Efficacy and safety of an intravenous monoclonal anti-HBs in chronic hepatitis B patients.
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.
van Nunen
A B
AB
Department of Hepatology & Gastroenterology, University Hospital Rotterdam, The Netherlands.
Baumann
M
M
Manns
M P
MP
Reichen
J
J
Spengler
U
U
Marschner
J P
JP
de Man
R A
RA
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
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