Randomised clinical trial: the benefit of combination therapy with adefovir and

StephenW

Source: Aliment Pharmacol Ther  |  Posted 6 days agoRandomised clinical trial: the benefit of combination therapy with adefovir and lamivudine for chronic hepatitis B; Ghany MG, Feld JJ, Zhao X, Heller T, Doo E, Rotman Y, Nagabhyru P, Koh C, Kleiner DE, Wright EC, Liang TJ, Hoofnagle JH; Alimentary Pharmacology & Therapeutics (Mar 2012)

BACKGROUND: Combination antiviral therapy holds the promise of increasing response rates while decreasing antiviral resistance, but has yet to be shown to be beneficial or necessary in chronic hepatitis B.

AIM: To evaluate the benefit of combination therapy with adefovir and lamivudine versus adefovir alone in maintaining virological, biochemical and histological responses.
METHODS: Patients with chronic hepatitis B with and without previous lamivudine therapy were randomised to receive adefovir alone (10 mg/daily) or adefovir and lamivudine (100 mg/daily) for up to 192 weeks. Study endpoints were (i) maintained virological (HBV DNA<500 copies/mL), biochemical and histological response, (ii) loss of HBeAg and (iii) loss of HBsAg. RESULTS: A total of 41 patients were enrolled, including 31 HBeAg -positive and 31 treatment-naïve subjects. 30 patients remained on assigned therapy at 192 weeks. The percentage of patients achieving a combined maintained response was higher in the combination than the monotherapy arm, both at week 48 (59% vs. 26%, P = 0.06) and 192 (68% vs. 31%, P = 0.03). At week 192, 76% of the combination vs. 36% of the monotherapy group had loss of HBeAg (P = 0.03). One patient receiving adefovir cleared HBsAg. Adefovir resistance developed in 6 of 19 (32%) monotherapy but none of 22 combination treated patients (P = 0.03).
CONCLUSIONS: Extended combination therapy with lamivudine and adefovir is associated with a high rate of long-term virological and biochemical response. Adefovir monotherapy appears to be less effective mainly because of poor initial response and the ultimate development of antiviral resistance (www.Clinical. Trials.gov NCT00023309).

StephenW

来源：Aliment药理学疗法|发表于6天前
随机临床试验：阿德福韦和拉米夫定治疗慢性乙型肝炎的联合疗法的好处; Ghany爵，费尔德林俊杰，赵X中，海勒ţ，斗E，罗特曼Ÿ，Nagabhyru带够，苏梅Ç，克莱纳DE，赖特欧共体，梁的TJ Hoofnagle JH;消化系统药理学与治疗（2012年3月）


背景：持有组合的抗病毒治疗增加回应率，同时降低抗病毒药物耐药的承诺，但至今尚未被证明是有益的或有必要在慢性乙型肝炎的
AIM：评价阿德福韦酯和拉米夫定与阿德福韦联合治疗的利益，仅在维持病毒学，生化和病理反应。
方法：与以前无拉米夫定治疗慢性乙型肝炎患者随机接受阿德福韦单（10毫克/每天）或阿德福韦酯和拉米夫定（100毫克/每天）长达192周。研究终点是：（一）保持病毒学（HBV  -  DNA <500拷贝/毫升），生化和病理反应，（二）HBeAg消失及（iii）对HBsAg的损失。结果：共有41例患者入选，其中包括31个HBeAg阳性和31天真的治疗科目。 192周保持对分配治疗30例。实现了联合维持反应的患者比例高于单药组的组合，无论是在第48周（59％和26％，P均= 0.06）和192（68％与31％，磷= 0.03）。在192周时，组合的76％与36％的单药治疗组的HBeAg（p = 0.03）的损失。一个病人接受阿德福韦清除乙肝表面抗原。阿德福韦耐药，在6 19（32％）单药治疗，但没有22组合治疗的患者（p = 0.03）。
结论：拉米夫定和阿德福韦扩展联合治疗是一个长期的病毒学和生化反应的高利率。阿德福韦单药治疗似乎要少，主要是因为有效的初步反应不佳和抗病毒药物耐药的最终发展（www.Clinical。NCT00023309 Trials.gov）。