Adding Adefovir Dipivoxil Versus Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B

Summary

Antiviral resistance mutations limit the efficacy of therapy for chronic hepatitis B. At year 2, resistance to adefovir may occur as high as 25% in patients with history of lamivudine resistance. Resistance to entecavir is reported to be 10% in lamivudine refractory patients during the same period. However, combination of lamivudine and adefovir decreased the adefovir resistance rate as low as 0% in the recent studies. By overcoming the antiviral resistance, the efficacy of therapy will be maximized. This study is intended to compare the efficacy of two strategies, combination of lamivudine and adefovir vs. entecavir monotherapy in patients with lamivudine resistance.

Conditions

• Chronic Hepatitis B

Interventions

DRUG

combination of lamivudine+adefovir vs entecavir

Lamivudine 100 mg/day, Adefovir 10 mg/day, Entecavir 0.5 mg/day

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Korea University

  lead OTHER

Principal Investigators

• Hyung Joon Yim, M.D. · Korea University

• Eileen Yoon · Korea University

• Yeon Seok Seo, M.D · Korea University

• Soon Ho Um, M.D · Korea University

• Chang Wook Kim, M.D · The Catholic University of Korea

• Chang Don Lee · The Catholic University of Korea

• Sang Hoon Park, M.D · Hallym University

• Myung Seok Lee, M.D · Hallym University

• Choong Kee Park, M.D · Hallym University

• Hee Bok Chae, M.D · Chungbuk National University

• Moon young Kim, M.D · Yonsei University

• Soon Koo Baik, M.D · Yonsei University

• Ju Hyun Kim, M.D · Gachon University Gil Medical Center

• Yun Soo Kim, M.D · Gachon University Gil Medical Center

• Jung Il Lee, M.D · Inha University

• Jin Woo Lee, M.D · Inha University

• Sun Pyo Hong, PhD · Genematrix Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-04-30

Primary Completion

2011-04-30

Completion

2012-10-31

Countries

• South Korea

Study Locations