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Clin Gastroenterol Hepatol. 2017 Feb 12. pii: S1542-3565(17)30149-0. doi: 10.1016/j.cgh.2017.01.032. [Epub ahead of print]
Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy.Jacobson IM1, Washington MK2, Buti M3, Thompson A4, Afdhal N5, Flisiak R6, Akarca US7, Tchernev KG8, Flaherty JF9, Schall RA9, Myers RP9, Subramanian GM9, McHutchison JG9, Younossi Z10, Marcellin P11, Patel K12.
Author information
- 1Department of Medicine, Mount Sinai Beth Israel Medical Center, New York, NY, USA. Electronic address: [email protected].
- 2Department of Pathology, Microbiology, and Immunology, Vanderbilt University, Nashville, TN, USA.
- 3Servei de Medicina Interna-Hepatologia, Hospital General Universitari Vall d'Hebron, and CIBEREHD del Instituto Carlos III, Barcelona, Spain.
- 4Hepatology Research, St Vincent's Hospital, Fitzroy, Victoria, Australia.
- 5Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
- 6Department of Infectious Diseases and Hepatology, Medical University of Bialystok, Bialystok, Poland.
- 7Department of Gastroenterology, Ege Universitesi Tip Fakultesi, Izmir, Turkey.
- 8Department of Internal Diseases, Medical University, Sofia, Bulgaria.
- 9Departments of Clinical Research and Clinical Biometrics, Gilead Sciences, Inc., Foster City, CA, USA.
- 10Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA.
- 11Service d'Hépatologie, Viral Hepatitis Research Centre, Hôpital Beaujon, Clichy, France.
- 12Division of Gastroenterology, Duke Clinical Research Institute and Duke University Medical Center, Durham, NC, USA.
AbstractBACKGROUND & AIM: Despite complete suppression of viral DNA with antiviral agents, in some patients with chronic hepatitis B (CHB), serum levels of alanine aminotransferase (ALT) do not normalize. We investigated factors associated with persistent increases in level of ALT in patients with CHB given long-term tenofovir disoproxil fumarate.
METHODS: We analyzed data from 471 hepatitis B e antigen (HBeAg)-positive and HBeAg-negative patients with CHB participating in 2 phase 3 trials. We identified patients with an increased level of ALT (above the upper limit of normal range) after 5 years (240 weeks) of tenofovir disoproxil fumarate therapy. We analyzed findings from liver biopsies collected from 467 patients (99%) at baseline and 339 patients (72%) at year 5 of treatment; biopsies were evaluated by an independent pathologist. We performed stepwise, forward, multivariate regression analyses of specified baseline characteristics and on-treatment response parameters to identify factors associated with persistent increases in level of ALT.
RESULTS: Of the 471 patients, 87 (18%) still had an increased level of ALT at year 5 of treatment. Factors independently associated with persistent increase in level of ALT were steatosis score of 5% or more (grade 1 or more) at baseline (odds ratio [OR], 2.224; 95% CI, 1.031-4.852; P=.042) and at year 5 (OR, 3.39; 95% CI 1.560≥7.375; P=.002), HBeAg seropositivity at baseline (OR, 3.30; 95% CI, 1.653-6.576; P<.001), and age of 40 years or more (OR, 2.10; 95% CI, 1.014-4.342; P=.046). Of the 42 HBeAg-positive patients with steatosis at baseline, 21 (50%) had an increased level of ALT at year 5 of treatment. Patients with persistent increases in ALT were more likely to have an increase in steatosis at year 5 than those with a normal level of ALT.
CONCLUSION: HBeAg seropositivity and hepatic steatosis contribute to persistent increases in level of ALT in patients with CHB receiving suppressive antiviral treatment. ClinicalTrials.gov no: NCT00116805.
Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.
KEYWORDS: HBV; adiponutrin/patatin-like phospholipase-3; hepatitis B virus infection; serum transaminase
PMID:28215615DOI:10.1016/j.cgh.2017.01.032
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