【据Hepatology International 2021年2月报道】题:PEG-IFN序贯核苷类似物治疗HBe Ag阳性慢性乙型肝炎患者的效果评价(作者Xu W等)目前慢性乙型肝炎抗病毒治疗策略优化主要有3种可能方案:(1)PEG-IFN和核苷类似物起始联合治疗;(2)核苷类...【据Hepatology International 2021年2月报道】题:PEG-IFN序贯核苷类似物治疗HBe Ag阳性慢性乙型肝炎患者的效果评价(作者Xu W等)目前慢性乙型肝炎抗病毒治疗策略优化主要有3种可能方案:(1)PEG-IFN和核苷类似物起始联合治疗;(2)核苷类似物序贯PEG-IFN治疗;(3)PEG-IFN序贯核苷类似物治疗。方案(1)和方案(2)目前已有较多研究评估,然而方案(3)的疗效尚缺乏临床研究评价。该研究旨在评估PEG-IFN序贯核苷类似物治疗HBe Ag阳性慢性乙型肝炎患者的疗效。展开更多
BACKGROUND:Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen(HBeAg)-negative chronic hepatitis B.METHODS:In this phase 3,doubl...BACKGROUND:Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen(HBeAg)-negative chronic hepatitis B.METHODS:In this phase 3,double-blind trial,we randomly assigned 648 patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue to receive 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks.The primary efficacy end point was histologic improvement(a decrease by at least two points in the Knodell necroinflammatory score,without worsening of fibrosis).RESULTS:Histologic improvement after 48 weeks of treatment occurred in 208 of 296 patients in the entecavir group who had adequate baseline liver-biopsy specimens that could be evaluated(70 percent),as compared with 174 of 287 such patients in the lamivudine group(61 percent,P=0.01).More patients in the entecavir group than in the lamivudine group had undetectable serum hepatitis B virus(HBV)DNA levels according to a polymerase-chain-reaction assay(90 percent vs.72 percent,P < 0.001)and normalization of alanine aminotransferase levels(78 percent vs.71 percent,P = 0.045).The mean reduction in serum HBV DNA levels from baseline to week 48 was greater with entecavir than with lamivudine(5.0 vs.4.5 log on a base-10 scale copies per milliliter,P < 0.001).There was no evidence of resistance to entecavir.Safety and adverse-event profiles were similar in the two groups.CONCLUSIONS:Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue,the rates of histologic improvement,virologic response,and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine.The safety profile of the two agents was similar,and there was no evidence of viral resistance to entecavir.展开更多
文摘BACKGROUND:Entecavir is a potent and selective antiviral agent that has demonstrated efficacy in phase 2 studies in patients with hepatitis B e antigen(HBeAg)-negative chronic hepatitis B.METHODS:In this phase 3,double-blind trial,we randomly assigned 648 patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue to receive 0.5 mg of entecavir or 100 mg of lamivudine once daily for a minimum of 52 weeks.The primary efficacy end point was histologic improvement(a decrease by at least two points in the Knodell necroinflammatory score,without worsening of fibrosis).RESULTS:Histologic improvement after 48 weeks of treatment occurred in 208 of 296 patients in the entecavir group who had adequate baseline liver-biopsy specimens that could be evaluated(70 percent),as compared with 174 of 287 such patients in the lamivudine group(61 percent,P=0.01).More patients in the entecavir group than in the lamivudine group had undetectable serum hepatitis B virus(HBV)DNA levels according to a polymerase-chain-reaction assay(90 percent vs.72 percent,P < 0.001)and normalization of alanine aminotransferase levels(78 percent vs.71 percent,P = 0.045).The mean reduction in serum HBV DNA levels from baseline to week 48 was greater with entecavir than with lamivudine(5.0 vs.4.5 log on a base-10 scale copies per milliliter,P < 0.001).There was no evidence of resistance to entecavir.Safety and adverse-event profiles were similar in the two groups.CONCLUSIONS:Among patients with HBeAg-negative chronic hepatitis B who had not previously been treated with a nucleoside analogue,the rates of histologic improvement,virologic response,and normalization of alanine aminotransferase levels were significantly higher at 48 weeks with entecavir than with lamivudine.The safety profile of the two agents was similar,and there was no evidence of viral resistance to entecavir.
