Randomized trial of lamivudine versus entecavir in entecavir-treated patients with undetectable hepatitis B virus DNA: Outcome at 2 Years

[Guest guest]

Hepatology. 2011 Apr;53(4):1148-53. doi: 10.1002/hep.24192.

Randomized trial of lamivudine versus entecavir in entecavir-treated patients

with undetectable hepatitis B virus DNA: Outcome at 2 Years.

Fung J, Lai CL, Yuen J, Cheng C, Wu R, Ka-Ho Wong D, Seto WK, Hung IF, Yuen MF.

Department of Medicine, University of Hong Kong.

Abstract

We aimed to determine the 2-year outcomes of entecavir followed by lamivudine in

patients with undetectable viral load (<12 IU/mL) and normal alanine

aminotransferase (ALT) after initial entecavir treatment for at least 6 months.

Patients were randomly assigned 1:1 to continue with entecavir or switch to

lamivudine. Liver biochemistry and hepatitis B virus (HBV) DNA were determined

at weeks 0, 4, 12, 24, 48, 72, and 96. Mutational analysis using line-probe

assay were performed at weeks 0, 24, 48, and 96 and at the time of HBV DNA

relapse. There was no elevation of ALT observed in any patients up to 96 weeks.

At 96 weeks of follow-up, 19/25 (76%) patients in the lamivudine arm had

persistently undetectable HBV DNA, compared with 25/25 (100%) patients in the

entecavir arm. Six patients in the lamivudine arm had HBV DNA >20 IU/mL,

occurring at a range of 12 to 96 weeks. Of these, four patients had HBV DNA of

less than 100 IU/mL during rebound (three had undetectable HBV DNA after

switching back to entecavir), and the remaining two patients had HBV DNA levels

of 7,973 and 699 IU/mL. Three patients (12%) had evidence of drug-resistant

mutations, of which two patients had rtM204I mutation and one patient had

rtM204V mutation. One of these three patients had previous lamivudine exposure

before entecavir treatment and one patient had questionable drug compliance.

Conclusion: Sequential therapy using entecavir followed by lamivudine resulted

in virological rebound in 24% of patients after 96 weeks. Prior optimal viral

suppression with entecavir did not confer any significant advantage in patients

who switched to lamivudine. (HEPATOLOGY 2011;).

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

PMID: 21480321 [PubMed - in process]

[Guest guest]

Hepatology. 2011 Apr;53(4):1148-53. doi: 10.1002/hep.24192.

Randomized trial of lamivudine versus entecavir in entecavir-treated patients

with undetectable hepatitis B virus DNA: Outcome at 2 Years.

Fung J, Lai CL, Yuen J, Cheng C, Wu R, Ka-Ho Wong D, Seto WK, Hung IF, Yuen MF.

Department of Medicine, University of Hong Kong.

Abstract

We aimed to determine the 2-year outcomes of entecavir followed by lamivudine in

patients with undetectable viral load (<12 IU/mL) and normal alanine

aminotransferase (ALT) after initial entecavir treatment for at least 6 months.

Patients were randomly assigned 1:1 to continue with entecavir or switch to

lamivudine. Liver biochemistry and hepatitis B virus (HBV) DNA were determined

at weeks 0, 4, 12, 24, 48, 72, and 96. Mutational analysis using line-probe

assay were performed at weeks 0, 24, 48, and 96 and at the time of HBV DNA

relapse. There was no elevation of ALT observed in any patients up to 96 weeks.

At 96 weeks of follow-up, 19/25 (76%) patients in the lamivudine arm had

persistently undetectable HBV DNA, compared with 25/25 (100%) patients in the

entecavir arm. Six patients in the lamivudine arm had HBV DNA >20 IU/mL,

occurring at a range of 12 to 96 weeks. Of these, four patients had HBV DNA of

less than 100 IU/mL during rebound (three had undetectable HBV DNA after

switching back to entecavir), and the remaining two patients had HBV DNA levels

of 7,973 and 699 IU/mL. Three patients (12%) had evidence of drug-resistant

mutations, of which two patients had rtM204I mutation and one patient had

rtM204V mutation. One of these three patients had previous lamivudine exposure

before entecavir treatment and one patient had questionable drug compliance.

Conclusion: Sequential therapy using entecavir followed by lamivudine resulted

in virological rebound in 24% of patients after 96 weeks. Prior optimal viral

suppression with entecavir did not confer any significant advantage in patients

who switched to lamivudine. (HEPATOLOGY 2011;).

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

PMID: 21480321 [PubMed - in process]