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Antimicrobial Agents and Chemotherapy, May 2006, p. 1642-1648, Vol. 50, No. 5
0066-4804/06/$08.00+0     doi:10.1128/AAC.50.5.1642-1648.2006
Copyright © 2006, American Society for Microbiology. All Rights Reserved.

Randomized, Double-Blind Study of Emtricitabine (FTC) plus Clevudine versus FTC Alone in Treatment of Chronic Hepatitis B

Seng Gee Lim,¹ Zahary Krastev,² Tay Meng Ng,³ Grigor Mechkov,^4, Iskren Andreev Kotzev,⁵ Sing Chan,⁶ Elsa Mondou,⁷ Andrea Snow,⁷ Jeff Sorbel,⁷ Franck Rousseau,^7* for the FTCB-204 Study Group

National University Hospital, Singapore,¹ University Hospital St. Ivan Rilsky, Sofia, Bulgaria,² Changi General Hospital, Singapore,³ Vth Polyprofile Hospital for Active Treatment, Sofia, Bulgaria,⁴ Multifunctional Active Treatment Hospital St. Marina, Varna, Bulgaria,⁵ New York Hospital at Queens, Flushing, New York,⁶ Gilead Sciences, Inc., Durham, North Carolina⁷

Received 29 November 2005/ Returned for modification 13 January 2006/ Accepted 15 February 2006

Emtricitabine (FTC) is approved for the treatment of human immunodeficiency virus. FTC and clevudine (CLV) have activity against hepatitis B virus (HBV). This report summarizes the results of a double-blind, multicenter study of patients with chronic hepatitis B who had completed a phase 3 study of FTC and were randomized 1:1 to 200 mg FTC once daily (QD) plus 10 mg CLV QD or 200 mg FTC QD plus placebo for 24 weeks with 24 weeks of follow-up. One hundred sixty-three patients were treated (82 with FTC plus CLV [FTC+CLV] and 81 with FTC); 72% were men, 53% were Asian, 47% were Caucasian, and 52% were hepatitis B e antigen positive, and the median baseline HBV DNA level was 6 log₁₀ copies/ml. After 24 weeks of treatment, 74% (FTC+CLV) versus 65% (FTC alone) had serum HBV DNA levels of <4,700 copies/ml (P = 0.114) (Digene HBV Hybrid Capture II assay). Twenty-four weeks posttreatment, the mean change in serum HBV DNA levels from baseline was –1.25 log₁₀ copies/ml (FTC+CLV), 40% had undetectable viremia (versus 23% for FTC alone), and 63% had normal alanine aminotransferase levels (versus 42% for FTC alone) (P 0.025 for all endpoints). The safety profile was similar between arms during treatment, with less posttreatment exacerbation of hepatitis B in the combination arm. In summary, after 24 weeks of treatment, no significant difference between arms was observed, but there was a significantly greater virologic and biochemical response 24 weeks posttreatment in the FTC+CLV arm.

Deceased.