葛兰素史克(GSK)旗下抗艾滋新药Tivicay（dolutegravir）50mg片剂已获批准上市
2013年8月12日美国食品和药品监督管理局(FDA)批准Tivicay(dolutegravir)，一个新药治疗HIV-1感染。
Tivicay是一种整合酶链转移抑制剂干扰HIV繁殖所需酶之一。它是每天与其他抗病毒药物联用的服用药丸。
Tivicay被批准在宽广HIV感染患者群中使用。可用于治疗从未用过HIV治疗的HIV-感染成年(未治疗过)和HIV-感染成年既往曾用 HIV治疗 (经受过治疗)，包括曾用其他整合酶链转移抑制剂治疗过患者。Tivicay还被批准为年龄12岁和以上体重至少40公斤，未治疗过或经受过治疗的儿童但是既往未曾用过整合酶链转移抑制剂。
美国FDA药物评价和研究中心抗微生物产品室主任Edward Cox，M.D.，M.P.H. 说：“HIV-感染个体需要治疗方案个体化以配合其情况和他们的需求，”“对FDA批准新药像Tivicay增加已存在选择方案仍是优先政策。”
根据美国疾病控制和预防中心：每年约50,000美国人成为受HIV感染者和约2010年约15,500 死于该病。
在四项临床试验纳入2,539例参加者中评价Tivicay的安全性和疗效。依赖于试验，参加者被随机赋予接受Tivicay或Isentress (拉替拉韦[raltegravir])，各与其他抗病毒药联用，或Atripla，一个固定剂量的依非韦伦[efavirenz]，恩曲他滨[emtricitabine]和替诺福韦[tenofovir]联用。结果显示含Tivicay方案有效减低病毒负荷。
第五项试验作为对年龄12岁和以上及体重至少40公斤既往未用过整合酶链转移抑制剂HIV感染儿童，治疗方案的一部分，确定Tivicay的药代动力学，安全性和活性。
在临床研究期间观察到常见副作用包括难以睡眠(失眠)和头痛。严重副作用包括超敏性反应和在合并乙型和/或丙型肝炎参加者异常肝功能。Tivicay说明书给建议监视患者严重副作用。
Tivicay由总部在北卡罗来纳三角研究园GlaxoSmithKline制造。Isentress是由总部Merck白宫站上市而Atripla由总部加州旧金山Gilead。

FDA Approves New Drug to Treat HIV Infection
The FDA has approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection.
Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.
Tivicay is approved for use in a broad population of HIV-infected patients. It can be used to treat HIV-infected adults who have never taken HIV therapy (treatment-naïve) and HIV-infected adults who have previously taken HIV therapy (treatment-experienced), including those who have been treated with other integrase strand transfer inhibitors. Tivicay is also approved for children ages 12 years and older weighing at least 40 kilograms (kg) who are treatment-naïve or treatment-experienced but have not previously taken other integrase strand transfer inhibitors.
“HIV-infected individuals require treatment regimens personalized to fit their condition and their needs,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “The approval of new drugs like Tivicay that add to the existing options remains a priority for the FDA.”
About 50,000 Americans become infected with HIV each year and about 15,500 died from the disease in 2010, according to the Centers for Disease Control and Prevention.
Tivicay’s safety and efficacy in adults was evaluated in 2,539 participants enrolled in four clinical trials. Depending on the trial, participants were randomly assigned to receive Tivicay or Isentress (raltegravir), each in combination with other antiretroviral drugs, or Atripla, a fixed-dose combination of efavirenz, emtricitabine and tenofovir. Results showed Tivicay-containing regimens were effective in reducing viral loads.
A fifth trial established the pharmacokinetics, safety and activity of Tivicay as part of treatment regimens for HIV-infected children ages 12 years and older weighing at least 40 kg who have not previously taken integrase strand transfer inhibitors.
Common side effects observed during clinical studies include difficulty sleeping (insomnia) and headache. Serious side effects include hypersensitivity reactions and abnormal liver function in participants co-infected with hepatitis B and/or C. The Tivicay label gives advice on how to monitor patients for the serious side effects.
Tivicay is manufactured by GlaxoSmithKline, based in Research Triangle Park, N.C. Isentress is marketed by Whitehouse Station, N.J.-based Merck, and Atripla is marketed by San Francisco, Calif.-based Gilead.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm364744.htm