title: Randomized, double-blind study of emtricitabine (FTC) plus clevudine versus FTC alone in treatment of chronic hepatitis B.
abstract: 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 log(10) 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 log(10) 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 < or = 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.
authors.affiliation: Gilead Sciences Inc., 4 University Place, 4611 University Drive, Durham, NC 27707, USA.
authors.forename: Seng Gee
authors.initials: SG
authors.lastname: Lim
authors.forename: Zahary
authors.initials: Z
authors.lastname: Krastev
authors.forename: Tay Meng
authors.initials: TM
authors.lastname: Ng
authors.forename: Grigor
authors.initials: G
authors.lastname: Mechkov
authors.forename: Iskren Andreev
authors.initials: IA
authors.lastname: Kotzev
authors.forename: Sing
authors.initials: S
authors.lastname: Chan
authors.forename: Elsa
authors.initials: E
authors.lastname: Mondou
authors.forename: Andrea
authors.initials: A
authors.lastname: Snow
authors.forename: Jeff
authors.initials: J
authors.lastname: Sorbel
authors.forename: Franck
authors.initials: F
authors.lastname: Rousseau
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D000681:Amylases / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001086:Arabinofuranosyluracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D001219:Aspartate Aminotransferases / Q000097:blood; D001639:Bicarbonates / Q000097:blood; D001663:Bilirubin / Q000097:blood; D001786:Blood Glucose / Q000032:analysis; D003402:Creatine Kinase / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004573:Electrolytes / Q000097:blood; D000068679:Emtricitabine; D005260:Female; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007770:L-Lactate Dehydrogenase / Q000097:blood; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic; D012709:Serum Albumin / Q000032:analysis
chemical_list: D000998:Antiviral Agents; D001639:Bicarbonates; D001786:Blood Glucose; D004279:DNA, Viral; D004573:Electrolytes; D006513:Hepatitis B e Antigens; D012709:Serum Albumin; D003841:Deoxycytidine; D001086:Arabinofuranosyluracil; D007770:L-Lactate Dehydrogenase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D003402:Creatine Kinase; D000469:Alkaline Phosphatase; D000681:Amylases; D000068679:Emtricitabine; C034935:clevudine; D001663:Bilirubin