title: Tenofovir therapy in hepatitis B virus-positive solid-organ transplant recipients.
abstract: BACKGROUND
  Tenofovir therapy has been found to be efficient in treating hepatitis B virus (HBV) in nontransplant patients. However, in the setting of solid-organ transplantation, the efficacy of tenofovir has not been tested. The aim of this pilot study was to assess the clinical and biologic response and tolerance to tenofovir therapy in HBV-positive organ transplant recipients.
  
  
  METHODS
  Seven patients, three kidney, three liver, and one cardiac transplant recipients, with chronic HBV infection were partial responders to adefovir (n=7), lamivudine (n=7), or entecavir (n=5) therapy. Consequently, they were placed on tenofovir therapy (245 mg daily, which was adapted to renal function) alone (n=4) or in combination with lamivudine (n=3). Tenofovir therapy was assessed at 1, 3, 6, and 12 months postinitiation or at the last follow-up.
  
  
  RESULTS
  HBV DNA viral load (4.16 [2.03-5.56] log10 copies/mL at baseline) became significantly decreased to 3.15 (1.08-5.17), 2.88 (1.3-4.3), 3.53 (1.3-5.75), 3.33 (1.3-7.57), and 2.31 (1.3-4.81) log copies/mL at 1, 3, 6, and 12 months posttenofovir initiation and at last follow-up, respectively (P=0.02). Three patients were HBV DNA negative at the last follow-up. Liver enzyme levels did not change significantly throughout the follow-up period. Clinical and biologic tolerance was excellent.
  
  
  CONCLUSIONS
  Even though HBV DNA clearance was not achieved in all patients, the results of this pilot study are encouraging and demonstrate that tenofovir therapy is safe and efficacious in treating HBV-positive organ transplant patients. However, a larger trial is needed to confirm these preliminary results.
authors.affiliation: Department of Nephrology, Dialysis and Organ Transplantation, Toulouse University Hospital, Toulouse, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Daudé
authors.forename: Lionel
authors.initials: L
authors.lastname: Rostaing
authors.forename: Karine
authors.initials: K
authors.lastname: Sauné
authors.forename: Laurence
authors.initials: L
authors.lastname: Lavayssière
authors.forename: Grégoire
authors.initials: G
authors.lastname: Basse
authors.forename: Laure
authors.initials: L
authors.lastname: Esposito
authors.forename: Joelle
authors.initials: J
authors.lastname: Guitard
authors.forename: Jacques
authors.initials: J
authors.lastname: Izopet
authors.forename: Laurent
authors.initials: L
authors.lastname: Alric
authors.forename: Nassim
authors.initials: N
authors.lastname: Kamar
mesh_terms: D000225:Adenine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004359:Drug Therapy, Combination; D004798:Enzymes / Q000097:blood; D005260:Female; D005602:France; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D019259:Lamivudine / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D016377:Organ Transplantation; D063065:Organophosphonates / Q000009:adverse effects / Q000627:therapeutic use*; D010865:Pilot Projects; D000068698:Tenofovir; D013997:Time Factors; D016896:Treatment Outcome; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D004798:Enzymes; D007166:Immunosuppressive Agents; D063065:Organophosphonates; D019259:Lamivudine; D000068698:Tenofovir; D000225:Adenine