News Alter:FDA Approves Combination Drug for Pediatric HCV Infection

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Yael Waknine
Authors and Disclosures

August 24, 2011 — The US Food and Drug Administration (FDA) has approved an expanded indication for peginterferon alfa-2a [40 KD] and ribavirin (Pegasys and Copegus, both made by Hoffman-LaRoche, Inc), allowing use of the combination treatment in pediatric patients aged 5 through 7 years with chronic hepatitis C (HCV) who have compensated liver disease and no prior history of interferon therapy.

The approval was based on the results of Study NV17424, which was conducted by the company in accordance with FDA postmarketing requirements for pediatric evaluation when approving the drug combination for adult use.

For the study, investigators randomly assigned 114 children to receive 48 weeks of treatment either with peginterferon alfa-2a (body surface area × 180 μg/1.73 m2 once weekly) plus ribavirin (~15 mg/kg/day in 2 divided doses) or with peginterferon alfa-2a plus placebo.

As previously demonstrated in adults, the addition of ribavirin to peginterferon alfa-2a therapy significantly improved the rate of sustained virologic response (HCV RNA < 50 IU/mL) at 24 weeks posttherapy (53% vs 20%). Treatment was particularly effective for eliciting a sustained response in patients with non–genotype 1 HCV compared with the difficult-to-treat genotype 1 (80% vs 47%).

The most important adverse event related to pediatric peginterferon alfa-2a/ribavirin therapy was growth delay relative to baseline: Weight and height for age z-scores and percentiles decreased during treatment but returned to normal for most children by 2 years posttherapy.

Other treatment-emergent effects were similar to those observed in adults and included influenza-like illness (91%), headache (62%), gastrointestinal disorders (56%), injection site reactions (45%), irritability (31%), fatigue (27%), rash (20%), pruritis (15%), and insomnia and decreased appetite (13% each). Dose modifications were required for about 35% of patients in each treatment group, most commonly because of neutropenia (peginterferon alfa-2a/ribavirin) and anemia (peginterferon alfa-2a monotherapy).

Peginterferon alfa-2a and ribavirin combination therapy is also approved by the FDA for the treatment of HCV in patients coinfected with HIV.

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将检测到英语译成中文(简体)作者：Yael Waknine
作者及披露

2011年8月24日 - 美国食品和药物管理局（FDA）已批准聚乙二醇干扰素α- 2a的[40第纳尔]和利巴韦林（派罗欣和COPEGUS，霍夫曼 - 拉罗什公司），允许使用相结合的扩大迹象治疗代偿期肝病和干扰素治疗没有事先历史与慢性丙型肝炎（HCV）5至7年的儿科患者。

审批的基础上，这是由该公司按照FDA批准成人使用的药物组合时，儿科评价上市后的要求进行的研究NV17424的结果。

在这项研究中，研究人员随机分配114名儿童接受聚乙二醇干扰素α- 2a（体表面积× 180μg/1.73平方米，每周一次）联合利巴韦林治疗48周（15毫克/公斤/天，分2剂量）或聚乙二醇干扰素α- 2a加安慰剂。

正如先前在成年人表明，利巴韦林除了聚乙二醇干扰素α- 2a干扰素治疗显着改善的持续病毒学应答率（HCV - RNA <50 IU / mL）的24周posttherapy（53％VS 20％）。引出一个非基因型1丙型肝炎患者的持续应答相比，治疗特别有效的难以治疗基因1型（80％VS 47％）。

儿科聚乙二醇干扰素alfa-2a/ribavirin治疗相关的不良事件的最重要的是相对基线：年龄Z -分数和减少治疗期间百分的重量和高度的生长延迟，但2年posttherapy，对于大多数孩子正常返回。

其他的治疗效果，在成年人中观察到的类似，包括流感样疾病（91％），头痛（62％），胃肠功能紊乱（56％），注射部位反应（45％），烦躁（31％），疲劳（27％），皮疹（20％），瘙痒（15％），和失眠，降低食欲（13％）。约35％的患者在各治疗组，最常用的，因为嗜中性白血球减少症（聚乙二醇alfa-2a/ribavirin）和贫血（聚乙二醇干扰素α- 2a单一疗法）所需的剂量调整。

聚乙二醇干扰素α- 2a和利巴韦林联合疗法也被FDA批准用于治疗丙型肝炎病毒与艾滋病毒双重感染的病人。