Extended treatment with lamivudine and adefovir dipivoxil in chronic hepatitis B patients with lamivudine resistance

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http://www.springerlink.com/content/84l5321435qj63v0/

Hepatology International

DOI: 10.1007/s12072-010-9228-9 Online Firstâ„¢

Original Article

Extended treatment with lamivudine and adefovir dipivoxil in chronic hepatitis B

patients with lamivudine resistance

P. Perrillo, Hie-Won Hann, Eugene Schiff, Mutimer, Bernard Willems,

Leung, M. Lee, Dixon, Woessner and Carol L. Brosgart,

et al.

Abstract

Purpose

We and others have reported that adding adefovir dipivoxil (adefovir) to

lamivudine results in virological and biochemical improvement in cases of

lamivudine resistance. The current study assessed the efficacy and safety of

combined therapy after 104 weeks of combined treatment and analyzed the

frequency of persistent lamivudine resistant HBV.

Methods

A total of 78 patients with compensated CHB (Group A) were maintained on either

adefovir 10 mg daily (n = 38) or placebo (n = 40) while continuing lamivudine.

An additional 38 patients with decompensated cirrhosis or post liver

transplantation (Group received lamivudine plus adefovir. The primary

endpoint was HBV DNA response at year 2.

Results

At week 104 of therapy, a significantly greater proportion of patients in Group

A on combination therapy (76%) had a decline in serum HBV DNA to ≤105 copies

or >2 log10 reduction from baseline compared to those receiving lamivudine alone

(13%; p < 0.001). Fifty-two percent of Group A patients on combination treatment

continued to have the M204V/I HBV mutation compared to 92% receiving lamivudine

alone (p = 0.0013). Virologic response occurred less frequently in patients

expressing persistent lamivudine resistant HBV. In Group B, 87% of patients had

HBV DNA response at week 104 (median change from baseline of −5.84 log10

copies/mL).

Conclusions

The combination of lamivudine and adefovir for 2 years generally proved

effective in lamivudine-resistant cases, but there was a persistently high rate

of detection of lamivudine resistant mutants and impaired virologic response in

compensated patients.

[Guest guest]

http://www.springerlink.com/content/84l5321435qj63v0/

Hepatology International

DOI: 10.1007/s12072-010-9228-9 Online Firstâ„¢

Original Article

Extended treatment with lamivudine and adefovir dipivoxil in chronic hepatitis B

patients with lamivudine resistance

P. Perrillo, Hie-Won Hann, Eugene Schiff, Mutimer, Bernard Willems,

Leung, M. Lee, Dixon, Woessner and Carol L. Brosgart,

et al.

Abstract

Purpose

We and others have reported that adding adefovir dipivoxil (adefovir) to

lamivudine results in virological and biochemical improvement in cases of

lamivudine resistance. The current study assessed the efficacy and safety of

combined therapy after 104 weeks of combined treatment and analyzed the

frequency of persistent lamivudine resistant HBV.

Methods

A total of 78 patients with compensated CHB (Group A) were maintained on either

adefovir 10 mg daily (n = 38) or placebo (n = 40) while continuing lamivudine.

An additional 38 patients with decompensated cirrhosis or post liver

transplantation (Group received lamivudine plus adefovir. The primary

endpoint was HBV DNA response at year 2.

Results

At week 104 of therapy, a significantly greater proportion of patients in Group

A on combination therapy (76%) had a decline in serum HBV DNA to ≤105 copies

or >2 log10 reduction from baseline compared to those receiving lamivudine alone

(13%; p < 0.001). Fifty-two percent of Group A patients on combination treatment

continued to have the M204V/I HBV mutation compared to 92% receiving lamivudine

alone (p = 0.0013). Virologic response occurred less frequently in patients

expressing persistent lamivudine resistant HBV. In Group B, 87% of patients had

HBV DNA response at week 104 (median change from baseline of −5.84 log10

copies/mL).

Conclusions

The combination of lamivudine and adefovir for 2 years generally proved

effective in lamivudine-resistant cases, but there was a persistently high rate

of detection of lamivudine resistant mutants and impaired virologic response in

compensated patients.