Original Article
Copyright ©2012 Baishideng Publishing Group Co., Limited. All rights reserved.
World J Gastroenterol. Nov 28, 2012; 18(44): 6437-6446
Published online Nov 28, 2012. doi: 10.3748/wjg.v18.i44.6437
Clonal evolution of hepatitis B virus polymerase gene mutations during lamivudine-adefovir combination treatment
Soon Young Ko, Byung Kook Kim, So Young Kwon, Kyun-Hwan Kim, Jeong Han Kim, Won Hyeok Choe, Chang Hong Lee
Soon Young Ko, Byung Kook Kim, So Young Kwon, Jeong Han Kim, Won Hyeok Choe, Chang Hong Lee, Department of Internal Medicine, Konkuk University School of Medicine, Seoul 143-729, South Korea
Kyun-Hwan Kim, Department of Pharmacology, Konkuk University School of Medicine, Seoul 143-729, South Korea
Author contributions: Ko SY and Kim BK contributed equally to the article; Kwon SY, Ko SY and Kim BK designed the research; Ko SY and Kim BK analyzed the data and wrote the paper; Ko SY, Kim BK, Kim KH, Kim JH, Choe WH and Lee CH performed the research.
Supported by A grant from the South Korea Heathcare Technology R and D Project, Ministry for Health, Welfare and Family Affairs, South Korea, No. A084826
Correspondence to: So Young Kwon, MD, Department of Internal Medicine, Konkuk University School of Medicine, 4-12 Hwayang-dong, Gwangjin-gu, Seoul 143-729, South Korea. sykwonmd@hotmail.com
Telephone: +82-2-20305010 Fax: +82-2-20305029
Received: June 12, 2012
Revised: August 23, 2012
Accepted: August 26, 2012
Published online: November 28, 2012
Abstract

AIM: To identify hepatitis B virus polymerase gene mutations during antiviral therapy using lamivudine-adefovir sequential monotherapy followed by lamivudine-adefovir combination therapy.

METHODS: The patient cohort included four adult chronic hepatitis B patients who had undergone sequential monotherapy, first with lamivudine (LMV) and then, after developing viral breakthrough, with adefovir (ADV) therapy. All of the patients had non-response or viral breakthrough after LMV-ADV sequential monotherapy, which resulted in the switching of their antiviral regimen to LMV-ADV combination therapy. Eleven serum samples from the four patients who showed non-response to rescue LMV-ADV combination therapy were collected sequentially at a time before the antiviral treatment and then during the LMV monotherapy, ADV monotherapy, and LMV-ADV combination therapy. For the genotypic analysis, the whole 1310-bp polymerase gene region was amplified, cloned and sequenced.

RESULTS: All patients had been previously treated with 100 mg of LMV once daily for a 15- to 26-mo period. The emergence of resistance mutations to LMV, such as rtM204V/I and/or rtL180M, were found in all patients. Their antiviral regimens were switched to ADV monotherapy as the second line treatment. All patients had viral breakthrough or non-response after the LMV-ADV sequential monotherapy. ADV-resistant mutations were detected after 13 to 19 mo of LMV-ADV sequential monotherapy. The rtA181V/T mutations were predominantly identified during the ADV treatment in the LMV-resistant patients. Twenty-seven of 38 clones were combined with an amino acid change at rt181; three clones had mutations in rt236 and one clone had a combined mutation. The rtA181V/T mutations were not suppressed by the LMV-ADV combination therapy. Thirty-nine of 64 clones showed an rtA181V/T mutation and six clones showed combined mutations in rt181 and rt236. Mutations in rt204 re-emerged during the combination treatment. The rt181 and rt204 mutations did not co-exist in one clone.

CONCLUSION: Add-on lamivudine therapy with adefovir for adefovir resistance may not suppress the pre-existing adefovir-resistant mutation that develops during lamivudine-adefovir sequential monotherapy.

Keywords: Hepatitis B virus; Lamivudine; Adefovir; Mutation; Drug resistance