Efficacy and safety of entecavir versus lamivudine over 5 years of treatment: A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B

Kwan Sik Lee, Young Oh Kweon, Soon-Ho Um, Byung Ho Kim, Young Suk Lim, Seung Woon Paik, Jeong Heo, Heon Ju Lee, Dong Joon Kim, Tae Hun Kim, Young Sok Lee, Kwan Soo Byun, Daeghon Kim, Myung Seok Lee, Kyungha Yu, Dong Jin Suh

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Abstract

BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.

Original languageEnglish
Pages (from-to)331-339
Number of pages9
JournalClinical and molecular hepatology
Volume23
Issue number4
DOIs
Publication statusPublished - 2017 Dec 1

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Lamivudine
Hepatitis B e Antigens
Chronic Hepatitis B
Randomized Controlled Trials
Safety
Therapeutics
entecavir
Hepatitis B virus
Antiviral Agents
Incidence

Keywords

  • Entecavir
  • Hepatitis B
  • Lamivudine
  • Long-term effects

ASJC Scopus subject areas

  • Hepatology
  • Molecular Biology

Cite this

Efficacy and safety of entecavir versus lamivudine over 5 years of treatment : A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B. / Lee, Kwan Sik; Kweon, Young Oh; Um, Soon-Ho; Kim, Byung Ho; Lim, Young Suk; Paik, Seung Woon; Heo, Jeong; Lee, Heon Ju; Kim, Dong Joon; Kim, Tae Hun; Lee, Young Sok; Byun, Kwan Soo; Kim, Daeghon; Lee, Myung Seok; Yu, Kyungha; Suh, Dong Jin.

In: Clinical and molecular hepatology, Vol. 23, No. 4, 01.12.2017, p. 331-339.

Research output: Contribution to journalArticle

Lee, Kwan Sik ; Kweon, Young Oh ; Um, Soon-Ho ; Kim, Byung Ho ; Lim, Young Suk ; Paik, Seung Woon ; Heo, Jeong ; Lee, Heon Ju ; Kim, Dong Joon ; Kim, Tae Hun ; Lee, Young Sok ; Byun, Kwan Soo ; Kim, Daeghon ; Lee, Myung Seok ; Yu, Kyungha ; Suh, Dong Jin. / Efficacy and safety of entecavir versus lamivudine over 5 years of treatment : A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B. In: Clinical and molecular hepatology. 2017 ; Vol. 23, No. 4. pp. 331-339.
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abstract = "BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9{\%} vs. 67.2{\%}, P=0.0006), week 96 (94.6{\%} vs. 48.4{\%}, P<0.0001), and week 240 (95.0{\%} vs. 47.6{\%}, P<0.0001). At week 96, ALT normalization was observed in 87.5{\%} and 51.6{\%} of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8{\%}) receiving ETV and 26 patients (42.6{\%}) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.",
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T1 - Efficacy and safety of entecavir versus lamivudine over 5 years of treatment

T2 - A randomized controlled trial in Korean patients with hepatitis B e antigen-negative chronic hepatitis B

AU - Lee, Kwan Sik

AU - Kweon, Young Oh

AU - Um, Soon-Ho

AU - Kim, Byung Ho

AU - Lim, Young Suk

AU - Paik, Seung Woon

AU - Heo, Jeong

AU - Lee, Heon Ju

AU - Kim, Dong Joon

AU - Kim, Tae Hun

AU - Lee, Young Sok

AU - Byun, Kwan Soo

AU - Kim, Daeghon

AU - Lee, Myung Seok

AU - Yu, Kyungha

AU - Suh, Dong Jin

PY - 2017/12/1

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N2 - BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.

AB - BACKGROUND/AIMS: Long-term data on antiviral therapy in Korean patients with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB) are limited. This study evaluated the efficacy and safety of entecavir (ETV) and lamivudine (LAM) over 240 weeks. METHODS: Treatment-naive patients with HBeAg-negative CHB were randomized to receive ETV 0.5 mg/day or LAM 100 mg/day during the 96 week double-blind phase, followed by open-label treatment through week 240. The primary endpoint was the proportion of patients with virologic response (VR; hepatitis B virus [HBV] DNA<300 copies/mL) at week 24. Secondary objectives included alanine aminotransferase (ALT) normalization and emergence of ETV resistance (week 96), VR and log reduction in HBV DNA levels (week 240), and safety evaluation. RESULTS: In total, 120 patients (>16 years old) were included (ETV, n=56; LAM, n=64). Baseline characteristics were comparable between the two groups. A significantly higher proportion of ETV-treated patients achieved VR compared to LAM at week 24 (92.9% vs. 67.2%, P=0.0006), week 96 (94.6% vs. 48.4%, P<0.0001), and week 240 (95.0% vs. 47.6%, P<0.0001). At week 96, ALT normalization was observed in 87.5% and 51.6% of ETV and LAM patients, respectively (P<0.0001). Virologic breakthrough occurred in one patient (1.8%) receiving ETV and 26 patients (42.6%) receiving LAM (P<0.0001) up to week 96. Emergence of resistance to ETV was not detected. The incidence of serious adverse events was low and unrelated to the study medications. CONCLUSIONS: Long-term ETV treatment was superior to LAM, with a significantly higher proportion of patients achieving VR. Both treatments were well tolerated.

KW - Entecavir

KW - Hepatitis B

KW - Lamivudine

KW - Long-term effects

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