Treatment eligibility of patients with chronic hepatitis B initially ineligible for therapy

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.