Preliminary Evidence of Rapid HBsAg Seroconversion

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23rd ICAR Abstract Issue
The Twenty-Third International Conference on
Antiviral Research


48
Preliminary Evidence of Rapid HBsAg Seroconversion in
Patients with Chronic Hepatitis B (CHB) Treated with a DNAbased
Amphipathic Polymer
Mamun Al-Mahtab1,∗, Michel Bazinet2, Andrew Vaillant 2
1 Sheikh Mujib Medical University, Dhaka, Bangladesh; 2 REPLICor Inc.,
Montreal, Canada
Background: REP 9AC is a DNA-based amphipathic polymer
that targets viral glycoproteins important for viral entry and/or
release. REP 9AC has been previously shown to result in the rapid
clearance of surface antigen and the development of protective
immunity in DHBV infected ducks which results in 56% of treated
ducks achieving SVR (DHBV DNA negative) at 16 weeks posttreatment.
The ability of REP 9AC to treat human patients with CHB
is currently being evaluated in a proof of concept trial.
Methods: Patients with CHB were subjected to REP 9AC therapy
administered by slow continuous infusion. Safety and virologic
response (HBV DNA, HBsAg, anti-HBs) were assessed weekly, 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
ArchitectTM testing platform.
Results: All patients treated to date have cleared HBsAg and
developed protective immunity (anti-HBs) which was observed as
early as 7 days following initiation of treatment at higher doses. At
the time of abstract submission, one patient has already exhibited
clear signs of a sustained virologic response (HBV DNA−, HBsAg−,
HBeAg−, anti-HBs+, anti-HBe+) for 12 continuous weeks off treatment
after receiving only 23 weeks of treatment with REP 9AC.
Conclusions: These results demonstrate that amphipathic polymers
are effective in rapidly reducing HBsAg levels in CHB patients
which is a critical event for allowing patients to achieve a rapid
seroconversion. Subsequent rapid appearance of anti-HBs and anti-
HBe antibodies observed in these patients are the best indicators
for achieving SVR and suggest that amphipathic polymers could
become an important new tool in the treatment of CHB.



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