AASLD guidelines for treatment of chronic hepatitis B

Hepatology

Volumn 63, Issue 1, 2016, Pages 261-283

  Terrault, Norah A ^a   Bzowej, Natalie H ^b   Chang, Kyong Mi ^c   Hwang, Jessica P ^d   Jonas, Maureen M ^e   Murad, M Hassan ^f  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b OCHSNER MEDICAL CENTER   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^e BOSTON CHILDREN S HOSPITAL   (United States)

^f MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALPHA2B INTERFERON; ANTIVIRUS AGENT; CIRCULAR DNA; ENTECAVIR; HEPATITIS B(E) ANTIBODY; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PEGINTERFERON; TENOFOVIR; VIRUS DNA; HEPATITIS B ANTIGEN;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIVIRAL THERAPY; ARTICLE; BONE DISEASE; CHRONIC HEPATITIS B; DECOMPENSATED LIVER CIRRHOSIS; DISEASE CLASSIFICATION; DISEASE SEVERITY; DISEASE SURVEILLANCE; HUMAN; IMMUNOREACTIVITY; KIDNEY DISEASE; LACTIC ACIDOSIS; LIVER BIOPSY; LIVER CANCER; LIVER CIRRHOSIS; LIVER HISTOLOGY; MIXED INFECTION; PATIENT COMPLIANCE; PATIENT MONITORING; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECURRENT DISEASE; SEROCONVERSION; TREATMENT DURATION; VIREMIA; VIRUS REPLICATION; BLOOD; COMPLICATION; HEPATITIS B, CHRONIC; IMMUNOLOGY; VIROLOGY;

ANTIVIRAL AGENTS; HEPATITIS B ANTIGENS; HEPATITIS B, CHRONIC; HUMANS; VIREMIA;

EID: 84951825509     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.28156     Document Type: Article

References (132)

1. Atkins D, Best D, Briss PA, Eccles M, Falck-Ytter Y, Flottorp S, et al. Grading quality of evidence and strength of recommendations. BMJ 2004;328:1490.
2. Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology 2009;50:661-662.
3. WHO. Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva Switzerland: World Health Organization; May 12, 2015.
4. Ott JJ, Stevens GA, Groeger J, Wiersma ST. Global epidemiology of hepatitis B virus infection: new estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine 2012;30:2212-2219.
5. Ioannou GN. Hepatitis B virus in the United States: infection, exposure, and immunity rates in a nationally representative survey. Ann Intern Med 2011;154:319-28.
6. Kowdley KV, Wang CC, Welch S, Roberts H, Brosgart CL. Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology 2012;56:422-433.
7. Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, et al. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet 2012;380:2095-2128.
8. Weinbaum C, Williams I, Mast E, Wang SA, Finelli L, Wasley A, et al. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. MMWR Recomm Rep 2008;57:1-20.
9. Chou R, Dana T, Bougatsos C, Blazina I, Khangura J, Zakher B. Screening for hepatitis B virus infection in adolescents and adults: a systematic review to update the U.S. Preventive Services Task Force recommendation. Ann Intern Med 2014;161:31-45.
10. Seto WK, Wong DK, Fung J, Huang FY, Liu KS, Lai CL, et al. Linearized hepatitis B surface antigen and hepatitis B core-related antigen in the natural history of chronic hepatitis B. Clin Microbiol Infect 2014;20:1173-1180.
11. Kim GA, Lee HC, Kim MJ, Ha Y, Park EJ, An J, et al. Incidence of hepatocellular carcinoma after HBsAg seroclearance in chronic hepatitis B patients: a need for surveillance. J Hepatol 2015;62:1092-1099.
12. Fattovich G. Natural history and prognosis of hepatitis B. Sem Liver Dis 2003;23:47-58.
13. Yim HJ, Lok AS. Natural history of chronic hepatitis B virus infection: what we knew in 1981 and what we know in 2005. Hepatology 2006;43(2 Suppl 1):S173-S181.
14. McMahon BJ. The natural history of chronic hepatitis B virus infection. Hepatology 2009;49(5 Suppl):S45-S55.
15. Chen CJ, Yang HI, Su J, Jen CL, You SL, Lu SN, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA 2006;295:65-73.
16. Iloeje UH, Yang HI, Su J, Jen CL, You SL, Chen CJ. Predicting cirrhosis risk based on the level of circulating hepatitis B viral load. Gastroenterology 2006;130:678-686.
17. Yang H, Lu S, Liaw Y, You SL, Sun CA, Wang LY, et al. Hepatitis B e antigen and the risk of hepatocellular carcinoma. N Engl J Med 2002;347:168-174.
18. Fattovich G, Stroffolini T, Zagni I, Donato F. Hepatocellular carcinoma in cirrhosis: incidence and risk factors. Gastroenterology 2004;127(5 Suppl 1):S35-S50.
19. Prati D, Taioli E, Zanella A, Della Torre E, Butelli S, Del Vecchio E, et al. Updated definitions of healthy ranges for serum alanine aminotransferase levels. Ann Intern Med 2002;137:1-10.
20. Vigano M, Paggi S, Lampertico P, Fraquelli M, Massironi S, Ronchi G, et al. Dual cut-off transient elastography to assess liver fibrosis in chronic hepatitis B: a cohort study with internal validation. Aliment Pharmacol Ther 2011;34:353-362.
21. WHO. Guidelines for the Prevention, Care and Treatment of Persons with Chronic Hepatitis B Infection. Geneva Switzerland: World Health Organization; 2015.
22. Chon YE, Choi EH, Song KJ, Park JY, Kim do Y, Han KH, et al. Performance of transient elastography for the staging of liver fibrosis in patients with chronic hepatitis B: a meta-analysis. PLoS One 2012;7:e44930.
23. Moraleda G, Saputelli J, Aldrich CE, Averett D, Condreay L, Mason WS. Lack of effect of antiviral therapy in nondividing hepatocyte cultures on the closed circular DNA of woodchuck hepatitis virus. J Virol 1997;71:9392-9399.
24. Wong DK, Seto WK, Fung J, Ip P, Huang FY, Lai CL, et al. Reduction of hepatitis B surface antigen and covalently closed circular DNA by nucleos(t)ide analogues of different potency. Clin Gastroenterol Hepatol 2013;11:1004-1010.e1.
25. Fontana RJ. Side effects of long-term oral antiviral therapy for hepatitis B. Hepatology 2009;49(5 Suppl):S185-S195.
26. Guidelines for Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents. Accessed April 30, 2015.
27. Yao GB, Ren H, Xu DZ, Zhou XQ, Jia JD, Wang YM, et al. Virological, serological and biochemical outcomes through 3 years of entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patients. J Viral Hepat 2010;17(Suppl 1):51-58.
28. Liu A, Ha NB, Lin B, Yip B, Trinh HN, Nguyen HA, et al. Low hepatitis B envelope antigen seroconversion rate in chronic hepatitis B patients on long-term entecavir 0.5 mg daily in routine clinical practice. Eur J Gastroenterol Hepatol 2013;25:338-343.
29. Zoutendijk R, Reijnders JG, Brown A, Zoulim F, Mutimer D, Deterding K, et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naive patients with a partial virological response. Hepatology 2011;54:443-451.
30. Heathcote EJ, Marcellin P, Buti M, Gane E, De Man RA, Krastev Z, et al. Three-year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology 2011;140:132-143.
31. Liaw YF, Jia JD, Chan HL, Han KH, Tanwandee T, Chuang WL, et al. Shorter durations and lower doses of peginterferon alfa-2a are associated with inferior hepatitis B e antigen seroconversion rates in hepatitis B virus genotypes B or C. Hepatology 2011;54:1591-1599.
32. Buster EH, Hansen BE, Lau GK, Piratvisuth T, Zeuzem S, Steyerberg EW, et al. Factors that predict response of patients with hepatitis B e antigen-positive chronic hepatitis B to peginterferon-alfa. Gastroenterology 2009;137:2002-2009.
33. 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. N Engl J Med 2005;352:2682-2695.
34. Janssen HL, van Zonneveld M, 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.
35. Buster EH, Flink HJ, Cakaloglu Y, Simon K, Trojan J, Tabak F, et al. Sustained HBeAg and HBsAg loss after long-term follow-up of HBeAg-positive patients treated with peginterferon alpha-2b. Gastroenterology 2008;135:459-467.
36. 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.
37. Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, et al. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology 2012;143:619-628.e1.
38. Gish RG, Lok AS, Chang TT, de Man RA, Gadano A, Sollano J, et al. Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 2007;133:1437-1444.
39. Marcellin P, Heathcote EJ, Buti M, Gane E, de Man RA, Krastev Z, et al. Tenofovir disoproxil fumarate versus adefovir dipivoxil for chronic hepatitis B. N Engl J Med 2008;359:2442-2455.
40. 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;351:1206-17.
41. Marcellin P, Bonino F, Lau GK, Farci P, Yurdaydin C, Piratvisuth T, et al. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a. Gastroenterology 2009;136:2169-2179.e1-4.
42. 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. N Engl J Med 2006;354:1011-1020.
43. Wong GL, Wong VW, Chan HL. Combination therapy of interferon and nucleotide/nucleoside analogues for chronic hepatitis B. J Viral Hepat 2014;21:825-834.
44. Lok A, McMahon B, Brown R, Wong JB, Ahmed HT, Wigdan F, et al. Antiviral therapy for chronic hepatitis B virus infection in adults: a systematic review and meta-analysis. Hepatology 2015;63:284-206. http://onlinelibrary.wiley.com/doi/10.1002/hep.28280/full.
45. Kemp W, Levy M, Weltman M, Lubel J, Australian Liver A. Australian Liver Association (ALA) expert consensus recommendations for the use of transient elastography in chronic viral hepatitis. J Gastroenterol Hepatol 2015;30:453-462.
46. Lai M, Hyatt BJ, Nasser I, Curry M, Afdhal NH. The clinical significance of persistently normal ALT in chronic hepatitis B infection. J Hepatol 2007;47:760-767.
47. Andreani T, Serfaty L, Mohand D, Dernaika S, Wendum D, Chazouillères O, et al. Chronic hepatitis B virus carriers in the immunotolerant phase of infection: histologic findings and outcome. Clin Gastroenterol Hepatol 2007;5:636-641.
48. Hui CK, Leung N, Yuen ST, Zhang HY, Leung KW, Lu L, et al. Natural history and disease progression in Chinese chronic hepatitis B patients in immune-tolerant phase. Hepatology 2007;46:395-401.
49. Chaung KT, Ha NB, Trinh HN, Garcia RT, Nguyen HA, Nguyen KK, et al. High frequency of recurrent viremia after hepatitis B e antigen seroconversion and consolidation therapy. J Clin Gastroenterol 2012;46:865-870.
50. Fung J, Lai CL, Tanaka Y, Mizokami M, Yuen J, Wong DK, et al. The duration of lamivudine therapy for chronic hepatitis B: cessation vs. continuation of treatment after HBeAg seroconversion. Am J Gastroenterol 2009;104:1940-1946.
51. Liaw YF. HBeAg seroconversion as an important end point in the treatment of chronic hepatitis B. Hepatol Int 2009;3:425-433.
52. Yang HI, Lu SN, Liaw YF, You SL, Sun CA, Wang LY, et al. Hepatitis B e antigen and the risk of hepatocellular carcinoma. N Engl J Med 2002;347:168-174.
53. You SL, Yang HI, Chen CJ. Seropositivity of hepatitis B e antigen and hepatocellular carcinoma. Ann Med 2004;36:215-224.
54. 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;116:829-834.
55. Lin SM, Yu ML, Lee CM, Chien RN, Sheen IS, Chu CM, et al. Interferon therapy in HBeAg positive chronic hepatitis reduces progression to cirrhosis and hepatocellular carcinoma. J Hepatol 2007;46:45-52.
56. Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. Hepatology 2003;38:1267-1273.
57. Yoon SK, Jang JW, Kim CW, Bae SH, Choi JY, Choi SW, et al. Long-term results of lamivudine monotherapy in Korean patients with HBeAg-positive chronic hepatitis B: response and relapse rates, and factors related to durability of HBeAg seroconversion. Intervirology 2005;48:341-349.
58. Summers J, Mason WS. Residual integrated viral DNA after hepadnavirus clearance by nucleoside analog therapy. Proc Natl Acad Sci U S A 2004;101:638-640.
59. Vigano M, Mangia G, Lampertico P. HBeAg-negative chronic hepatitis B: why do I treat my patients with nucleos(t)ide analogues? Liver Int 2014;349Suppl 1):120-126.
60. 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.
61. Huang YH, Wu JC, Chang TT, Sheen IJ, Lee PC, Huo TI, et al. Analysis of clinical, biochemical and viral factors associated with early relapse after lamivudine treatment for hepatitis B e antigen-negative chronic hepatitis B patients in Taiwan. J Viral Hepat 2003;10:277-284.
62. Santantonio T, Mazzola M, Iacovazzi T, Miglietta A, Guastadisegni A, Pastore G. Long-term follow-up of patients with anti-HBe/HBV DNA-positive chronic hepatitis B treated for 12 months with lamivudine. J Hepatol 2000;32:300-306.
63. Fung SK, Wong F, Hussain M, Lok AS. Sustained response after a 2-year course of lamivudine treatment of hepatitis B e antigen-negative chronic hepatitis B. J Viral Hepat 2004;11:432-438.
64. Liu F, Wang L, Li XY, Wang JB, Zhang ZH, Wang YZ. Poor durability of lamivudine effectiveness despite stringent cessation criteria: a prospective clinical study in hepatitis B e antigen-negative chronic hepatitis B patients. J Gastroenterol Hepatol 2011;26:456-460.
65. Hadziyannis SJ, Sevastianos V, Rapti I, Vassilopoulos D, Hadziyannis E. Sustained responses and loss of HBsAg in HBeAg-negative patients with chronic hepatitis B who stop long-term treatment with adefovir. Gastroenterology 2012;143:629-636.e1.
66. Jeng WJ, Sheen IS, Chen YC, Hsu CW, Chien RN, Chu CM, et al. Off-therapy durability of response to entecavir therapy in hepatitis B e antigen-negative chronic hepatitis B patients. Hepatology 2013;58:1888-1896.
67. Chang ML, Jeng WJ, Liaw YF. Clinical events after cessation of lamivudine therapy in patients recovered from hepatitis B flare with hepatic decompensation. Clin Gastroenterol Hepatol 2015;13:979-986.
68. Laprise C, Baril JG, Dufresne S, Trottier H. Association between tenofovir exposure and reduced kidney function in a cohort of HIV-positive patients: results from 10 years of follow-up. Clin Infect Dis 2013;56:567-575.
69. Hall AM, Hendry BM, Nitsch D, Connolly JO. Tenofovir-associated kidney toxicity in HIV-infected patients: a review of the evidence. Am J Kidney Dis 2011;57:773-780.
70. Parsonage MJ, Wilkins EG, Snowden N, Issa BG, Savage MW. The development of hypophosphataemic osteomalacia with myopathy in two patients with HIV infection receiving tenofovir therapy. HIV Med 2005;6:341-346.
71. Cooper RD, Wiebe N, Smith N, Keiser P, Naicker S, Tonelli M. Systematic review and meta-analysis: renal safety of tenofovir disoproxil fumarate in HIV-infected patients. Clin Infect Dis 2010;51:496-505.
72. 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.
73. Lampertico P, Soffredini R, Yurdaydin C, Idilman R, Papatheodoridis GV, Margariti A, et al. Four years of tenofovir monotherapy for NUC naïve field practice European patients suppresses HBV replication in most patients with a favorable renal safety profile but does not prevent HCC in patients with or without cirrhosis. Digestive and Liver Disease, Vol. 46, e14.
74. Liaw YF, Raptopoulou-Gigi M, Cheinquer H, Sarin SK, Tanwandee T, Leung N, et al. Efficacy and safety of entecavir versus adefovir in chronic hepatitis B patients with hepatic decompensation: a randomized open-label study. Hepatology 2011;54:91-100.
75. Lange CM, Bojunga J, Hofmann WP, Wunder K, Mihm U, Zeuzem S, et al. Severe lactic acidosis during treatment of chronic hepatitis B with entecavir in patients with impaired liver function. Hepatology 2009;50:2001-2006.
76. Mauss S, Berger F, Filmann N, Hueppe D, Henke J, Hegener P, et al. Effect of HBV polymerase inhibitors on renal function in patients with chronic hepatitis B. J Hepatol 2011;55:1235-1240.
77. Tien C, Xu JJ, Chan LS, Chang M, Lim C, Lee S, et al. Long-term treatment with tenofovir in Asian-American chronic hepatitis B patients is associated with abnormal renal phosphate handling. Dig Dis Sci 2015;60:566-572.
78. Cholongitas E, Papatheodoridis GV, Goulis J, Vlachogiannakos J, Karatapanis S, Ketikoglou J, et al. The impact of newer nucleos(t)ide analogues on patients with hepatitis B decompensated cirrhosis. Ann Gastroenterol 2015;28:109-117.
79. Mallet V, Schwarzinger M, Vallet-Pichard A, Fontaine H, Corouge M, Sogni P, et al. Effect of nucleoside and nucleotide analogues on renal function in patients with chronic hepatitis B virus monoinfection. Clin Gastroenterol Hepatol 2015;13:1181-1188.e1.
80. Hung CH, Hu TH, Lu SN, Lee CM, Chen CH, Kee KM, et al. Tenofovir versus entecavir in the treatment of chronic hepatitis B with severe acute exacerbation. Antimicrob Agents Chemother 2015;59:3168-3173.
81. Huang X, Xu Y, Yang Q, Chen J, Zhang T, Li Z, et al. Efficacy and biological safety of lopinavir/ritonavir based anti-retroviral therapy in HIV-1-infected patients: a meta-analysis of randomized controlled trials. Sci Rep 2015;5:8528.
82. Batirel A, Guclu E, Arslan F, Kocak F, Karabay O, Ozer S, et al. Comparable efficacy of tenofovir versus entecavir and predictors of response in treatment-naive patients with chronic hepatitis B: a multicenter real-life study. Int J Infect Dis 2014;28:153-159.
83. Ceylan B, Yardimci C, Fincanci M, Eren G, Tozalgan U, Muderrisoglu C, et al. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci 2013;17:2467-2473.
84. Doğan ÜB, Kara B, Gümürdülü Y, Soylu A, Akin MS. Comparison of the efficacy of tenofovir and entecavir for the treatment of nucleos(t)ide-naive patients with chronic hepatitis B. Turk J Gastroenterol 2012;23:247-252.
85. Gish RG, Clark MD, Kane SD, Shaw RE, Mangahas MF, Baqai S. Similar risk of renal events among patients treated with tenofovir or entecavir for chronic hepatitis B. Clin Gastroenterol Hepatol 2012;10:941-946; quiz, e68.
86. Koklu S, Tuna Y, Gulsen MT, Demir M, Köksal AŞ, Koçkar MC, et al. Long-term efficacy and safety of lamivudine, entecavir, and tenofovir for treatment of hepatitis B virus-related cirrhosis. Clin Gastroenterol Hepatol 2013;11:88-94.
87. Liaw YF, Sheen IS, Lee CM, Akarca US, Papatheodoridis GV, Suet-Hing Wong F, et al. Tenofovir disoproxil fumarate (TDF), emtricitabine/TDF, and entecavir in patients with decompensated chronic hepatitis B liver disease. Hepatology 2011;53:62-72.
88. Sriprayoon T, Lueangarun S, Suwanwela C, Pattaranutaporn P, Tanwandee T. Efficacy and safety of entecavir versus tenofovir treatment in chronic hepatitis B patients: a randomized controlled trial. Gastroenterology 2012;142(Suppl 1):S695.
89. Wong GL, Tse YK, Wong VW, Fung TY, Choi KK, Chan HL. Long-term safety of oral nucleos(t)ide analogues for patients with chronic hepatitis B-a cohort study of 53, 500 subjects. Hepatology 2015;62:684-693.
90. Fung S, Kwan P, Fabri M, Horban A, Pelemis M, Hann HW, et al. Randomized comparison of tenofovir disoproxil fumarate vs emtricitabine and tenofovir disoproxil fumarate in patients with lamivudine-resistant chronic hepatitis B. Gastroenterology 2014;146:980-988.
91. Berg T, Zoulim F, Moeller B, Trinh H, Marcellin P, Chan S, 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;60:715-722.
92. Lee YB, Lee JH, Lee DH, Cho H, Ahn H, Choi WM, et al. Efficacy of entecavir-tenofovir combination therapy for chronic hepatitis B patients with multidrug-resistant strains. Antimicrob Agents Chemother 2014;58:6710-6716.
93. Lim YS, Byun KS, Yoo BC, Kwon SY, Kim YJ, An J, 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 2015 Jan 16. pii: gutjnl-2014-308353. doi: 10.1136/gutjnl-2014-308353. [Epub ahead of print]
94. Lim YS, Yoo BC, Byun KS, Kwon SY, Kim YJ, An J, et al. 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 2015 Mar 23. pii: gutjnl-2014-308435. doi: 10.1136/gutjnl-2014-308435. [Epub ahead of print]
95. Chang TT, Lai CL, Kew Yoon S, Lee SS, Coelho HS, Carrilho FJ, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010;51:422-430.
96. Zoutendijk R, Reijnders JG, Brown A, Zoulim F, Mutimer D, Deterding K, et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naive patients with a partial virological response. Hepatology 2011;54:443-451.
97. Perry CM, Simpson D. Tenofovir disoproxil fumarate: in chronic hepatitis B. Drugs 2009;69:2245-2256.
98. Thabut D, Thibault V, Bernard-Chabert B, Mouquet C, Di Martino V, Le Calvez S, et al. Long-term therapy with lamivudine in renal transplant recipients with chronic hepatitis B. Eur J Gastroenterol Hepatol 2004;16:1367-1373.
99. Papatheodoridis GV, Dimou E, Laras A, Papadimitropoulos V, Hadziyannis SJ. Course of virologic breakthroughs under long-term lamivudine in HBeAg-negative precore mutant HBV liver disease. Hepatology 2002;36:219-226.
100. Salpini R, Alteri C, Cento V, Pollicita M, Micheli V, Gubertini G, et al. Snapshot on drug-resistance rate and profiles in patients with chronic hepatitis B receiving nucleos(t)ide analogues in clinical practice. J Med Virol 2013;85:996-1004.
101. Tohme RA, Bulkow L, Homan CE, Negus S, McMahon BJ. Rates and risk factors for hepatitis B reactivation in a cohort of persons in the inactive phase of chronic hepatitis B-Alaska, 2001-2010. J Clin Virol 2013;58:396-400.
102. Chu CM, Liaw YF. Incidence and risk factors of progression to cirrhosis in inactive carriers of hepatitis B virus. Am J Gastroenterol 2009;104:1693-1699.
103. Zacharakis GH, Koskinas J, Kotsiou S, Papoutselis M, Tzara F, Vafeiadis N, et al. Natural history of chronic HBV infection: a cohort study with up to 12 years follow-up in North Greece (part of the Interreg I-II/EC-project). J Med Virol 2005;77:173-179.
104. Fattovich G, Pantalena M, Zagni I, Realdi G, Schalm SW, Christensen E. Effect of hepatitis B and C virus infections on the natural history of compensated cirrhosis: a cohort study of 297 patients. Am J Gastroenterol 2002;97:2886-2895.
105. Chang ML, Jeng WJ, Liaw YF. Clinical events after cessation of lamivudine therapy in patients recovered from hepatitis B flare with hepatic decompensation. Clin Gastroenterol Hepatol 2015;13:979-986.
106. Manolakopoulos S, Karatapanis S, Elefsiniotis J, Mathou N, Vlachogiannakos J, Iliadou E, et al. Clinical course of lamivudine monotherapy in patients with decompensated cirrhosis due to HBeAg negative chronic HBV infection. Am J Gastroenterol 2004;99:57-63.
107. Tseng TC, Liu CJ, Yang HC, Su TH, Wang CC, Chen CL, et al. High levels of hepatitis B surface antigen increase risk of hepatocellular carcinoma in patients with low HBV load. Gastroenterology 2012;142:1140-1149.
108. Schiff ER, Lee SS, Chao YC, Kew Yoon S, Bessone F, Wu SS, et al. Long-term treatment with entecavir induces reversal of advanced fibrosis or cirrhosis in patients with chronic hepatitis B. Clin Gastroenterol Hepatol 2011;9:274-276.
109. Chang TT, Liaw YF, Wu SS, Schiff E, Han KH, Lai CL, et al. Long-term entecavir therapy results in the reversal of fibrosis/cirrhosis and continued histological improvement in patients with chronic hepatitis B. Hepatology 2010;52:886-893.
110. 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.
111. Ye XG, Su QM. Effects of entecavir and lamivudine for hepatitis B decompensated cirrhosis: meta-analysis. World J Gastroenterol 2013;19:6665-6678.
112. Jang JW, Choi JY, Kim YS, Woo HY, Choi SK, Lee CH, et al. Long-term effect of antiviral therapy on disease course after decompensation in patients with hepatitis B virus-related cirrhosis. Hepatology 2015;61:1809-1820.
113. Manolakopoulos S, Karatapanis S, Elefsiniotis J, Mathou N, Vlachogiannakos J, Iliadou E, et al. Clinical course of lamivudine monotherapy in patients with decompensated cirrhosis due to HBeAg negative chronic HBV infection. Am J Gastroenterol 2004;99:57-63.
114. Kim SS, Hwang JC, Lim SG, Ahn SJ, Cheong JY, Cho SW. Effect of virological response to entecavir on the development of hepatocellular carcinoma in hepatitis B viral cirrhotic patients: comparison between compensated and decompensated cirrhosis. Am J Gastroenterol 2014;109:1223-1233.
115. Wiseman E, Fraser M, Holden S, Glass A, Kidson BL, Heron LG, et al. Perinatal transmission of hepatitis B virus: an Australian experience. Med J Aust 2009;190:489-492.
116. Sun KX, Li J, Zhu FC, Liu JX, Li RC, Zhai XJ, et al. A predictive value of quantitative HBsAg for serum HBV DNA level among HBeAg-positive pregnant women. Vaccine 2012;30:5335-40.
117. Zou H, Chen Y, Duan Z, Zhang H, Pan C. Virologic factors associated with failure to passive-active immunoprophylaxis in infants born to HBsAg-positive mothers. J Viral Hepat 2012;19:e18-25.
118. Kubo A, Shlager L, Marks AR, Lakritz D, Beaumont C, Gabellini K, et al. Prevention of vertical transmission of hepatitis B: an observational study. Ann Intern Med 2014;160:828-835.
119. Brown RS, McMahon BJ, Lok A, Wong JB, Ahmed AT, Mouchli MA, et al. Antiviral therapy in chronic hepatitis B virus infection during pregnancy: a systematic review and meta-analysis. Hepatology 2015;63:319-333. http://onlinelibrary.wiley.com/doi/10.1002/hep.28302/full.
120. Siberry GK, Jacobson DL, Kalkwarf HJ, Wu JW, DiMeglio LA, Yogev R, et al. Lower newborn bone mineral content associated with maternal use of tenofovir disoproxil fumarate during pregnancy. Clin Infect Dis 2015;61:996-1003.
121. Han L, Zhang HW, Xie JX, Zhang Q, Wang HY, Cao GW. A meta-analysis of lamivudine for interruption of mother-to-child transmission of hepatitis B virus. World J Gastroenterol 2011;17:4321-4333.
122. Shapiro RL, Holland DT, Capparelli E, Lockman S, Thior I, Wester C, et al. Antiretroviral concentrations in breast-feeding infants of women in Botswana receiving antiretroviral treatment. J Infect Dis 2005;192:720-727.
123. Corbett AH, Kayira D, White NR, Davis NL, Kourtis AP, Chasela C, et al. Antiretroviral pharmacokinetics in mothers and breastfeeding infants from 6 to 24 weeks post-partum: results of the BAN Study. Antivir Ther 2014;19:587-595.
124. Mirochnick M, Thomas T, Capparelli E, Zeh C, Holland D, Masaba R, et al. Antiretroviral concentrations in breast-feeding infants of mothers receiving highly active antiretroviral therapy. Antimicrob Agents Chemother 2009;53:1170-1176.
125. Benaboud S, Pruvost A, Coffie PA, Ekouévi DK, Urien S, Arrivé E, et al. Concentrations of tenofovir and emtricitabine in breast milk of HIV-1-infected women in Abidjan, Cote d'Ivoire, in the ANRS 12109 TEmAA Study, Step 2. Antimicrob Agents Chemother 2011;55:1315-1317.
126. Mirochnick M, Taha T, Kreitchmann R, Nielsen-Saines K, Kumwenda N, Joao E, et al. Pharmacokinetics and safety of tenofovir in HIV-infected women during labor and their infants during the first week of life. J Acquir Immune Defic Syndr 2014;65:33-41.
127. Hu Y, Chen J, Wen J, Xu C, Zhang S, Xu B, et al. Effect of elective cesarean section on the risk of mother-to-child transmission of hepatitis B virus. BMC Pregnancy Childbirth 2013;13:119.
128. The Antiretroviral Pregnancy Registry Interim Report for 1 January 1989 through 31 January 2015. http://apregistry.com/forms/exec-summary.pdf. Accessed August 1, 2015.
129. Jonas MM, Block JM, Haber BA, Karpen SJ, London WT, Murray KF, et al. Treatment of children with chronic hepatitis B virus infection in the United States: patient selection and therapeutic options. Hepatology 2010;52:2192-2205.
130. Jonas M, Lok A, McMahon BJ, Brown RS, Wong JB, Ahmed AT, et al. Antiviral therapy in management of chronic hepatitis B virus infection in children: a systematic review and meta-analysis. Hepatology 2015;63:307-318. http://onlinelibrary.wiley.com/doi/10.1002/hep.28278/full
131. Jonas M, Chang MH, Sokal E, Schwarz KB, Kelly D, Kim KM, et al. Randomized controlled trial of entecavir versus placebo in children with HBeAg-positive chronic hepatitis B. Hepatology 2015 Jul 29. doi: 10.1002/hep.28015. [Epub ahead of print]
132. Schwimmer JB, Dunn W, Norman GJ, Pardee PE, Middleton MS, Kerkar N, et al. SAFETY study: alanine aminotransferase cutoff values are set too high for reliable detection of pediatric chronic liver disease. Gastroenterology 2010;138:1357-1364.e2.