Triumeq(abacavir, dolutegravir and lamivudine)
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授权形式： |
免费版 |
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| 文件大小： |
5.38 Kb |
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| 软件语言： |
简体中文 |
更新时间： |
2015-04-23 |
| 版本号： |
1.0 |
软件平台： |
Win2000/WinXP/Win2003 |
| 软件类别： |
国产软件 |
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| 评分等级： |
★★★☆☆ |
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| 发布人： |
admin |
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9（今日：4，本周：4，本月：5） |
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137 |
2014年8月27日,美国FDA批准Triumeq（阿巴卡韦600mg、Dolutegravir 50mg及拉米夫定300mg）片用于HIV-1感染治疗。Triumeq是ViiV医疗保健的首款基于Dolutegravir的固定剂量复方药物，它为好多HIV患者提供了一种单一药片用药方案选择，这款药物将整合酶链转移抑制(INSTI) Dolutegravir与核苷逆转录酶抑制剂(NRTIs) 阿巴卡韦及拉米夫定结合在了一起。
Triumeq单独用药不被推荐用于目前或过去对Triumeq中任何成分耐药的患者。Triumeq单独用药不被推荐用于对整合酶替药物有相关耐药性或临床疑似INSTI耐药性的患者，因为在Triumeq中的Dolutegravir剂量不足以用于这些人群。
在初始使用含有阿巴卡韦产品治疗之前，要对基因标志物HLA-B*5701等位基因的存在进行筛查，这种筛查应在所有HIV感染者中进行，不管患者来自何种种族。含有阿巴卡韦的产品不应用于已知携带有HLA-B*5701等位基因的患者。
ViiV医疗保健首席执行官Limet博士表示：“今天Triumeq的批准为美国的许多HIV患者提供了首个含有Dolutegravir的单一药片给药方案。ViiV医疗保健致力于在护理及新治疗药物选择上为医师及HIV患者带来进步。我非常自豪能够宣布这一重要的里程碑，这也标志着我们研发线上的第二款新药在美国获得批准。”
这次批准主要基于两项临床试验数据：
之前未经治疗的成年患者参与的3期研究(SINGLE)，患者分别给予Dolutegravir和阿巴卡韦/拉米夫定。
阿巴卡韦、Dolutegravir和拉米夫定组成的固定剂量的单一药片与Dolutegravir和阿巴卡韦/拉米夫定单独用药相比较的生物等效性研究。
SINGLE研究是一项非劣效性试验，并且预先设定了优势分析，试验中，Dolutegravir及阿巴卡韦/拉米夫定治疗组与最常用的单一药片Atripla（依法韦仑、恩曲他滨及泰诺福韦）相比，更多患者的疾病感染检测不到（HIV-1 RNA<50拷贝/mL）。两组间有统计学意义上的显著性差异，达到了预先设定的优势检测。这种差异性源于Atripla治疗组因不良事件而导致的更高中止率。
在经过96周的治疗后，以Dolutegravir为基础方案治疗的受试者中有80%患者的病毒得到抑制，相比之下Atripla治疗组只有72%的患者其病毒得到抑制。以Dolutegravir为基础方案治疗的患者2-4级紧急不良反应发生率为2%，或更多患者出现失眠(3%)、头痛(2%)和疲劳(2%)。
TRIUMEQ Rx
Pharmacological Class:
Nucleoside reverse transcriptase inhibitors (NRTIs) + integrase strand transfer inhibitor (INSTI).
Active Ingredient(s):
Abacavir 600mg, dolutegravir 50mg, lamivudine 300mg; tablets.
Company
ViiV Healthcare
Indication(s):
HIV-1 infection. Limitations of use: not recommended alone in patients with current or history of resistance to any of the components; or alone in resistance-associated integrase substitutions or INSTI resistance due to insufficient dolutegravir dose in Triumeq in these subpopulations.
Pharmacology:
Dolutegravir inhibits HIV integrase by binding to the active site and blocking the strand transfer step of retroviral DNA integration. Abacavir inhibits the activity of HIV-1 reverse transcriptase by competing with the natural substrate deoxyguanosine-5'-triphosphate and by its incorporation into viral DNA. Lamivudine inhibits HIV reverse transcriptase via DNA chain termination after incorporation of the nucleotide analog.
Clinical Trials:
The efficacy of Triumeq is supported by data from a randomized, controlled trial in antiretroviral treatment-naïve subjects, SINGLE, and other trials in treatment-naïve subjects. The efficacy of dolutegravir, in combination with ≥2 active background regimens in treatment-experienced, INSTI-naïve subjects is supported by data from SAILING.
For clinical trials data, see full labeling for Triumeq and Tivicay.
Legal Classification:
Rx
Adults:
1 tablet daily. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin: give additional dolutegravir 50mg separated by 12 hours from Triumeq.
Children:
Not established.
Contraindication(s):
Presence of HLA-B*5701 allele. Previous hypersensitivity reaction to any of the components. Concomitant dofetilide. Moderate or severe hepatic impairment.
Warnings/Precautions:
See full labeling re: fatal hypersensitivity reactions with abacavir; discontinue as soon as suspected; do not restart. Evaluate for presence of HLA-B*5701 allele prior to starting therapy or reinitiation; if (+), abacavir is contraindicated; discontinue permanently if hypersensitivity cannot be ruled out even if other diagnoses are possible, regardless of HLA-B*5701 status. If stopped for reasons other than hypersensitivity, restart only if medical care can be readily accessed; monitor. Suspend if lactic acidosis or hepatotoxicity occurs. Increased risk for worsening/development of elevated transaminases in patients with hepatitis B or C; monitor LFTs prior to starting, during therapy, and for at least several months after stopping treatment (discontinuing may exacerbate HBV infection). Decompensated liver disease; monitor. Immune reconstitution syndrome. Fat redistribution. Myocardial infarction: consider CHD risk before starting therapy and minimize modifiable risk factors (eg, HTN). Renal impairment (CrCl <50mL/min): not recommended. Use individual components if lamivudine or abacavir dose reductions are required. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s)
Concomitant other abacavir- or lamivudine-containing products: not recommended. Ethanol may increase abacavir levels. Abacavir may increase clearance of methadone. Dolutegravir may be affected by drugs that induce or inhibit UGT1A1, CYP3A, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort. Potentiates metformin; consider reducing metformin dose. Concomitant etravirine without atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir: not recommended. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin: requires extra dolutegravir dose (see Adults). Concomitant cation-containing antacids or laxatives, sucralfate, buffered drugs, oral calcium/iron supplements, multivitamins; give Triumeq 2hrs before or 6hrs after; alternatively, oral calcium/iron can be used at the same time when taken with food. Monitor for toxicities with IFN-α ± ribavirin (consider reducing dose or discontinue one or both drugs).
Adverse Reaction(s)
Insomnia, headache, fatigue.
How Supplied:
Tabs—30
LAST UPDATED:
12/2/2014
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