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

Research output: Contribution to journalArticle

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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 Dec 1

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Lamivudine
Chronic Hepatitis B
Hepatitis B e Antigens
DNA
entecavir
Antiviral Agents

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology
  • Pharmacology (medical)
  • Infectious Diseases

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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. / 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.

In: Antiviral Therapy, Vol. 17, No. 8, 01.12.2012, p. 1563-1570.

Research output: Contribution to journalArticle

Heo, J, Park, JY, Lee, HJ, Tak, WY, Um, S-H, Kim, DY, Yoon, KT, Park, SY, Seo, YS, Han, KH, Cho, M & Ahn, SH 2012, 'A 96-week randomized trial of switching to entecavir in chronic hepatitis B patients with a partial virological response to lamivudine', Antiviral Therapy, vol. 17, no. 8, pp. 1563-1570. https://doi.org/10.3851/IMP2277
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. / A 96-week randomized trial of switching to entecavir in chronic hepatitis B patients with a partial virological response to lamivudine. In: Antiviral Therapy. 2012 ; Vol. 17, No. 8. pp. 1563-1570.
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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.",
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AU - Heo, Jeong

AU - Park, Jun Yong

AU - Lee, Heon Ju

AU - Tak, Won Young

AU - Um, Soon-Ho

AU - Kim, Do Young

AU - Yoon, Ki Tae

AU - Park, Soo Young

AU - Seo, Yeon Seok

AU - Han, Kwang Hyub

AU - Cho, Mong

AU - Ahn, Sang Hoon

PY - 2012/12/1

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N2 - 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.

AB - 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.

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