Henry Lik-Yuen Chan1, Magdy Elkhashab2, Huy Trinh3, Won Young Tak4, Xiaoli Ma5, Wan-Long Chuang6, Yoon Jun Kim7, Eduardo B Martins8, Lanjia Lin8, Phillip Dinh8, Prista Charuworn8, Graham R Foster9, Patrick Marcellin10. 1. Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong. 2. Toronto Liver Centre, Toronto, Ontario, Canada. 3. San Jose Gastroenterology, San Jose, CA, USA. 4. Kyungpook National University Hospital, Daegu, South Korea. 5. Drexel University College of Medicine, Philadelphia, PA, USA. 6. Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. 7. Seoul National University Hospital, Seoul, South Korea. 8. Gilead Sciences, Inc, Foster City, CA, USA. 9. Queen Mary University of London, London, United Kingdom. 10. Hôpital Beaujon, University of Paris, Paris, France.
Abstract
BACKGROUND & AIMS: 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.
RCT Entities:
BACKGROUND & AIMS: 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 CHBpatients 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 CHBpatients. Baseline vitamin D levels are not associated with treatment outcomes, but were associated with normal ALT.
Authors: Nghiem Xuan Hoan; Hoang Van Tong; Le Huu Song; Christian G Meyer; Thirumalaisamy P Velavan Journal: World J Gastroenterol Date: 2018-01-28 Impact factor: 5.742
Authors: Noemi Hernández-Alvarez; Juan Manuel Pascasio Acevedo; Enrique Quintero; Inmaculada Fernández Vázquez; María García-Eliz; Juan de la Revilla Negro; Javier Crespo García; Manuel Hernández-Guerra Journal: BMJ Open Gastroenterol Date: 2017-03-04
Authors: Nghiem Xuan Hoan; Nguyen Khuyen; Mai Thanh Binh; Dao Phuong Giang; Hoang Van Tong; Phan Quoc Hoan; Ngo Tat Trung; Do Tuan Anh; Nguyen Linh Toan; Christian G Meyer; Peter G Kremsner; Thirumalaisamy P Velavan; Le Huu Song Journal: BMC Infect Dis Date: 2016-09-23 Impact factor: 3.090