TDF VS LAM + ADV in LAM + ADV Treated LAM-resistant CHB Patients With Undetectable Hepatitis B Virus DNA

Phase 4 Completed 171 enrolled Keimyung University Dongsan Medical Center Daegu Catholic University Medical Center · collab DongGuk University · collab Kyungpook National University Hospital · collab Pusan National University Hospital · collab Yeungnam University Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This study will provide a rationale for switch from lamivudine plus adefovir to tenofovir monotherapy in Lamivudine plus Adefovir Treated Lamivudine-resistant chronic hepatitis B patients with Undetectable Hepatitis B Virus DNA

Timeline

Start: 2012-11
Primary completion: 2016-03
Completion: 2016-04

Outcome

Met primary endpoint

paper CONCLUSIONS: Stable switching to TDF monotherapy yielded non-inferior results at 96 weeks compared to the results obtained with LAM+ADV combination therapy PMID 29329305 ↗

Publications

Lee HJ, Kim SJ, Kweon YO, Park SY, Heo J, Woo HY, Hwang JS, Chung WJ, Lee CH, Kim BS, Suh JI, Tak WY, Jang BK. Evaluating the efficacy of switching from lamivudine plus adefovir to tenofovir disoproxil fumarate monotherapy in lamivudine-resistant stable hepatitis B patients. PLoS One. 2018 Jan 12;13(1):e0190581. doi: 10.1371/journal.pone.0190581. eCollection 2018.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Adefovir	Unknown	10 mg	—
Comparator	Lamivudine	Other / unclassified	100 mg	—
Subject	Tenofovir	Small molecule	300 mg	—