Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Entecavir; Drug: Lamivudine

• Registration Number: NCT00625560
• Lead Sponsor: Yonsei University

Brief Summary

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

Detailed Description

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-28
• Primary Completion: 2009-11
• Study Completion: 2010-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-07
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.

Exclusion Criteria

• All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
• Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
• Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
• Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
• Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Entecavir	entecavir 1.0 mg QD
B	Lamivudine	lamivudine 100 mg QD

Primary Outcome Measures

Name	Time	Method
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy	at Week 96

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mean HBV DNA	at Week 48 and 96
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion	at Week 48 and 96
Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy	at Week 48
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment	Follow up period
Percentage number of patients who developed drug resistant mutations while on randomized therapy	at Week 48 and Week 96

Trial Locations

Locations (2)

Pusan National University School of Medicine; 🇰🇷 Busan, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of