Volume 66, Issue 1, Pages (January 2017)

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Volume 66, Issue 1, Pages 11-18 (January 2017) Tenofovir disoproxil fumarate (TDF) vs. emtricitabine (FTC)/TDF in lamivudine resistant hepatitis B: A 5-year randomised study Scott Fung, Peter Kwan, Milotka Fabri, Andrzej Horban, Mijomir Pelemis, Hie-Won Hann, Selim Gurel, Florin A. Caruntu, John F. Flaherty, Benedetta Massetto, Kyungpil Kim, Kathryn M. Kitrinos, G. Mani Subramanian, John G. McHutchison, Leland J. Yee, Magdy Elkhashab, Thomas Berg, Ioan Sporea, Cihan Yurdaydin, Petr Husa, Maciej S. Jablkowski, Edward Gane Journal of Hepatology Volume 66, Issue 1, Pages 11-18 (January 2017) DOI: 10.1016/j.jhep.2016.08.008 Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Fig. 1 CONSORT flow diagram. FTC, emtricitabine; TDF, tenofovir disoproxil fumarate. *Investigator’s discretion (n=6), withdrew consent (n=5), safety/tolerability/efficacy reasons (n=3), lost to follow-up (n=3), protocol violation (n=2), study discontinued at site (n=1). †Investigator’s discretion (n=5), withdrew consent (n=6), safety/tolerability/efficacy reasons (n=4), lost to follow-up (n=3), protocol violation (n=3). Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Fig. 2 Percentage of patients with HBV DNA<400copies/ml (69IU/ml) by visit. Full analysis set. Missing patients were classed as failures. Error bars represent 95% confidence intervals. FTC, emtricitabine; TDF, tenofovir disoproxil fumarate. Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Fig. 3 Sequence results for qualifying TDF and FTC/TDF patients. Patients who were viraemic at week 240 or their last study visit qualified for sequence analysis of pol/RT. FTC, emtricitabine; pol/RT, polymerase/reverse transcriptase; TDF, tenofovir disoproxil fumarate. Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Fig. 4 Mean viral load declines. Mean HBV DNA (log10cp/ml) in patients with and without entecavir (ETV) exposure (A), ETV resistance (B), or adefovir dipivoxil (ADV) exposure (C) up to week 240. ADV-E, adefovir exposure; ETV-E, entecavir exposure; ETV-R, entecavir resistance; FTC, emtricitabine; TDF, tenofovir disoproxil fumarate. Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions

Fig. 5 Mean percentage change in bone mineral density (BMD). Dual energy X-ray absorptiometry (DEXA) scans of the spine (A) and hip (B) were performed at baseline and then at regular intervals up to week 240. Error bars represent 95% confidence intervals (CIs). FTC, emtricitabine; TDF, tenofovir disoproxil fumarate. Journal of Hepatology 2017 66, 11-18DOI: (10.1016/j.jhep.2016.08.008) Copyright © 2016 European Association for the Study of the Liver Terms and Conditions