Long-term safety of oral nucleos(t)ide analogs for patients with chronic hepatitis B: A cohort study of 53,500 subjects

Hepatology

Volumn 62, Issue 3, 2015, Pages 684-693

  Wong, Grace Lai Hung ^a   Tse, Yee Kit ^a   Wong, Vincent Wai Sun ^a   Yip, Terry Cheuk Fung ^a   Tsoi, Kelvin Kam Fai ^a   Chan, Henry Lik Yuen ^a  

^a CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

[No Author keywords available]

Indexed keywords

NUCLEOSIDE ANALOG; NUCLEOTIDE DERIVATIVE; ANTIVIRUS AGENT; NUCLEOSIDE; NUCLEOTIDE;

ADULT; ARTICLE; BONE DISEASE; CHRONIC HEPATITIS B; CHRONIC KIDNEY FAILURE; COHORT ANALYSIS; CONTROLLED STUDY; DRUG SAFETY; FEMALE; FOLLOW UP; FRACTURE; HIP FRACTURE; HUMAN; KIDNEY DISEASE; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; PROPENSITY SCORE; RENAL REPLACEMENT THERAPY; SPINE FRACTURE; TREATMENT OUTCOME; ACUTE KIDNEY INJURY; CHEMICALLY INDUCED; COMPARATIVE STUDY; DOSE RESPONSE; DRUG ADMINISTRATION; EVALUATION STUDY; FACTUAL DATABASE; FRACTURES, BONE; HEPATITIS B, CHRONIC; HONG KONG; MIDDLE AGED; MORTALITY; ORAL DRUG ADMINISTRATION; RETROSPECTIVE STUDY; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TIME;

ACUTE KIDNEY INJURY; ADMINISTRATION, ORAL; ADULT; ANTIVIRAL AGENTS; COHORT STUDIES; DATABASES, FACTUAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; FEMALE; FOLLOW-UP STUDIES; FRACTURES, BONE; HEPATITIS B, CHRONIC; HONG KONG; HUMANS; MALE; MIDDLE AGED; NUCLEOSIDES; NUCLEOTIDES; RETROSPECTIVE STUDIES; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; TIME FACTORS; TREATMENT OUTCOME;

EID: 84939652358     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.27894     Document Type: Article

References (45)

1. Trepo C, Chan HL, Lok A. Hepatitis B virus infection. Lancet 2014;384:2053-2063.
2. Kwon H, Lok AS. Hepatitis B therapy. Nat Rev Gastroenterol Hepatol 2011;8:275-284.
3. Lo AO, Wong GL. Current developments in nucleoside/nucleotide analogues for hepatitis B. Expert Rev Gastroenterol Hepatol 2014;8:607-622.
4. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of chronic hepatitis B virus infection. J Hepatol 2012;57:167-185.
5. Liaw YF, Kao JH, Piratvisuth T, Piratvisuth T, Gane E, Han KH, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int 2012;6:531-561.
6. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009;50:661-662.
7. Lok AS, 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.
8. 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. N Engl J Med 2005;352:2673-2681.
9. 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.
10. Marcellin P, Gane E, Buti M, Afdhal N, Sievert W, Jacobson IM, et al. Regression of cirrhosis during treatment with tenofovir disoproxil fumarate for chronic hepatitis B: a 5-year open-label follow-up study. Lancet 2013;381:468-475.
11. Rouillard S, Lane NE. Hepatic osteodystrophy. Hepatology 2001;33:301-307.
12. Amini-Bavil-Olyaee S, Herbers U, Sheldon J, Luedde T, Trautwein C, Tacke F. The rtA194T polymerase mutation impacts viral replication and susceptibility to tenofovir in hepatitis B e antigen-positive and hepatitis B e antigen-negative hepatitis B virus strains. Hepatology 2009;49:1158-1165.
13. Kim du H, Sung DH, Min YK. Hypophosphatemic osteomalacia induced by low-dose adefovir therapy: focus on manifestations in the skeletal system and literature review. J Bone Miner Metab 2013;31:240-246.
14. Tsai NC, Marcellin P, Buti M, Washington MK, Lee SS, Chan S, et al. Viral suppression and cirrhosis regression with tenofovir disoproxil fumarate in asians with chronic hepatitis B. Dig Dis Sci 2015;60:260-268.
15. Cheung NT, Fung V, Chow YY, Tung Y. Structured data entry of clinical information for documentation and data collection. Stud Health Technol Inform 2001;84:609-613.
16. Hospital Authority. Hot links page. 2015. http://www.ha.org.hk/visitor/ha_visitor_index.asp?Content_ID=10008&Lang=ENG&Dimension=100&Parent_ID=10004&Ver=HTML. Accessed January 12, 2015.
17. Wong GL, Chan HL, Mak CW, Lee SK, Ip ZM, Lam AT, et al. Entecavir treatment reduces hepatic events and deaths in chronic hepatitis B patients with liver cirrhosis. Hepatology 2013;58:1537-1547.
18. Bow CH, Tsang SW, Loong CH, Soong CS, Yeung SC, Kung AW. Bone mineral density enhances use of clinical risk factors in predicting ten-year risk of osteoporotic fractures in Chinese men: the Hong Kong Osteoporosis Study. Osteoporos Int 2011;22:2799-2807.
19. Ho YW, Chau KF, Choy BY, Fung KS, Cheng YL, Kwan TH, et al. Hong Kong Renal Registry Report 2012. Hong Kong J Nephrol 2013;15:28-43.
20. Levesque LE, Hanley JA, Kezouh A, Suissa S. Problem of immortal time bias in cohort studies: example using statins for preventing progression of diabetes. BMJ 2010;340:b5087.
21. Anderson JR, Cain KC, Gelber RD. Analysis of survival by tumor response. J Clin Oncol 1983;1:710-719.
22. Dafni U. Landmark analysis at the 25-year landmark point. Circ Cardiovasc Qual Outcomes 2011;4:363-371.
23. Buti M, Tsai N, Petersen J, Flisiak R, Gurel S, Krastev Z, et al. Seven-year efficacy and safety of treatment with tenofovir disoproxil fumarate for chronic hepatitis B virus infection. Dig Dis Sci 2015;60:1457-1464.
24. Braitman LE, Rosenbaum PR. Rare outcomes, common treatments: analytic strategies using propensity scores. Ann Intern Med 2002;137:693-695.
25. McCaffrey DF, Ridgeway G, Morral AR. Propensity score estimation with boosted regression for evaluating causal effects in observational studies. Psychol Methods 2004;9:403-425.
26. McCaffrey DF, Griffin BA, Almirall D, Slaughter ME, Ramchand R, Burgette LF. A tutorial on propensity score estimation for multiple treatments using generalized boosted models. Stat Med 2013;32:3388-3414.
27. Friedman JH. Greedy function approximation: a gradient boosting machine. Ann Stat 2001;29:1189-1232.
28. Madigan D, Ridgeway G. Discussion of 'least angle regression' by Efron et al. Ann Stat 2004;32:465-469.
29. Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med 2009;28:3083-3107.
30. Hamilton BH, Ko CY, Richards K, Hall BL. Missing data in the American College of Surgeons National Surgical Quality Improvement Program are not missing at random: implications and potential impact on quality assessments. J Am Coll Surg 2010;210:125-139.e2.
31. Little RJ, D'Agostino R, Cohen ML, Dickersin K, Emerson SS, Farrar JT, et al. The prevention and treatment of missing data in clinical trials. N Engl J Med 2012;367:1355-1360.
32. White IR, Royston P. Imputing missing covariate values for the Cox model. Stat Med 2009;28:1982-1998.
33. Austin PC. The use of propensity score methods with survival or time-to-event outcomes: reporting measures of effect similar to those used in randomized experiments. Stat Med 2014;33:1242-1258.
34. Rubin DB, Schenker N. Multiple imputation in health-care databases: an overview and some applications. Stat Med 1991;10:585-598.
35. Ridruejo E, Silva MO. Safety of long-term nucleos(t)ide treatment in chronic hepatitis B. Expert Opin Drug Saf 2012;11:357-360.
36. Manns MP, Akarca US, Chang TT, Sievert W, Yoon SK, Tsai N, et al. Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901. Expert Opin Drug Saf 2012;11:361-368.
37. Van Rompay KK, Durand-Gasselin L, Brignolo LL, Ray AS, Abel K, Cihlar T, et al. Chronic administration of tenofovir to rhesus macaques from infancy through adulthood and pregnancy: summary of pharmacokinetics and biological and virological effects. Antimicrob Agents Chemother 2008;52:3144-3160.
38. Uteng M, Mahl A, Beckmann N. Preclinical assessment on renal function and toxicity of chronic hepatitis B (CHB) drugs telbivudine, entecavir, tenofovir and adefovir. Asian Pacific Association for the Study of the Liver (APASL) Liver Week 2013, June 6-10, 2013, Singapore.
39. Lai KN, Li PK, Lui SF, Au TC, Tam JS, Tong KL, Lai FM. Membranous nephropathy related to hepatitis B virus in adults. N Engl J Med 1991;324:1457-1463.
40. Fisher L, Fisher A. Vitamin D and parathyroid hormone in outpatients with noncholestatic chronic liver disease. Clin Gastroenterol Hepatol 2007;5:513-520.
41. Schulze-Krebs A, Preimel D, Popov Y, Bartenschlager R, Lohmann V, Pinzani M, Schuppan D. Hepatitis C virus-replicating hepatocytes induce fibrogenic activation of hepatic stellate cells. Gastroenterology 2005;129:246-258.
42. Wong GL, Chan HL, Chan HY, Tse CH, Chim AM, Lo AO, Wong VW. Adverse effects of vitamin D deficiency on outcomes of patients with chronic hepatitis B. Clin Gastroenterol Hepatol 2015;13:783-790.e1.
43. Byrne DD, Newcomb CW, Carbonari DM, Nezamzadeh MS, Leidl KB, Herlim M, et al. Risk of hip fracture associated with untreated and treated chronic hepatitis B virus infection. J Hepatol 2014;61:210-218.
44. Fung J, Seto WK, Lai CL, Yuen MF. Extrahepatic effects of nucleoside and nucleotide analogues in chronic hepatitis B treatment. J Gastroenterol Hepatol 2014;29:428-434.
45. Pintilie M. Dealing with competing risks: testing covariates and calculating sample size. Stat Med 2002;21:3317-3324.