title: Tenofovir in the treatment of naïve and refractory chronic Hepatitis B: A single center experience in Saudi Arabia.
abstract: OBJECTIVE
  Tenofovir disoproxil fumarate (TDF) is a nucleotide analog used in the treatment of chronic hepatitis B (CHB) infection. This study evaluated the efficacy of TDF in achieving undetectable HBV DNA after 48 weeks of treatment in a Saudi cohort of CHB patients.
  
  
  METHODS
  This retrospective study included patients treated at a tertiary care center in Saudi Arabia from January 2009 to December 2012. Of the 68 eligible patients, 51 were treatment naïve and 17 were treatment-refractory. Twenty-three patients tested positive for HBeAg. The remaining 45 patients were HBeAg-negative.
  
  
  RESULTS
  The mean HBV DNA viral load decreased from 95 million IU/mL at baseline to 263 IU/mL after 48 weeks of treatment (P < 0.001). Overall, 62% of patients achieved a complete virological response (CVR) and 37% a partial virological response (PVR). Respective CVR and PVR rates according to subgroup were: HBeAg-positive (21.7% and 78.3%) and HBeAg-negative (84.4% and 15.6%). At 48 weeks, HBV DNA was undetectable in 66.7% of treatment-naÏve and 53% of treatment-refractory patients (P = 0.3). Seroconversion occurred in 13 (57%) of HBeAg-positive patients. Two (3%) of the HBeAg-negative patients lost HBsAg at follow up. Mean alanine aminotransferase decreased significantly from 134 U/L before treatment to 37 U/L at 48 weeks (P < 0.001). Significant adverse events were not encountered during the study period.
  
  
  CONCLUSIONS
  Forty-eight weeks of treatment with TDF reduced HBV DNA to undetectable levels in more than half of our patients regardless of whether they were treatment-naïve or refractory. HBeAg-negative (vs positive) patients experienced a better response rate.
authors.affiliation: Department of Medicine, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia.
authors.forename: Fahad
authors.initials: F
authors.lastname: Alsohaibani
authors.forename: Noura
authors.initials: N
authors.lastname: Alturaif
authors.forename: Ahmed
authors.initials: A
authors.lastname: Abdulshakour
authors.forename: Saad
authors.initials: S
authors.lastname: Alghamdi
authors.forename: Alfadel
authors.initials: A
authors.lastname: Alshaibani
authors.forename: Hamad
authors.initials: H
authors.lastname: Alashgar
authors.forename: Khalid
authors.initials: K
authors.lastname: Alkahtani
authors.forename: Ingvar
authors.initials: I
authors.lastname: Kagevi
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000378:metabolism; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000378:metabolism; D006513:Hepatitis B e Antigens / Q000378:metabolism; D006515:Hepatitis B virus / Q000302:isolation & purification*; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000378:metabolism / Q000821:virology; D006801:Humans; D017674:Hypophosphatemia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012529:Saudi Arabia; D000068698:Tenofovir / Q000009:adverse effects / Q000627:therapeutic use*; D062606:Tertiary Care Centers; D016896:Treatment Outcome; D019562:Viral Load / Q000187:drug effects
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D006513:Hepatitis B e Antigens; D000068698:Tenofovir; D000410:Alanine Transaminase