Abstract
Background and Aims
Chronic hepatitis B (CHB) is a major cause of cirrhosis and end-stage liver disease. Not all patients with CHB require antiviral treatment but long-term monitoring is critical to identify patients who would benefit from antiviral therapy. CHB patients followed in various clinical settings may differ in disease characteristics and rates of treatment eligibility in long-term follow-up.
Methods
We conducted a retrospective cohort study of 359 consecutive treatment-naive, treatment-ineligible CHB patients (228 from community GI clinics; 73 from university hepatology clinic; 58 from primary care clinic). Primary end points were the proportion of patients meeting eligibility criteria in follow-up, and the eligibility comparison among patients in various clinical settings. Univariate and multivariate Cox’s proportional hazard models were used to calculate hazard ratios to identify predictors of treatment eligibility in follow-up.
Results
While the majority of patients remained treatment ineligible by guideline recommendations, a sizeable proportion (23 %, 95 % CI 18–27 %) of patients subsequently met treatment eligibility in study follow-up. Reasons for meeting US Panel treatment eligibility on multivariate analysis included baseline ALT ≥ ULN (HR 1.91, p = 0.03) and baseline HBV DNA ≥ 2000 IU/mL (HR 2.6, p = 0.001). Practice setting was not a predictor.
Conclusions
A significant number of patients with CHB (23 %) who were not initially treatment eligible later met treatment criteria in longer-term follow-up. Significant independent predictors of treatment eligibility included a baseline ALT ≥ ULN and elevated HBV DNA (≥2000 IU/mL for US Panel eligibility and ≥20,000 IU/mL for AASLD eligibility). This study underscores the importance of long-term follow-up for patients with CHB.
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Abbreviations
- AASLD:
-
American Association for the Study of Liver Diseases
- ALT:
-
Alanine aminotransferase
- CHB:
-
Chronic hepatitis B
- ESLD:
-
End-stage liver disease
- HBeAg:
-
Hepatitis B e antigen
- HBV DNA:
-
Hepatitis B virus deoxyribonucleic acid
- HCC:
-
Hepatocellular carcinoma
- HCV:
-
Hepatitis C virus
- HDV:
-
Hepatitis delta virus
- HIV:
-
Human immunodeficiency virus
References
Lok AS. Chronic hepatitis B. N Engl J Med. 2002;346:1682–1683.
Mast EE, Margolis HS, Fiore AE, 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;54:1–31.
Guidelines for the prevention, care and treatment of persons with chronic hepatitis B infection. Geneva: World Health Organization; 2015. Available from: http://www.ncbi.nlm.nih.gov/books/NBK305553/.
Chen CJ, Yang HI, Su J, et al. Risk of hepatocellular carcinoma across a biological gradient of serum hepatitis B virus DNA level. JAMA. 2006;295:65–73.
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.
McMahon BJ. The natural history of chronic hepatitis B virus infection. Hepatology. 2009;49:S45–S55.
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.
Keeffe EB, Dieterich DT, Han SH, 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. (quiz 1286).
Liaw Y-F, Kao J-H, Piratvisuth T, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2012 update. Hepatol Int. 2012;6:531–561.
Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50:661–662.
Uribe LA, O’Brien CG, Wong RJ, Gish RR, Tsai N, Nguyen MH. Current treatment guidelines for chronic hepatitis B and their applications. J Clin Gastroenterol. 2014;48:773–783.
Batts KP, Ludwig J. Chronic hepatitis. An update on terminology and reporting. Am J Surg Pathol. 1995;19:1409–1417.
Papatheodoridis GV, Chrysanthos N, Hadziyannis E, Cholongitas E, Manesis EK. Longitudinal changes in serum HBV DNA levels and predictors of progression during the natural course of HBeAg-negative chronic hepatitis B virus infection. J Viral Hepat. 2008;15:434–441.
Bosch FX, Ribes J, Borras J. Epidemiology of primary liver cancer. Semin Liver Dis. 1999;19:271–285.
Degertekin B, Lok AS. Indications for therapy in hepatitis B. Hepatology. 2009;49:S129–S137.
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.
Nguyen MH, Garcia RT, Trinh HN, et al. Histological disease in Asian-Americans with chronic hepatitis B, high hepatitis B virus DNA, and normal alanine aminotransferase levels. Am J Gastroenterol. 2009;104:2206–2213.
Tong MJ, Hsien C, Hsu L, Sun HE, Blatt LM. Treatment recommendations for chronic hepatitis B: an evaluation of current guidelines based on a natural history study in the United States. Hepatology. 2008;48:1070–1078.
Ku KC, Li J, Ha NB, Martin M, Nguyen VG, Nguyen MH. Chronic hepatitis B management based on standard guidelines in community primary care and specialty clinics. Dig Dis Sci. 2013;58:3626–3633.
Zhang S, Ristau JT, Trinh HN, Garcia RT, Nguyen HA, Nguyen MH. Undertreatment of Asian chronic hepatitis B patients on the basis of standard guidelines: a community-based study. Dig Dis Sci. 2012;57:1373–1383.
Sonneveld MJ, Zoutendijk R, Janssen HL. Hepatitis B surface antigen monitoring and management of chronic hepatitis B. J Viral Hepat. 2011;18:449–457.
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Uribe, L.A., Nguyen, N., Kim, L. et al. Rates of Treatment Eligibility in Follow-Up of Patients with Chronic Hepatitis B (CHB) Across Various Clinical Settings Who Were Initially Ineligible at Presentation. Dig Dis Sci 61, 618–625 (2016). https://doi.org/10.1007/s10620-015-3982-4
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DOI: https://doi.org/10.1007/s10620-015-3982-4