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

Yonsei University

Status and phase

Completed

Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: Entecavir

Drug: Lamivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT00625560

4-2007-0351

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.