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Efficacy and safety of entecavir versus tenofovir treatment in chronic hepatitis B patients: A randomized controlled trial.

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Sriprayoon T, Mahidol C, Ungtrakul T, Chun-On P, Soonklang K, Pongpun W, Laohapand C, Dechma J, Pothijaroen C, Auewarakul C, Tanwandee T,


Sriprayoon T, Mahidol C, Ungtrakul T, Chun-On P, Soonklang K, Pongpun W, Laohapand C, Dechma J, Pothijaroen C, Auewarakul C, Tanwandee T, (click to view)

Sriprayoon T, Mahidol C, Ungtrakul T, Chun-On P, Soonklang K, Pongpun W, Laohapand C, Dechma J, Pothijaroen C, Auewarakul C, Tanwandee T,

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Hepatology research : the official journal of the Japan Society of Hepatology 2016 5 13() doi 10.1111/hepr.12743

Abstract
AIM
Entecavir (ETV) and Tenofovir Disoproxil Fumarate (TDF) have been considered among the most potent antiviral agents for the treatment of chronic hepatitis B infection. We aimed to compare treatment efficacy and safety of ETV and TDF in nucleoside-naïve chronic hepatitis B patients.

METHODS
Inclusion criteria were compensated chronic hepatitis B patients who were either HBeAg positive or negative. Exclusion criteria were co-infection with HCV and/or HIV, concurrent malignancy, and decompensated cirrhosis. Virological, biochemical, and serological endpoints at week 96 and 144 were compared. Of 400 patients, 200 patients received ETV and 200 received TDF.

RESULTS
There were no significant differences between the two groups in baseline characteristics including age (41.6 ± 11.5 vs. 41.2 ± 11.6, mean baseline HBV DNA (5.91 ± 1.79 vs. 5.94 ± 1.68 log10 IU mL-1), mean baseline ALT (68.1 ± 64.1 vs. 76.8 ± 79.8 U L-1), and cirrhosis (15.5% vs. 14.5%). At week 144 of treatment, 91 and 94% of ETV and TDF group, respectively achieved undetectable HBV DNA. In HBeAg positive patients, HBeAg seroconversion could be achieved in 27.4% and 33.7% at week 144 for ETV and TDF group, respectively. qHBsAg dropped significantly over 144 weeks of treatment period but only 1.0 to 1.5% experience HBsAg loss. Safety profiles were consistent with previous reports of monotherapy.

CONCLUSION
ETV and TDF showed a potent antiviral activity against hepatitis B. Either ETV or TDF can be recommended as a treatment of choice for chronic hepatitis B patients. Both drugs were safe and well tolerate.

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