FDA批准Sovaldi和Harvoni为小儿丙型肝炎患者

StephenW

FDA Approves Sovaldi and Harvoni for Pediatric Hepatitis C Patients
By Carolina Henriques

Sovaldi (sofosbuvir) and Harvoni (ledipasvir / sofosbuvir) were recently added to the list of approved medications for the treatment of hepatitis C virus (HCV) in pediatric patients ages 12 to 17 by the U.S. Food and Drug Administration (FDA).

Sovaldi and Harvoni are the first direct-acting antiviral treatments approved for pediatric HCV patients. Direct-acting antiviral drugs are designed to reduce the amount of HCV in the body by preventing the virus from multiplying.

Both drugs are produced and commercialized by Gilead, and already already approved for the treatment of HCV in adult patients.

The two drugs are now also informed for children ages 12 and older who weigh at least 77 pounds (35 kg).

Sovaldi can be administered with or without ribavirin, and it is indicated for the treatment of HCV genotypes 2 and 3. The effectiveness of the therapeutic combination of Sovaldi plus ribavirin was evaluated in a clinical trial enrolling 50 pediatric patients with results do with those found in Adults. In a follow-up 12 weeks after finishing treatment, 100 percent of patients with HCV genotype 2 and 97 percent of patients with HCV genotype 3 had no virus detected in their blood.

Harvoni is indicated for pediatric patients with the HCV genotypes 1, 4, 5 or 6 who have no cirrhosis or mild cirrhosis.

The safety, pharmacokinetics and effectiveness of Harvoni for the treatment of HCV genotype 1 were established in a trial enrolling 100 pediatric patients. Results were compared on those observed in adults - 98 percent of patients had no signs of HCV in their blood 12 weeks after treatment The

For the assessment in the HCV genotypes 4, 5 and 6, safety and effective were measured based on data showing similar results in adults and teens with HVC genotypes 1, 4, 5 and 6.

The most common adverse equipment observed with the combination therapy Sovaldi plus ribavirin, as well as with Harvoni, were fatigue and headache.

"These approvals will help change the landscape for HCV treatment by interpreted an unmet need in children and adolescents," Edward Cox, MD, director of the FDA's Office of Antimicrobial Products, said in a press release.

In other related news, the European Public Health Alliance (EPHA) plus 30 other civil society organizations from 17 European countries recently filed a coordinated patent against on Sovaldi and Harvoni contesting the high prices of the drugs. Results of this progress might translate into more accessible Treatment for European patients.

StephenW

FDA批准Sovaldi和Harvoni为小儿丙型肝炎患者
由Carolina Henriques

最近，美国食品和药物管理局（FDA）将Sovaldi（sofosbuvir）和Harvoni（ledipasvir / sofosbuvir）添加到12至17岁儿科患者中用于治疗丙型肝炎病毒（HCV）的批准药物清单。

Sovaldi和Harvoni是第一个批准用于儿科HCV患者的直接作用的抗病毒治疗。直接作用的抗病毒药物旨在通过防止病毒繁殖来减少身体中的HCV的量。

这两种药物都是由吉利德生产和商业化的，已经在成人患者中已经被批准用于治疗HCV。

这两种药物现在也被告知体重至少为77磅（35公斤）的12岁及以上的儿童。

Sovaldi可以与有或没有利巴韦林一起给药，并且用于治疗HCV基因型2和3。在临床试验中评估了Sovaldi加利巴韦林治疗组合的有效性，其中有50例儿科患者的结果与成人在完成治疗后12周的随访中，100％的HCV基因型2患者和97％的HCV基因型3患者在其血液中没有检测到病毒。

Harvoni适用于没有肝硬化或轻度肝硬化的HCV基因型1,4,5或6的儿科患者。

Harvoni治疗HCV基因型1的安全性，药代动力学和有效性建立在入选100例儿科患者的试验中。对成年人观察结果进行比较 - 治疗后12周，98％的患者血液中没有HCV血症

对于HCV基因型4,5和6的评估，基于在HVC基因型1,4,5和6的成年人和青少年中显示类似结果的数据来测量安全性和有效性。

用联合治疗Sovaldi加利巴韦林以及Harvoni观察到的最常见的不良设备是疲劳和头痛。

FDA的抗菌产品办公室主任爱德华·考克斯（Edward Cox，MD）在新闻稿中表示：“这些批准将有助于通过解释儿童和青少年未满足的需求来改变HCV治疗的风景。

在其他相关消息中，欧洲公共卫生联盟（EPHA）以及来自17个欧洲国家的其他30个民间社会组织最近就Sovaldi和Harvoni提出了一项协调专利，以反对高价格的药物。这一进展的结果可能转化为欧洲患者更容易治疗。