Efficacy and safety of prolonged 3-year telbivudine treatment in patients with chronic hepatitis B

Liver International

Volumn 31, Issue 5, 2011, Pages 676-684

  Gane, Edward J ^a   Wang, Yuming ^b   Liaw, Yun Fan ^c   Hou, Jinlin ^d   Thongsawat, Satawat ^e   Wan, Mobin ^f   Moon, Young M ^g   Jia, Jidong ^h   Chao, You C ⁱ   Niu, Junqi ^j   Leung, Nancy ^k   Samuel, Didier ^l   Hsu, Chao Wei ^c   Bao, Weibin ^m   Lopez, Patricia ^m   Avila, Claudio ^m  

^a AUCKLAND CITY HOSPITAL   (New Zealand)

^b THIRD MILITARY MEDICAL UNIVERSITY   (China)

^c CHANG GUNG UNIVERSITY COLLEGE OF MEDICINE   (Taiwan)

^d SOUTHERN MEDICAL UNIVERSITY   (China)

^e CHIANG MAI UNIVERSITY   (Thailand)

^f SECOND MILITARY MEDICAL UNIVERSITY   (China)

^g Kwandong University College of Medicine   (South Korea)

^h CAPITAL MEDICAL UNIVERSITY   (China)

ⁱ TRI SERVICE GENERAL HOSPITAL   (Taiwan)

^j JILIN UNIVERSITY   (China)

^k ALICE HO MIU LING NETHERSOLE HOSPITAL   (Hong Kong)

^l ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS   (France)

^m NOVARTIS PHARMA AG   (Switzerland)

more..

Author keywords

ALT normalization; GLOBE trial; HBeAg seroconversion; HBV DNA; Viral suppression

Indexed keywords

ALANINE AMINOTRANSFERASE; ENTECAVIR; HEPATITIS B(E) ANTIGEN; TELBIVUDINE; VIRUS DNA;

ADULT; AGED; ARTICLE; BIOCHEMISTRY; CHRONIC DISEASE; CONTROLLED STUDY; CORONARY ARTERY DISEASE; DEPRESSION; DIABETIC KETOACIDOSIS; DRUG EFFICACY; DRUG MEGADOSE; FEMALE; FOLLOW UP; FRACTURE; GENOTYPE; HEPATITIS B; HUMAN; HYPOGLYCEMIA; LIVER CELL CARCINOMA; LYMPHOMA; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEPHROLITHIASIS; PATIENT SAFETY; PERICARDITIS; PNEUMONIA; RETINA DETACHMENT; SEROCONVERSION; VIREMIA; VIRUS RESISTANCE; VOMITING;

ADOLESCENT; ADULT; AGED; ALANINE TRANSAMINASE; ANTIVIRAL AGENTS; BIOLOGICAL MARKERS; DNA, VIRAL; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, VIRAL; FEMALE; HEPATITIS B E ANTIGENS; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; MALE; MIDDLE AGED; NUCLEOSIDES; PYRIMIDINONES; TIME FACTORS; TREATMENT OUTCOME; VIRAL LOAD; YOUNG ADULT;

EID: 79953315167     PISSN: 14783223     EISSN: 14783231     Source Type: Journal    
DOI: 10.1111/j.1478-3231.2011.02490.x     Document Type: Article

References (42)

1. Lai CL, Gane E, Liaw YF, et al. Telbivudine versus lamivudine in patients with chronic hepatitis B. N Engl J Med 2007; 357: 2576-88.
2. Lee HW, Kim HJ, Kim MH. Entecavir induced HBV DNA suppression at 12 weeks in treatment-naive patients with chronic hepatitis B is a good predictive factor for virological response at 48 weeks (abstract no. 969). Hepatology 2008; 48 (Suppl. 1): 741A.
3. Locarnini S, Qi X, Arterburn S, et al. Incidence and predictors of emergence of adefovir resistant HBV during four years of adefovir dipivoxil (ADV) therapy for patients with chronic hepatitis B (CHB) (abstract no. 36). J Hepatol 2005; 42 (Suppl. 2): 17.
4. Mommeja-Marin H, Mondou E, Blum MR, Rousseau F. Serum HBV DNA as a marker of efficacy during therapy for chronic HBV infection: analysis and review of the literature. Hepatology 2003; 37: 1309-19.
5. van der Eijk AA, Hansen BE, Niesters HG, et al. Viral dynamics during tenofovir therapy in patients infected with lamivudine-resistant hepatitis B virus mutants. J Viral Hepat 2005; 12: 364-72.
6. van der Eijk AA, Niesters HG, Hansen BE, et al. Quantitative HBV DNA levels as an early predictor of nonresponse in chronic HBe-antigen positive hepatitis B patients treated with interferon-alpha. J Viral Hepat 2006; 13: 96-103.
7. Yuen MF, Sablon E, Hui CK, et al. Factors associated with hepatitis B virus DNA breakthrough in patients receiving prolonged lamivudine therapy. Hepatology 2001; 34: 785-91.
8. Yurdaydin C, Sollano J, Hadziyannis S, et al. Entecavir results in continued virologic and biochemical improvement and HBeAg seroconversion through 96 weeks of treatment in lamivudine-refractory, HBeAg(+)chronic hepatitis B patients (ETV-026) (abstract no. 80). J Hepatol 2006; 44 (Suppl. 2): S36.
9. European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B. J Hepatol 2009; 50: 227-42.
10. Liaw Y-F, Leung N, Kao J-H, et al. For the Chronic Hepatitis B Guideline Working Party of the Asian-Pacific Association for the Study of the Liver Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008; 2: 263-83.
11. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009; 50: 661-2.
12. Liaw YF, Gane E, Leung N, et al. 2-Year GLOBE trial results: telbivudine is superior to lamivudine in patients with chronic hepatitis B. Gastroenterology 2009; 136: 486-95.
13. Zeuzem S, Gane E, Liaw YF, et al. Baseline characteristics and early on-treatment response predict the outcomes of 2 years of telbivudine treatment of chronic hepatitis B. J Hepatol 2009; 51: 11-20.
14. Locarnini S, Hatzakis A, Heathcote J, et al. Management of antiviral resistance in patients with chronic hepatitis B. Antivir Ther 2004; 9: 679-93.
15. National Institute of Allergy and Infectious Diseases. Division of AIDS Table for Grading Severity of Adult Adverse Experiences. Bethesda, MD: National Institute of Allergy and Infectious Diseases, 1992.
16. Keeffe EB, Zeuzem S, Koff RS, et al. Report of an international workshop: roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol 2007; 5: 890-7.
17. 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.
18. Liaw Y-F. HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B. Hepatol Int 2009; 3: 425-33.
19. 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.
20. Gish RG, Lok AS, Chang TT, et al. Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 2007; 133: 1437-44.
21. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B for up to 5 years. Gastroenterology 2006; 131: 1743-51.
22. Heathcote E, Gane EJ, deMan RA. Two year tenofovir disoproxil fumarate (TDF) treatment and adefovir dipivoxil (ADV) switch data in HBeAg-positive patients with chronic hepatitis B (study 103) (abstract no. 158). Hepatology 2008; 48 (Suppl. 1): 376A.
23. Lau DT, Khokhar MF, Doo E, et al. Long-term therapy of chronic hepatitis B with lamivudine. Hepatology 2000; 32: 828-34.
24. Dienstag JL, Cianciara J, Karayalcin S, et al. Durability of serologic response after lamivudine treatment of chronic hepatitis B. Hepatology 2003; 37: 748-55.
25. Hadziyannis SJ, Tassopoulos NC, Heathcote EJ, et al. Long-term therapy with adefovir dipivoxil for HBeAg-negative chronic hepatitis B. N Engl J Med 2005; 352: 2673-81.
26. Marcelin P, Buti M, Krastev Z, et al. Two year tenofovir disoproxil fumarate (TDF) treatment and adefovir dipivoxil (ADV) switch data in HBeAg-negative patients with chronic hepatitis B (study 102), preliminary analysis (abstract no. 146). Hepatology 2008; 48 (Suppl. 4): 370A.
27. Shouval D, Lai CL, Chang TT, et al. Relapse of hepatitis B in HBeAg-negative chronic hepatitis B patients who discontinued successful entecavir treatment: the case for continuous antiviral therapy. J Hepatol 2009; 50: 289-95.
28. Chu CM, Hung SJ, Lin J, Tai DI, Liaw YF. Natural history of hepatitis B e antigen to antibody seroconversion in patients with normal serum aminotransferase levels. Am J Med 2004; 116: 829-34.
29. Hsu YS, Chien RN, Yeh CT, et al. Long-term outcome after spontaneous HBeAg seroconversion in patients with chronic hepatitis B. Hepatology 2002; 35: 1522-27.
30. Lin SM, Yu ML, Lee CM, et al. Interferon therapy in HBeAg positive chronic hepatitis reduces progression to cirrhosis and hepatocellular carcinoma. J Hepatol 2007; 46: 45-52.
31. Niederau C, Heintges T, Lange S, et al. Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B. N Engl J Med 1996; 334: 1422-7.
32. Yang HI, Lu SN, Liaw YF, et al. Hepatitis B e antigen and the risk of hepatocellular carcinoma. N Engl J Med 2002; 347: 168-74.
33. Piratvisuth T, Lau G, Chao Y. Sustained response to peginterferon alfa-2a (40 kD) with or without lamivudine in Asian patients with HBeAg-positive and HBeAg-negative chronic hepatitis B. Hepatol Int 2008; 2: 102-10.
34. 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.
35. Marcellin P, Chang TT, Lim SG, et al. Long-term efficacy and safety of adefovir dipivoxil for the treatment of hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2008; 48: 750-8.
36. Leung N, Peng CY, Sollano J, et al. Entecavir (ETV) results in higher HBV DNA reduction versus Adefovir (ADV) in antivial-naive HBeAg(+) adults with high HBV DNA: week 96 results (E.A.R.L.Y. study). J Hepatol 2008; 48 (Suppl. 4): S373-4.
37. Yao G-B, Xu DZ, Ren H. Three years of continuous treatment with entecavir results in high proportions of Chinese nucleoside-naive patients with undetectable HBV DNA results from studies ETV-023 and -050. J Hepatol 2008; 48 (Suppl. 4): S266-7.
38. Yao G, Chen C-W, Lu W-L, et al. Virologic, serologic, and biochemical outcomes through 2 years of treatment with entecavir and lamivudine in nucleoside-naïve Chinese patients with chronic hepatitis B: a randomized, multicenter study. Hepatol Int 2008; 2: 486-93.
39. Evans A, Riva A, Cooksley H, et al. Programmed death 1 expression during antiviral treatment of chronic hepatitis B: impact of hepatitis B e-antigen seroconversion. Hepatology 2008; 48: 759-69.
40. Wu Z, Yan W, Guo W, et al. Telbivudine preserves Th1 cytokine and inhibits Th2 cytokine production in MHV-3 induced viral hepatitis model (poster no. 945). Hepatology 2008; 48 (Suppl. 1): 731A.
41. Zoulim F, Perrillo R. Hepatitis B. Reflections on the current approach to antiviral therapy. J Hepatol 2008; 48 (Suppl. 4): S2-19.
42. Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to entecavir in nucleoside-naive patients is rare through 5 years of therapy. Hepatology 2009; 49: 1503-14.