title: Association of baseline vitamin D levels with clinical parameters and treatment outcomes in chronic hepatitis B.
abstract: OBJECTIVE
  The relationship between vitamin D levels and chronic hepatitis B (CHB) infection and treatment outcomes are poorly elucidated. We measured pre-treatment serum vitamin D (25-hydroxyvitamin D3; 25[OH]D3) levels and determined their association with clinical parameters and treatment outcomes in active CHB patients without advanced liver disease enrolled in a global clinical trial.
  
  
  METHODS
  Patients were randomly assigned to either 48 weeks of tenofovir disoproxil fumarate (TDF) plus peginterferon alfa-2a (PegIFN), TDF plus PegIFN for 16 weeks followed by TDF for 32 weeks, PegIFN for 48 weeks, or TDF for 120 weeks. Univariate and multivariate analyses were conducted to determine associations between vitamin D, baseline factors, and week 48 clinical outcome.
  
  
  RESULTS
  Of 737 patients, 35% had insufficient (⩾20 but <31 ng/ml) and 58% had deficient (<20 ng/ml) vitamin D levels. In univariate analysis, lower vitamin D levels were significantly associated with the following baseline parameters: younger age, lower uric acid levels, HBeAg-positive status, lower calcium levels, blood draw in winter or autumn, and HBV genotype D. On multivariate analysis, only HBV genotype, season of blood draw, calcium level, and age retained their association. High baseline level of vitamin D was associated with low HBV DNA, normal ALT and HBsAg at week 48 independent of treatment groups, but the association, with the exception of ALT, became statistically insignificant after adjusting for age, gender, HBeAg and HBV genotype.
  
  
  CONCLUSIONS
  Abnormally low vitamin D levels are highly prevalent among untreated, active CHB patients. Baseline vitamin D levels are not associated with treatment outcomes, but were associated with normal ALT.
authors.affiliation: Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong.
authors.forename: Henry Lik-Yuen
authors.initials: HL
authors.lastname: Chan
authors.affiliation: Toronto Liver Centre, Toronto, Ontario, Canada.
authors.forename: Magdy
authors.initials: M
authors.lastname: Elkhashab
authors.affiliation: San Jose Gastroenterology, San Jose, CA, USA.
authors.forename: Huy
authors.initials: H
authors.lastname: Trinh
authors.affiliation: Kyungpook National University Hospital, Daegu, South Korea.
authors.forename: Won Young
authors.initials: WY
authors.lastname: Tak
authors.affiliation: Drexel University College of Medicine, Philadelphia, PA, USA.
authors.forename: Xiaoli
authors.initials: X
authors.lastname: Ma
authors.affiliation: Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
authors.forename: Wan-Long
authors.initials: WL
authors.lastname: Chuang
authors.affiliation: Seoul National University Hospital, Seoul, South Korea.
authors.forename: Yoon Jun
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Eduardo B
authors.initials: EB
authors.lastname: Martins
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Lanjia
authors.initials: L
authors.lastname: Lin
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Phillip
authors.initials: P
authors.lastname: Dinh
authors.affiliation: Gilead Sciences, Inc, Foster City, CA, USA.
authors.forename: Prista
authors.initials: P
authors.lastname: Charuworn
authors.affiliation: Queen Mary University of London, London, United Kingdom.
authors.forename: Graham R
authors.initials: GR
authors.lastname: Foster
authors.affiliation: Hôpital Beaujon, University of Paris, Paris, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000032:analysis; D004337:Drug Carriers; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000150:complications / Q000188:drug therapy* / Q000821:virology; D006801:Humans; D016898:Interferon-alpha / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011994:Recombinant Proteins / Q000627:therapeutic use; D000068698:Tenofovir / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014804:Vitamin B Deficiency / Q000097:blood* / Q000188:drug therapy / Q000209:etiology; D014807:Vitamin D / Q000493:pharmacokinetics*; D014815:Vitamins / Q000493:pharmacokinetics; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D004337:Drug Carriers; D016898:Interferon-alpha; D011994:Recombinant Proteins; D014815:Vitamins; D014807:Vitamin D; D011092:Polyethylene Glycols; D000068698:Tenofovir; C100416:peginterferon alfa-2a
keywords: Hepatitis B; Seasonal variation; Tenofovir disoproxil fumarate; Vitamin D deficiency