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Published byManuela Díaz Olivares Modified over 6 years ago
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Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of HBeAg- positive chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non- inferiority trial Prof Henry L Y Chan, MD, Scott Fung, MD, Wai Kay Seto, MD, Prof Wan-Long Chuang, MD, Chi-Yi Chen, MD, Hyung Joon Kim, MD, Aric Josun Hui, MD, Harry L A Janssen, MD, Prof Abhijit Chowdhury, MD, Tak Yin Owen Tsang, MD, Rajiv Mehta, MD, Edward Gane, MD, John F Flaherty, PharmD, Benedetta Massetto, MD, Anuj Gaggar, MD, Kathryn M Kitrinos, PhD, Lanjia Lin, PhD, G Mani Subramanian, MD, John G McHutchison, MD, Prof Young-Suk Lim, MD, Prof Subrat K Acharya, MD, Kosh Agarwal, MD The Lancet Gastroenterology & Hepatology Volume 1, Issue 3, Pages (November 2016) DOI: /S (16) Copyright © 2016 Elsevier Ltd Terms and Conditions
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Figure 1 Trial profile *The most common reasons for not meeting screening criteria were hepatitis B e antigen status, and HBV DNA or alanine aminotransferase concentrations. The Lancet Gastroenterology & Hepatology 2016 1, DOI: ( /S (16) ) Copyright © 2016 Elsevier Ltd Terms and Conditions
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Figure 2 Viral suppression and alanine aminotransferase (ALT) normalisation by visit week (A) Proportion of patients with HBV DNA less than 29 IU/mL by study visit. Bars are 95% CI. (B) Proportion of patients achieving ALT normalisation by central laboratory (Covance Laboratories) criteria (≤43 U/L for men and ≤34 U/L for women <69 years of age; ≤35 U/L for men and ≤32 U/L for women >69 years of age) by study visit. (C) Proportion of patients achieving ALT normalisation by American Association for the Study of Liver Diseases criteria (≤19 U/L for women and ≤30 U/L for men) by study visit. The Lancet Gastroenterology & Hepatology 2016 1, DOI: ( /S (16) ) Copyright © 2016 Elsevier Ltd Terms and Conditions
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Figure 3 Changes in bone mineral density
(A) Mean percentage change in hip bone mineral density at weeks 24 and 48 of treatment. Bars are 95% CI. (B) Mean percentage change in spine bone mineral density at weeks 24 and 48 of treatment. Bars are 95% CI. The Lancet Gastroenterology & Hepatology 2016 1, DOI: ( /S (16) ) Copyright © 2016 Elsevier Ltd Terms and Conditions
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Figure 4 Change in serum creatinine, by treatment group
Mean change from baseline in serum creatinine (mg/dL) by study visit. Bars are 95% CI. The Lancet Gastroenterology & Hepatology 2016 1, DOI: ( /S (16) ) Copyright © 2016 Elsevier Ltd Terms and Conditions
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