Adefovir dipivoxil and pegylated interferon alpha for the treatment of chronic hepatitis B: An updated systematic review and economic evaluation

Health Technology Assessment

Volumn 13, Issue 35, 2009, Pages

  Jones, J ^a   Shepherd, J ^a   Baxter, L ^a   Gospodarevskaya, E ^a   Hartwell, D ^a   Harris, P ^a   Price, A ^b  

^a Southampton Health Technology Assessments Centre   (United Kingdom)

^b NIHR Evaluationm Trials and Studies Coordinating Centre (NETSCC)   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; ALPHA INTERFERON; LAMIVUDINE; PEGINTERFERON ALPHA; PEGINTERFERON ALPHA2A; PEGINTERFERON ALPHA2B; PLACEBO; ADENINE; ANTIVIRUS AGENT; DRUG DERIVATIVE; PHOSPHONIC ACID DERIVATIVE;

CHEMICAL ANALYSIS; CHRONIC HEPATITIS; CLINICAL TRIAL; COCHRANE LIBRARY; COST EFFECTIVENESS ANALYSIS; ECONOMIC EVALUATION; EMBASE; HEPATITIS B; HISTOLOGY; HUMAN; MEDLINE; MONOTHERAPY; QUALITY OF LIFE; REVIEW; STATISTICAL SIGNIFICANCE; SYSTEMATIC REVIEW; TREATMENT OUTCOME; ADULT; AGED; ECONOMICS; FEMALE; MALE; MIDDLE AGED;

ADENINE; ADULT; AGED; ANTIVIRAL AGENTS; FEMALE; HEPATITIS B, CHRONIC; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; ORGANOPHOSPHONATES;

EID: 70349596357     PISSN: 13665278     EISSN: None     Source Type: Journal    
DOI: 10.3310/hta13350     Document Type: Review

References (90)

1. Chu CM, Karayiannis P, Fowler MJ, Monjardino J, Liaw YF, Thomas HC. Natural history of chronic hepatitis B virus infection in Taiwan: studies of hepatitis B virus DNA in serum. Hepatology 1985;5:431-434 (Pubitemid 15065950)
2. Thomas HC. Best practice in the treatment of chronic hepatitis B: a summary of the European Viral Hepatitis Educational Initiative (EVHEI) 93. J Hepatol 2007;47:588-597
3. De Franchis R, Hadengue A, Lau G, Lavanchy D, Lok A, McIntyre N, et al. EASL international consensus conference on hepatitis B. Switzerland: Geneva; 13-14 September 2002. Consensus statement (long version). J Hepatol 2003;39:S3-25.
4. Carman WF, Jacyna MR, Hadziyannis S, Karayiannis P, McGarvey MJ, Makris A, et al. Mutation preventing formation of hepatitis B e antigen in patients with chronic hepatitis B infection. Lancet 1989;2:588-591 (Pubitemid 19216208)
5. Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet 2003;362:2089-2094
6. Department of Health. Getting ahead of the curve: a strategy for combating infectious diseases (including other aspects of health protection). London: HMSO; 2002.
7. Pendleton S, Wilson-Webb P. Rising curve - chronic hepatitis B infection in the UK. Canterbury: Hepatitis B Foundation; 2007.
8. Wong J B, Koff RS, Tine F, Pauker SG. Cost-effectiveness of interferon-alpha 2b treatment for hepatitis B e antigen-positive chronic hepatitis B. Ann Intern Med 1995;122:664-675
9. Foster GR, Goldin RD, Thomas HC. Chronic hepatitis C virus infection causes a significant reduction in quality of life in the absence of cirrhosis [see comment]. Hepatology 1998;27:209-12.
10. Pojoga C, Dumitrascu DL, Pascu O, Grigorescu M, Radu C, Damian D. Impaired health-related quality of life in Romanian patients with chronic viral hepatitis before antiviral therapy. Eur J Gastroenterol Hepatol 2004;16:27-31. (Pubitemid 39043699)
11. Nowak MA, Bonhoeffer S, Hill AM, Boehme R, Thomas HC, McDade H. Viral dynamics in hepatitis B virus infection. Proc Natl Acad Sci USA; 1996;93:4398-4402
12. Shepherd J, Jones J, Takeda A, Davidson P, Price A. Adefovir dipivoxil and pegylated interferon alfa-2a for the treatment of chronic hepatitis B: a systematic review and economic evaluation. Health Technol Assess 2006;10(28). (Pubitemid 44548800)
13. NHS Centre for Reviews and Dissemination. Undertaking systematic reviews of research on effectiveness: CRD's guidance for those carrying out or commissioning reviews. CRD Report Number 4, 2nd edition. York: York Publishing Services; 2001.
14. Bonino F, Marcellin P, Lau GK, Hadziyannis S, Jin R, Piratvisuth T, et al. Predicting response to peginterferon alpha-2a, lamivudine and the two combined for HBeAg-negative chronic hepatitis B. Gut 2007;56:699-705. (Pubitemid 46662938)
15. Chow WC, Cooksley G, Chang WY, Manns M, Thongsawat S, Zhang HF, et al. Predicting response in a large, multinational trial of peginterferon alfa-2a (40 kDa + lamivudine vs lamivudine alone) in HBeAg-positive chronic hepatitis B. Liver Int 2005;25:1296-1297
16. Cooksley G, Manns M, Lau GKK, Liaw YF, Marcellin P, Chow WC, et al. Effect of genotype and other baseline factors on response to peginterferon alpha-2a (40 kDa) (PEGASYS) in HBeAg-positive chronic hepatitis B: results from a large, randomised study. J Hepatol 2005;42:30-31
17. Hui CK, Zhang HY, Lee NP, Chan W, Yueng YH, Leung KW, et al. Serum adiponectin is increased in advancing liver fibrosis and declines with reduction in fibrosis in chronic hepatitis B. J Hepatol 2007;47:191-202. (Pubitemid 47021251)
18. Rapti I, Dimou E, Mitsoula P, Hadziyannis SJ. Adding-on versus switching-to adefovir therapy in lamivudine-resistant HBeAg-negative chronic hepatitis B [see comment]. Hepatology 2007;45:307-13. (Pubitemid 46374587)
19. Zeng M, Mao Y, Yao G, Wang H, Hou J, Wang Y, et al. A double-blind randomized trial of adefovir dipivoxil in Chinese subjects with HBeAg-positive chronic hepatitis B. Hepatology 2006;44:108-116 (Pubitemid 44049144)
20. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology 2006;131:1743-1751 (Pubitemid 44958517)
21. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-negative chronic hepatitis B. N Engl J Med 2003;348:800-807 (Pubitemid 36245756)
22. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, Chang TT, Kitis G, Rizzetto M, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B [see comment]. N Engl J Med 2005;352:2673-2681 (Pubitemid 41007822)
23. Chan HL, Wong VW, Chim AM, Choi PC, Chan HY, Hui AY, et al. Virological response to different combination regimes of peginterferon alpha-2b and lamivudine in hepatitis B c antigen positive chronic hepatitis B. Antivir Ther 2007;12:815-823
24. Chan HLY, Leung NWY, Hui AY, Wong VWS, Liew CT, Chim AML, et al. A randomized, controlled trial of combination therapy for chronic hepatitis B: comparing pegylated interferon-alpha 2b and lamivudine with lamivudine alone. Ann Intern Med 2005;142:240-250 (Pubitemid 40216241)
25. Kaymakoglu S, Oguz D, Gur G, Gurel S, Tankurt E, Ersoz G, et al. Pegylated interferon alfa-2b monotherapy and pegylated interferon alfa-2b plus lamivudine combination therapy for patients with hepatitis B virus e antigen-negative chronic hepatitis B. Antimicrob Agents Chemother 2007;51:3020-3022 (Pubitemid 47206252)
26. Janssen HL, van ZM, Senturk H, Zeuzem S, Akarca US, Cakaloglu Y, et al. Pegylated interferon alfa-2b alone or in combination with lamivudine for HBeAg-positive chronic hepatitis B: a randomised trial. Lancet 2005;365:123-129 (Pubitemid 40091801)
27. Zhao H, Kurbanov F, Wan MB, Yin YK, Niu JQ, Hou JL, et al. Genotype B and younger patient age associated with better response to low-dose therapy: a trial with pegylated/nonpegylated interferon-alpha-2b for hepatitis B e antigen-positive patients with chronic hepatitis B in China. Clin Infect Dis 2007;44:541-548 (Pubitemid 46233256)
28. Chan HL, Hui AY, Wong VW, Chim AM, Wong ML, Sung JJ. Long-term follow-up of peginterferon and lamivudine combination treatment in HBeAg-positive chronic hepatitis B. Hepatology 2005;41:1357-1364 (Pubitemid 40770289)
29. van Zonneveld M, Zondervan PE, Cakaloglu Y, Simon C, Akarca US, So TM, et al. Peg-interferon improves liver histology in patients with HBeAg-positive chronic hepatitis B: no additional benefit of combination with lamivudine. Liver Int 2006;26:399-405.
30. van Zonneveld M, Flink HJ, Verhey E, Senturk H, Zeuzem S, Akarca US, et al. The safety of pegylated interferon alpha-2b in the treatment of chronic hepatitis B: predictive factors for dose reduction and treatment discontinuation. Aliment Pharmacol Ther 2005;21:1163-1171 (Pubitemid 40646544)
31. Buster EH, Hansen BE, Buti M, Delwaide J, Niederau C, Michielsen PP, et al. Peginterferon alpha-2b is safe and effective in HBeAg-positive chronic hepatitis B patients with advanced fibrosis. Hepatology 2007;46:388-394 (Pubitemid 47344773)
32. Flink HJ, van Zonneveld M, Hansen BE, de Man RA, Schalm SW, Janssen HL, et al. Treatment with Peg-interferon alpha-2b for HBeAg-positive chronic hepatitis B: HBsAg loss is associated with HBV genotype. Am J Gastroenterol 2006;101:297-303. (Pubitemid 43381671)
33. ter Borg MJ, van Zonneveld M, Zeuzem S, Senturk H, Akarca US, Simon C, et al. Patterns of viral decline during PEG-interferon alpha-2b therapy in HBeAg-positive chronic hepatitis B: relation to treatment response. Hepatology 2006;44:721-727
34. Ghany MG, Doo EC. Management of chronic hepatitis B. Gastroenterol Clin North Am 2004;33:563-79.
35. Pai SB. Characterization of hepatitis B virus inhibition by novel 2′-fluoro-2′,3′-unsaturated beta-D- and L-nucleosides. Antivir Chem Chemother 2005;16:183-192 (Pubitemid 41512159)
36. Drummond M, O'Brien BJ, Stoddart G, Torrance GW. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 1997.
37. Philips Z, Ginnelly L, Sculpher M, Claxton K, Golder S, Riemsma R, et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess 2004;8(36). (Pubitemid 39585963)
38. Kanwal F, Gralnek IM, Martin P, Dulai GS, Farid M, Spiegel BM. Treatment alternatives for chronic hepatitis B virus infection: a cost-effectiveness analysis. Ann Intern Med 2005;142:821-831 (Pubitemid 40664041)
39. Dusheiko GM, Roberts JA. Treatment of chronic type B and C hepatitis with interferon alfa: an economic appraisal. Hepatology 1995;22:1863-1873
40. Brooks EA, Lacey LF, Payne SL, Miller DW. Economic evaluation of lamivudine compared with interferon-alpha in the treatment of chronic hepatitis B in the United States. Am J Manag Care 2001;7:677-682
41. Orlewska E. The cost-effectiveness of alternative therapeutic strategies for the management of chronic hepatitis B in Poland. Value Heath 2002;5:404-420
42. Crowley SJ. Cost-effectiveness analysis of lamivudine for the treatment of chronic hepatitis B. PharmacoEconomics 2000;17:409-1277
43. Crowley S, Tognarini D, Desmond P, Lees M, Saal G. Introduction of lamivudine for the treatment of chronic hepatitis B: expected clinical and economic outcomes based on 4-year clinical trial data. J Gastroenterol Hepatol 2002;17:153-164 (Pubitemid 34415668)
44. Veenstra DL, Sullivan SD, Dusheiko GM, Jacobs M, Aledort JE, Lewis G, et al. Cost-effectiveness of peginterferon alpha-2a compared with lamivudine treatment in patients with HBe-antigen-positive chronic hepatitis B in the United Kingdom. Eur J Gastroenterol Hepatol 2007;19:631-638 (Pubitemid 47067060)
45. Sullivan SD, Veenstra DL, Chen PJ, Chang TT, Chuang WL, Tsai C, et al. Cost-effectiveness of peginterferon alfa-2a compared to lamivudine treatment in patients with hepatitis B e antigen positive chronic hepatitis B in Taiwan. J Gastroenterol Hepatol 2007;22:1494-1499 (Pubitemid 47274568)
46. Kanwal F, Farid M, Martin P, Chen G, Gralnek IM, Dulai GS, et al. Treatment alternatives for hepatitis B cirrhosis: a cost-effectiveness analysis. Am J Gastroenterol 2006;101:2076-2089 (Pubitemid 44337634)
47. Buti M, Casado MA, Calleja JL, Salmeron J, Aguilar J, Rueda M, et al. Cost-effectiveness analysis of lamivudine and adefovir dipivoxil in the treatment of patients with HBeAg-negative chronic hepatitis B. Aliment Pharmacol Ther 2006;23:409-419 (Pubitemid 43382021)
48. Sun X, Qin WX, Li YP, Jiang XH. Comparative cost-effectiveness of antiviral therapies in patients with chronic hepatitis B: a systematic review of economic evidence. J Gastroenterol Hepatol 2007;22:1369-1377 (Pubitemid 47274592)
49. Pwu RF, Chan KA. Cost-effectiveness analysis of interferon-alpha therapy in the treatment of chronic hepatitis B in Taiwan. J Formos Med Assoc 2002;101:632-641 (Pubitemid 36149873)
50. Lau GK, Piratvisuth T, Luo KX, Marcellin P, Thongsawat S, Cooksley G, et al. Peginterferon alfa-2a, lamivudine, and the combination for HBeAg-positive chronic hepatitis B [see comment]. N Engl J Med 2005;352:2682-2695
51. Liaw YF, Leung NW, Chang TT, Guan R, Tai DI, Ng KY, et al. Effects of extended lamivudine therapy in Asian patients with chronic hepatitis B. Asia Hepatitis Lamivudine Study Group. Gastroenterology 2000;119:172-180 (Pubitemid 30452590)
52. Leung NWY, Lai CL, Chang TT, Guan R, Lee CM, Ng KY, et al. Extended lamivudine treatment in patients with chronic hepatitis B enhances hepatitis e antigen seroconversion rates: results after three years of therapy. Hepatology 2001;33:1527-1532 (Pubitemid 32496991)
53. Lok ASF, Lai CL, Leung N, Yao GB, Cui ZY, Schiff ER, et al. Long-term safety of lamivudine treatment in patients with chronic hepatitis B. Gastroenterology 2003;125:1714-1722 (Pubitemid 37500436)
54. Wang CC, Kowdley K. Built to last? Durability of lamivudine-induced serocoversion in patients with chronic hepatitis B. Gastroenterology 2004;126:1917-19.
55. Bennett WG, Inoue Y, Beck JR, Wong JB, Pauker SG, Davis GL. Estimates of the cost-effectiveness of a single course of interferon-alpha 2b in patients with histologically mild chronic hepatitis C. Ann Intern Med 1997;127:855-865 (Pubitemid 27490622)
56. Levy AR, Kowdley K, Iloeje U, Tafesse E, Mukherjee J, Gish R, et al. The impact of chronic hepatitis B on quality of life: a multinational study of utilities from infected and uninfected persons. Value in Health. Online early, doi: 10.1111/j.1524-4733.2007.00297.x. 17-12-2007.
57. Kind P, Hardman G, Macran SUK. Population norms for EQ-5D. CHE Discussion Paper No. 172. York: Centre for Health Economics, University of York; 1999.
58. Wright M, Forton D, Main J, Goldin R, Torok E, Tedder R, et al. Treatment of histologically mild hepatitis C virus infection with interferon and ribavirin: a multicentre randomized controlled trial. J Viral Hepat 2005;12:58-66. (Pubitemid 40188775)
59. Chong CA, Gulamhussein A, Heathcote EJ, Lilly L, Sherman M, Naglie G, et al. Health-state utilities and quality of life in hepatitis C patients. Am J Gastroenterol 2003;98:630-638 (Pubitemid 36348537)
60. Ratcliffe J, Longworth L, Young T, Bryan S, Burroughs A, Buxton M, et al. Assessing health-related quality of life pre- and post-liver transplantation: a prospective multicenter study. Liver Transpl 2002;8:263-270 (Pubitemid 34257209)
61. Curtis L. Unit costs of health and social care. Canterbury: Personal Social Services Research Unit, University of Kent; 2007.
62. Joint Formulary Committee. British national formulary. No.55. London: British Medical Association and Royal Pharmaceutical Society of Great Britain; 2008.
63. Briggs AH, Claxton K, Sculpher M. Decision modelling for health economic evaluation. Oxford: Oxford University Press; 2006.
64. Fenwick E, Claxton K, Sculpher M. Representing uncertainty: the role of cost-effectiveness acceptability curves. Health Econ 2001;10:779-787 (Pubitemid 34041389)
65. Marcellin P, Chang TT, Lim SG, Tong MJ, Sievert W, Shiffman ML, et al. Adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. N Engl J Med 2003;348:808-816 (Pubitemid 36245757)
66. Perrillo R, Hann HW, Mutimer D, Willems B, Leung N, Lee WM, et al. Adefovir dipivoxil added to ongoing lamivudine in chronic hepatitis B with YMDD mutant hepatitis B virus. Gastroenterology 2004;126:81-90. (Pubitemid 38040726)
67. Peters MG, Hann HH, Martin P, Heathcote EJ, Buggisch P, Rubin R, et al. Adefovir dipivoxil alone or in combination with lamivudine in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2004;126:91-101. (Pubitemid 38040727)
68. Sung JJ, Lai JY, Zeuzem S, Chow WC, Heathcote EJ, Perrillo RP, et al. Lamivudine compared with lamivudine and adefovir dipivoxil for the treatment of HBeAg-positive chronic hepatitis B. J Hepatol 2008;48:728-735
69. Sasadeusz JJ, Locarnini SL, Macdonald G. Why do we not yet have combination chemotherapy for chronic hepatitis B? Med J Aust 2007;186:204-206
70. Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-1010 (Pubitemid 43357804)
71. Yao G, Chen C, Lu W, Ren H, Tan D, Wang Y, et al. Efficacy and safety of entecavir compared to lamivudine in nucleoside-naïve patients with chronic hepatitis B: a randomized double-blind trial in China 92. Hepatol Int 2007;1:365-372
72. Lai CL, Shouval D, Lok AS, Chang TT, Cheinquer H, Goodman Z, et al. Entecavir versus lamivudine for patients with HBeAg-negative chronic hepatitis B [see comment]. [Erratum appears in N Engl J Med 2006;354:1863.] N Engl J Med 2006;354:1011-1020
73. Lai CL, Gane E, Liaw YF, Hsu C-W, Thongsawat S, Wang Y, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007;357:2576-2588 (Pubitemid 350294224)
74. Hui AY, Chan HL, Cheung AY, Cooksley G, Sung JJ. Systematic review: treatment of chronic hepatitis B virus infection by pegylated interferon [review; 26 refs]. Aliment Pharmacol Ther 2005;22:519-528 (Pubitemid 41360798)
75. Fattovich G. Natural history of hepatitis B. J Hepatol 2003;39:50-58
76. Marcellin P, Lau GK, Bonino F, Farci P, Hadziyannis S, Jin R, et al. 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 (Pubitemid 39296307)
77. Cooksley WG, Piratvisuth T, Lee SD, Mahachai V, Chao YC, Tanwandee T, et al. 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. (Pubitemid 36801917)
78. Sung JJY, Chan HLY, Hui AY, Chan FKL, Chim AML, Wong ML, et al. Combination of pegylated interferon and lamivudine is superior to lamivudine monotherapy in the treatment of chronic hepatitis B: a randomized trial [abstract]. J Hepatol 2003;38:33.
79. Liaw YF, Tai DI, Chu CM, Chen TJ. The development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Hepatology 1988;8:493-496 (Pubitemid 18173751)
80. van Nunen AB, Hansen BE, Suh DJ, Lohr HF, Chemello L, Fontaine H, et al. Durability of HBeAg seroconversion following antiviral therapy for chronic hepatitis B: relation to type of therapy and pretreatment serum hepatitis B virus DNA and alanine aminotransferase. Gut 2003;52:420-424 (Pubitemid 36250065)
81. Di Bisceglie A, Rustgi V, Hoofnagle J, Dusheiko G, Lotze MT. Hepatocellular carcinoma. NIH conference. Ann Intern Med 1988;108:390-401.
82. Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, et al. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med 2004;351:1521-1531 (Pubitemid 39315319)
83. Lok AS, Lai CL, Wu PC, Leung EK, Lam TS. Spontaneous hepatitis B e antigen to antibody seroconversion and reversion in Chinese patients with chronic hepatitis B virus infection. Gastroenterology 1987;92:1839-1843 (Pubitemid 17072230)
84. Liaw YF, Tai DI, Chu CM, Lin DY, Sheen IS, Chen TJ, et al. Early detection of hepatocellular carcinoma in patients with chronic type B hepatitis. A prospective study. Gastroenterology 1986;90:263-267 (Pubitemid 16136663)
85. Fattovich G, Brollo L, Giustina G, Noventa F, Pontisso P, Alberti A, et al. Natural history and prognostic factors for chronic hepatitis type B. Gut 1991;32:294-298
86. Lau DT, Everhart J, Kleiner DL. Long-term follow-up of patients with chronic hepatitis B treated with interferon alfa. Gastroenterology 1997;113:1660-1667 (Pubitemid 27461254)
87. Liaw YF, Lin DY, Chen TJ, Chu CM. Natural course after the development of cirrhosis in patients with chronic type B hepatitis: a prospective study. Liver 1989;9:235-241 (Pubitemid 19206852)
88. Marcellin P, Hadziyannis S, ES, Peters M, Benhamou Y, Brosgart C, et al. Adefovir dipivoxil 10 mg results in consistent efficacy in chronic hepatitis B patients with diverse baseline characteristics. J Hepatol 2003;38:153-154
89. Goodman Z, Dhillon AP, Wu PC, et al. Lamivudine treatment reduces progression to cirrhosis in patients with chronic hepatitis B. J Hepatol 1999;30:59. (Pubitemid 29489740)
90. Chen CH, Su WW, Yang SS, et al. Long-term trends and geographical variations in the survival rates of hepatocellular carcinoma: analysis of 11,312 patients in Taiwan. J Gastroenterol Hepatol 2006;21:1561-1566