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Efficacy and safety of entecavir versus tenofovir treatment in chronic hepatitis B patients: A randomized controlled trial
Author(s) -
Sriprayoon Tassanee,
Mahidol Chulabhorn,
Ungtrakul Teerapat,
Chunon Pattra,
Soonklang Kamonwan,
Pongpun Wanvisa,
Laohapand Charlie,
Dechma Jiraporn,
Pothijaroen Charinthip,
Auewarakul Chirayu,
Tanwandee Tawesak
Publication year - 2017
Publication title -
hepatology research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.123
H-Index - 75
eISSN - 1872-034X
pISSN - 1386-6346
DOI - 10.1111/hepr.12743
Subject(s) - entecavir , medicine , hbeag , gastroenterology , hepatitis b , hepatitis b virus , cirrhosis , serology , hbsag , immunology , virus , antibody , lamivudine
Aim Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are 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 hepatitis B e antigen (HBeAg)‐positive or HBeAg‐negative. Exclusion criteria were co‐infection with hepatitis C virus and/or HIV, concurrent malignancy, and decompensated cirrhosis. Virological, biochemical, and serological end‐points 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 hepatitis B virus DNA (5.91 ± 1.79 vs. 5.94 ± 1.68 log 10 IU/mL), mean baseline alanine aminotransferase (68.1 ± 64.1 vs. 76.8 ± 79.8 U/L), and cirrhosis (15.5% vs. 14.5%). At week 144 of treatment, 91 and 94% of the ETV and TDF groups, respectively, achieved undetectable hepatitis B virus DNA. In HBeAg‐positive patients, HBeAg seroconversion could be achieved in 27.4% and 33.7% at week 144 for ETV and TDF groups, respectively. Quantitative hepatitis B surface antigen dropped significantly over 144 weeks of treatment period but only 1.0 to 1.5% experienced hepatitis B surface antigen loss. Safety profiles were consistent with previous reports of monotherapy. Conclusion Both ETV and TDF showed potent antiviral activity against hepatitis B. Either ETV or TDF can be recommended as a treatment of choice for patients with chronic hepatitis B. Both drugs were safe and well tolerated.