Adherence to Chronic Hepatitis B Treatment Guideline Recommendations for Laboratory Monitoring of Patients Who Are Not Receiving Antiviral Treatment
Hepatitis B virus (HBV) DNA and alanine aminotransferase (ALT) levels predict future complications in chronic hepatitis B (CHB) patients. To determine when to initiate antiviral therapy, treatment guidelines recommend monitoring of HBV DNA and ALT levels at least annually. This study aimed to assess adherence to treatment guideline-recommended monitoring of CHB patients not receiving antiviral treatment and to identify predictors of laboratory monitoring and subsequent initiation of antiviral therapy.
This retrospective cohort study used data from a large US health care claims database over a 5-year period (January 1, 2003 to December 31, 2007). The study population included patients 18–65 years of age with at least two paid medical claims with an ICD-9 code for CHB, at least one positive hepatitis B surface antigen test, and at least 12 months of continuous health plan enrollment after initial diagnosis. Descriptive statistics assessed the proportion of patients with claims for ALT and/or HBV DNA monitoring. Multivariate logistic regression models were used to determine predictors of monitoring and subsequent antiviral therapy.
The study included 1,168 CHB patients, with a mean follow-up of 728 days (median = 696 days). The proportion monitored at least every 12 months was 53.3% for ALT, 39.0% for HBV DNA, and 35.1% for both. Significant predictors of monitoring were a higher Deyo-Charlson Comorbidity Index (DCCI) score for ALT (OR 1.90, p < 0.001), male gender for HBV DNA (OR 1.49, p < 0.01), and a higher DCCI score (OR 1.10, p < 0.05) and male gender (1.46, p < 0.01) for both. Significant predictors of subsequent initiation of antiviral treatment were HBV DNA monitoring (OR 2.08, p < 0.001), a higher DCCI score (OR 1.24, p < 0.001), and male gender (OR 1.53, p < 0.01).
Laboratory monitoring of CHB patients not receiving antiviral treatment is below guideline recommendations, suggesting that initiation of antiviral therapy may also be delayed, leaving patients at risk for disease progression.
- McMahon BJ. Epidemiology and natural history of hepatitis B. Semin Liver Dis. 2005;25(Suppl 1):3–8. CrossRef
- Sorrell MF, Belongia EA, Costa J, et al. National Institutes of Health Consensus Development Conference Statement: management of hepatitis B. Ann Intern. Med. 2009;150:104–10.
- 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. CrossRef
- 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:S173–81. CrossRef
- Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hepatology. 2009;50:661–2. CrossRef
- Institute of Medicine. Hepatitis and Liver Cancer. A National Strategy for Prevention and Control of Hepatitis B and C. Available at: http://books.nap.edu/openbook.php?record_id=12793&page=R1 (accessed September 2010).
- American Association for the Study of Liver Diseases. The Route from the IOM to Public Health Passes through AASLD. AASLD News; May 6, 2010. Available at: http://www.aasld.org/journals/archive/050610/Pages/default.aspx (accessed September 2010).
- 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.
- Gish RG. Hepatitis B treatment: Current best practices, avoiding resistance. Cleve. Clin J Med. 2009;76 Suppl 3:S14–9.
- Widjaja D, Yarlagadda S, Singu BS, et al. Characteristics of patients with chronic hepatitis-B virus infection in an urban hospital. J Natl. Med Assoc. 2007;99:384–8.
- Giannini EG, Torre F, Basso M, et al. A significant proportion of patients with chronic hepatitis B who are candidates for antiviral treatment are untreated: A region-wide survey in Italy. J Clin Gastroenterol. 2009;43:1001–7. CrossRef
- Wolters Kluwer Pharma Solutions, Inc. Chronic Hepatitis B, Total Prescription Sales Data, Sep 2009–Feb 2010. Philadelphia, PA, March 2010.
- 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. CrossRef
- 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;130:678–86. CrossRef
- Iloeje UH, Yang HI, Jen CL, et al. Risk and predictors of mortality associated with chronic hepatitis B infection. Clin Gastroenterol Hepatol. 2007;5:921–31. CrossRef
- Chen G, Lin W, Shen F, Iloeje UH, London WT, Evans AA. Past HBV viral load as predictor of mortality and morbidity from HCC and chronic liver disease in a prospective study. Am J Gastroenterol. 2006;101:1797–803. CrossRef
- Liu CJ, Chen BF, Chen PJ, et al. Role of hepatitis B viral load and basal core promoter mutation in hepatocellular carcinoma in hepatitis B carriers. J Infect Dis. 2006;193:1258–65. CrossRef
- Ohata K, Hamasaki K, Toriyama K, Ishikawa H, Nakao K, Eguchi K. High viral load is a risk factor for hepatocellular carcinoma in patients with chronic hepatitis B virus infection. J Gastroenterol Hepatol. 2004;19:670–5. CrossRef
- Yu MW, Yeh SH, Chen PJ, et al. Hepatitis B virus genotype and DNA level and hepatocellular carcinoma: a prospective study in men. J Natl. Cancer Inst. 2005;97:265–72. CrossRef
- Chevaliez S, Pawlotsky JM. Virological techniques for the diagnosis and monitoring of hepatitis B and C. Ann Hepatol. 2009;8:7–12.
- European Association For The Study Of The Liver. EASL Clinical Practice Guidelines. Management of chronic hepatitis B. J Hepatol. 2009;50:227–42. CrossRef
- Liaw YF, Leung N, Kao JH, et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int. 2008;2:263–83. CrossRef
- 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;6:1315–41. CrossRef
- Prati D, Taioli E, Zanella A, et al. Updated definitions of healthy ranges for serum alanine aminotransferase levels. Ann Intern. Med. 2002;137:1–10.
- Mitra D, Davis KL, Beam C, Medjedovic J, Rustgi V. Treatment patterns and adherence among patients with chronic hepatitis C virus in a US managed care population. Value Health. 2010;13:479–86. CrossRef
- Berger ML, Mamdani M, Atkins D, Johnson ML. Good research practices for comparative effectiveness research: defining, reporting and interpreting nonrandomized studies of treatment effects using secondary data sources: the ISPOR Good Research Practices for Retrospective Database Analysis Task Force report-part I. Value Health. 2009;12:1044–52. CrossRef
- International Classification of Diseases, 9th Revision, Clinical Modification. 5th edition Medicode Publications, Salt Lake City UT, 1997.
- Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45:613–9. CrossRef
- Rein DB, Lesesne SB, Leese PJ, Weinbaum CM. Community-based hepatitis B screening programs in the United States in 2008. J Viral Hepat. 2010;17:28–33. CrossRef
- Adherence to Chronic Hepatitis B Treatment Guideline Recommendations for Laboratory Monitoring of Patients Who Are Not Receiving Antiviral Treatment
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Journal of General Internal Medicine
Volume 26, Issue 3 , pp 239-244
- Cover Date
- Print ISSN
- Online ISSN
- Additional Links
- hepatitis B virus DNA
- alanine aminotransferase
- treatment guidelines
- antiviral therapy
- Industry Sectors
- Author Affiliations
- 1. Research & Development, Bristol-Myers Squibb Co., 777 Scudders Mill Road, Plainsboro, NJ, 08536, USA
- 2. Currently at Eisai, 100 Tice Blvd, Woodcliff Lake, NJ, USA