Hepsera(阿迪福韦)持续48周以上用药研究
发布时间:2007-12-30 作者:路人乙 来源:网络资源
< 400 copies/mL at their last evaluation.
Among 74 patients who remained HBeAg positive during the first 48 wk, an additional 4 (5%) in the ADV group had undergone HBeAg seroconversion. ALT values were > ULN in 41 of 85 patients on ADV 10 mg at wk 48 but normalized in 11 (27%) at the time of the interim analysis.
In addition, the prospective virology surveillance substudy of Study 437 identified no HBV mutations associated with resistance to adefovir in HBeAg positive CHB patients with up to 48 wk of treatment with ADV.
Conclusion: Continued treatment of HBeAg positive CHB patients with ADV 10 mg beyond 48 weeks resulted in additional suppression in serum HBV DNA and ALT levels, and further HBeAg seroconversion. The sustained and continued improvement in virological, biochemical, and serological parameters may be due to the absence of resistance development.
This study will continue for up to 5 years duration to evaluate the long-term safety and efficacy of daily ADV 10 mg and to observe for the potential development of resistance.
01/20/03
Reference
Patrick Marcellin and others. ADEFOVIR DIPIVOXIL (ADV) 10 MG FOR THE TREATMENT OF PATIENTS WITH HBeAG CHRONIC HEPATITIS B: CONTINUED EFFICACY BEYOND 48 WEEKS. Abstract 840. 53rd AASLD. November 1-5, 2002. Boston, MA. Hepatology 2002: Vol 36 No 4, Pt 2 of 2.
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