Long-term outcome and hepatocellular carcinoma development in chronic hepatitis B or cirrhosis patients after nucleoside analog treatment with entecavir or lamivudine

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http://onlinelibrary.wiley.com/doi/10.1111/j.1872-034X.2011.00785.x/abstract

Long-term outcome and hepatocellular carcinoma development in chronic hepatitis

B or cirrhosis patients after nucleoside analog treatment with entecavir or

lamivudine

Haruhiko Kobashi1,*, Yasuhiro Miyake1, Fusao Ikeda1, Tetsuya Yasunaka1, Ken

Nishino2, Akio Moriya2, Jyunichi Kubota3, Shinichiro Nakamura1, Akinobu Takaki1,

Kazuhiro Nouso1, Gotaro Yamada2, Kazuhide Yamamoto1Article first published

online: 21 MAR 2011

DOI: 10.1111/j.1872-034X.2011.00785.x

© 2011 The Japan Society of Hepatology

Issue

Hepatology Research

Volume 41, Issue 5, pages 405–416, May 2011

Abstract

Aim:  We conducted this prospective study to elucidate the long-term outcome

and incidence of hepatocellular carcinoma (HCC) development after nucleos(t)ide

analog (NA) treatment in patients with chronic hepatitis B (CHB) or cirrhosis.

Methods:  CHB or cirrhosis patients without past NA treatment or HCC were

started on entecavir (ETV) or lamivudine (LVD), and prospectively followed up

with monthly blood tests, and with abdominal imaging every 6 months in CHB and

every 3 months in cirrhosis patients.

Results:  A total of 256 subjects with CHB (n = 194) or cirrhosis (n = 62)

received ETV (n = 129) or LVD (n = 127) for 4.25 years (range: 0.41–10.0).

After NA treatment, serum HBV DNA, alanine aminotransferase and α-fetoprotein

(AFP) dropped significantly, along with significant increases in serum albumin

and prothrombin time. Drug-resistance developed in 60 cases in the LVD group and

in only one case in the ETV group. HCC developed in 35 patients, and the

incidence at years 1, 3, 5, 7 and 10 was significantly higher in patients with

cirrhosis (8.1%, 17.5%, 43.2%, 46.7% and 53.4%, respectively) than chronic

hepatitis (1.6%, 3.5%, 3.5%, 7.1% and 29.6%, respectively), with no difference

between ETV and LVD. After NA treatment, the sensitivity/specificity for HCC of

AFP and des-γ-carboxy prothrombin (DCP) was 45.7%/97.3% and 33.3%/96.2%,

respectively, with the specificity of AFP being higher than at baseline (64.4%),

at the cut-off of 10 ng/mL.

Conclusion:  NA exerted a long-term efficacy and improved hepatic reservation

in CHB and cirrhosis. After NA treatment, AFP dropped to lower than 10 ng/mL

with marked elevation of specificity, leading to an earlier detection of HCC.