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Preliminary Evidence of Rapid HBsAg Seroconversion in Patients with
Chronic Hepatitis B (CHB) Treated with a DNA-based Amphipathic
Polymer
Mamun Al-Mahtab1, Michel Bazinet2, Andrew Vaillant2
1Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh,
2REPLICor Inc, Laval, Canada
Background: REP9AC is a DNA-based amphipathic polymer whose antiviral
activity is linked to targeting viral glycoproteins important for viral entry and/
or release. The preclinical evaluation of 28 days of REP 9AC therapy in ducks
persistently infected with DHBV demonstrated rapid clearance of DHBV
DNA, DHBsAg and rapid appearance of anti-DHBs antibodies in 55% of ducks
whose blood had no detectable evidence of DHBV infection 16 weeks after
cessation of REP 9AC therapy. 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 REP9AC 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: Interim data has shown that all patients treated to date have cleared
HBsAg and developed protective immunity. Clearance of HBsAg and
development of protective levels of anti-HBs occurred 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 8 continuous
weeks off treatment after receiving only 23 weeks of treatment with REP9AC.
Conclusions: These results demonstrate that amphipathic polymers are effective
in rapidly reducing HBsAg levels in CHB patients which allows patients to
seroconvert. The rapid appearance of anti-HBs and anti-HBe antibodies in these
patients, the best predictors of SVR in patients with CHB, suggest that amphipathic
polymers could become an important new tool in the treatment of CHB. |
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楼主: lemonades
发表于 2010-3-28 13:17
