Efficacy and Safety of Long-Term Adefovir Dipivoxil Therapy in Children with Chr

StephenW

Pediatr Infect Dis J. 2012 Mar 29. [Epub ahead of print]
Efficacy and Safety of Long-Term Adefovir Dipivoxil Therapy in Children with Chronic Hepatitis B Infection.Jonas MM, Kelly D, Pollack H, Mizerski J, Sorbel J, Frederick D, Mondou E, Rousseau F, Sokal E.
Source1 Children's Hospital Boston, Boston, MA 2 Birmingham Children's Hospital, Birmingham, UK 3 New York University, New York, NY 4 John Paul II Hospital, Krakow, Poland 5 Deceased, formerly Gilead Sciences, Foster City, CA 6 Catholic University of Louvain, Brussels, Belgium.

Abstract: Safety and efficacy of adefovir dipivoxil (ADV) for chronic hepatitis B (CHB) infection in children was demonstrated in a randomized, placebo-controlled trial. Those children were followed for 4 more years, and many continued to receive ADV for all or part of this time.
OBJECTIVES: To examine the therapeutic effects and safety of prolonged ADV therapy in children with CHB infection.
METHODS: After 48 weeks of double-blind treatment, all placebo-treated subjects who did not exhibit HBeAg seroconversion at week 44, and all ADV-treated subjects, were offered open-label ADV for up to 192 additional weeks. Treatment was discontinued if there was no virologic effect, except for adolescents with previous lamivudine exposure, in whom lamivudine was added to ADV. Durability of HBeAg seroconversion was assessed. Annual resistance surveillance was conducted in subjects who had detectable HBV DNA.
RESULTS: Of the 170 subjects who completed the 48-week study, 162 participated in the open-label study. ADV was discontinued in 61 subjects due to virologic failure. In subjects who continued treatment, either as monotherapy or with lamivudine, continued viral suppression and ALT normalization were noted. HBeAg seroconversions were observed in 55 subjects, and HBsAg seroconversion in 5. Mean duration of HBeAg seroconversion at last observation was 762 ± 371.2 days in the ADV-ADV group and 643 ± 291.5 days in the PLB-ADV group. ADV was safe and well-tolerated. Resistance to ADV was observed in 1 child on ADV monotherapy. Nine treatment-experienced subjects entered the study with mutations associated with lamivudine. All responded to ADV therapy.
CONCLUSIONS: Prolonged ADV treatment is safe in children. If reserved only for those with virologic response within 6 months, viral resistance was minimal.

StephenW

儿科杂志感染派息研究2012 03月29日。 [出处提前打印]
长期阿德福韦酯治疗慢性乙型肝炎儿童的疗效和安全性。
乔纳斯的MM，凯利ð，波拉克Mizerski J，Sorbel J，冯检基ð，Mondoué，卢梭F，索卡尔E.
源

波士顿1个儿童医院，波士顿，马2伯明翰儿童的医院，伯明翰，英国3新的纽约大学，纽约州，纽约州4约翰·保罗第二医院，克拉科夫，波兰5死者，原吉利德科学，福斯特市，CA 6天主教大学鲁汶，比利时的布鲁塞尔。

摘要

在一项随机，安慰剂对照试验证明：阿德福韦（ADV），慢性乙型肝炎（CHB）感染儿童的安全和疗效。这些儿童随访4年多，许多人继续接受ADV这段时间的全部或部分。
目的：

检查在慢性乙型肝炎感染的儿童长期ADV治疗的疗效和安全性。
方法：

48周的双盲治疗后，所有安慰剂治疗的患者并没有表现出在第44周，HBeAg血清转换和所有，ADV-治疗的受试者，提供高达192周开放标签副词。停止治疗，如果有是没有病毒学影响，除了以前拉米夫定曝光，拉米夫定在其中添加到ADV青少年。 HBeAg血清转换的耐久性进行了评估。曾检测到HBV DNA的科目进行年度性监测。
结果：

谁完成了48周的研究的170个学科，162个参加在开放标签研究。 ADV停止在61个科目，由于病毒学失败。谁继续作为单一治疗或与拉米夫定治疗的受试者中，持续的病毒抑制和ALT正常化。 HBeAg的seroconversions观察，在55个科目，并在5乙肝表面抗原转阴。最后观察的HBeAg血清转换的平均持续时间为762±371.2天，ADV-ADV组和643±291.5天，在小巴ADV组。 ADV是安全的，耐受性良好。抗ADV，ADV单药治疗观察1个孩子。九个治疗经验的受试者进入与拉米夫定相关的基因突变的研究。所有回应ADV治疗。
结论：

ADV长期治疗是儿童的安全。如果只为6个月内的病毒学应答者保留，病毒的抵抗是微不足道的

咬牙硬挺

希望早日出现比替诺还好的药