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FDA批准替诺福韦艾拉酚胺用于慢性乙肝及肝病患者治疗

FDA approves tenofovir alafenamide for patients with chronic hepatitis B and liver disease

发布者:Frontline Medical News 发布时间:2016-11-22

The Food and Drug Administration has approved tenofovir alafenamide (marketed as Vemlidy by Gilead Sciences) for the treatment of adults with chronic hepatitis B virus infection with compensated liver disease.

FDA批准了替诺福韦艾拉酚胺(吉利德科学公司以商品名“Vemlidy”上市),用于治疗伴有代偿性肝病的慢性乙型肝炎病毒感染成人患者。

Tenofovir alafenamide is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to tenofovir disoproxil fumarate (Viread) at significantly lower doses.

替诺福韦艾拉酚胺是一种创新性、靶向性替诺福韦前药,已证明其在显著较低剂量时,与富马酸替诺福韦二吡呋酯(韦瑞德)具有相似的抗病毒疗效。

Approval for this drug was based on two international phase III clinical trials that, together, enrolled 1,298 treatment-naive and treatment-experienced adult patients with chronic hepatitis B virus infection, 425 of whom were HBeAg negative and 873 of whom were HBeAg positive. In both studies, participants were randomly treated with either tenofovir alafenamide or tenofovir disoproxil fumarate, and tenofovir alafenamide met the primary endpoint of noninferiority to tenofovir disoproxil fumarate, according to a written statement published by Gilead Sciences.

该药物获批是基于两项国际III期临床试验,试验共计入组1,298例未接受治疗和曾接受治疗的慢性乙型肝炎病毒感染成人患者,其中425例HBeAg阴性,873例HBeAg阳性。根据吉利德科学公司发布的声明,在两项研究中,受试者随机接受替诺福韦艾拉酚胺或富马酸替诺福韦二吡呋酯治疗,替诺福韦艾拉酚胺均达到了疗效不劣于富马酸替诺福韦二吡呋酯的主要终点。

Compared with tenofovir disoproxil fumarate, tenofovir alafenamide has “greater plasma stability and more efficiently delivers tenofovir to hepatocytes” which allows tenofovir alafenamide to be administered in daily doses of 25mg while tenofovir disoproxil fumarate requires a dose of 300 mg to be as effective.

与富马酸替诺福韦二吡呋酯相比,替诺福韦艾拉酚胺具有“更好的血浆稳定性,能更有效地将替诺福韦转运至肝细胞,”从而使得替诺福韦艾拉酚胺有效每日剂量为25 mg,而富马酸替诺福韦二吡呋酯则需要300 mg剂量。

In addition, patients treated with tenofovir alafenamide demonstrated “improvements in certain bone and renal laboratory parameters.”

此外,已证明替诺福韦艾拉酚胺治疗患者“在某些骨骼和肾脏实验室指标方面获得改善。”

Overall, tenofovir alafenamide was well tolerated. Only 1% of patients discontinued treatment because of adverse events, and the most common adverse events were headache, abdominal pain, fatigue, cough, nausea, and back pain. Vemlidy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis and severe acute exacerbation of hepatitis B with discontinuation.

总体而言,替诺福韦艾拉酚胺耐受性良好,仅有1%的患者因不良事件中止治疗,最常见的不良事件包括头疼、腹痛、疲乏、咳嗽、恶心以及背痛。Vemlidy药品说明书中含有一则关于乳酸性酸中毒/严重肝肿大伴脂肪变性以及中断治疗乙型肝炎病情严重急性恶化的黑框警告。

 “Vemlidy is the first medication approved to treat this disease in nearly a decade,” said President and Chief Executive Officer of Gilead Sciences John Milligan. “We are excited to offer a new, effective option to help advance long-term care for patients.”

吉利德科学公司总裁暨首席执行官John Milligan指出:“Vemlidy是近十年来首个获准治疗这类疾病的药物。我们很高兴能够提供一种新的有效选择,有助于促进这些患者的长期治疗。”

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来源: Frontline Medical News

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