title: Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings.
abstract: OBJECTIVE
  Chronic hepatitis B (CHB) disproportionately affects the Asian-American population in the USA. Tenofovir disoproxil fumarate (TDF) has demonstrated potent antiviral activity in clinical trials, but data in Asian-Americans from community studies are lacking.
  
  
  METHODS
  Adult Asian-American patients with CHB from private medical and community-based practices were prospectively enrolled and treated with open-label TDF 300 mg once daily in a single-arm study for 48 weeks. After Week 48, patients had the option to transition to commercially available CHB therapy. The primary efficacy endpoint was hepatitis B virus (HBV) DNA <400 copies/mL at Week 48. Secondary endpoints were safety and tolerability, serologic and biochemical responses, liver fibrosis by FibroTest, and the development of drug-resistant mutations.
  
  
  RESULTS
  Of the 90 patients enrolled, 53 (58%) were hepatitis B e antigen (HBeAg)-positive at baseline. At Week 48, 74 patients (82% overall; 70% HBeAg-positive and 100% HBeAg-negative) had HBV DNA <400 copies/mL. Six (12%) HBeAg-positive patients achieved HBeAg loss/seroconversion. The percentage of patients with alanine aminotransferase in the normal range increased from 26% at baseline to 66% at Week 48. The percentage of patients with F0 (no or minimal) fibrosis by FibroTest increased from 48% to 51%, and those with F4 (severe) fibrosis decreased from 4% to 1%. No resistance to TDF developed. Treatment was well tolerated. Most adverse events were mild in severity and considered unrelated to study drug.
  
  
  CONCLUSIONS
  TDF is effective and well tolerated in Asian-American CHB patients in community clinic-based settings, consistent with larger registration trials. Improvement in liver fibrosis was seen in a proportion of patients. No resistance to TDF developed through 48 weeks of treatment.
  
  
  BACKGROUND
  Clinicaltrial.gov identifier NCT00736190.
authors.affiliation: Division of Gastroenterology, Department of Medicine, New York University Langone Medical Center, New York University School of Medicine, New York, United States of America.
authors.forename: Calvin Q
authors.initials: CQ
authors.lastname: Pan
authors.affiliation: San Jose Gastroenterology, San Jose, California, United States of America.
authors.forename: Huy
authors.initials: H
authors.lastname: Trinh
authors.affiliation: AE & LY Medical Associates, Flushing, New York, United States of America.
authors.forename: Alan
authors.initials: A
authors.lastname: Yao
authors.affiliation: Asian Pacific Liver Center, St. Vincent Medical Center, Los Angeles, California, United States of America.
authors.forename: Ho
authors.initials: H
authors.lastname: Bae
authors.affiliation: Nexus Development, Palo Alto, California, United States of America.
authors.forename: Lillian
authors.initials: L
authors.lastname: Lou
authors.affiliation: Sing Chan Endoscopy, Flushing, New York, United States of America.
authors.forename: Sing
authors.initials: S
authors.lastname: Chan
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D001213:Asian; D003404:Creatinine / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000009:adverse effects* / Q000627:therapeutic use*; D012111:Residence Characteristics; D000068698:Tenofovir; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D063065:Organophosphonates; D000068698:Tenofovir; D003404:Creatinine; D000225:Adenine