Long-term adefovir dipivoxil monotherapy for up to 5 years in lamivudine-resistant chronic hepatitis B

Jung Min Lee, Jun Yong Park, Do Young Kim, Tin Nguyen, Sun Pyo Hong, Soo Ok Kim, Chae Yoon Chon, Kwang Hyub Han, Sang Hoon Ahn

Research output: Contribution to journalArticle

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Abstract

Background: Large clinical studies assessing long-term adefovir dipivoxil salvage monotherapy in patients with lamivudine-resistant chronic hepatitis B (CHB) are lacking, particularly In patients positive for hepatitis B e antigen (HBeAg). We assessed the efficacy and resistance profile of adefovir dipivoxil monotherapy for up to 5 years in a large cohort of Korean patients with lamivudine-resistant CHB. Methods: A total of 320 patients (81.3% HBeAg-positive; 100% genotype C) with confirmed genotypic lamivudine-reslstant CHB were switched to adefovir dipivoxil 10 mg once daily. Liver function tests and HBV DNA were monitored every 3 months. Genotypic resistance to adefovir dipivoxil was performed In patients with detectable HBV DNA. Results: The overall cumulative virological response rate at 5 years of adefovir dipivoxil therapy was 48.8%. The virological response rate was significantly higher in HBeAgnegative patients (62.0% versus 45.9%; P=0.010). Most cases of virological response (131/134, 97.8%) occurred within the first 36 months of therapy. The 5-year cumulative probability of genotypic resistance and virological breakthrough was 65.6% and 61.8%, respectively. Predictive factors for a virological response included baseline HBeAg seronegativity, HBV DNA≤8 log10 copies/ml and achievement of an on-treatment initial virological response. Conclusions: Adefovir dipivoxil salvage monotherapy for lamlvudine-reslstant CHB resulted in a modest cumulative virological response rate at 5 years, which was associated with progressive antiviral resistance. Consequently, adefovir monotherapy is not preferable as a first-line strategy for lamivudine resistance where combination lamivudlne plus adefovir dipivoxil therapy is available.

Original languageEnglish
Pages (from-to)235-241
Number of pages7
JournalAntiviral therapy
Volume15
Issue number2
DOIs
Publication statusPublished - 2010 Apr 16

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Lamivudine
Chronic Hepatitis B
Hepatitis B e Antigens
Liver Function Tests
DNA
Therapeutics
adefovir dipivoxil
Antiviral Agents
Genotype

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

Cite this

@article{27505ce6411044eda3c69795471bccd3,
title = "Long-term adefovir dipivoxil monotherapy for up to 5 years in lamivudine-resistant chronic hepatitis B",
abstract = "Background: Large clinical studies assessing long-term adefovir dipivoxil salvage monotherapy in patients with lamivudine-resistant chronic hepatitis B (CHB) are lacking, particularly In patients positive for hepatitis B e antigen (HBeAg). We assessed the efficacy and resistance profile of adefovir dipivoxil monotherapy for up to 5 years in a large cohort of Korean patients with lamivudine-resistant CHB. Methods: A total of 320 patients (81.3{\%} HBeAg-positive; 100{\%} genotype C) with confirmed genotypic lamivudine-reslstant CHB were switched to adefovir dipivoxil 10 mg once daily. Liver function tests and HBV DNA were monitored every 3 months. Genotypic resistance to adefovir dipivoxil was performed In patients with detectable HBV DNA. Results: The overall cumulative virological response rate at 5 years of adefovir dipivoxil therapy was 48.8{\%}. The virological response rate was significantly higher in HBeAgnegative patients (62.0{\%} versus 45.9{\%}; P=0.010). Most cases of virological response (131/134, 97.8{\%}) occurred within the first 36 months of therapy. The 5-year cumulative probability of genotypic resistance and virological breakthrough was 65.6{\%} and 61.8{\%}, respectively. Predictive factors for a virological response included baseline HBeAg seronegativity, HBV DNA≤8 log10 copies/ml and achievement of an on-treatment initial virological response. Conclusions: Adefovir dipivoxil salvage monotherapy for lamlvudine-reslstant CHB resulted in a modest cumulative virological response rate at 5 years, which was associated with progressive antiviral resistance. Consequently, adefovir monotherapy is not preferable as a first-line strategy for lamivudine resistance where combination lamivudlne plus adefovir dipivoxil therapy is available.",
author = "Lee, {Jung Min} and Park, {Jun Yong} and Kim, {Do Young} and Tin Nguyen and Hong, {Sun Pyo} and Kim, {Soo Ok} and Chon, {Chae Yoon} and Han, {Kwang Hyub} and Ahn, {Sang Hoon}",
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Long-term adefovir dipivoxil monotherapy for up to 5 years in lamivudine-resistant chronic hepatitis B. / Lee, Jung Min; Park, Jun Yong; Kim, Do Young; Nguyen, Tin; Hong, Sun Pyo; Kim, Soo Ok; Chon, Chae Yoon; Han, Kwang Hyub; Ahn, Sang Hoon.

In: Antiviral therapy, Vol. 15, No. 2, 16.04.2010, p. 235-241.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Long-term adefovir dipivoxil monotherapy for up to 5 years in lamivudine-resistant chronic hepatitis B

AU - Lee, Jung Min

AU - Park, Jun Yong

AU - Kim, Do Young

AU - Nguyen, Tin

AU - Hong, Sun Pyo

AU - Kim, Soo Ok

AU - Chon, Chae Yoon

AU - Han, Kwang Hyub

AU - Ahn, Sang Hoon

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N2 - Background: Large clinical studies assessing long-term adefovir dipivoxil salvage monotherapy in patients with lamivudine-resistant chronic hepatitis B (CHB) are lacking, particularly In patients positive for hepatitis B e antigen (HBeAg). We assessed the efficacy and resistance profile of adefovir dipivoxil monotherapy for up to 5 years in a large cohort of Korean patients with lamivudine-resistant CHB. Methods: A total of 320 patients (81.3% HBeAg-positive; 100% genotype C) with confirmed genotypic lamivudine-reslstant CHB were switched to adefovir dipivoxil 10 mg once daily. Liver function tests and HBV DNA were monitored every 3 months. Genotypic resistance to adefovir dipivoxil was performed In patients with detectable HBV DNA. Results: The overall cumulative virological response rate at 5 years of adefovir dipivoxil therapy was 48.8%. The virological response rate was significantly higher in HBeAgnegative patients (62.0% versus 45.9%; P=0.010). Most cases of virological response (131/134, 97.8%) occurred within the first 36 months of therapy. The 5-year cumulative probability of genotypic resistance and virological breakthrough was 65.6% and 61.8%, respectively. Predictive factors for a virological response included baseline HBeAg seronegativity, HBV DNA≤8 log10 copies/ml and achievement of an on-treatment initial virological response. Conclusions: Adefovir dipivoxil salvage monotherapy for lamlvudine-reslstant CHB resulted in a modest cumulative virological response rate at 5 years, which was associated with progressive antiviral resistance. Consequently, adefovir monotherapy is not preferable as a first-line strategy for lamivudine resistance where combination lamivudlne plus adefovir dipivoxil therapy is available.

AB - Background: Large clinical studies assessing long-term adefovir dipivoxil salvage monotherapy in patients with lamivudine-resistant chronic hepatitis B (CHB) are lacking, particularly In patients positive for hepatitis B e antigen (HBeAg). We assessed the efficacy and resistance profile of adefovir dipivoxil monotherapy for up to 5 years in a large cohort of Korean patients with lamivudine-resistant CHB. Methods: A total of 320 patients (81.3% HBeAg-positive; 100% genotype C) with confirmed genotypic lamivudine-reslstant CHB were switched to adefovir dipivoxil 10 mg once daily. Liver function tests and HBV DNA were monitored every 3 months. Genotypic resistance to adefovir dipivoxil was performed In patients with detectable HBV DNA. Results: The overall cumulative virological response rate at 5 years of adefovir dipivoxil therapy was 48.8%. The virological response rate was significantly higher in HBeAgnegative patients (62.0% versus 45.9%; P=0.010). Most cases of virological response (131/134, 97.8%) occurred within the first 36 months of therapy. The 5-year cumulative probability of genotypic resistance and virological breakthrough was 65.6% and 61.8%, respectively. Predictive factors for a virological response included baseline HBeAg seronegativity, HBV DNA≤8 log10 copies/ml and achievement of an on-treatment initial virological response. Conclusions: Adefovir dipivoxil salvage monotherapy for lamlvudine-reslstant CHB resulted in a modest cumulative virological response rate at 5 years, which was associated with progressive antiviral resistance. Consequently, adefovir monotherapy is not preferable as a first-line strategy for lamivudine resistance where combination lamivudlne plus adefovir dipivoxil therapy is available.

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