Treatment of children with chronic hepatitis B virus infection in the United States: Patient selection and therapeutic options

Hepatology

Volumn 52, Issue 6, 2010, Pages 2192-2205

  Jonas, Maureen M ^a   Block, Joan M ^b   Haber, Barbara A ^c   Karpen, Saul J ^d   London, W Thomas ^e   Murray, Karen F ^f   Narkewicz, Michael R ^g   Rosenthal, Philip ^h   Schwarz, Kathleen B ⁱ   McMahon, Brian J ^j  

^a BOSTON CHILDREN S HOSPITAL   (United States)

^b HEPATITIS B FOUNDATION   (United States)

^c CHILDREN S HOSPITAL OF PHILADELPHIA   (United States)

^d BAYLOR COLLEGE OF MEDICINE   (United States)

^e FOX CHASE CANCER CENTER   (United States)

^f UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^h UNIVERSITY OF CALIFORNIA   (United States)

ⁱ JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^j ALASKA NATIVE MEDICAL CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; ALANINE AMINOTRANSFERASE; ALPHA2B INTERFERON; ENTECAVIR; HEPATITIS B SURFACE ANTIGEN; HEPATITIS B(E) ANTIGEN; LAMIVUDINE; PEGINTERFERON ALPHA2A; PLACEBO; TELBIVUDINE; TENOFOVIR DISOPROXIL; VIRUS DNA;

ALANINE AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BONE MARROW TOXICITY; CASE REPORT; CHILD; CLINICAL PRACTICE; DEPRESSION; DRUG WITHDRAWAL; FATIGUE; GASTROINTESTINAL DISEASE; GENOTYPE; HEPATITIS B; HEPATITIS B VIRUS; HISTOPATHOLOGY; HUMAN; IMMUNOLOGICAL TOLERANCE; IMMUNOPROPHYLAXIS; INFLUENZA; LIVER HISTOLOGY; LONG TERM CARE; NEUTROPENIA; NONHUMAN; PATIENT MONITORING; PATIENT SELECTION; PRIORITY JOURNAL; SEROCONVERSION; SIDE EFFECT; THYROID DISEASE; TREATMENT FAILURE; TREATMENT INDICATION; TREATMENT RESPONSE; UNITED STATES; WEIGHT REDUCTION;

ADENINE; ADOLESCENT; ADULT; ALANINE TRANSAMINASE; ANTIVIRAL AGENTS; CHILD; CHILD, PRESCHOOL; DNA, VIRAL; DRUG RESISTANCE, VIRAL; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; INFANT; INTERFERON ALFA-2B; LAMIVUDINE; PATIENT SELECTION; PHOSPHONIC ACIDS;

EID: 78649572605     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.23934     Document Type: Article

References (73)

1. Keeffe EB, Dieterich DT, Han SH, Jacobson IM, Martin P, Schiff ER, et al. A treatment algorithm for the management of chronic hepatitis B virus infection in the United States: 2008 update. Clin Gastroenterol Hepatol 2008; 6: 1315-1341.
2. Liaw YF, Leung N, Kao JH, Piratvisuth T, Gane E, Han KH, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008; 2: 263-283.
3. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009; 50: 227-242.
4. Lok, AS, McMahon, BJ. Chronic Hepatitis B: Update 2009. AASLD Practice Guideline. Hepatology 2009;50:661-662. Full guideline posted online at
5. Haber BA, Block JM, Jonas MM, Karpen SJ, London WT, McMahon BJ, et al. Recommendations for screening, monitoring, and referral of pediatric chronic hepatitis B. Pediatrics 2009; 124: e1007-e1013.
6. Mast EE, Margolis HS, Fiore AE, Brink EW, Goldstein ST, Wang SA, et al. A Comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Part 1: Immunization of infants, children, and adolescents. MMWR 2005; 54(RR16): 1-31.
7. Ngui SL, Andrews NJ, Underhill GS, Heptonstall J, Teo CG. Failed postnatal immunoprophylaxis for hepatitis B: characteristics of maternal hepatitis B virus as risk factors. Clin Infect Dis 1998; 27: 100-106.
8. Beasley RP, Hwang LY, Lee GC, Lan CC, Roan CH, Huang FY, et al. Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 1983; 2: 1099-1102.
9. McMahon BJ, Alward WL, Hall DB, Heyward WL, Bender TR, Francis DP, et al. Acute hepatitis B virus infection: relation of age to the clinical expression of disease and subsequent development of the carrier state. J Infect Dis 1985; 151: 599-603.
10. Coursaget P, Yvonnet B, Chotard J, Vincelot P, Sarr M, Diouf C, et al. Age- and sex-related study of hepatitis B virus chronic carrier state in infants from an endemic area (Senegal). J Med Virol 1987; 22: 1-5.
11. Hoofnagle JH, Doo E, Liang TJ, Fleischer R, Lok ASF. Management of hepatitis B: summary of a clinical research workshop. HEPATOLOGY 2007; 45: 1056-1075.
12. McMahon, BJ. The natural history of chronic hepatitis B virus infection. HEPATOLOGY 2009; 49( 5 Suppl): S45-S55.
13. Hsu HY, Chang MH, Chen DS, Lee CY, Sung JL. Baseline seroepidemiology of hepatitis B virus infection in children in Taipei, 1984: a study just before mass hepatitis B vaccination program in Taiwan. J Med Virol 1986; 18: 301-307.
14. Bortolotti F, Cadrobbi P, Crivellaro C, Guido M, Rugge M, Noventa F, et al. Long-term outcome of chronic type B hepatitis in patients who acquire hepatitis B virus infection in childhood. Gastroenterology 1990; 99: 805-810.
15. Bortolotti F, Jara P, Crivellaro C, Hierro L, Cadrobbi P, Frauca E, et al. Outcome of chronic hepatitis B in Caucasian children during a 20-year observation period. J Hepatol 1998; 29: 184-190.
16. Livingston SE, Simonetti JP, Bulkow LR, Homan CE, Snowball MM, Cagle HH, et al. Clearance of hepatitis B e antigen in patients with chronic hepatitis B and genotypes A, B, C, D, and F. Gastroenterology 2007; 133: 1452-1457.
17. 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.
18. Chen CJ, Iloeje UH, Yang, HI. Long-term outcomes in hepatitis B: The REVEAL-HBV Study. Clin Liver Dis 2007; 11: 797-816.
19. Lai CL, Yuen MF. The natural history and treatment of chronic hepatitis B: a critical evaluation of standard treatment criteria and end points. Ann Intern Med 2007; 147: 58-61.
20. Fung J, Lai CL, But D, Wong D, Cheung TK, Yuen MF. Prevalence of fibrosis and cirrhosis in chronic hepatitis B: implications for treatment and management. Am J Gastroenterol 2008; 103: 1421-1426.
21. Bruix J, Sherman M. AASLD Practice Guideline: Management of hepatocellular carcinoma. HEPATOLOGY 2005; 42: 1208-1236.
22. Simonetti J, Bulkow L, McMahon BJ, Homan C, Snowball M, Negus S, et al. Clearance of hepatitis B surface antigen and risk of hepatocellular carcinoma in a cohort chronically infected with hepatitis B virus. HEPATOLOGY 2010; 51: 1531-1537.
23. Wen WH, Chang MH, Hsu HY, Ni YH, Chen HL. The development of hepatocellular carcinoma among prospectively followed children with chronic hepatitis B virus infection. J Pediatr 2004; 144: 397-399.
24. Giannini E, Botta F, Fasoli A, Ceppa P, Risso D, Lantieri PB, et al. Progressive liver functional impairment is associated with an increase in AST/ALT ratio. Dig Dis Sci 1999; 44: 1249-1253.
25. Sheth SG, Flamm SL, Gordon FD, Chopra S. AST/ALT ratio predicts cirrhosis in patients with chronic hepatitis C virus infection. Am J Gastroenterol 1998; 93: 44-48.
26. Park GJ, Lin BP, Ngu MC, Jones DB, Katelaris PH. Aspartate aminotransferase: alanine aminotransferase ratio in chronic hepatitis C infection: is it a useful predictor of cirrhosis? Gastroenterol Hepatol 2000; 15: 386-390.
27. Kim BK, Kim DY, Park JY, Ahn SH, Chon CY, Kim JK, et al. Validation of FIB-4 and comparison with other simple noninvasive indices for predicting liver fibrosis and cirrhosis in hepatitis B virus-infected patients. Liver Int 2010; 30: 546-553.
28. 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.
29. D'Antiga L, Aw M, Atkins M, Moorat A, Vergani D, Mieli-Vergani G. Combined lamivudine/interferon-alpha treatment in "immunotolerant" children perinatally infected with hepatitis B: a pilot study. J Pediatr 2006; 148: 228-233.
30. Dikici B, Kalayci AG, Ozgenc F, Bosnak M, Davutoglu M, Ece A, et al. Therapeutic vaccination in the immunotolerant phase of children with chronic hepatitis B infection. Pediatr Infect Dis J 2003; 22: 345-349.
31. Dikici B, Dagli A, Ucmak H, Bilici M, Ece A. Efficacy of vitamin E in children with immunotolerant-phase chronic hepatitis B infection. Pediatr Int 2007; 49: 603-607.
32. Zoulim F, Locarnini S. Hepatitis B virus resistance to nucleos (t)ide analogues. Gastroenterology 2009; 137: 1593-1608.
33. 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.
34. Sokal EM, Conjeevaram HS, Roberts EA, Alvarez F, Bern EM, Goyens P, et al. Interferon alfa therapy for chronic hepatitis B in children: a multinational randomized controlled trial. Gastroenterology 1998; 114: 988-995.
35. Jonas MM, Kelley DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Clinical trial of lamivudine in children with chronic hepatitis B. N Engl J Med 2002; 346: 1706-1713.
36. Jonas MM, Kelly D, Pollack H, Mizerski J, Sorbel J, Frederick D, et al. Safety, efficacy, and pharmacokinetics of adefovir dipivoxil in children and adolescents (aged 2 to <18 years) with chronic hepatitis B. HEPATOLOGY 2008; 47: 1863-1871.
37. 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.
38. Harris RA, Chen G, Lin WY, Shen FM, London WT, Evans AA. Spontaneous clearance of high-titer serum HBV DNA and risk of hepatocellular carcinoma in a Chinese population. Cancer Causes Control 2003; 14: 995-1000.
39. 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.
40. Shah U, Kelly D, Chang MH, Fujisawa T, Heller S, González-Peralta RP, et al. Management of chronic hepatitis B in children. J Pediatr Gastroenterol Nutr 2009; 48: 399-404.
41. McMahon BJ, Holck P, Bulkow L, Snowball MM. Serologic and clinical outcomes in 1536 Alaska Natives chronically infected with hepatitis B virus. Ann Intern Med 2001; 759-768.
42. Woynarowski M, Cielecka-Kuszyk J, Kałuzyński A, Omulecka A, Sobaniec-Łotowska M, Stolarczyk J, et al. Inter-observer variability in histopathological assessment of liver biopsies taken in a pediatric open label therapeutic program for chronic HBV infection treatment. World J Gastroenterol 2006; 12: 1713-1717.
43. Hom X, Little NR, Gardner SD, Jonas MM. Predictors of virologic response to lamivudine treatment in children with chronic hepatitis B. Pediatr Infect Dis J 2004; 23: 441-445.
44. Terrault NA, Jacobson IM. Treating chronic hepatitis B infection in patients who are pregnant or are undergoing immunosuppressive chemotherapy. Semin Liver Dis 2007; 27( Suppl 1): 18-24.
45. Katz LH, Fraser A, Gafter-Gvili A, Leibovici L, Tur-Kaspa R. Lamivudine prevents reactivation of hepatitis B and reduces mortality in immunosuppressed patients: systematic review and meta-analysis. J Viral Hepat 2008; 15: 89-102.
46. Kao JH. Hepatitis B viral genotypes: clinical relevance and molecular characteristics. J Gastroenterol Hepatol 2002; 17: 643-650.
47. Arauz-Ruiz P, Norder H, Robertson BH, Magnius LO. Genotype H: a new Amerindian genotype of hepatitis B virus revealed in Central America. J Gen Virol 2002; 83: 2059-2073.
48. McMahon, BJ. The influence of hepatitis B genotype and subgenotype on the natural history of chronic hepatitis B. Hepatol Int 2009; 3: 334-342.
49. Chan HL, Hui AY, Wong ML, Tse AM, Hung LC, Wong VW, et al. Genotype C hepatitis B virus infection is associated with an increased risk of hepatocellular carcinoma. Gut 2004; 53: 1494-1498.
50. Yuen MF, Wong DK, Sablon E, Tse E, Ng IO, Yuan HJ, et al. HBsAg seroclearance in chronic hepatitis B in the Chinese: virological, histological, and clinical aspects. HEPATOLOGY 2004; 39: 1694-1701.
51. Wai CT, Chu CJ, Hussain M, Lok AS. HBV genotype B is associated with better response to interferon therapy in HBeAg(+) chronic hepatitis than genotype C. HEPATOLOGY 2002; 36: 1425-1430.
52. Erhardt A, Blondin D, Hauck K, Sagir A, Kohnle T, Heintges T, et al. Response to interferon alfa is hepatitis B virus genotype dependent: genotype A is more sensitive to interferon than genotype D. Gut 2005; 54: 1009-1013.
53. Elisofon SA, Jonas MM. Hepatitis B and C in children: current treatment and future strategies. Clin Liver Dis 2006; 10: 133-148.
54. Burczynska B, Madalinski K, Pawlowska J, Woynarowski M, Socha J, Gerlich WH, et al. The value of quantitative measurement of HBeAg and HBsAg before interferon-alpha treatment of chronic hepatitis B in children. J Hepatol 1994; 21: 1097-1102.
55. Narkewicz MR, Smith D, Silverman A, Vierling J, Sokol RJ. Clearance of chronic hepatitis B virus infection in young children after alpha interferon treatment. J Pediatr 1995; 127: 815-818.
56. Kobak GE, MacKenzie T, Sokol RJ, Narkewicz MR. Interferon treatment for chronic hepatitis B: enhanced response in children 5 years old or younger. J Pediatr 2004; 145: 340-345.
57. Lindh A, Uhnoo I, Blackberg J, Dufberg AS, Friman S, Fischler B, et al. Treatment of chronic hepatitis B infection: an update of Swedish recommendations. Scand J Infect Dis 2008; 40: 436-450.
58. Sokal EM, Kelly DA, Mizerski J, Badia IB, Areias JA, Schwarz KB, et al. Long-term lamivudine therapy for children with HBeAg-positive chronic hepatitis B. HEPATOLOGY 2006; 43: 225-232.
59. Jonas MM, Little NR, Gardner SD, and members of the International Pediatric Lamivudine Investigator Group. Long-term lamuvidine treatment of children with chronic hepatitis B: durability of therapeutic responses and safety. J Viral Hepat 2008; 15: 20-27.
60. Epivir [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2009.
61. Locarnini S. Primary resistance, multidrug resistance, and cross-resistance pathways in HBV as a consequence of treatment failure. Hepatol Int 2008; 2: 147-151.
62. Hepsera [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2009.
63. Marcellin P, Chang TT, Lim SG, Sievert W, Tong M, Arterburn S, 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: 750-758.
64. Modi AA, Feld JJ. Viral hepatitis and HIV in Africa. AIDS Rev 2007; 9: 25-39.
65. Thio CL, Seaberg EC, Skolasky R Jr, Phair J, Visscher B, Munoz A, et al. HIV-1, hepatitis B virus, and risk of liver-related mortality in the Multicenter Cohort Study (MACS). Lancet 2002; 360: 1921-1926.
66. Benhamou Y, Bochet M, Thibault V, Di Martino V, Caumes E, Bricaire F, et al. Long-term incidence of hepatitis B virus resistance to lamivudine in human immunodeficiency virus-infected patients. HEPATOLOGY 1999; 30: 1302-1306.
67. Soriano V, Puoti M, Bonacini M, Brook G, Cargnel A, Rockstroh J, et al. Care of patients with chronic hepatitis B and HIV co-infection: recommendations from an HIV-HBV International Panel. AIDS 2005; 19: 221-240.
68. Mofenson LM, Brady MT, Danner SP, Dominguez KL, Hazra R, Handelsman E, et al. Guidelines for the prevention and treatment of opportunistic infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep 2009; 58( RR-11): 1-166.
69. Rizzetto M. Hepatitis D: thirty years after. J Hepatol 2009; 50: 1043-1050.
70. Romeo R, Del Ninno E, Rumi M, Russo A, Sangiovanni A, de Franchis R, et al. A 28-year study of the course of hepatitis Delta infection: a risk factor for cirrhosis and hepatocellular carcinoma. Gastroenterology 2009; 136: 1629-1638.
71. Jonas MM. Hepatitis B and pregnancy: an underestimated issue. Liver Int 2009; 29( s1): 133-139.
72. Purdy JB, Gafni RI, Reynolds JC, Zeichner S, Hazra R. Decreased bone mineral density with off-label use of tenofovir in children and adolescents infected with human immunodeficiency virus. J Pediatr 2008; 152: 582-584.
73. Zoulim F, Perrillo R. Hepatitis B: reflections on the current approach to antiviral therapy. J Hepatol 2008; 48( Suppl 1): S2-S19.