Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the majority of naive patients with a partial virological response

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Hepatology. 2011 May 11. doi: 10.1002/hep.24406. [Epub ahead of print]

Entecavir treatment for chronic hepatitis B: Adaptation is not needed for the

majority of naïve patients with a partial virological response.

Zoutendijk R, Reijnders JG, Brown A, Zoulim F, Mutimer D, Deterding K, sen

J, Hofmann WP, Buti M, Santantonio T, van Bömmel F, Pradat P, Oo Y,

Luetgehetmann M, Berg T, Hansen BE, Wedemeyer H, Janssen HL; for the VIRGIL

Surveillance Study Group.

Source

Department of Gastroenterology and Hepatology, Erasmus MC University Medical

Center Rotterdam, Rotterdam, the Netherlands.

Abstract

Entecavir (ETV) is a potent inhibitor of viral replication in nucleos(t)ide

analogue (NA)-naïve chronic hepatitis B (CHB) patients. The aim of this study

was to investigate the long term efficacy and safety of ETV in NA-naïve CHB

patients, particularly in those with detectable HBV DNA after 48 weeks, in whom

treatment adaptation is suggested by current guidelines. In a multi-center

cohort study we investigated 333 CHB patients treated with entecavir

monotherapy. The NA-naïve population consisted of 243 patients, while 90 were

NA-experienced. Virological response (VR, HBV DNA <80 IU/mL) was achieved in

48%, 76% and 90% of HBeAg-positive and in 89%, 98% and 99% of HBeAg-negative

NA-naïve patients at week 48, 96 and 144, respectively. Thirty-six of 175 (21%)

NA-naïve patients with at least 48 weeks follow-up had a detectable load at week

48 (partial virological response, PVR). Twenty-nine (81%) patients with PVR

reached VR during prolonged ETV monotherapy and none of them developed

ETV-resistance. Among 22 patients with HBV DNA <1000 IU/mL at week 48, VR was

achieved in 21 (95%) patients, compared to eight (57%) of 14 patients with HBV

DNA <1000 IU/mL. Continuous HBV DNA decline was observed in most patients

without VR during follow-up and in three patients adherence was suboptimal

according to the treating physician. ETV was safe and did not affect renal

function or cause lactic acidosis. Conclusion: ETV monotherapy can be continued

in NA-naïve patients with a detectable HBV DNA at week 48, particularly in those

with a low viral load at week 48, as long-term ETV leads to a virological

response in the vast majority of patients.

(HEPATOLOGY 2011.).

Copyright © 2011 American Association for the Study of Liver Diseases.

PMID: 21563196 [PubMed - as supplied by publisher]