A 96-week randomized trial of switching to entecavir in chronic hepatitis B patients with a partial virological response to lamivudineopen access
- Authors
- Heo, Jeong; Park, Jun Yong; Lee, Heon Ju; Tak, Won Young; Um, Soon Ho; Kim, Do Young; Yoon, Ki Tae; Park, Soo Young; Seo, Yeon Seok; Han, Kwang-Hyub; Cho, Mong; Ahn, Sang Hoon
- Issue Date
- Aug-2012
- Publisher
- INT MEDICAL PRESS LTD
- Citation
- ANTIVIRAL THERAPY, v.17, no.8, pp 1563 - 1570
- Pages
- 8
- Indexed
- SCI
SCIE
SCOPUS
- Journal Title
- ANTIVIRAL THERAPY
- Volume
- 17
- Number
- 8
- Start Page
- 1563
- End Page
- 1570
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/30856
- DOI
- 10.3851/IMP2277
- ISSN
- 1359-6535
2040-2058
- 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 log(10) IU/ml, respectively. A greater proportion of entecavirswitch 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 log(10) 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.
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Collections - 2. Clinical Science > Department of Gastroenterology and Hepatology > 1. Journal Articles
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