Aa
AASLD 2010 Annual Meeting
http://www.aasld.org/lm/abstracts/Pages/default.aspx - Abstracts
483
SIGNIFICANCE OF SERUM HBSAG LEVELS FOR THE
DEFINITION OF THE INACTIVE HEPATITIS B CARRIER
STATE
Emanuel K. Manesis, George V. Papatheodoridis, Emilia Hadziyan-
nis; Division of Internal Medicine, Athens University School of Med-
icine, Athens, Greece
CONCLUSIONS: 1. ICs have significantly lower serum HBsAg
levels compared to CHBe- patients. 2. Finding HBsAg <1000
IU/mL in a patient with normal ALT and HBV DNA <10,000
copies/mL is highly predictive of IC state. 3. Younger ICs have
significantly higher serum HBsAg and ALT levels and should be
followed more closely for possible reversion to CHBe- state.
SIGNIFICANCE OF SERUM HBSAG LEVELS FOR THE
DEFINITION OF THE INACTIVE HEPATITIS B CARRIER
STATE
Emanuel K. Manesis, George V. Papatheodoridis, Emilia Hadziyan-
nis; Division of Internal Medicine, Athens University School of Med-
icine, Athens, Greece
CONCLUSIONS: 1. ICs have significantly lower serum HBsAg
levels compared to CHBe- patients. 2. Finding HBsAg <1000
IU/mL in a patient with normal ALT and HBV DNA <10,000
copies/mL is highly predictive of IC state. 3. Younger ICs have
significantly higher serum HBsAg and ALT levels and should be
followed more closely for possible reversion to CHBe- state.
482
REP 9AC: A POTENT HBSAG RELEASE INHIBITOR THAT
CAN RAPIDLY RESTORE IMMUNOCOMPETENCE IN
PATIENTS WITH CHRONIC HEPATITIS B
Mamun A. Mahtab, Michel Bazinet, Andrew Vaillant
Banga-bandhu Sheikh Mujib Medical University, Dhaka, Bangladesh;
REPLICor Inc., Montreal, QC, Canada
BACKGROUND:
Many groups have suggested that HBsAg may
play a role in suppressing the immune system and may allow
the infection to be chronically maintained in the liver. REP 9AC
is a DNA-based amphipathic polymer which has been shown to
potently inhibit the release of HBsAg from infected hepatocytes.
In preclinical studies in DHBV infected ducks, DHBsAg seroclearance
was observed in all ducks after only two weeks of
treatment. Four weeks of REP 9AC therapy resulted in 55% of
ducks achieving a SVR 16 weeks after cessation of treatment.
The ability of REP 9AC to treat human patients with chronic hepatitis
B (CHB) is currently being evaluated in a proof of concept
clinical trial.
METHODS:
All patients were HBeAg+, HBsAg+
with pre-treatment HBV DNA titers between 10^6 and 10^12
copies/ml. Additionally, all patients were shown to have significant
liver fibrosis as assessed by pre-treatment liver biopsy.
Patients with CHB were subjected to parenteral REP 9AC therapy.
Safety and virologic response (HBV DNA, HBsAg, anti-
HBs) were assessed weekly during treatment, either at the trial
site or by confirmatory testing (HBsAg, HBeAg, anti-HBs, anti-
HBe) of frozen serum samples at a separate location using the
Architect™ testing platform.
RESULTS:
Interim data shows that 5
out of 6 patients treated to date have cleared serum HBsAg and
anti-HBsAg antibodies have been observed in all patients.
Clearance of HBsAg and development of anti-HBs have been
observed as early as 7 days and no later than 15 weeks following
initiation of treatment at higher doses. At the time of
abstract submission, 3 patients have achieved a 3 to 7 log
reduction in their HBV DNA titers from pre-treatment levels after
7-13 weeks of treatment. Additionally, two other patients have
achieved a complete control of their infection after 23 or 24
weeks of treatment (HBV DNA -, HBsAg -, HBeAg -, anti-HBs +,
anti-HBe +) and are being followed off treatment. One of these
patients is currently maintaining control over his infection 6
months after stopping treatment.
CONCLUSIONS:
These results demonstrate that REP 9AC can rapidly and effectively clear
HBsAg from the serum of infected patients. This rapid HBsAg
seroclearance appears to allow the restoration of an effective
immune response, as evidenced by substantial reductions in
serum HBV DNA, seroconversion for HBsAg and HBeAg, and
the achievement of a 6 month SVR in at least one patient to
date. These results suggest that REP 9AC may become an
important new tool in the treatment of chronic hepatitis B.
Disclosures:
Michel Bazinet - Board Membership: REPLICor Inc.; Employment: REPLICor Inc.;
Management Position: REPLICor Inc.; Stock Shareholder: REPLICor Inc.
Andrew Vaillant - Employment: REPLICor
The following people have nothing to disclose: Mamun A. Mahtab
REP 9AC: A POTENT HBSAG RELEASE INHIBITOR THAT
CAN RAPIDLY RESTORE IMMUNOCOMPETENCE IN
PATIENTS WITH CHRONIC HEPATITIS B
Mamun A. Mahtab, Michel Bazinet, Andrew Vaillant
Banga-bandhu Sheikh Mujib Medical University, Dhaka, Bangladesh;
REPLICor Inc., Montreal, QC, Canada
BACKGROUND:
Many groups have suggested that HBsAg may
play a role in suppressing the immune system and may allow
the infection to be chronically maintained in the liver. REP 9AC
is a DNA-based amphipathic polymer which has been shown to
potently inhibit the release of HBsAg from infected hepatocytes.
In preclinical studies in DHBV infected ducks, DHBsAg seroclearance
was observed in all ducks after only two weeks of
treatment. Four weeks of REP 9AC therapy resulted in 55% of
ducks achieving a SVR 16 weeks after cessation of treatment.
The ability of REP 9AC to treat human patients with chronic hepatitis
B (CHB) is currently being evaluated in a proof of concept
clinical trial.
METHODS:
All patients were HBeAg+, HBsAg+
with pre-treatment HBV DNA titers between 10^6 and 10^12
copies/ml. Additionally, all patients were shown to have significant
liver fibrosis as assessed by pre-treatment liver biopsy.
Patients with CHB were subjected to parenteral REP 9AC therapy.
Safety and virologic response (HBV DNA, HBsAg, anti-
HBs) were assessed weekly during treatment, either at the trial
site or by confirmatory testing (HBsAg, HBeAg, anti-HBs, anti-
HBe) of frozen serum samples at a separate location using the
Architect™ testing platform.
RESULTS:
Interim data shows that 5
out of 6 patients treated to date have cleared serum HBsAg and
anti-HBsAg antibodies have been observed in all patients.
Clearance of HBsAg and development of anti-HBs have been
observed as early as 7 days and no later than 15 weeks following
initiation of treatment at higher doses. At the time of
abstract submission, 3 patients have achieved a 3 to 7 log
reduction in their HBV DNA titers from pre-treatment levels after
7-13 weeks of treatment. Additionally, two other patients have
achieved a complete control of their infection after 23 or 24
weeks of treatment (HBV DNA -, HBsAg -, HBeAg -, anti-HBs +,
anti-HBe +) and are being followed off treatment. One of these
patients is currently maintaining control over his infection 6
months after stopping treatment.
CONCLUSIONS:
These results demonstrate that REP 9AC can rapidly and effectively clear
HBsAg from the serum of infected patients. This rapid HBsAg
seroclearance appears to allow the restoration of an effective
immune response, as evidenced by substantial reductions in
serum HBV DNA, seroconversion for HBsAg and HBeAg, and
the achievement of a 6 month SVR in at least one patient to
date. These results suggest that REP 9AC may become an
important new tool in the treatment of chronic hepatitis B.
Disclosures:
Michel Bazinet - Board Membership: REPLICor Inc.; Employment: REPLICor Inc.;
Management Position: REPLICor Inc.; Stock Shareholder: REPLICor Inc.
Andrew Vaillant - Employment: REPLICor
The following people have nothing to disclose: Mamun A. Mahtab
it's passwork protected now.....did anybody saved the abstracts about hbv therapy?i read some but couldn t read all this afternoon, they were interesting but the first data i read was already known
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