Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue

Summary

The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue. In efficacy, the non-inferiority of GSK548470 to ETV will be verified using the antiviral effect as the index.

Timeline

Start

2011-11

Primary completion

2013-01

Completion

2014-11

Outcome

Met primary endpoint

registry analysis (non-inferiority or equivalence test); TDF 300 mg OD vs ETV 0.5 mg OD; p <0.0001 NCT01480284 ↗

paper indicating the non-inferiority of TDF to ETV (P < 0.0001). PMID 28374496 ↗

Publications

• Koike K, Suyama K, Ito H, Itoh H, Sugiura W. Randomized prospective study showing the non-inferiority of tenofovir to entecavir in treatment-naive chronic hepatitis B patients. Hepatol Res. 2018 Jan;48(1):59-68. doi: 10.1111/hepr.12902. Epub 2017 May 24.

Drugs

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

Indications