11月18日，整合酶抑制剂Vitekta(elvitegravir)已获FDA批准，用于无任何已知elvitegravir抗性相关突变的HIV-1成人感染者的治疗。 批准日期：2013年11月18日 公司：Gilead VITEKTA（elvitegravir）片剂，口服使用 最初美国批准：2012 作用机理 VITEKTA是HIV-1的抗病毒药物[见微生物学]。 适应症和用法 VITEKTA是人免疫缺陷病毒1型（HIV-1）的组合使用HIV蛋白酶抑制剂合用与利托那韦以及与其它抗逆转录病毒药物（多个）整合酶链转移抑制剂在抗逆转录病毒治疗的HIV-1感染的指示治疗经历成年人。 使用限制： 有没有比较的药代动力学和临床资料cobicistat评估VITEKTA单实体相比STRIBILD®。 不推荐VITEKTA与蛋白酶抑制剂和cobicistat联合给药。 不建议使用的剂量方案或除表1中呈现的其他HIV-1蛋白酶抑制剂VITEKTA合用。 用法用量 VITEKTA必须结合使用HIV蛋白酶抑制剂合用与利托那韦和另一抗逆转录病毒药物。 食物每日一次采取推荐用量： 伴随利托那韦的伴随蛋白酶抑制剂用量VITEKTA用量用法用量 85毫克口服，每日一次，阿扎那韦300 mg口服每天一次100毫克，每天一次口服 洛匹那韦400毫克口服，每日两次100毫克，每天两次口服 150毫克口服，每日一次，达芦那韦600毫克口服，每日两次100毫克，每天两次口服 夫沙那韦700毫克口服，每日两次100毫克口服，每日两次 替拉那韦500毫克口服，每日两次200毫克，每天两次口服 剂型和规格 片剂：85毫克和150毫克 禁忌症 有没有禁忌VITEKTA。 由于需要使用VITEKTA与蛋白酶抑制剂合用与利托那韦，协商合用蛋白酶抑制剂和利托那韦对他们的禁忌症的处方信息。 警告和注意事项 不要用cobicistat合用蛋白酶抑制剂使用。 不要与其它含elvitegravir的药物，包括STRIBILD使用。 免疫重建综合征：可能需要进一步的评估和治疗。 不良反应 最常见的不良反应为VITEKTA（所有等级）是腹泻。 要报告疑似不良反应，请联系吉利德科学公司1-800-GILEAD-5或FDA电话1-800-FDA-1088或www.fda.gov/medwatch。 药物相互作用 CYP3A诱导：能降elvitegravir是导致疗效丧失的浓度。 蛋白酶抑制剂和利托那韦：可能增加通过CYP3A代谢的药物浓度。 之前和治疗潜在的药物相互作用过程中，请咨询完整处方信息。 特殊人群中使用 妊娠：只有潜在效益合理的潜在风险在怀孕期间使用。 哺乳母亲：女性艾滋病病毒感染者应指示由于不进行母乳喂养，为艾滋病毒传播的可能性。 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=be87c3bc-97bb-49cb-8053-9b0c756a1965 FDA Approves Two HIV Drugs: Tybost and Vitekta The U.S. Food and Drug Administration recently approved the HIV treatment boosting agent cobicistat (Tybost). Already a component of the combination drug Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir), cobicistat is only the second boosting agent to be approved for separate use, after ritonavir (Norvir). Cobicistat is used to increase the level of two protease inhibitors in the blood by suppressing an enzyme that metabolizes these drugs in the body. It is indicated for once-daily use with either atazanavir (Reyataz) or darunavir (Prezista). The safety and efficacy of cobicistat when used with atazanavir were demonstrated during a Phase three randomized, double-blind clinical trial where treatment-naïve participants received either atazanavir 300 mg + cobicistat 150 mg or atazanavir 300 mg + ritonavir 100 mg once daily. All participants received concomitant treatment with tenofovir DF 300 mg and emtricitabine 200 mg administered as a single tablet of Truvada. Atazanavir and cobicistat had similar effects on decreasing viral load. After 48 weeks, 85.2% and 87.4% of participants had a viral load less than 50 copies/mL in the cobicistat and atazanavir groups, respectively. Participants receiving cobicistat also had similar increases in CD4 cell counts from baseline compared to those on the ritonavir regimen. The most common adverse effects reported from cobicistat included jaundice, ocular icterus (yellowing of the eyes), and nausea. Elvitegravir (Vitekta) A separate component of Stribild has also been approved by the FDA for use in HIV treatment. Elvitegravir (Vitekta) is the third integrase inhibitor to be FDA approved in addition to raltegravir (Isentress) and dolutegravir (Tivicay). It is commonly prescribed alongside a concomitant protease inhibitor and the boosting agent ritonavir (Norvir) as a second-line regimen. In a phase three clinical trial with treatment-experienced participants, elvitegravir was as effective as raltegravir in helping participants achieve viral suppression. After 48 weeks of treatment, a total of 59% of individuals taking elvitegravir 150 mg once a day compared to 58% of individuals taking raltegravir 400 mg twice a day achieved viral load suppression less than 50 copies/mL (individuals in both groups also took a background regimen of a ritonavir-boosted protease inhibitor and a second antiretroviral drug). After 96 weeks, the percent of individuals achieving viral suppression less than 50 copies/mL was lower in each group, yet similar (48% of individuals taking elvitegravir; 45% of individuals taking raltegravir). The amount of adverse events attributed to the study medication was also comparable between groups after 96 weeks, with more participants taking elvitegravir reporting diarrhea. ----------------------------------------------- 产地国家： 美国 原产地英文商品名: VITEKTA 85mgg/Tablets 30Tablets/bottle 原产地英文药品名: elvitegravir 中文参考商品译名: VITEKTA片 85毫克/片 30片/瓶 中文参考药品译名: elvitegravir 生产厂家中文参考译名: 吉利德科学 生产厂家英文名: Gilead ----------------------------------------------- 产地国家： 美国 原产地英文商品名: VITEKTA 150mgg/Tablets 30Tablets/bottle 原产地英文药品名: elvitegravir 中文参考商品译名: VITEKTA片 50毫克/片 30片/瓶 中文参考药品译名: elvitegravir 生产厂家中文参考译名: 吉利德科学 生产厂家英文名: Gilead