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Entecavir safety and effectiveness in a national cohort of treatment‐naïve chronic hepatitis B patients in the US – the ENUMERATE study
Author(s) -
Ahn J.,
Lee H. M.,
Lim J. K.,
Pan C. Q.,
Nguyen M. H.,
Ray Kim W.,
Mannalithara A.,
Trinh H.,
Chu D.,
Tran T.,
Min A.,
Do S.,
Te H.,
Reddy K. R.,
Lok A. S.
Publication year - 2016
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13440
Subject(s) - medicine , entecavir , hbeag , hbsag , gastroenterology , adverse effect , seroconversion , hepatitis b virus , cohort , retrospective cohort study , decompensation , hepatitis b , immunology , virus , lamivudine
Summary Background Entecavir ( ETV ) has been shown to be safe and efficacious in randomised controlled trials in highly selected patients with hepatitis B virus ( HBV ) infection. Aim To determine the safety and effectiveness of ETV in ‘real‐world’ HBV patients in the United States ( US ). Methods Treatment‐naïve HBV patients ≥18 years old who received ETV for ≥12 months between 2005 and 2013 were included in a retrospective, cohort study. Rates of ALT normalisation, undetectable HBV DNA , HB eAg and HB sAg loss/seroconversion, adverse events ( AE ) and clinical outcomes were evaluated. Results Of 841 patients, 658 [65% male, 83% Asian; median age 47 years] met the inclusion criteria. 36% were HB eAg+ and 9.3% cirrhotic. 89% had abnormal ALT . Baseline median HBV DNA was 5.8 log 10 IU / mL . Median duration of ETV treatment was 4 years. Rates of ALT normalisation at 1, 3 and 5 years were 37.2%, 48.7% and 56.2% in HB eAg+ and 39.6%, 46.8% and 55.6% in HB eAg‐ patients. HBV DNA was undetectable at 1, 3 and 5 years in 34.6%, 64.7% and 84.6% in HB eAg+ patients, and 81.9%, 90.3% and 96.2% in HB eAg patients. Five‐year cumulative probability of HB eAg loss and seroconversion was 46% and 33.7% and HB sAg loss was 4.6%. ETV was discontinued due to adverse events in 1.2% of patients. Hepatic decompensation occurred in 0.8%, liver cancer in 2.7% and death in 0.6%. Conclusion Entecavir treatment was safe in a large cohort of US patients, but ALT normalisation and hepatitis B virus DNA suppression rates were lower than previously reported in clinical trials.