Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B

Anna S Lok; Huy Trinh; Giampiero Carosi; Ulus Salih Akarca; Adrian Gadano; Francois Habersetzer; William Sievert; David Wong; Meghan Lovegren; David Cohen; Cyril Llamoso

doi:10.1053/j.gastro.2012.05.037

Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B

Anna S Lok, Huy Trinh, Giampiero Carosi, Ulus Salih Akarca, Adrian Gadano, Francois Habersetzer, William Sievert, David Wong, Meghan Lovegren, David Cohen, Cyril Llamoso

Medicine Monash Health

Research output: Contribution to journal › Article › Research › peer-review

137 Citations (Scopus)

Abstract

Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent antiviral agents that might have additive or synergistic antiviral activity in treatment of patients with chronic hepatitis B (CHB). We compared the efficacy and safety of ETV monotherapy with those of a combination of ETV and TDF. METHODS: We performed a randomized, open-label, multicenter, superiority study of 379 nucleos(t)ide-naive patients with hepatitis B e antigen (HBeAg)-positive (n = 264) or HBeAg-negative (n = 115) CHB. Subjects were given ETV 0.5 mg (n = 182) or a combination of ETV 0.5 mg and TDF 300 mg (n = 197) for 100 weeks. RESULTS: At week 96, comparable proportions of patients in each study arm achieved the primary end point of a level of hepatitis B virus (HBV) DNA /= 10(8) IU/mL (79 vs 62 ) and not in those with baseline levels of HBV DNA /= 10(8) IU/mL.

Original language	English
Pages (from-to)	619 - 628
Number of pages	10
Journal	Gastroenterology
Volume	143
Issue number	3 (Art. ID: e1)
DOIs	https://doi.org/10.1053/j.gastro.2012.05.037
Publication status	Published - 2012

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1053/j.gastro.2012.05.037

Cite this

Lok, A. S., Trinh, H., Carosi, G., Akarca, U. S., Gadano, A., Habersetzer, F., Sievert, W., Wong, D., Lovegren, M., Cohen, D., & Llamoso, C. (2012). Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology, 143(3 (Art. ID: e1)), 619 - 628. https://doi.org/10.1053/j.gastro.2012.05.037

@article{c23740acb5034520848ae944f226990f,

title = "Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B",

abstract = "Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent antiviral agents that might have additive or synergistic antiviral activity in treatment of patients with chronic hepatitis B (CHB). We compared the efficacy and safety of ETV monotherapy with those of a combination of ETV and TDF. METHODS: We performed a randomized, open-label, multicenter, superiority study of 379 nucleos(t)ide-naive patients with hepatitis B e antigen (HBeAg)-positive (n = 264) or HBeAg-negative (n = 115) CHB. Subjects were given ETV 0.5 mg (n = 182) or a combination of ETV 0.5 mg and TDF 300 mg (n = 197) for 100 weeks. RESULTS: At week 96, comparable proportions of patients in each study arm achieved the primary end point of a level of hepatitis B virus (HBV) DNA /= 10(8) IU/mL (79 vs 62 ) and not in those with baseline levels of HBV DNA /= 10(8) IU/mL.",

author = "Lok, {Anna S} and Huy Trinh and Giampiero Carosi and Akarca, {Ulus Salih} and Adrian Gadano and Francois Habersetzer and William Sievert and David Wong and Meghan Lovegren and David Cohen and Cyril Llamoso",

year = "2012",

doi = "10.1053/j.gastro.2012.05.037",

language = "English",

volume = "143",

pages = "619 -- 628",

journal = "Gastroenterology",

issn = "0016-5085",

publisher = "Elsevier",

number = "3 (Art. ID: e1)",

}

TY - JOUR

T1 - Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B

AU - Lok, Anna S

AU - Trinh, Huy

AU - Carosi, Giampiero

AU - Akarca, Ulus Salih

AU - Gadano, Adrian

AU - Habersetzer, Francois

AU - Sievert, William

AU - Wong, David

AU - Lovegren, Meghan

AU - Cohen, David

AU - Llamoso, Cyril

PY - 2012

Y1 - 2012

N2 - Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent antiviral agents that might have additive or synergistic antiviral activity in treatment of patients with chronic hepatitis B (CHB). We compared the efficacy and safety of ETV monotherapy with those of a combination of ETV and TDF. METHODS: We performed a randomized, open-label, multicenter, superiority study of 379 nucleos(t)ide-naive patients with hepatitis B e antigen (HBeAg)-positive (n = 264) or HBeAg-negative (n = 115) CHB. Subjects were given ETV 0.5 mg (n = 182) or a combination of ETV 0.5 mg and TDF 300 mg (n = 197) for 100 weeks. RESULTS: At week 96, comparable proportions of patients in each study arm achieved the primary end point of a level of hepatitis B virus (HBV) DNA /= 10(8) IU/mL (79 vs 62 ) and not in those with baseline levels of HBV DNA /= 10(8) IU/mL.

AB - Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are potent antiviral agents that might have additive or synergistic antiviral activity in treatment of patients with chronic hepatitis B (CHB). We compared the efficacy and safety of ETV monotherapy with those of a combination of ETV and TDF. METHODS: We performed a randomized, open-label, multicenter, superiority study of 379 nucleos(t)ide-naive patients with hepatitis B e antigen (HBeAg)-positive (n = 264) or HBeAg-negative (n = 115) CHB. Subjects were given ETV 0.5 mg (n = 182) or a combination of ETV 0.5 mg and TDF 300 mg (n = 197) for 100 weeks. RESULTS: At week 96, comparable proportions of patients in each study arm achieved the primary end point of a level of hepatitis B virus (HBV) DNA /= 10(8) IU/mL (79 vs 62 ) and not in those with baseline levels of HBV DNA /= 10(8) IU/mL.

UR - http://www.sciencedirect.com/science/article/pii/S0016508512008025

U2 - 10.1053/j.gastro.2012.05.037

DO - 10.1053/j.gastro.2012.05.037

M3 - Article

SN - 0016-5085

VL - 143

SP - 619

EP - 628

JO - Gastroenterology

JF - Gastroenterology

IS - 3 (Art. ID: e1)

ER -

Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B

Abstract

UN SDGs

Access to Document

Other files and links

Cite this