title: Tenofovir disoproxil fumarate vs adefovir dipivoxil in Chinese patients with chronic hepatitis B after 48 weeks: a randomized controlled trial.
abstract: Tenofovir disoproxil fumarate (TDF) has demonstrated long-term efficacy and a high barrier to resistance in multiple chronic hepatitis B (CHB) populations outside of China. This study aimed to evaluate the efficacy and safety of TDF compared with adefovir dipivoxil (ADV) in Chinese patients with CHB during 48 weeks of treatment (ClinicalTrial.gov number, NCT01300234). A Phase 3, multicentred, randomized, double-blind, controlled trial compared the efficacy and safety of TDF with ADV in Chinese patients with CHB. The primary endpoint was the proportion of patients with HBV DNA <400 copies/mL in each treatment group at Week 48, using an unpooled Z-test for superiority. Secondary endpoints included viral suppression, serologic response, histological improvement, normalization of alanine aminotransferase (ALT) levels and the emergence of resistance mutations. A total of 509 patients, 202 hepatitis B e antigen (HBeAg)-positive and 307 HBeAg-negative, with HBV DNA ≥10(5) copies/mL received either TDF 300 mg od or ADV 10 mg od. At Week 48, TDF demonstrated superior viral suppression compared with ADV in both HBeAg-positive (76.7% vs 18.2%, P < 0.0001) and HBeAg-negative (96.8% vs 71.2%, P < 0.0001) patients. The majority of patients in both treatment arms achieved ALT normalization (>85%). No resistance to TDF was observed. The frequency of adverse events was comparable between treatment arms (TDF 3.9% vs ADV 4.8%). In this double-blind, randomized, clinical trial, TDF demonstrated superiority over ADV with respect to viral suppression in Chinese patients with CHB at 48 weeks of treatment and without the development of resistance.
authors.affiliation: Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Guangzhou, China.
authors.forename: J L
authors.initials: JL
authors.lastname: Hou
authors.forename: Z L
authors.initials: ZL
authors.lastname: Gao
authors.forename: Q
authors.initials: Q
authors.lastname: Xie
authors.forename: J M
authors.initials: JM
authors.lastname: Zhang
authors.forename: J F
authors.initials: JF
authors.lastname: Sheng
authors.forename: J
authors.initials: J
authors.lastname: Cheng
authors.forename: C W
authors.initials: CW
authors.lastname: Chen
authors.forename: Q
authors.initials: Q
authors.lastname: Mao
authors.forename: W
authors.initials: W
authors.lastname: Zhao
authors.forename: H
authors.initials: H
authors.lastname: Ren
authors.forename: D M
authors.initials: DM
authors.lastname: Tan
authors.forename: J Q
authors.initials: JQ
authors.lastname: Niu
authors.forename: S J
authors.initials: SJ
authors.lastname: Chen
authors.forename: C
authors.initials: C
authors.lastname: Pan
authors.forename: H
authors.initials: H
authors.lastname: Tang
authors.forename: H
authors.initials: H
authors.lastname: Wang
authors.forename: Y M
authors.initials: YM
authors.lastname: Mao
authors.forename: J D
authors.initials: JD
authors.lastname: Jia
authors.forename: Q
authors.initials: Q
authors.lastname: Ning
authors.forename: M
authors.initials: M
authors.lastname: Xu
authors.forename: S M
authors.initials: SM
authors.lastname: Wu
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: X X
authors.initials: XX
authors.lastname: Zhang
authors.forename: Y
authors.initials: Y
authors.lastname: Ji
authors.forename: J
authors.initials: J
authors.lastname: Dong
authors.forename: J
authors.initials: J
authors.lastname: Li
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D002681:China; D004279:DNA, Viral / Q000097:blood; D004311:Double-Blind Method; D024882:Drug Resistance, Viral; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D000068698:Tenofovir; D016896:Treatment Outcome; D019562:Viral Load; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine; C106812:adefovir dipivoxil
keywords: antiviral therapy; chronic hepatitis B; efficacy; tenofovir disoproxil fumarate