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Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy.

Publication ,  Journal Article
Jacobson, IM; Washington, MK; Buti, M; Thompson, A; Afdhal, N; Flisiak, R; Akarca, US; Tchernev, KG; Flaherty, JF; Aguilar Schall, R; Myers, RP ...
Published in: Clin Gastroenterol Hepatol
July 2017

BACKGROUND & AIMS: 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 ALT level 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 biopsy specimens collected from 467 patients (99%) at baseline and 339 patients (72%) at year 5 of treatment; biopsy specimens 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 ALT level. RESULTS: Of the 471 patients, 87 (18%) still had an increased ALT level at year 5 of treatment. Factors associated significantly with a persistent increase in ALT level were a steatosis score of 5% or greater (grade 1 or more) at baseline (odds ratio [OR], 2.236; 95% confidence interval [CI], 1.031-4.852; P = .042) and at year 5 (OR, 3.392; 95% CI, 1.560 ≥ 7.375; P = .002), HBeAg seropositivity at baseline (OR, 3.297; 95% CI, 1.653-6.576; P < .001), and age 40 years or older (OR, 2.099; 95% CI, 1.014-4.342; P = .046). Of the 42 HBeAg-positive patients with steatosis at baseline, 21 (50%) had an increased ALT level at year 5 of treatment. Patients with persistent increases in ALT level were more likely to have an increase in steatosis at year 5 than those with a normal ALT level. CONCLUSIONS: HBeAg seropositivity and hepatic steatosis contribute to persistent increases in ALT level in patients with CHB receiving suppressive antiviral treatment. ClinicalTrials.gov registration numbers: NCT00117676 and NCT00116805.

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Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

July 2017

Volume

15

Issue

7

Start / End Page

1087 / 1094.e2

Location

United States

Related Subject Headings

  • Young Adult
  • Tenofovir
  • Middle Aged
  • Male
  • Liver
  • Humans
  • Histocytochemistry
  • Hepatitis B, Chronic
  • Hepatitis B e Antigens
  • Gastroenterology & Hepatology
 

Citation

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Jacobson, I. M., Washington, M. K., Buti, M., Thompson, A., Afdhal, N., Flisiak, R., … Patel, K. (2017). Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol, 15(7), 1087-1094.e2. https://doi.org/10.1016/j.cgh.2017.01.032
Jacobson, Ira M., Mary K. Washington, Maria Buti, Alexander Thompson, Nezam Afdhal, Robert Flisiak, Ulus Salih Akarca, et al. “Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy.Clin Gastroenterol Hepatol 15, no. 7 (July 2017): 1087-1094.e2. https://doi.org/10.1016/j.cgh.2017.01.032.
Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, et al. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2.
Jacobson, Ira M., et al. “Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy.Clin Gastroenterol Hepatol, vol. 15, no. 7, July 2017, pp. 1087-1094.e2. Pubmed, doi:10.1016/j.cgh.2017.01.032.
Jacobson IM, Washington MK, Buti M, Thompson A, Afdhal N, Flisiak R, Akarca US, Tchernev KG, Flaherty JF, Aguilar Schall R, Myers RP, Subramanian GM, McHutchison JG, Younossi Z, Marcellin P, Patel K. Factors Associated With Persistent Increase in Level of Alanine Aminotransferase in Patients With Chronic Hepatitis B Receiving Oral Antiviral Therapy. Clin Gastroenterol Hepatol. 2017 Jul;15(7):1087-1094.e2.
Journal cover image

Published In

Clin Gastroenterol Hepatol

DOI

EISSN

1542-7714

Publication Date

July 2017

Volume

15

Issue

7

Start / End Page

1087 / 1094.e2

Location

United States

Related Subject Headings

  • Young Adult
  • Tenofovir
  • Middle Aged
  • Male
  • Liver
  • Humans
  • Histocytochemistry
  • Hepatitis B, Chronic
  • Hepatitis B e Antigens
  • Gastroenterology & Hepatology