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A 96-week randomized trial of switching to entecavir in chronic hepatitis B patients with a partial virological response to lamivudine

Authors
 Jeong Heo  ;  Jun Yong Park  ;  Heon Ju Lee  ;  Won Young Tak  ;  Soon Ho Um  ;  Do Young Kim  ;  Ki Tae Yoon  ;  Soo Young Park  ;  Yeon Seok Seo  ;  Kwang-Hyub Han  ;  Mong Cho  ;  Sang Hoon Ahn 
Citation
 ANTIVIRAL THERAPY, Vol.17(8) : 1563-1570, 2012 
Journal Title
 ANTIVIRAL THERAPY 
ISSN
 1359-6535 
Issue Date
2012
MeSH
Adult ; Aged ; Aged, 80 and over ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use* ; Drug Resistance, Viral ; Drug Substitution ; Female ; Guanine/administration & dosage ; Guanine/adverse effects ; Guanine/analogs & derivatives* ; Guanine/therapeutic use ; Hepatitis B, Chronic/drug therapy* ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Lamivudine/therapeutic use* ; Male ; Middle Aged ; Prognosis ; ROC Curve ; Treatment Outcome ; Viral Load ; Young Adult
Keywords
Adult ; Aged ; Aged, 80 and over ; Antiviral Agents/administration & dosage ; Antiviral Agents/adverse effects ; Antiviral Agents/therapeutic use* ; Drug Resistance, Viral ; Drug Substitution ; Female ; Guanine/administration & dosage ; Guanine/adverse effects ; Guanine/analogs & derivatives* ; Guanine/therapeutic use ; Hepatitis B, Chronic/drug therapy* ; Humans ; Lamivudine/administration & dosage ; Lamivudine/adverse effects ; Lamivudine/therapeutic use* ; Male ; Middle Aged ; Prognosis ; ROC Curve ; Treatment Outcome ; Viral Load ; Young Adult
Abstract
Background: Growing numbers of chronic hepatitis B (CHB) patients in the Asia-Pacific region have failed first-line therapy with low genetic barrier drugs. This prospective, 96-week study investigated the antiviral efficacy, safety and tolerability of switching to entecavir versus maintaining lamivudine in CHB patients with a partial virological response to lamivudine. Methods: A total of 72 hepatitis B e antigen (HBeAg)-positive patients, with serum HBV DNA≥60 IU/ml after ≥6 months lamivudine monotherapy were randomized 1:1 to receive either entecavir 1.0 mg/day, or continued lamivudine 100 mg/day. Results: Mean duration of prior lamivudine treatment was 15.1 months in the lamivudine-maintained patients and 16.1 months in the entecavir-switch patients, with mean baseline HBV DNA levels of 4.66 and 4.55 log10 IU/ml, respectively. A greater proportion of entecavir-switch than lamivudine-maintained patients achieved undetectable HBV DNA at all time points (67.6% versus 11.4% at week 96; P<0.001). Entecavir-switch patients achieved a greater mean decrease in HBV DNA level by week 4, maintained through week 96. Entecavir-switch patients with baseline HBV DNA<5 log10 IU/ml were more likely to achieve a virological response at week 96. A total of 6 (17.6%) entecavir-switch and 2 (5.7%) lamivudine-maintained patients achieved HBeAg loss, and 3 (8.8%) entecavir and 1 (2.9%) lamivudine patients achieved HBeAg seroconversion. Genotypic resistance to the assigned intervention emerged in 82.9% (29/35) of lamivudine-maintained patients, and in 3% (1/34) of entecavir-switch patients after 96 weeks. Conclusions: Switching to entecavir in patients with a partial virological response to lamivudine resulted in increased virological efficacy and lower rates of antiviral resistance than maintaining lamivudine.
Full Text
http://www.intmedpress.com/journals/avt/article.cfm?id=2277&pid=88&sType=AVT
DOI
22872647
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Do Young(김도영)
Park, Jun Yong(박준용) ORCID logo https://orcid.org/0000-0001-6324-2224
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/89585
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