2016年4月4日，FDA批准Descovy(emtricitabine 200mg/tenofovir alafenamide 25mg, F/TAF), 组合剂量治疗HIV 。Descovy与其他抗逆转录病毒药物联合治疗HIV-1 感染的12岁以及12岁以上患者。Descovy不用预防性给药(PrEP)，以减少通过性传播，获得HIV-1 感染风险。
DESCOVY（恩曲他滨和替诺福韦alafenamide）片剂，供口服使用
最初美国批准：2015年
警告：
脂肪变性和乙肝的治疗后急性加重乳酸性酸中毒/重度肝肿大请参阅完整的黑框警告完整的处方信息。
乳酸性酸中毒和严重肝肿大伴脂肪变性，包括致命的情况下，已经报告了使用核苷类似物。
DESCOVY没有被批准用于治疗慢性乙型肝炎病毒（HBV）感染的治疗。乙肝严重的急性加重已在谁是病人合并感染HIV-1和HBV并有含恩曲他滨（FTC）和/或富马酸替诺福韦酯（TDF）停产产品的报道，并与DESCOVY停药可能会出现。肝功能应密切在这些患者进行监测。如果适当的话，抗乙肝治疗开始可能有必要。
作用机理
DESCOVY是抗逆转录病毒药物恩曲他滨（FTC）和替诺福韦alafenamide（TAF）的固定剂量组合[见微生物学]。
适应症和用法
DESCOVY是恩曲他滨（FTC）和替诺福韦alafenamide（TAF）的两药物组合，两者的HIV核苷类似物逆转录酶抑制剂（NRTIs），以及在与其他抗逆转录病毒药物组合的适应症为治疗成人HIV-1感染的和儿童患者12岁及以上。
使用限制：
DESCOVY不是为暴露前预防（PrEP的）使用，以降低高风险性收购HIV-1在成人的风险指示。
用法用量
测试：在此之前DESCOVY开始时，患者应为乙型肝炎病毒感染进行测试，和肌酐清除率，尿糖及尿蛋白应获得。
推荐用量：有或无的患者中12岁及以上体重至少35公斤，肌酐清除率大于或等于每分钟30毫升的食物，每天服用一次一粒。
患者低于每分钟30毫升肌酐清除率不推荐DESCOVY：肾功能损害。
剂型和规格
片剂：200毫克的FTC和25mg TAF。
禁忌症
没有。
警告和注意事项
体内脂肪重新分配/积累：在接受抗逆转录病毒治疗的患者中观察到。
免疫重建综合征：可能需要进一步的评估和治疗。
新发或加重肾功能损害：评估肌酐清除率，尿糖，并在所有患者尿蛋白开始DESCOVY治疗前和治疗过程中监控。监测患者的慢性肾脏病血清磷。
骨丢失和矿化缺陷：考虑监视BMD患者的病理性骨折或骨质疏松或骨流失的其他危险因素的历史。
不良反应
最常见的不良反应（发生率大于或等于10％，所有等级）是恶心。
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
之前和治疗潜在的药物相互作用过程中，请查阅完整的处方信息。
特殊人群中使用
哺乳期：感染艾滋病毒的妇女应指示不进行母乳喂养，由于艾滋病毒传播的可能性。
儿科：不建议用于患者小于12岁或体重低于35公斤。

FDA Approves Descovy as New HIV Treatment
The FDA yesterday approved Gilead's newest therapy for HIV-positive individuals aged 12 and older.  There is already buzz that this could be the new PrEP, though it has not yet been approved for use as a prophylaxis against HIV. 
Read the press release below:
Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.
Descovy has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B.
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
“As the first new HIV treatment backbone approved by the FDA in more than a decade, Descovy represents an important evolution in HIV care. As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health,” said  Norbert Bischofberger , PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “With today’s approval, Gilead is now able to offer patients and providers in the United States a range of options from our TAF based-portfolio, which is designed to help address the diverse needs of HIV patients worldwide.”
The approval of Descovy is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg, E/C/F/TAF) met its primary objective of non-inferiority compared to a F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg, E/C/F/TDF) among treatment naïve adult patients. Tests of certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen.
The approval also is supported by a Phase 3 study (Study 109) evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adult patients who switched from F/TDF-based regimens. In the study, the F/TAF-based regimen was found to be statistically non-inferior to the F/TDF-based regimens and demonstrated improvements in certain bone and renal laboratory parameters compared to the F/TDF-based regimens. Additionally, the approval is supported by data from Phase 3 studies evaluating the F/TAF-based regimen (administered as Genvoya) among virologically suppressed adults with mild-to-moderate renal impairment and among treatment naïve adolescents. Finally, bioequivalence studies demonstrated that Descovy achieved the same drug levels of TAF and emtricitabine in the blood as Genvoya.
Descovy does not cure HIV infection or AIDS.