Treatment Eligibility of Patients With Chronic Hepatitis B Initially Ineligible for Therapy

School of Medicine at the University of California, San Diego, CA.
Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association (Impact Factor: 7.9). 01/2013; 11(5). DOI: 10.1016/j.cgh.2012.12.028
Source: PubMed


BACKGROUND & AIMS: Chronic hepatitis B (CHB) is a dynamic disease, so patients initially ineligible for treatment, based on current guidelines, often become eligible during follow up. 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-naïve community-based patients with chronic hepatitis B (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 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%) based on only the US Panel algorithm and the rest 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 HB e antigen (HBeAg)-positive patients with levels of HB virus (HBV) DNA >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 that included age; sex; and levels of HBeAg, alanine aminotransferase (ALT), and HBV DNA, an increase in HBV DNA was the only factor from the US panel associated with treatment eligibility (hazard ratio [HR], 1.43; P <.001), and an increase in ALT was the only factor from the AASLD guidelines (HR, 1.03; P =.001). CONCLUSION: Although most patients with CHB who are not initially eligible for treatment remain ineligible, almost 30% became treatment eligible within 3 y. These findings indicate the importance of carefully following disease status in patients with CHB.

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    ABSTRACT: Background/aim: Treatment practices for patients with chronic hepatitis B (CHB) varies across the world and several professional associations have issued treatment recommendations. This synopsis aims to review the major principles of CHB and its management, and to systematically summarize and compare the recommendations of the major treatment guidelines by: the Asian-Pacific Association for the Study of the Liver, the US Panel, the European Association for the Study of the Liver, and the American Association for the Study of the Liver. Methods: Treatment recommendations were summarized separately for hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients. Conclusions: Treatment for CHB is recommended on the basis of a variety of host and viral factors, and the ultimate goal of treatment is the prevention of decompensated liver disease, hepatocellular carcinoma, cirrhosis, and premature death. Despite updates and improvements in these guidelines during the past decade, greater patient and physician education as well as better noninvasive markers to identify high-risk patients are still needed. Significant improvements in the application of current practice guidelines, however, can be made by relatively simple educational efforts, and new molecular and genomic techniques may hold promise for more accurate selection of high-risk patients for further therapeutic interventions in a near future.
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