Treatment Eligibility of Patients With Chronic Hepatitis B Initially Ineligible for Therapy
ABSTRACT 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: The goal of chronic hepatitis B (CHB) treatment is to improve survival by preventing disease progression to decompensated cirrhosis and hepatocellular carcinoma which is the cause of over 1 million deaths annually. The risk of disease progression is reduced when a sustained reduction of hepatitis B virus (HBV) DNA to undetectable levels and suppression of HBV replication are obtained which can result in regression of liver fibrosis and may even reverse cirrhosis. However, even if HBsAg loss occurs, HBV is not completely eradicated by treatment, and long-term therapy is required in patients who are HBeAg(-) and HBeAg(+) who do not maintain off-treatment virological suppression and in those with advanced liver disease. The recently updated European Association of the Study of the Liver (EASL) clinical practical guidelines for HBV have clarified, first, how to treat HBV (interferon or the most potent oral drugs with optimal resistance profiles, i.e. entecavir and tenofovir disoproxil fumarate, should be used as first-line monotherapies); second, who should be treated (CHB in patients with significant liver disease but also patients who are HBsAg(+) and are receiving immunosuppressive treatment, patients coinfected with HBV and human immunodeficiency virus, mothers who are HBsAg(+) with high viral load in late pregnancy associated with sero vaccination to reduce the risk of vertical transmission of HBV; and third, when to stop antiviral therapies. The aim of this review was to clarify how to treat HBV and who should be treated, as well as when to stop treatment. Although the answer to these questions is clear for pegylated interferon, it is more debatable for nucleos(t)ide analogues (anti-HBe seroconversion, HBsAg loss or anti-HBs seroconversion with undetectable HBV DNA are clear indications to discontinue treatment but sustained undetectable HBV DNA in patients who are anti-HBe(+) without significant fibrosis might be another indication).Therapeutic Advances in Gastroenterology 07/2014; 7(4):148-55. DOI:10.1177/1756283X14524614
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ABSTRACT: & Aims: The availability of potent, well-tolerated oral antivirals with low rates of resistance has led many experts to recommend liberalizing indications for treatment of chronic hepatitis B (CHB). This study sought to determine the rate of transitions to an active phase of infection, the frequency of treatment initiation, and the clinical outcomes of patients with CHB who did not meet treatment criteria at presentation.Gastroenterology 07/2014; 146(5). DOI:10.1016/j.cgh.2014.07.019 · 13.93 Impact Factor