Original article
Pancreas, biliary tract, and liver
Treatment Eligibility of Patients With Chronic Hepatitis B Initially Ineligible for Therapy

https://doi.org/10.1016/j.cgh.2012.12.028Get rights and content

Background & Aims

Chronic hepatitis B (CHB) is a dynamic disease, therefore patients initially ineligible for treatment, based on current guidelines, often become eligible at some point during their follow-up evaluation. We investigated the reasons for this change and developed a timeline for treatment eligibility for this population.

Methods

We performed a retrospective cohort study of 245 consecutive treatment-naive, community-based patients with CHB who were not eligible for treatment when they first presented, from March 2007 through June 2010 (mean age, 44 y, almost all Asian). The patients were followed up for a median period of 26 months, receiving standard laboratory tests. They were treated according to US panel 2008 and American Association for Liver Disease (AASLD) 2009 guidelines.

Results

Fifty-four patients (22%) became eligible for treatment during the follow-up period; most of these (n = 47; 87%) were based on only the US Panel algorithm and the rest were based on AASLD guidelines (n = 7; 13%). Six percent of patients met the treatment criteria at 1 year, 18% at 2 years, and 29% at 3 years. Among hepatitis B e antigen–positive patients with levels of hepatitis B virus (HBV) DNA greater than 3 log IU/mL at baseline, 11% met treatment criteria at 1 year, 52% at 2 years, and 80% at 3 years. Based on Cox multivariate analysis, which included age; sex; and levels of hepatitis B e antigen, alanine aminotransferase, and HBV DNA, an increase in HBV DNA level was the only factor from the US panel associated with treatment eligibility (hazard ratio, 1.43; P < .001), and an increase in alanine aminotransferase was the only factor associated with treatment eligibility from the AASLD guidelines (hazard ratio, 1.03; P = .001).

Conclusions

Although most patients with CHB who initially are not eligible for treatment remain ineligible, almost 30% become eligible within 3 years. These findings indicate the importance of carefully following disease status in patients with CHB.

Section snippets

Study Design

We conducted a retrospective cohort study of all consecutive patients who presented for CHB evaluation at 2 community-based gastroenterology clinics in Northern California between March 2007 and June 2010.

Electronic medical records of study subjects, inclusive of laboratory, radiology, and pathology results, were collected using a case report form. Laboratory tests were performed at local laboratories operated either by Quest Diagnostics (San Juan Capistrano, CA) or LabCorp (Burlington, NC).

Baseline Clinical Characteristics of Patients at the Initial Evaluation

Of the total 549 treatment-naive patients seen at the initial presentation, more than half (55%) were eligible for anti-HBV treatment, whereas 245 patients (45%) did not meet the criteria for treatment (Figure 2).

Demographic and clinical characteristics of all patients who initially were ineligible for treatment are summarized in Table 1 and by treatment eligibility status during the follow-up evaluation. All patients were either Vietnamese or Vietnamese-Chinese. When compared with patients who

Discussion

In the current study, approximately one-fifth of patients with CHB who initially did not meet treatment criteria for antiviral therapy became eligible for treatment during their follow-up evaluation. There were significantly more patients who became eligible by the US panel algorithm only compared with the AASLD guideline (19% vs 3%; P < .0001). This difference in proportions can be attributed to the lower requirements for HBV DNA (<2000 IU/mL for HBeAg-negative patients) and ALT cut-off values

References (43)

  • M. Lai et al.

    The clinical significance of persistently normal ALT in chronic hepatitis B infection

    J Hepatol

    (2007)
  • M. Kumar et al.

    Virologic and histologic features of chronic hepatitis B virus-infected asymptomatic patients with persistently normal ALT

    Gastroenterology

    (2008)
  • D. Lavanchy

    Hepatitis B virus epidemiology, disease burden, treatment, and current and emerging prevention and control measures

    J Viral Hepat

    (2004)
  • B.J. McMahon

    Epidemiology and natural history of hepatitis B

    Semin Liver Dis

    (2005)
  • G.M. McQuillan et al.

    Prevalence of hepatitis B virus infection in the United States: the National Health and Nutrition Examination Surveys, 1976 through 1994

    Am J Public Health

    (1999)
  • S.Y. Lin et al.

    Why we should routinely screen Asian American adults for hepatitis B: a cross-sectional study of Asians in California

    Hepatology

    (2007)
  • C. Cohen et al.

    Underestimation of chronic hepatitis B virus infection in the United States of America

    J Viral Hepat

    (2008)
  • J.W. Ward et al.

    Hepatitis B in the United States: a major health disparity affecting many foreign-born populations

    Hepatology

    (2012)
  • K.V. Kowdley et al.

    Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin

    Hepatology

    (2012)
  • Screening for chronic hepatitis B among Asian/Pacific Islander populations–New York City, 2005

    MMWR Morb Mortal Wkly Rep

    (2006)
  • C.M. Weinbaum et al.

    Recommendations for identification and public health management of persons with chronic hepatitis B virus infection

    Hepatology

    (2009)
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      The rates of transition to a more active phase and initiation of antiviral treatment during follow-up evaluation were similar in a secondary analysis with lower values as the ULN for ALT. Another study of 245 Asian patients in the United States who did not meet treatment criteria at presentation found that almost 30% of the patients became treatment-eligible based on the US Panel Algorithm and the AASLD guideline after a median follow-up evaluation of 26 months.16 The REACH-B score predicting HCC risk derived from the Risk Evaluation of Viral Load Elevation and Associated Liver disease/Cancer-HBV study cohort and validated in an external cohort from 3 Asian liver centers could not be calculated in 27% of our patients because of their ages (<30 or >65 y).11

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    Conflicts of interest The authors disclose no conflicts.

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