Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B

Robert G. Gish, Anna S. Lok, Ting Tsung Chang, Robert A. de Man, Adrian Gadano, José Sollano, KwangHyub Han, You Chen Chao, Shou Dong Lee, Melissa Harris, Joanna Yang, Richard Colonno, Helena Brett-Smith

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Abstract

Background & Aims: Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks. Methods: 709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed. Results: Among patients treated in year 2, 74% of entecavir-treated versus 37% of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79% of entecavir-treated versus 68% of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11% vs 12%, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80% vs 39%; P < .0001) and ALT normalization (87% vs 79%; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups. Conclusions: Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.

Original languageEnglish
Pages (from-to)1437-1444
Number of pages8
JournalGastroenterology
Volume133
Issue number5
DOIs
Publication statusPublished - 2007 Jan 1

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Hepatitis B e Antigens
Chronic Hepatitis B
Lamivudine
Therapeutics
Alanine Transaminase
Hepatitis B virus
entecavir
DNA
Safety
Polymerase Chain Reaction
Nucleosides

All Science Journal Classification (ASJC) codes

  • Gastroenterology

Cite this

Gish, R. G., Lok, A. S., Chang, T. T., de Man, R. A., Gadano, A., Sollano, J., ... Brett-Smith, H. (2007). Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B. Gastroenterology, 133(5), 1437-1444. https://doi.org/10.1053/j.gastro.2007.08.025
Gish, Robert G. ; Lok, Anna S. ; Chang, Ting Tsung ; de Man, Robert A. ; Gadano, Adrian ; Sollano, José ; Han, KwangHyub ; Chao, You Chen ; Lee, Shou Dong ; Harris, Melissa ; Yang, Joanna ; Colonno, Richard ; Brett-Smith, Helena. / Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B. In: Gastroenterology. 2007 ; Vol. 133, No. 5. pp. 1437-1444.
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abstract = "Background & Aims: Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks. Methods: 709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed. Results: Among patients treated in year 2, 74{\%} of entecavir-treated versus 37{\%} of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79{\%} of entecavir-treated versus 68{\%} of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11{\%} vs 12{\%}, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80{\%} vs 39{\%}; P < .0001) and ALT normalization (87{\%} vs 79{\%}; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31{\%} of entecavir-treated versus 25{\%} of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups. Conclusions: Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.",
author = "Gish, {Robert G.} and Lok, {Anna S.} and Chang, {Ting Tsung} and {de Man}, {Robert A.} and Adrian Gadano and Jos{\'e} Sollano and KwangHyub Han and Chao, {You Chen} and Lee, {Shou Dong} and Melissa Harris and Joanna Yang and Richard Colonno and Helena Brett-Smith",
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Gish, RG, Lok, AS, Chang, TT, de Man, RA, Gadano, A, Sollano, J, Han, K, Chao, YC, Lee, SD, Harris, M, Yang, J, Colonno, R & Brett-Smith, H 2007, 'Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B', Gastroenterology, vol. 133, no. 5, pp. 1437-1444. https://doi.org/10.1053/j.gastro.2007.08.025

Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B. / Gish, Robert G.; Lok, Anna S.; Chang, Ting Tsung; de Man, Robert A.; Gadano, Adrian; Sollano, José; Han, KwangHyub; Chao, You Chen; Lee, Shou Dong; Harris, Melissa; Yang, Joanna; Colonno, Richard; Brett-Smith, Helena.

In: Gastroenterology, Vol. 133, No. 5, 01.01.2007, p. 1437-1444.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Entecavir Therapy for up to 96 Weeks in Patients With HBeAg-Positive Chronic Hepatitis B

AU - Gish, Robert G.

AU - Lok, Anna S.

AU - Chang, Ting Tsung

AU - de Man, Robert A.

AU - Gadano, Adrian

AU - Sollano, José

AU - Han, KwangHyub

AU - Chao, You Chen

AU - Lee, Shou Dong

AU - Harris, Melissa

AU - Yang, Joanna

AU - Colonno, Richard

AU - Brett-Smith, Helena

PY - 2007/1/1

Y1 - 2007/1/1

N2 - Background & Aims: Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks. Methods: 709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed. Results: Among patients treated in year 2, 74% of entecavir-treated versus 37% of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79% of entecavir-treated versus 68% of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11% vs 12%, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80% vs 39%; P < .0001) and ALT normalization (87% vs 79%; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups. Conclusions: Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.

AB - Background & Aims: Entecavir demonstrated superior benefit to lamivudine at 48 weeks in nucleoside-naive patients with hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB). We evaluated continued entecavir and lamivudine treatment through 96 weeks. Methods: 709 HBeAg-positive CHB patients were randomized to entecavir 0.5 mg (n = 354) or lamivudine 100 mg (n = 355) once daily. At week 52, protocol-defined virologic responders could continue blinded treatment for up to 96 weeks. Patients continuing in year 2 (entecavir, n = 243; lamivudine, n = 164) were assessed for serum hepatitis B virus (HBV) DNA, alanine aminotransferase (ALT) normalization, HBeAg seroconversion, and safety. Cumulative confirmed proportions of all treated patients who achieved these responses were also analyzed. Results: Among patients treated in year 2, 74% of entecavir-treated versus 37% of lamivudine-treated patients achieved HBV DNA <300 copies/mL by polymerase chain reaction (PCR), and 79% of entecavir-treated versus 68% of lamivudine-treated patients normalized ALT levels. Similar proportions of entecavir-treated and lamivudine-treated patients achieved HBeAg seroconversion (11% vs 12%, respectively). Higher proportions of entecavir-treated than lamivudine-treated patients achieved cumulative confirmed HBV DNA <300 copies/mL by PCR (80% vs 39%; P < .0001) and ALT normalization (87% vs 79%; P = .0056) through 96 weeks. Cumulative confirmed HBeAg seroconversion occurred in 31% of entecavir-treated versus 25% of lamivudine-treated patients (P = NS). Through 96 weeks, no patient experienced virologic breakthrough due to entecavir resistance. The safety profile was comparable in both groups. Conclusions: Entecavir treatment through 96 weeks results in continued benefit for patients with HBeAg-positive CHB.

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