Tenofovir alafenamide versus tenofovir disoproxil fumarate for the treatment of patients with HBeAg-negative chronic hepatitis B virus infection: a randomised, double-blind, phase 3, non-inferiority trial  Prof Maria Buti, MD, Edward Gane, MD, Wai Kay Seto, MD, Prof Henry L Y Chan, MD, Prof Wan-Long Chuang, MD, Tatjana Stepanova, MD, Aric-Josun Hui, MD, Prof Young-Suk Lim, MD, Rajiv Mehta, MD, Harry L A Janssen, MD, Prof Subrat K Acharya, MD, John F Flaherty, PharmD, Benedetta Massetto, MD, Andrea L Cathcart, PhD, Kyungpil Kim, PhD, Anuj Gaggar, MD, G Mani Subramanian, MD, John G McHutchison, MD, Prof Calvin Q Pan, MD, Maurizia Brunetto, MD, Namiki Izumi, MD, Prof Patrick Marcellin, MD  The Lancet Gastroenterology & Hepatology  Volume 1, Issue 3, Pages 196-206 (November 2016) DOI: 10.1016/S2468-1253(16)30107-8 Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile The Lancet Gastroenterology & Hepatology 2016 1, 196-206DOI: (10.1016/S2468-1253(16)30107-8) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 2 Viral suppression and alanine aminotransferase (ALT) normalisation by study week (A) Proportion of patients with HBV DNA less than 29 IU/mL by study week. Bars are 95% CIs. (B) Proportion of patients achieving ALT normalisation by central laboratory (Covance) criteria by study week (≤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). (C) Proportion of patients achieving ALT normalisation by American Association for the Study of Liver Diseases (AASLD) criteria (≤19 U/L for women and ≤30 U/L for men) by study week. The Lancet Gastroenterology & Hepatology 2016 1, 196-206DOI: (10.1016/S2468-1253(16)30107-8) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 3 Changes in bone mineral density (A) Mean percentage change in hip bone mineral density at weeks 24 and 48 of treatment. (B) Mean percentage change in spine bone mineral density at weeks 24 and 48 of treatment. Bars are 95% CIs. The Lancet Gastroenterology & Hepatology 2016 1, 196-206DOI: (10.1016/S2468-1253(16)30107-8) Copyright © 2016 Elsevier Ltd Terms and Conditions

Figure 4 Mean change from baseline in serum creatinine (mg/dL) by study week Bars are 95% CIs. The Lancet Gastroenterology & Hepatology 2016 1, 196-206DOI: (10.1016/S2468-1253(16)30107-8) Copyright © 2016 Elsevier Ltd Terms and Conditions