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BACKGROUND AND AIM: The incidence and consequences of flares during first-line nucleos(t)ide analogue therapy are largely unknown. We aimed to investigate the incidence and outcome of ALT flares during long-term entecavir (ETV) in chronic hepatitis B (CHB).
METHODS: CHB patients treated with ETV monotherapy from 11 European centers were studied. Flare was defined as >3x increase in ALT compared with baseline or lowest on-treatment level, and an absolute ALT >3x upper limit of normal. Flares were designated as host-induced (preceded by HBV DNA decline), virus-induced (HBV DNA increase), or indeterminate (stable HBV DNA).
RESULTS: 729 patients were treated with ETV for median of 3.5 years. Thirty patients developed a flare with cumulative incidence of 6.3% at year 5. Baseline HBeAg-positivity (HR 2.84; p = 0.005) and high HBV DNA (HR 1.30; p = 0.003) predicted flares. There were 12 (40%) host-induced, 7 (23%) virus-induced, and 11 (37%) indeterminate flares. Host-induced flares occurred earlier than virus-induced (median: 15 vs. 83 weeks; p = 0.027) or indeterminate flares (15 vs. 109 weeks; p = 0.011). Host-induced flares were associated with biochemical remission, and HBeAg (n = 3) and HBsAg (n = 2) seroconversions were exclusively observed among patients with these flares. Virus-induced flares were associated with ETV resistance (n = 2) and non-compliance (n = 1).
CONCLUSION: The incidence of ALT flares during ETV was low in this real-life cohort. ETV can be safely continued in patients with host-induced flares. Treatment adherence and drug resistance must be assessed in patients with virus-induced flares. This article is protected by copyright. All rights reserved.
|Journal||Journal of Gastroenterology and Hepatology|
|Publication status||Published - 24 Mar 2016|
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