"阿迪福韦"安全问题全面分析总结...

liver411

[B]Hepsera (adefovir dipivoxil 10mg) Once Daily For Chronic HBV: An Integrated Analysis of Safety in Two Phase III Studies[/B] Hepsera (adefovir dipivoxil /ADV) is a nucleotide analog with activity against wild-type, precore and lamivudine-resistant hepatitis B virus (HBV) resulting in significant histological, serological, and biochemical improvement. The aim of this study was to report safety results of treatment with ADV 10 mg qd for up to 109 weeks in compensated HBeAg+ or HBeAg- CHB patients. Data from two phase III studies were integrated. Clinical and laboratory adverse events (AEs) from 492 patients receiving ADV 10 mg qd were analyzed. Patients were 78% male, 48% Caucasian, 47% Asian, median age 40 years (range x to y years); median ADV exposure: 49 weeks (range 0.4-109.4 weeks). Frequency and nature of AEs was similar to that seen with ADV and placebo in the first 48 weeks. AEs leading to drug discontinuation in 3% of patients and Serious AEs were reported in 5% of patients. No single SAE occurred in > 2 patients (< 1% each). One unrelated death was reported. Two patients (<1%) had a confirmed serum creatinine increase > or = 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 elevations > 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. Reference M Tong and others. Long-Term Safety Beyond 48 Weeks Of Adefovir Dipivoxil (ADV) 10 Mg Once Daily For Chronic Hepatitis B (CHB): An Integrated Analysis Of Two Phase III Studies. Abstract 340 (topic forum). Abstracts of Digestive Disease Week 2003. May 17-22, 2003. Orlando, FL