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吉利德HIV疗法增强剂Tybost获欧盟批准

  1. HIV
  2. Tybost
  3. 吉利德
  4. 药效增强剂

来源:生物谷 2013-09-27 14:47

2013年9月26日讯/生物谷BIOON/--吉利德科学(GileadSciences)9月25日宣布,Tybost(cobicistat150mg)获欧盟委员会(EC)批准,作为每日一次的药代动力学增强剂,提高特定艾滋病(HIV)药物的血药浓度。

2013年9月26日讯/生物谷BIOON/--吉利德科学(GileadSciences)9月25日宣布,Tybost(cobicistat150mg)获欧盟委员会(EC)批准,作为每日一次的药代动力学增强剂,提高特定艾滋病(HIV)药物的血药浓度。Tybost旨在作为HIV蛋白酶抑制剂阿扎那韦(atazanavir,300mg,每天一次)和地瑞那韦(darunavir,800mg,每天一次)的增强剂,作为抗逆转录病毒联合疗法的一部分,用于HIV-1成人感染者的治疗。此次批准,适用于所有28个欧盟成员国。

Tybost的获批,是基于关键性III期研究(Study114)的48周数据,研究结果证明了在与一种抗逆转录病毒疗法【阿扎那韦(atazanavir)+Truvada(恩曲他滨200mg+替诺福韦245mg)】联合用于初治HIV-1成人感染者时Tybost相较于利托那韦(ritanovi)的非劣性(non-inferior)。此外,药代动力学数据表明,Tybost提升atazanavir和darunavir血药浓度的水平,与ritonavir相似。Tybost仅适用于与atazanavir或darunavir联合用药。

Study114研究中,Tybost的耐受性良好,大部分不良事件为轻度至中度。最常见的不良反应为黄疸、眼黄疸、恶心。

Tybost是四合一型抗HIV新药Stribild(elvitegravir150mg/cobicistat150mg/emtricitabine200mg/tenofovirdisoproxil(asfumarate)245mg)的一个组成部分。Stribild是一种每日一次的单一片剂,分别于2012年8月和2013年5月获FDA和欧盟批准,用于HIV-1成人感染者。(生物谷Bioon.com)

英文原文:European Commission Approves Gilead Sciences’ Tybost™, a New Boosting Agent for HIV Therapy -

– Tybost Facilitates Once-Daily Dosing of the Protease Inhibitors Atazanavir and Darunavir –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 25, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for once-daily Tybost™ (cobicistat 150 mg tablets), a pharmacokinetic enhancer that boosts blood levels of certain HIV medicines. Tybost is indicated as a boosting agent for the HIV protease inhibitors atazanavir 300 mg once daily and darunavir 800 mg once daily as part of antiretroviral combination therapy in adults with HIV-1 infection. Today’s approval allows for the marketing of Tybost in all 28 countries of the European Union (EU).

“Gilead is pleased to offer HIV patients who rely on protease inhibitors a new boosting option to help facilitate once-daily dosing – an important factor in supporting treatment adherence,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences.

The EU approval of Tybost is supported by 48-week data from a pivotal Phase 3 study (Study 114), which found that Tybost was non-inferior to ritonavir when administered with an antiretroviral regimen of atazanavir plus Truvada® (emtricitabine 200 mg and tenofovir disoproxil (as fumarate) 245 mg) in HIV-infected treatment-naïve adults. Approval is also supported by pharmacokinetic data demonstrating that Tybost boosts blood levels of atazanavir and darunavir similar to ritonavir. Tybost should only be co-administered with atazanavir or darunavir.

In Study 114, Tybost was well tolerated and most adverse events were mild to moderate. The most common adverse reactions (incidence greater than or equal to 10 percent, all grades) were jaundice, ocular icterus and nausea.

Tybost is a component of Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil (as fumarate) 245 mg), a once-daily complete single tablet regimen for the treatment of HIV-1 infection that was approved in the United States in August 2012 and in the European Union in May 2013. Gilead submitted a new drug application to the U.S. Food and Drug Administration (FDA) for Tybost as a single agent in June 2012 and received a Complete Response Letter in April 2013. Gilead is working on resubmitting the application to the FDA. Tybost is approved as a single agent in Canada.

About Tybost

Tybost is a cytochrome P450 3A (CYP3A) inhibitor. It boosts blood levels of atazanavir and darunavir by suppressing CYP3A, an enzyme that metabolizes these drugs in the body. Tybost acts only as a pharmacokinetic enhancer and has no antiviral activity.

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