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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