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回复 cwy121 的帖子
不知道。论文摘要的资料很少。我认为最重要的事情是:
1。 REP9AC是仍在测试
2。它吸引了其他研究人员的注意
AASLD 2011. An updated progress report of the ongoing phase I/II study on the safety and efficacy of REP 9AC in patients with chronic HBV (CHB) infection is presented.
METHODS: All patients were HBsAg+ with pre-treatment HBV DNA titers between 106 and 1012 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 [Roche Cobas T], HBsAg, anti-HBs [Immunilite]) were assessed weekly at the trial site/. Off site confirmatory testing of HBsAg, HBeAg, anti-HBs, anti-HBe was conducted using the using the Architect T platform.
RESULTS: Interim data shows that 7 out of 8 patients treated to date have either cleared or have only residual levels of 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 32 weeks. At the time of abstract submission, 6 out of 7 patients with serum HBsAg reductions had achieved a 3 to 7 log reduction in their HBV DNA titers from pre-treatment levels after 7-13 weeks of treatment. Additionally, three of these seven patients have achieved a complete control of their infection with 20-27 weeks of treatment (HBV DNA < 400cpm-, HBsAg -, HBeAg -, anti-HBs +, anti-HBe +) and are being followed off treatment. These three patients have demonstrated durable immunological control over their infections, having SVRs of 18 months, 12 months and 10.5 months after cessation of 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 SVRs in three patients to date. These results suggest that REP 9AC may become an important new tool in the treatment of chronic hepatitis B. |
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