Entecavir (Baraclude) Less Effective for Patients with Multidrug-Resistant Hepatitis B

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Entecavir (Baraclude) Less Effective for Patients with Multidrug-Resistant

Hepatitis B

Details Category: HBV Treatment Published on Tuesday, 04 October 2011 00:00

Written by Liz Highleyman . .

The nucleoside analog antiviral drug entecavir (Baraclude) was minimally

effective against hepatitis B virus (HBV) that had already developed resistance

to lamivudine (Epivir-HBV) and adefovir (Hepsera), researchers reported in the

October 2011 Journal of Viral Hepatitis. Patient who achieved good early

response, however, can do well if they stay on entecavir.

Korean researchers looked at the long-term outcome of switching to entecavir

for chronic hepatitis B patients who had developed multidrug resistance after

sequential therapy using lamivudine and adefovir.

The study included 33 patients with HBV infection who showed evidence of active

viral replication (HBV DNA > 105 copies/mL) or a history of treatment failure

with lamivudine/adefovir sequential therapy between April 2007 and July 2009.

Participants were treated with 1.0 mg/day entecavir for at least 48 weeks and

some for 96 weeks.

Results

66.7% of entecavir-treated patients experienced alanine aminotransferase (ALT)

normalization at 48 weeks.

24.2% achieved undetectable HBV DNA at 48 weeks.

Initial HBV viral load was the only factor significantly associated with

undetectable HBV DNA after 48 weeks on entecavir, with lower viral load

predicting better response.

At 96 weeks, 77.8% of participants experienced ALT normalization.

The proportion with undetectable viral load fell to 16.7% at 96 weeks.

21.2% of patients experienced viral breakthrough by week 48, rising to 78.9% by

week 96.

Participants who achieved HBV DNA < 4 log copies/mL at 48 weeks maintained

similar viral load and normal ALT through 96 weeks.

Based on these findings, the researchers concluded, " Entecavir monotherapy for

96 weeks was not efficacious for patients with lamivudine/adefovir-resistant

HBV. The initial HBV DNA level was the only predictive factor for antiviral

efficacy. "

However, they continued, " patients who achieved a HBV DNA level of < 4 log10

copies/mL with a normal ALT level at 48 weeks should maintain, rather than stop,

entecavir therapy. "

Investigator affiliations: Department of Internal Medicine, National Health

Insurance Corporation Ilsan Hospital; Department of Internal Medicine, Ilsan

Paik Hospital, Inje University College of Medicine, Goyang, Korea.

10/4/11

Reference

MS Kwak, JW Choi, JS Lee, et al. Long-term efficacy of entecavir therapy in

chronic hepatitis B patients with antiviral resistance to lamivudine and

adefovir. Journal of Viral Hepatitis 18(10): e432-e438 (abstract). October 2011.

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2893.2011.01461.x/abstract