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62楼
发表于 2004-8-8 02:12
以下是引用cfz5在2004-8-7 11:37:13的发言：
刚从浙一回来，病毒变异检测结果是YIDD变异。跟医生聊了会，在他那边挂了个号，准备有临床试验抗病毒变异药物时，请他通知一声。老F也可以去问问。
听医生说，有可能是国产的阿德。也跟他聊了恩替、LDT。据他说恩替的副作用较大；阿德的肾毒性较轻；LDT由于病例较少还不十分清楚，但目前看副作用不大。
请问liver411：有没有阿德连续使用一年，二年后，。。。，产生肾毒性的概率数据、停药后的肾功能恢复情况。
聚会主席可可：会议安排进展如何？
[此贴子已经被作者于2004-8-7 11:51:06编辑过] [B]Long Term Safety of Hepsera (adefovir dipivoxil) 10 mg Once Daily for Patients with Chronic Hepatitis B: An Integrated Analysis of Two Phase III Studies [/B]
Abstract Summary
Hepsera (adefovir dipivoxil/ADV) is a nucleotide analog with activity against wild type and Epivir-HBV- (lamivudine)-resistant hepatitis B virus (HBV), resulting in significant histological, serological, and biochemical improvement.
The objective of the present study was to report safety results of treatment with ADV 10 mg daily for up to 109 weeks in compensated HBeAg+ or HBeAg- patients with chronic hepatitis B (CHB).
Data from two phase III studies were integrated. Clinical and laboratory adverse events (AE) from 492 patients receiving ADV 10 mg/d were analyzed.
Study participants were 78% male, 48% White, 47% Asian, and median age 40 years; median ADV exposure: 49 weeks (range 0.4-109.4). Frequency and nature of AEs was similar to that seen with ADV and placebo in the first 48 weeks. AEs led to drug discontinuation in 3% and serious AEs were reported in 5% of patients.
No single severe AE occurred in > 2 patients (< 1% each). One unrelated death was reported. Two patients (<1%) had a confirmed serum creatinine increase > 0.5 mg/dL from baseline; both resolved. Of 111 patients who switched from ADV to placebo in the second 48 weeks, 25% had ALT elevation > 10 x ULN; none experienced liver decompensation.
Conclusion: ADV 10 mg once daily was well tolerated in up to 109 weeks of dosing. Serum creatinine elevation was rare. Patients who discontinue HBV therapy, including ADV should be closely monitored for ALT flares.
03/26/03
Reference
TT Chang and other. LONG-TERM SAFETY OF ADEFOVIR DIPIVOXIL (ADV) 10 MG ONCE DAILY FOR CHRONIC HEPATITIS B (CHB): AN INTEGRATED ANALYSIS OF TWO PHASE III STUDIES. Abstract 3681.00. Abstracts of the 38th Annual Meeting of the European Association of the Study of the Liver (EASL). [B]Hepsera Added to Ongoing Epivir Treatment of HBV Patients with YMDD Mutant HBV [/B]
These data on the effects of Hepsera (adefovir dipivoxil) on Epivir-HBV (lamivudine)-resistant HBV have been previously published by HIV and Hepatitis.com. They appear in the current (January 2004) issue of Gastroenterology.
Prolonged lamivudine therapy is associated with the emergence of treatment-resistant YMDD mutant hepatitis B virus (HBV). Researchers evaluated the efficacy and safety of adding adefovir dipivoxil to lamivudine in 135 patients with chronic hepatitis B (CHB) and YMDD mutant HBV.
Ninety-five patients with compensated CHB (group A) were randomized to adefovir 10 mg daily (n = 46) or placebo (n = 49) for 52 weeks while continuing treatment with lamivudine. Forty patients with decompensated hepatitis B or post-liver transplantation (group B) received adefovir and lamivudine. The primary end point was a decline in serum HBV DNA level to 10(5) copies/mL or a >2 log(10) reduction from baseline at weeks 48 and 52.
Study Results
HBV DNA response occurred in 85% of patients (39 of 46) in group A given combined therapy versus 11% (5 of 46) receiving lamivudine alone (P < 0.001), with a significant change in HBV DNA level from baseline (P < 0.001) between treatment groups (median, -4.6 vs. +0.3 log(10) copies/mL, respectively).
Normalization of alanine aminotransferase levels occurred in 31% of patients (14 of 45) receiving combined therapy versus 6% (3 of 48) receiving lamivudine alone (P = 0.002).
Ninety-two percent of patients (36 of 39) in group B had an HBV DNA response (median change of -4.6 log(10) copies/mL) and improved liver chemistries (P |
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