux G-P, Zoulim F, Causse X, et al. Long-term treatment with tenofovir in treatment-naive or -experienced CHB patients is effective and well tolerated in real-life practice: 3 years results of the VIREAL study. J Hepatol 2014;60:S430.
49. Zoulim F, Locarnini S. Hepatitis B virus resistance to nucleos(t)ide analogues. Gastroenterology 2009;137:1593-608.