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

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

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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.

Original languageEnglish
Pages (from-to)1563-1570
Number of pages8
JournalAntiviral Therapy
Volume17
Issue number8
DOIs
Publication statusPublished - 2012

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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    Heo, J., Park, J. Y., Lee, H. J., Tak, W. Y., Um, S. H., Kim, D. Y., Yoon, K. T., Park, S. Y., Seo, Y. S., Han, K. H., Cho, M., & Ahn, S. H. (2012). A 96-week randomized trial of switching to entecavir in chronic hepatitis B patients with a partial virological response to lamivudine. Antiviral Therapy, 17(8), 1563-1570. https://doi.org/10.3851/IMP2277