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

Yonsei University72 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B, Chronic

Interventions

EntecavirDRUG

entecavir 1.0 mg QD

LamivudineDRUG

lamivudine 100 mg QD

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (2)

Pusan National University School of Medicine

Busan, Busan, South Korea

Severance Hospital

Seoul, Seoul, South Korea

Outcomes

Primary Outcomes

Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy

Time frame: at Week 96

Secondary Outcomes

Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy

Time frame: at Week 48

Percentage number of patients who developed drug resistant mutations while on randomized therapy

Time frame: at Week 48 and Week 96

Change from baseline in mean HBV DNA

Time frame: at Week 48 and 96

Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion

Time frame: at Week 48 and 96

Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment

Time frame: Follow up period

Data from ClinicalTrials.gov

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