title: Long-term clinical outcomes in cirrhotic chronic hepatitis B patients treated with tenofovir disoproxil fumarate for up to 5 years.
abstract: BACKGROUND
  Phase 3 clinical studies have shown that long-term treatment with tenofovir disoproxil fumarate (TDF) can suppress hepatitis B viral load and promote significant fibrosis regression and cirrhosis reversal in a majority of treated chronic hepatitis B (CHB) patients. This retrospective analysis investigated the impact of baseline cirrhosis status on virologic, serologic, and histologic outcomes in patients treated with TDF.
  
  
  METHODS
  Patients enrolled in studies GS-US-174-0102 and GS-US-174-0103 who had baseline liver biopsy-diagnosed cirrhosis and entered the open-label phase of the studies were included in the virologic and serologic analyses. Patients (both HBeAg positive and negative) with paired liver biopsies at baseline and 5 years (N = 348) were included in a histologic analysis.
  
  
  RESULTS
  After 5 years on study, comparing patients with and without baseline cirrhosis, respectively: 99.2 and 98.0% achieved virologic response (hepatitis B viral load < 69 IU/ml) (p = 0.686); 79.7 and 81.9% had normal serum levels of alanine aminotransferase (p = 0.586); 4.0 and 1.2% developed hepatocellular carcinoma (p = 0.044). In HBeAg-positive patients with and without baseline cirrhosis, HBsAg loss occurred in 14.4 and 8.3% of patients, respectively (p = 0.188). One HBeAg-negative patient had HBsAg loss.
  
  
  CONCLUSIONS
  This represents the largest analyses to date of CHB patients with sequential liver biopsies demonstrating that treatment with TDF for up to 5 years is associated with favorable virologic, serologic, and histologic outcomes, regardless of baseline cirrhosis status. Notably, histologic improvement was observed in the majority of cirrhotic and noncirrhotic patients.
authors: Servei de Medicina Interna-Hepatologia, Hospital General Universitari Vall d'Hebron, Pg. Vall d'Hebron, 119-129, 08035, Barcelona, Spain, mbuti@vhebron.net.
authors: Maria
authors: M
authors: Buti
authors: Scott
authors: S
authors: Fung
authors: Edward
authors: E
authors: Gane
authors: Nezam H
authors: NH
authors: Afdhal
authors: Robert
authors: R
authors: Flisiak
authors: Selim
authors: S
authors: Gurel
authors: John F
authors: JF
authors: Flaherty
authors: Eduardo B
authors: EB
authors: Martins
authors: Leland J
authors: LJ
authors: Yee
authors: Phillip
authors: P
authors: Dinh
authors: Jeffrey D
authors: JD
authors: Bornstein
authors: G
authors: G
authors: Mani Subramanian
authors: Harry L A
authors: HL
authors: Janssen
authors: Jacob
authors: J
authors: George
authors: Patrick
authors: P
authors: Marcellin
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000821:virology*; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006513:Hepatitis B e Antigens / Q000097:blood; D019694:Hepatitis B, Chronic / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D008103:Liver Cirrhosis / Q000473:pathology* / Q000821:virology; D008113:Liver Neoplasms / Q000821:virology*; D008297:Male; D012189:Retrospective Studies; D000068698:Tenofovir / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; 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