title: Efficacy and safety of an intravenous monoclonal anti-HBs in chronic hepatitis B patients.
abstract: OBJECTIVE
  In this study the safety and efficacy of a monoclonal anti-HBs, Tuvirumab (Mab), were investigated. Tuvirumab is a human monoclonal antibody recognizing the stable 'a'-determinant of the HBsAg.
  
  
  METHODS
  We included ten chronic hepatitis B patients: four received monotherapy, and six combination therapy with interferon alpha 2b.
  
  
  RESULTS
  Because the development of insoluble [HBsAg-HBsAb] complexes led to adverse events, the Mab dose had to be reduced in seven patients. In nine patients treatment was stopped prematurely because of lack of efficacy, i.e. neutralization of HBsAg in serum. However, temporary HBsAg levels were reduced by at least 50% in all patients; in three patients receiving combination therapy, background levels of HBsAg in serum were reached. A loss of serum HBV-DNA was seen in three patients in the combination group, followed by HBeAg seroconversion in two patients.
  
  
  CONCLUSIONS
  We conclude that Mab was not effective in achieving primary efficacy as assessed by neutralization of circulating HBsAg. Whether a combination of Mab with an antiviral agent that reduces the HBsAg load--and therefore minimizes the risk of adverse events--may result in clinical efficacy should be investigated.
authors: Department of Hepatology & Gastroenterology, University Hospital Rotterdam, The Netherlands.
authors: A B
authors: AB
authors: van Nunen
authors: M
authors: M
authors: Baumann
authors: M P
authors: MP
authors: Manns
authors: J
authors: J
authors: Reichen
authors: U
authors: U
authors: Spengler
authors: J P
authors: JP
authors: Marschner
authors: R A
authors: RA
authors: de Man
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000627:therapeutic use*; D000998:Antiviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000097:blood / Q000627:therapeutic use*; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D019694:Hepatitis B, Chronic / Q000188:drug therapy*; D006801:Humans; D007275:Injections, Intravenous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D017211:Treatment Failure
chemical_list: D000911:Antibodies, Monoclonal; D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins