Telbivudine管理慢性乙型肝炎病毒感染。
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马修斯SJ
Telbivudine管理慢性乙型肝炎病毒感染。
未来。2007;12月29日(12):2635 - 53。doi: 10.1016 / j.clinthera.2007.12.032。
- PubMed ID
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18201580 (在PubMed]
- 文摘
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背景:Telbivudine (LdT)是一种L-nucleoside结构与拉米夫定。是高度选择性的乙型肝炎病毒(HBV) DNA合成,抑制病毒。LdT是美国食品和药物管理局批准的10月25日,2006年,治疗慢性乙型肝炎病毒感染的成年人有活跃的病毒复制和海拔在肝脏转氨酶或活跃的肝脏疾病的迹象,组织学检查。目的:本文综述了药理学、药物动力学和LdT的治疗效果。潜在的药物相互作用和不良事件相关使用LdT也回顾了。方法:确定搜索的相关出版物MEDLINE(1996 - 2007年6月),Cochrane图书馆、生命现必威国际app象(1993 - 2007年6月)。必威国际app搜索条件包括,但不限于,telbivudine, beta-L-thymidine, LdT,药理学,药物动力学,不良事件,耐药性,药物的相互作用,乙型肝炎,治疗使用。额外的出版物被确定的参考列表确定论文,会议摘要和函授LdT的制造商。结果:治疗52周后在全球第三阶段的研究中,乙肝病毒抵抗(突破和电阻突变)LdT发生在3%的患者乙型肝炎e抗原(e抗原)积极和2%的患者e抗原阴性。104周的治疗后,HBeAg-positive 17.8%到21.6%和7.3%到8.6%的HBeAg-negative LdT-treated患者HBV DNA的反弹与突破和电阻突变有关。 After 24 weeks of treatment, the risk of resistance was greater in patients with HBV DNA titers >3 log(10) copies/mL than in those with lower numbers of copies. LdT is not active against lamivudine-resistant HBV. The proportion of HBeAg-positive patients with undetectable HBV DNA (by polymerase chain reaction assay) after 104 weeks of therapy in the GLOBE study was significantly greater with LdT compared with lamivudine (56% vs 39%, respectively; P < 0.05). After 104 weeks of therapy, the corresponding proportions of HBeAg-negative patients with undetectable HBV DNA were 82% and 57% (P < 0.05). Patients who failed lamivudine therapy in the GLOBE study showed cross-resistance to LdT. The most common adverse events associated with LdT are upper respiratory tract infection (14%-17%), fatigue and malaise (12%-14%), nasopharyngitis (11%-15%), headache (11%-12%), and abdominal pain (6%-12%). Grade 3/4 adverse events included elevations in serum creatine kinase, which were more common in patients receiving LdT than in those receiving lamivudine (9% vs 3%, respectively). Elevations in creatine kinase are typically asymptomatic; however, myopathy has been reported in 3 of 680 patients receiving LdT. CONCLUSIONS: LdT joins the increasing number of antiviral agents for the management of chronic HBV infection. Questions concerning the optimal length of therapy and long-term efficacy await the results of on-going clinical trials. Concerns about increasing resistance over time may relegate LdT to second-line status in the management of chronic HBV infection. The role of LdT in combination therapy is under investigation.
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