title: Tenofovir disoproxil fumarate in Asian or Pacific Islander chronic hepatitis B patients with high viral load (≥ 9 log10 copies/ml).
abstract: OBJECTIVE
  We evaluated the antiviral response of Asian or Pacific Islander (API) patients with chronic hepatitis B (CHB) who had baseline high viral load (HVL), defined as pre-treatment hepatitis B virus (HBV) DNA ≥9 log10 copies/ml, following up to 288 weeks of tenofovir disoproxil fumarate (TDF) treatment.
  
  
  METHODS
  A total of 205 HBeAg-negative and HBeAg-positive self-described API patients received 48 weeks of TDF 300 mg (HVL n = 18) or adefovir dipivoxil 10 mg (HVL n = 15) in a blinded fashion, followed by open-label TDF for an additional 240 weeks. The proportions of HVL vs. non-HVL patients with HBV DNA <400 copies/ml were compared. Mean declines in HBV DNA were evaluated in API vs. non-API patients.
  
  
  RESULTS
  Throughout the first 72 weeks of treatment, a smaller proportion of HVL API patients reached HBV DNA <400 copies/ml than non-HVL API patients. However, after this timepoint similar proportions of HVL and non-HVL API patients achieved HBV DNA <400 copies/ml (100% vs. 97%, respectively), which was maintained through week 288, where 92% of HVL patients and 99% of non-HVL API patients on treatment had HBV DNA <400 copies/ml. During the 288 weeks of treatment, API patients had similar mean HBV DNA declines as non-API patients, regardless of whether patients were HVL or non-HVL. No API HVL patient had persistent viremia at week 288. No resistance was detected among HVL or non-HVL patients.
  
  
  CONCLUSIONS
  API patients with HVL CHB achieve HBV DNA <400 copies/ml with long-term TDF treatment; however, achieving viral suppression may take longer for HVL patients relative to non-HVL API patients.
authors.affiliation: University of Toronto, Ontario, Canada.
authors.forename: Scott
authors.initials: S
authors.lastname: Fung
authors.forename: Stuart C
authors.initials: SC
authors.lastname: Gordon
authors.forename: Zahary
authors.initials: Z
authors.lastname: Krastev
authors.forename: Andrzej
authors.initials: A
authors.lastname: Horban
authors.forename: Jörg
authors.initials: J
authors.lastname: Petersen
authors.forename: Jan
authors.initials: J
authors.lastname: Sperl
authors.forename: Edward
authors.initials: E
authors.lastname: Gane
authors.forename: Ira M
authors.initials: IM
authors.lastname: Jacobson
authors.forename: Leland J
authors.initials: LJ
authors.lastname: Yee
authors.forename: Phillip
authors.initials: P
authors.lastname: Dinh
authors.forename: Eduardo B
authors.initials: EB
authors.lastname: Martins
authors.forename: John F
authors.initials: JF
authors.lastname: Flaherty
authors.forename: Kathryn M
authors.initials: KM
authors.lastname: Kitrinos
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Dusheiko
authors.forename: Huy
authors.initials: H
authors.lastname: Trinh
authors.forename: Robert
authors.initials: R
authors.lastname: Flisiak
authors.forename: Vinod K
authors.initials: VK
authors.lastname: Rustgi
authors.forename: Maria
authors.initials: M
authors.lastname: Buti
authors.forename: Patrick
authors.initials: P
authors.lastname: Marcellin
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D044466:Asian People; D024882:Drug Resistance, Viral / Q000502:physiology; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D044468:Native Hawaiian or Pacific Islander; D063065:Organophosphonates / Q000494:pharmacology / Q000627:therapeutic use*; D018709:Statistics, Nonparametric; D000068698:Tenofovir; D019562:Viral Load / Q000187:drug effects
chemical_list: D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine
keywords: Asian; hepatitis B; tenofovir disoproxil fumarate; viremia