Entecavir Plus Tenofovir Combination Therapy Versus Entecavir Monotherapy in Naive Subjects With Chronic Hepatitis B

Summary

The purpose of this study is to compare the effectiveness of entecavir plus tenofovir combination therapy with that of entecavir monotherapy. Safety will also be studied.

Timeline

Start

2007-04

Primary completion

2010-10

Completion

2010-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); ETV 0.5 mg vs ETV 0.5 mg +TDF 300 mg; p = 0.0882; Mean Difference (Final Values) 6.9 (95% CI -1.0 to 14.9); Cochran-Mantel-Haenszel NCT00410072 ↗

paper 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 <50 IU/mL (83.2% vs 76.4%; P = .088). PMID 22643350 ↗

release “results from a Phase IIIb study comparing BARACLUDE ® monotherapy versus BARACLUDE ® plus tenofovir in combination that showed no statistical difference between the study arms.” bms.com ↗

release “In this study, no statistically significant difference was observed between the two treatment arms in the primary efficacy endpoint of HBV DNA < 50 IU/mL” bms.com ↗

Publications

• Lok AS, Trinh H, Carosi G, Akarca US, Gadano A, Habersetzer F, Sievert W, Wong D, Lovegren M, Cohen D, Llamoso C. Efficacy of entecavir with or without tenofovir disoproxil fumarate for nucleos(t)ide-naive patients with chronic hepatitis B. Gastroenterology. 2012 Sep;143(3):619-628.e1. doi: 10.1053/j.gastro.2012.05.037. Epub 2012 May 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Entecavir	Small molecule	0.5 mg	Oral
Subject	Tenofovir disoproxil fumarate	Small molecule	300 mg	Oral

Indications