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本帖最后由 cshbv 于 2011-12-14 17:33 编辑
http://www.informedhorizons.com/hepdart2011/pdf/FinalProgram&Abstract%20Book_HEPDART2011.pdf
Abstract 59
Nucleic acid polymers (REP 9AC / REP 9AC’) elicit sustained immunological control of chronic HBV infection
M Al-Mahtab1, M Bazinet2, and A Vaillant2
1 Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh; 2 REPLICor Inc., Montreal, Canada
BACKGROUND: Secreted HBsAg plays a critical role in suppressing host immunity which permits chronic maintenance of HBV infection. REP 9AC / REP 9AC’ are nucleic acid-based amphipathic polymers (NAPs) which inhibit the release of subviral particles from infected hepatocytes. Previous interim clinical data has shown that REP 9AC rapidly clears serum HBsAg in infected patients and allows patients to regain immunological control over their HBV infection. The current clinical experience with REP 9AC and a 4th generation NAP (REP 9AC’) will be presented.
METHODS: All patients were, HBsAg+ with pre-treatment HBV DNA titers between 10^6 and 10^12 copies/ml. REP 9AC or REP 9AC’ was administered by IV infusion. Safety and virologic response (HBV DNA [Roche Cobas], HBsAg anti-HBs (Abbott Architect)] were assessed weekly during treatment.
RESULTS:
(REP 9AC) Treatment achieved > 99.5% reduction of serum HBsAg in seven out of eight patients. Effective clearance of HBsAg and development of anti-HBs were observed as early as 7 days and no later than 32 weeks. All patients responding to REP 9AC achieved a 3 - 7 log reduction in HBV DNA titers and four of these seven patients achieved complete control of their infection with 20-44 weeks of treatment (HBV DNA < 500cpm). Off treatment, three of these four patients are currently experiencing a sustained immunological
control of their infection (HBV DNA < 500cpm, and HBsAg < 10 IU) for 24, 12 and 12 months respectively. The other four patients are experiencing partial immunological control of their infection with sustained > 90% reductions in serum HBsAg and 3-7 log reductions in HBV DNA. Mild pro-inflammatory side effects were consistently observed during drug
administration.(REP 9AC' ). REP 9AC was modified to reduce pro-inflammatory activity and improve compound stability. Early interim data from seven new HBV patients treated with REP 9AC’ show effective clearance or substantial HBsAg reductions in all patients in the first 10 weeks of treatment. Three of these patients have already experienced a 3-4 log decline in their HBV DNA. No pro-inflammatory side effects have been observed to date with REP 9AC’ administration.
CONCLUSIONS: These results demonstrate rapid effective clearance of serum HBsAg by NAPs which appears to allow the restoration of host immunity. In many cases patients experience a durable immunological control after treatment is stopped. These results suggest that NAPs may become an important new tool in the treatment of chronic hepatitis B.
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发表于 2011-12-14 17:29
