Effects of adefovir dipivoxil therapy in Asian and Caucasian patients with chron

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Alimentary Pharmacology & Therapeutics (OnlineAccepted Articles).

doi:10.1111/j.1365-2036.2007.03506.x

Abstract

Effects of adefovir dipivoxil therapy in Asian and Caucasian patients with

chronic hepatitis B

SG LIM11National University Hospital, Singapore, P MARCELLIN22Hopital

Beaujon, Paris, France, N TASSOPOULOS33Dept. of Hepatology, Metropolitan

Hospital, Athens, Greece, S HADZIYANNIS44Henry Dunant Hospital, Liver

Research Unit, Greece, TT CHANG55National Cheng Kung University Hospital,

PRC, M TONG66Huntington Memorial Hospital, CA, USA, W SIEVERT77Monash

Medical Center, , Australia, P HU88Peking Union Medical College

Hospital, PRC, S ARTERBURN99Gilead Sciences, Inc, City, CA USA, & CL

BROSGART99Gilead Sciences, Inc, City, CA USA, ON BEHALF OF THE

INTERNATIONAL INVESTIGATOR GROUPS FOR STUDIES 437 AND 4381National

University Hospital, Singapore 2Hopital Beaujon, Paris, France 3Dept. of

Hepatology, Metropolitan Hospital, Athens, Greece 4Henry Dunant Hospital,

Liver Research Unit, Greece 5National Cheng Kung University Hospital, PRC

6Huntington Memorial Hospital, CA, USA 7Monash Medical Center, ,

Australia 8Peking Union Medical College Hospital, PRC 9Gilead Sciences, Inc,

City, CA USA

Corresponding author

Seng Gee Lim, M.D.

National University Hospital

Department of Medicine, Division of Gastroenterology

5 Lower Kent Ridge Road

Singapore 119074, SINGAPORE

Phone: 65.67.724369

Fax: 65.67.794112

e-mail: mdclimsg@...

Abstract Summary

Background

Two-thirds of the 350 million people infected with chronic hepatitis B virus

(CHB) live in the Asia-Pacific region.

Methods

The safety and efficacy of 10 mg of adefovir dipivoxil (ADV) was compared to

placebo in 501 Asian (n=259) or Caucasian (n=242) HBeAg+ and HBeAg- CHB

patients treated for 48 weeks in two randomized, double-blind,

placebo-controlled studies.

Findings

At week 48, histological improvement was observed in 60% and 56% of

Caucasian and Asian patients, respectively. Change in serum HBV DNA from

baseline to week 48 for the ADV-treated patients was -3.89 and -3.70 log10

copies per milliliter in Caucasian and Asian patients, respectively, while

34 percent of Caucasian patients and 39 percent of Asian patients had

undetectable serum HBV DNA (< 400 copies/mL) at week 48. The percentage of

patients achieving ALT normalization at week 48 was similar in both groups

(Caucasian 64 percent, Asian 63 percent). No patients developed resistance

through week 48. No differences in adverse events or grade 3 or 4 laboratory

abnormalities were observed between groups.

Interpretation

There were no significant differences in treatment response between Asians

and Caucasians. ADV was well tolerated and no resistance developed up to

week 48 in either racial group.

http://www.blackwell-synergy.com/doi/abs/10.1111/j.1365-2036.2007.03506.x

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