ESTABLISHMENT OF A POTENT ANTI-HBSAG RESPONSE AND DURABLE IMMUNOLOGICAL CONTROL OF VIREMIA WITH SHORT TERM IMMUNOTHERAPY AFTER REP 9AC'- INDUCED HBSAG SEROCLEARANCE IN CHRONIC HBV INFECTION
M. Al-Mahtab1, M. Bazinet2, A. Vaillant2*
1Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, 2REPLICor Inc., Montreal, QC, Canada. ****@****
Background: HBsAg is known to block cytokine responses and its persistent circulation during immunotherapy may block immune stimulation in patients with chronic HBV. REP 9AC' is a nucleic acid-based polymer (NAP) that clears serum HBsAg by blocking HBV subviral particle formation and release. The ability of add-on immunotherapy after REP 9AC'- induced HBsAg seroclearance to establish a permanent immunological control of chronic HBV infection was examined.
Methods: Add on immunotherapy to existing REP 9AC' therapy was initiated in patients experiencing HBsAg seroclearance with persistent serum HBV DNA. Immmunotherapy consisted of thymosin α1 (Zadaxin™) or pegylated interferon α-2a (Pegasys™). Virologic responses were monitored by measuring serum HBV DNA (Roche Cobas™), serum HBsAg and serum anti-HBs (Abbott Architect™).
Results: REP 9AC'- induced HBsAg seroclearance was achieved in most patients with 8-16 weeks of treatment and was accompanied by the appearance of moderate free anti-HBs titers (50-60 mIU/ml) and reductions in serum HBV DNA (to 1000-3000 CPM). Addition of Zadaxin™ or Pegasys™ to REP 9AC' therapy resulted in rapid and profound increases in anti-HBs titers after as little as 6 weeks of immunotherapy to titers comparable to or greater than those observed in healthy patients with a strong vaccine response. In 8 of 9 patients, all treatment was halted after 13 - 27 weeks of immunotherapy exposure. In these patients, anti HBs titers off-treatment are currently comparable to or exceed those observed in uninfected subjects with a strong HBV vaccine response up to 4 months off treatment. Additionally, serum HBV DNA is also supressed or is declining in all of these patients off-treatment. Currently, serum HBV DNA levels have reached < 500 cpm (2 patients), < 150 cpm (1 patient) or < 116 cpm (LLOQ) in the remaining 5 patients.
Conclusions: REP 9AC'-induced HBsAg seroclearance appears to potentiate the immunostimulatory effects of either Zadaxin™ or Pegasys ™ in all patients, suggesting that circulating HBsAg may play a direct role in blocking the stimulation of immune function by immunotherapy. Short term exposure to immunotherapy in the absence of HBsAg may induce permanent immunological control of HBV infection in most patients.
Dr. Andrew Vaillant, REPLICor Inc. , Montreal , Canada
Assigned in sessions:
26.04.2013, 09:00-18:00, Poster Session, P02-07c, Category 07c: Viral Hepatitis B & D: Clinical (therapy, new compounds, resistance), Poster Area
i am not a doctor and i do suggest you change current doctor because the drugs used are not on hbv guidelines anymore and after using zefix you cant use bacavir (entecavir) because you will develop resistance to it.the only thing to accept zefix prescription is if no other drugs were available in ur country at that time
the only drug without resistance on hbv and safe after using zefix is tenofovir, if you dont have kidneys problems it is best you look for a generic drug of tenofovir, most potent on hbv and no resistance, it should be even cheaper than bacavir
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