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J Hepatol. 2015 Jul 1. pii: S0168-8278(15)00452-3. doi: 10.1016/j.jhep.2015.06.025. [Epub ahead of print]
Association of Baseline Vitamin D Levels With Clinical Parameters and Treatment Outcomes in Chronic Hepatitis B.Chan HL1, Elkhashab M2, Trinh H3, Tak WY4, Ma X5, Chuang WL6, Kim YJ7, Martins EB8, Lin L8, Dinh P8, Charuworn P8, Foster GR9, Marcellin P10.
Author information
- 1Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. Electronic address: [email protected].
- 2Toronto Liver Centre, Toronto, Ontario, Canada.
- 3San Jose Gastroenterology, San Jose, CA, USA.
- 4Kyungpook National University Hospital, Daegu, South Korea.
- 5Drexel University College of Medicine, Philadelphia, PA, USA.
- 6Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan.
- 7Seoul National University Hospital, Seoul, South Korea.
- 8Gilead Sciences, Inc, Foster City, CA, USA.
- 9Queen Mary University of London, London, United Kingdom.
- 10Hôpital Beaujon, University of Paris, Paris, France.
AbstractBACKGROUND & AIMS: The relationships 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[OHD3) 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 (PEG-IFN), TDF plus PEG-IFN for 16 weeks followed by TDF for 32 weeks, PEG-IFN 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 and 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.
Copyright © 2015. Published by Elsevier B.V.
KEYWORDS: Hepatitis B; Seasonal variation; Tenofovir disoproxil fumarate; Vitamin D deficiency
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