Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

Condition(s) targeted: Hepatitis B, Chronic

Intervention: Entecavir (Drug); Lamivudine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Yonsei University

Official(s) and/or principal investigator(s):
Jeong Heo, M.D. Ph.D, Study Chair, Affiliation: Pusan National University School of Medicine
Sang Hoon Ahn, M.D.Ph.D, Study Director, Affiliation: Yonsei Univsersity College of Medicine
Do Young Kim, M.D, Study Director, Affiliation: Yonsei University College of Medicine
Jun Yong Park, M.D, Principal Investigator, Affiliation: Yonsei University College of Medicine

Overall contact:
Jeong Heo, M.D.Ph.D, Phone: +82-51-240-7869, Email: jheo@pusan.ac.kr

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0. 5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Official title: Randomized, Open-Labeled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B Who Achieved Undetectable HBV DNA

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

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

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

Detailed description: Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA < 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 status.

Exclusion Criteria:

- 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.

Jeong Heo, M.D.Ph.D, Phone: +82-51-240-7869, Email: jheo@pusan.ac.kr

Pusan National University School of Medicine, Busan 602-739, Korea, Republic of; Recruiting
Jeong Heo, M.D.Ph.D, Phone: +82-51-240-7869, Email: jheo@pusan.ac.kr
Jeong Heo, M.D.Ph.D, Principal Investigator

Severance Hospital, Seoul 120-752, Korea, Republic of; Recruiting
Sang Hoon Ahn, M.D.Ph.D, Phone: +82-11-419-8087, Email: ahnsh@yuhs.ac
Jun Yong Park, M.D, Phone: +82-10-8353-0670, Email: drpjy@yuhs.ac
Jun Yong Park, M.D, Principal Investigator

Starting date: February 2008
Ending date: November 2010
Last updated: September 17, 2008