Randomized clinical trial: Efficacy and safety of telbivudine and lamivudine in treatment-naïve patients with HBV-related decompensated cirrhosis

Journal of Viral Hepatitis

Volumn 19, Issue 10, 2012, Pages 732-743

  Chan, H L Y ^a   Chen, Y C ^b   Gane, E J ^c   Sarin, S K ^d   Suh, D J ^e   Piratvisuth, T ^f   Prabhakar, B ^g   Hwang, S G ^h   Choudhuri, G ⁱ   Safadi, R ^j   Tanwandee, T ^k   Chutaputti, A ^l   Yurdaydin, C ^m   Bao, W ⁿ   Avila, C ⁿ   Trylesinski, A ⁿ  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^b CHANG GUNG UNIVERSITY COLLEGE OF MEDICINE   (Taiwan)

^c AUCKLAND CITY HOSPITAL   (New Zealand)

^d INSTITUTE OF LIVER AND BILIARY SCIENCES   (India)

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

^f PRINCE OF SONGKLA UNIVERSITY   (Thailand)

^g OSMANIA MEDICAL COLLEGE   (India)

^h CHA University   (South Korea)

ⁱ SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES   (India)

^j HADASSAH HEBREW UNIVERSITY MEDICAL CENTER   (Israel)

^k MAHIDOL UNIVERSITY   (Thailand)

^l PHRAMONGKUTKLAO HOSPITAL   (Thailand)

^m ANKARA UNIVERSITY   (Turkey)

ⁿ NOVARTIS PHARMA AG   (Switzerland)

more..

Author keywords

chronic hepatitis B; decompensated hepatitis; telbivudine

Indexed keywords

ALANINE AMINOTRANSFERASE; LAMIVUDINE; TELBIVUDINE; VIRUS DNA;

ADULT; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; CHILD TURCOTTE PUGH SCORE; CHRONIC HEPATITIS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DECOMPENSATED LIVER CIRRHOSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; GLOMERULUS FILTRATION RATE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; INTENTION TO TREAT ANALYSIS; LACTIC ACIDOSIS; MAJOR CLINICAL STUDY; MALE; MYOPATHY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHABDOMYOLYSIS; SIDE EFFECT; SURVIVAL; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; ALANINE TRANSAMINASE; ANTIVIRAL AGENTS; DNA, VIRAL; DOUBLE-BLIND METHOD; FEMALE; HEPATITIS B, CHRONIC; HUMANS; LAMIVUDINE; LIVER CIRRHOSIS; LIVER FAILURE; MALE; MIDDLE AGED; MULTICENTER STUDIES AS TOPIC; NUCLEOSIDES; PROSPECTIVE STUDIES; PYRIMIDINONES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84866237345     PISSN: 13520504     EISSN: 13652893     Source Type: Journal    
DOI: 10.1111/j.1365-2893.2012.01600.x     Document Type: Article

References (32)

1. de Jongh FE, Janssen HL, de Man RA, Hop WC, Schalm SW, van Blankenstein M. Survival and prognostic indicators in hepatitis B surface antigen- positive cirrhosis of the liver. Gastroenterology 1992; 103: 1630-1635.
2. Sakata H, Tamura S, Sugawara Y, Kokudo N. Cost analysis of adultadult living donor liver transplantation in Tokyo University Hospital. J Hepatobiliary Pancreat Sci 2011; 18: 184-189.
3. Kapoor D, Guptan RC, Wakil SM et al. Beneficial effects of lamivudine in hepatitis B virus-related decompensated cirrhosis. J Hepatol 2000; 33: 308-312.
4. Villeneuve JP, Condreay LD, Willems B et al. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. Hepatology 2000; 31: 207-210.
5. Yao FY, Bass NM. Lamivudine treatment in patients with severely decompensated cirrhosis due to replicating hepatitis B infection. J Hepatol 2000; 33: 301-307.
6. Yao FY, Terrault NA, Freise C, Maslow L, Bass NM. Lamivudine treatment is beneficial in patients with severely decompensated cirrhosis and actively replicating hepatitis B infection awaiting liver transplantation: a comparative study using a matched, untreated cohort. Hepatology 2001; 34: 411-416.
7. Perrillo RP, Wright T, Rakela J et al. A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B. Hepatology 2001; 33: 424-432.
8. 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: 1521-1531.
9. Zoulim F, Radenne S, Ducerf C. Management of patients with decompensated hepatitis B virus associated cirrhosis. Liver Transpl 2008; 14(Suppl 2): S1-S7.
10. Messori A, Del Santo F, Maratea D, Trippoli S. Single-drug treatments for chronic hepatitis B: summarising current information by network meta-analysis. Aliment Pharmacol Ther 2011; 34: 105-107.
11. Liaw YF, Sheen IS, Lee CM et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011; 53: 62-72.
12. Shim JH, Lee HC, Kim KM et al. Efficacy of entecavir in treatment-naive patients with hepatitis B virusrelated decompensated cirrhosis. J Hepatol 2010; 52: 176-182.
13. D'Amico G, Garcia-Tsao G, Pagliaro L. Natural history and prognostic indicators of survival in cirrhosis: a systematic review of 118 studies. J Hepatol 2006; 44: 217-231.
14. James CW, Steinhaus MC, Szabo S, Dressier RM. Tenofovir-related nephrotoxicity: case report and review of the literature. Pharmacotherapy 2004; 24: 415-418.
15. Lange CM, Bojunga J, Hofmann WP et al. Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology 2009; 50: 2001-2006.
16. Liaw YF, Raptopoulou-Gigi M, Cheinquer H et al. Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with evidence of hepatic decompensation. Hepatology 2009; 50: 505A. [Abstract].
17. Tamori A, Enomoto M, Kobayashi S et al. Add-on combination therapy with adefovir dipivoxil induces renal impairment in patients with lamivudine- refractory hepatitis B virus. J Viral Hepat 2010; 17: 123-129.
18. European Association for the Study of The Liver. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009; 50: 227- 242.
19. Liaw YF, Leung N, Kao JH et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008; 2: 263-283.
20. Fontana RJ. Management of patients with decompensated HBV cirrhosis. Semin Liver Dis 2003; 23: 89-100.
21. Fontana RJ, Hann HW, Perrillo RP et al. Determinants of early mortality in patients with decompensated chronic hepatitis B treated with antiviral therapy. Gastroenterology 2002; 123: 719-727.
22. Schiff E, Lai CL, Hadziyannis S et al. Adefovir dipivoxil for wait-listed and post-liver transplantation patients with lamivudine-resistant hepatitis B: final long-term results. Liver Transpl 2007; 13: 349-360.
23. Schiff ER, Lai CL, Hadziyannis S et al. Adefovir dipivoxil therapy for lamivudine- resistant hepatitis B in pre- and post-liver transplantation patients. Hepatology 2003; 38: 1419-1427.
24. Hou J, Yin YK, Xu D et al. Telbivudine versus lamivudine in Chinese patients with chronic hepatitis B: results at 1 year of a randomized, double-blind trial. Hepatology 2008; 47: 447-454.
25. Lai CL, Gane E, Liaw YF et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007; 357: 2576-2588.
26. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009; 50: 661-662.
27. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461-470.
28. Levey AS, Stevens LA, Schmid CH et al. A new equation to estimate glomerular filtration rate. Ann Intern Med 2009; 150: 604-612.
29. Brown Jr RS, Lombardero M, Lake JR. Outcome of patients with renal insufficiency undergoing liver or liver-kidney transplantation. Transplantation 1996; 62: 1788-1793.
30. Nair S, Verma S, Thuluvath PJ. Pretransplant renal function predicts survival in patients undergoing orthotopic liver transplantation. Hepatology 2002; 35: 1179-1185.
31. Gish RG, Mangahas MF, Baqai SF, Shaw RE, Clark MD, Kane SD. Risk of renal toxicity with tenofovir DF (TDF) for chronic hepatitis B (CHB). Hepatology 2010; 52: 529A.
32. Wong VW, Wong GL, Yiu KK et al. Entecavir treatment in patients with severe acute exacerbation of chronic hepatitis B. J Hepatol 2011; 54: 236- 242.