Switching to Entecavir(ETV) plus Tenofovir Disoproxil Fumarate(TDF) combination will result
in faster and greater antiviral activity and lower rates of resistance emergence over
maintaining Lamivudine(LAM)/Telbivudine(LdT)+Adefovir(ADV) combination in partial responders
to LAM/LdT+ADV rescue therapy.
Earlier switching to combination with the most potent regimen will be more effective to
achieve virologic response(VR) and prevent further resistance emergence.
All subjects will orally take assigned drugs once daily for 48 weeks. All subjects will be
assessed at baseline and every three months thereafter. Evaluations at each visit will
include vital signs, physical examinations, laboratory tests, HBV DNA levels and adverse
events. At baseline and every six months thereafter, serum will be assayed for HBV serology.
Genotypic analysis will be performed at baseline and 48 weeks.
Phase:
Phase 4
Details
Lead Sponsor:
Yonsei University
Collaborators:
Bristol-Myers Squibb Chonbuk National University Hospital Hallym University Medical Center Kyungpook National University Kyungpook National University Hospital Pusan National University Hospital Seoul St. Mary's Hospital Soonchunhyang University Hospital The Catholic University of Korea