Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable 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):
Sang Hoon Ahn, M.D.Ph.D, Study Chair, 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
Jeong Heo, M.D.Ph.D, Study Director, Affiliation: Pusan National University School of Medicine

Overall contact:
Sang Hoon Ahn, M.D.Ph.D, Phone: +82-2-2228-1930, Email: ahnsh@yuhs.ac

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.

Official title: Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable 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 while on randomized therapy

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

Change from baseline in mean HBV DNA

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 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.

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 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.

Sang Hoon Ahn, M.D.Ph.D, Phone: +82-2-2228-1930, Email: ahnsh@yuhs.ac

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., Principal Investigator

Starting date: February 2008
Ending date: November 2010
Last updated: February 19, 2008