Hepsera (adefovir dipivoxil)>>>HBeAG(-) patients

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Hepsera (adefovir dipivoxil) Proves Safe and Effective in Treating HBeAg Negative HBV Patients By Brian Boyle, MD Treatment for chronic hepatitis B virus (HBV) is advancing rapidly. There are now 3 therapies approved for the treatment of HBV, including interferon, Epivir-HBV (lamivudine) and Hepsera (adefovir). Hepsera, the last agent to be approved, has a somewhat checkered past, with it failing to obtain approval for the treatment of HIV infection in large part due to the risk of renal tubular dysfunction. Fortunately, Hepsera is effective against HBV at much lower doses than those required for HIV therapy and studies to date have failed to show significant rates of toxicity at the 10mg per day dose used in the treatment of HBV. In a study published in The New England journal of Medicine, the efficacy and safety of Hepsera in the treatment of hepatitis B e antigen (HBeAg) negative chronic HBV was evaluated. The prospective, placebo-controlled study enrolled 185 patients who were randomized to receive either 10 mg of Hepsera or placebo once daily for 48 weeks. The investigators found that at week 48 the patients that received Hepsera had a significantly higher rate of improvement in histologic liver abnormalities than patients who received placebo (64% vs. 33%, P<0.001). Further, serum HBV DNA levels were reduced to <400 copies/mL in 51% and 0% of the patients treated with Hepsera or placebo, respectively (P<0.001) and the median decrease in HBV DNA levels was greater with Hepsera than placebo (3.91 vs. 1.35 log copies per milliliter, P<0.001). At week 48, alanine aminotransferase (ALT) levels normalized in 72% of Hepsera patients and only 29% of those receiving placebo (P<0.001) and no patient developed resistance to Hepsera. Finally, the safety and tolerability of Hepsera were quite remarkable with the safety profile of Hepsera similar to that of placebo. The authors conclude, "In patients with HBeAg-negative chronic hepatitis B, 48 weeks of adefovir dipivoxil treatment resulted in significant histologic, virologic, and biochemical improvement, with an adverse-event profile similar to that of placebo. There was no evidence of the emergence of adefovir-resistant HBV polymerase mutations." 02/28/03 Reference S Hadziyannis and others. Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Negative Chronic Hepatitis B. The New England Journal of Medicine 2003;348:800-807.

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epsera (adefovir dipivoxil)>>>HBeAG(-) patients Hepsera (adefovir dipivoxil) Proves Safe and Effective in Treating HBeAg Negative HBV Patients 贺普喜（阿第福为片剂）被证明对治疗 HBeAg阴性的HBV患者安全有效 By Brian Boyle, MD Treatment for chronic hepatitis B virus (HBV) is advancing rapidly. There are now 3 therapies approved for the treatment of HBV, including interferon, Epivir-HBV (lamivudine) and Hepsera (adefovir). 慢性HBV的治疗正快速进步。目前有3种药物批准用于治疗HBV，包括干扰素，贺普丁（拉米夫定片剂）， 贺普喜（阿第福为片剂）。 ** Hepsera, the last agent to be approved, has a somewhat checkered past, with it failing to obtain approval for the treatment of HIV infection in large part due to the risk of renal tubular dysfunction. 贺普喜是最新批准的药物。它在过去被宣布不能得到治疗HIV感染的批准，原因是它有导致肾小管失调的危险。 Fortunately, Hepsera is effective against HBV at much lower doses than those required for HIV therapy and studies to date have failed to show significant rates of toxicity at the 10mg per day dose used in the treatment of HBV. 幸运的是，贺普喜可有效对抗HBV，其所需剂量比HIV治疗小的多。研究数据表明，用于治疗HBV的每天10mg的剂量， 没有明显的毒性。 In a study published in The New England journal of Medicine, the efficacy and safety of Hepsera in the treatment of hepatitis B e antigen (HBeAg) negative chronic HBV was evaluated. The prospective, placebo-controlled study enrolled 185 patients who were randomized to receive either 10 mg of Hepsera or placebo once daily for 48 weeks. The investigators found that at week 48 the patients that received Hepsera had a significantly higher rate of improvement in histologic liver abnormalities than patients who received placebo (64% vs. 33%, P<0.001). 发表在《新英格兰医学期刊》的一项研究中，评估了贺普喜治疗HBeAg阴性的慢性HBV个体的 安全性与效果。 计划中，双盲实验招募了185名患者，随机分成每天接受10mg贺普喜或安慰剂，共48周。 调查人员发现在48周中，接受贺普喜的患者比起安慰剂组，既往的肝脏异常有明显改善(64% vs. 33%, P<0.001). *** Further, serum HBV DNA levels were reduced to <400 copies/mL in 51% and 0% of the patients treated with Hepsera or placebo, respectively (P<0.001) and the median decrease in HBV DNA levels was greater with Hepsera than placebo (3.91 vs. 1.35 log copies per milliliter, P<0.001). 另外，血清HBV DNA水平，贺普喜在治疗组中，有51%减少到 <400 copies/mL，而安慰剂组是0%(P<0.001)。HBV DNA的中 值减少治疗组也比安慰组高的多 (3.91 vs. 1.35 log copies per milliliter, P<0.001) ** At week 48, alanine aminotransferase (ALT) levels normalized in 72% of Hepsera patients and only 29% of those receiving placebo (P<0.001) and no patient developed resistance to Hepsera. Finally, the safety and tolerability of Hepsera were quite remarkable with the safety profile of Hepsera similar to that of placebo. 48周后，贺普喜治疗的患者， ALT水平72%变正常，而安慰组只有29% (P<0.001) ，没有人对 贺普喜产生抗药性。 最后，贺普喜的安全性和耐受性与安慰剂结果相当。 The authors conclude, "In patients with HBeAg-negative chronic hepatitis B, 48 weeks of adefovir dipivoxil treatment resulted in significant histologic, virologic, and biochemical improvement, with an adverse-event profile similar to that of placebo. There was no evidence of the emergence of adefovir-resistant HBV polymerase mutations." 作者认为，“ HBeAg阴性的慢性HBV患者，经48周的贺普喜治疗，产生了显著的 组织学，病毒学，和生物化学方面 的改善，其负面影响与安慰剂相当。没有出现贺普喜耐药聚合酶变异的证据。” 02/28/03 Reference S Hadziyannis and others. Adefovir Dipivoxil for the Treatment of Hepatitis B e Antigen-Negative Chronic Hepatitis B. The New England Journal of Medicine 2003;348:800-807.