Genvoya(elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide)是新一代四合一复方单片，疗效好，安全性更高，适用人群更广，是全球HIV患者的福音
2015年11月5日，美国食品和药品监管局(FDA)批准Genvoya(一种固定剂量组合片剂，包含埃替拉韦，cobicistat，恩曲他滨和替诺福韦艾拉酚胺)，作为一个完整的疗程，用于12岁及以上的儿童和成年人HIV-1感染患者
据美国疾病控制预防中心（CDC）估计，美国12岁以上的HIV感染者有120万人，另外有大约15万12岁以上的HIV患者不知道自己罹患艾滋病。在过去十年间，每年新增的HIV感染者的数量始终保持稳定。
美国FDA药品评价和研究中心，抗菌药物办公室主任爱德华·考克斯说：“今天批准的一种含有新型替诺福韦的固定剂量组合片剂，为HIV-1感染患者提供另一种有效的治疗，每日服用一片，即可抑制体内HIV-1病毒。”
批准的Genvoya药物使用人群限于12岁及以上的患者，体重至少达到35公斤(77磅)，之前从未针对艾滋病毒进行治疗过，或者艾滋病毒感染但病毒处于抑制状态的成人。对于肾功能严重损害的病人，研究人员不建议使用Genvoya，但是轻度和重度肾功能损害的病人仍可使用Genvoya。
Genvoya的安全性和疗效在4次临床试验和3171例HIV患者中得到验证。在临床试验中，HIV患者被随机分配成两组，一组服用Genvoya，另一组服用获FDA批准的其它抗艾滋药物。结果表明，相比另一组抗艾滋药物，Genvoya可大大降低患者体内的病毒数量。
Genvoya复方用药包含一种新型研发的替诺福韦。能够有效地降低患者血液中艾滋病病毒的数量。Genvoya减少了药物对人体产生的副作用，且能够改善肾功能和减轻骨质疏松问题。在研究中发现，与接受其他治疗方案的患者相比，接受Genvoya治疗的患者提高了血清脂质（总胆固醇和低密度脂蛋白的数量）。
Genvoya带有黑框警告：服用Genvoya可能会导致血液中乳酸的大量积累和严重的肝脏问题，两者都可能危及生命。黑框警告还提醒患者，Genvoya没有被批准用于治疗慢性乙型肝炎病毒感染。Genvoya最常见副作用是恶心，严重的副作用包括引发肾脏问题，骨密度下降，免疫系统改变和脂肪重新分配等。建议医护人员监测肾脏和骨骼的影响。Genvoya不与其他抗逆转录病毒产品，以及其他可能存在互作的常用药物同时服用。

GENVOYA (Elvitegravir,Cobicistat ,Emtricitabine,Tenofovir alafenamide)

GENVOYA Rx
Generic Name and Formulations:
Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir alafenamide (AF) 10mg; tabs.

Company:
Gilead Sciences, Inc.
Indications for GENVOYA:
As a complete regimen for HIV-1 infection in patients who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in virologically-suppressed (HIV-1 RNA <50 copies/mL) patients on a stable ARV regimen for ≥6 months with no history of treatment failure or no known substitutions associated with resistance to any components of Genvoya.

Adults and Children:
<12yrs: not established. ≥12yrs (≥35kg): 1 tab once daily with food. Severe hepatic or renal impairment (CrCl <30mL/min): not recommended.

Contraindications:
Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, pimozide, sildenafil (when dosed for PAH), triazolam, oral midazolam.

Warnings/Precautions:
Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Not for treating chronic hepatitis B; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Monitor CrCl, urine glucose, urine protein, serum phosphorus (in patients at risk for renal impairment; discontinue if significant renal dysfunction or Fanconi syndrome occurs). History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD). Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid with concurrent or recent use of nephrotoxic agents. Do not co-administer with other antiretroviral agents (eg, elvitegravir, cobicistat, emtricitabine, tenofovir DF, lamivudine, adefovir dipivoxil, ritonavir) or antimycobacterials (eg, rifabutin, rifapentine). May be potentiated by CYP3A inhibitors, antagonized by CYP3A inducers. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). May potentiate drugs metabolized by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1 or OATP1B3. May antagonize CYP2C9 substrates. Separate antacids by at least 2 hours. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), telithromycin, IV midazolam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole, itraconazole, voriconazole, beta-blockers, calcium channel blockers, fluticasone (use alternatives), atorvastatin, immunosuppressants, neuroleptics, sedatives/hypnotics, PDE5 inhibitors. Antagonized by oxcarbazepine, systemic dexamethasone; use alternatives. Concomitant colchicine (see full labeling); avoid in renal or hepatic impairment. Concomitant buprenorphine/naloxone; monitor. Discontinue bosentan ≥36 hours prior to initiation of Genvoya; resume bosentan after ≥10 days following initiation. Concomitant salmeterol: not recommended; increased risk of cardiovascular events. Use alternative non-hormonal methods of contraception. Monitor INR with warfarin.

Pharmacological Class:
HIV-1 integrase strand transfer inhibitor + pharmacokinetic enhancer + nucleos(t)ide analog reverse transcriptase inhibitors.

Adverse Reactions:
Nausea, diarrhea, fatigue, headache; decreased BMD, new onset or worsening renal impairment.

Metabolism:
Hepatic (CYP3A, 2D6).

Elimination:
Fecal (major); renal.

Generic Availability:
NO

How Supplied:
Tabs—30