Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B

Summary

The primary objectives of this study are to evaluate the safety and efficacy of GS-4774 in adults with chronic hepatitis B (CHB) viral infection who have been virally suppressed with an oral antiviral (OAV) medication.

Timeline

Start

2013-09-13

Primary completion

2014-09-09

Completion

2015-03-03

Outcome

Missed primary endpoint

paper There were no significant differences between groups in mean HBsAg declines from baseline to week 24 or 48. PMID 27210427 ↗

paper GS-4774 was well tolerated, but did not provide significant reductions in serum HBsAg in virally suppressed patients with chronic hepatitis B. PMID 27210427 ↗

Publications

• Lok AS, Pan CQ, Han SH, Trinh HN, Fessel WJ, Rodell T, Massetto B, Lin L, Gaggar A, Subramanian GM, McHutchison JG, Ferrari C, Lee H, Gordon SC, Gane EJ. Randomized phase II study of GS-4774 as a therapeutic vaccine in virally suppressed patients with chronic hepatitis B. J Hepatol. 2016 Sep;65(3):509-16. doi: 10.1016/j.jhep.2016.05.016. Epub 2016 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GS-4774	Vaccine	2 unknown	Subcutaneous
Subject	GS-4774	Vaccine	10 unknown	Subcutaneous
Subject	GS-4774	Vaccine	40 unknown	Subcutaneous
Background	Adefovir	Unknown	—	—
Background	Entecavir	Small molecule	—	—
Background	Lamivudine	Other / unclassified	—	—
Background	Telbivudine	Small molecule	—	—
Background	Tenofovir disoproxil fumarate	Small molecule	—	—

Indications