drugset / Trial / NCT01491295

Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients

NCT01491295

RandomizedParallel-groupOpen-labelTreatment

Summary

1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir 1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R) 2. Long-term adefovir add-on therapy was effective for viral suppression. However, the economic burden for such dual antiviral therapy is heavy because of infinite treatment. 3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients. 4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by LAM/ADV combination treatment in LAM-R CHB patients.

Timeline

Start
2012-09
Primary completion
2019-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adefovir Unknown 10 mg
Comparator Lamivudine Other / unclassified 100 mg
Subject Tenofovir disoproxil fumarate Small molecule 300 mg