Birkus G, Wang R, Liu X et al. 22. Brief Report: A Randomized, Double-Blind Comparison of Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate, Each Coformulated With Elvitegravir, Cobicistat, and Emtricitabine for Initial HIV-1 Treatment: Week 96 Results. It is important to take this medication exactly as prescribed by your doctor. 15. Ray AS, Fordyce MW, Hitchcock MJ. Panel on Antiretroviral Therapy and Medical Management of HIV-infected Children, US Department of Health and Human Services (HHS). Genvoya, Stribild may interact with other antiretroviral medications, drugs metabolized by CYP3A or CYP2D6, alpha 1-adrenoreceptor antagonists, anticonvulsants, antimycobacterials, ergot derivatives, St. John's wort, cisapride, HMG-CoA reductase inhibitors, pimozide, sildenafil, and sedative/hypnotics. Genvoya: This is a combination product that contains 4 medications in 1 tablet: cobicistat, emtricitabine, elvitegravir, and tenofovir alafenamide. German P, Liu HC, Szwarcberg J et al. Bonora S, Calcagno A, Trentalange A et al. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. Effect of cobicistat on glomerular filtration rate in subjects with normal and impaired renal function. Cathepsin A is the major hydrolase catalyzing the intracellular hydrolysis of the antiretroviral nucleotide phosphonoamidate prodrugs GS-7340 and GS-9131. Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. Akanbi MO, Scarsi KK, Scarci K et al. Wohl D, Oka S, Clumeck N et al. Switching to Tenofovir Alafenamide, Coformulated With Elvitegravir, Cobicistat, and Emtricitabine, in HIV-Infected Patients With Renal Impairment: 48-Week Results From a Single-Arm, Multicenter, Open-Label Phase 3 Study. Combination of two pathways involved in raltegravir resistance confers dolutegravir resistance. Malet I, Thierry E, Wirden M et al. These 4 medications are used in combination to treat human immunodeficiency virus (HIV) infection.
Fixed combination of EVG/c/FTC/TAF not indicated for treatment of chronic HBV infection.Severe, acute exacerbations of HBV reported following discontinuance of preparations containing emtricitabine and/or the tenofovir prodrug tenofovir disoproxil fumarate (tenofovir DF; TDF) in patients coinfected with HIV and HBV;Monitor hepatic function closely with both clinical and laboratory follow-up for at least several months after EVG/c/FTC/TAF discontinued in patients coinfected with HIV and HBV.Antiretroviral; fixed combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (EVG/c/FTC/TAF).Treatment of HIV-1 infection in antiretroviral-naive (have not previously received antiretroviral therapy) or antiretroviral-experienced (previously treated) adults and pediatric patients ≥12 years of age.Fixed combination of EVG/c/FTC/TAF used alone as a complete regimen for treatment of HIV-1 infection;For antiretroviral-experienced adults and pediatric patients ≥12 years of age, manufacturer states EVG/c/FTC/TAF can be used to replace the current antiretroviral regimen in those with plasma HIV-1 RNA levels <50 copies/mL on a stable antiretroviral regimen for ≥6 months who have no history of treatment failure and are infected with HIV-1 with no known substitutions associated with resistance to the antiretroviral components of the fixed combination (i.e., elvitegravir, emtricitabine, tenofovir).Test for HBV infection prior to initiation of EVG/c/FTC/TAF.Administer fixed combination of EVG/c/FTC/TAF orally once daily with food.Each fixed-combination tablet of EVG/c/FTC/TAF contains elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg.Tenofovir alafenamide component provided as tenofovir alafenamide fumarate; dosage expressed in terms of tenofovir alafenamide.Pediatric patients ≥12 years of age weighing ≥35 kg: 1 tablet of EVG/c/FTC/TAF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg) once daily.1 tablet of EVG/c/FTC/TAF (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg, tenofovir alafenamide 10 mg) once daily.Mild or moderate hepatic impairment (Child-Pugh class A or B): Dosage adjustments not needed.Severe hepatic impairment (Child-Pugh class C): Do Concomitant use with drugs highly dependent on CYP3A for metabolism and for which elevated plasma concentrations are associated with serious and/or life-threatening events (e.g., alfuzosin, cisapride, ergot alkaloids, lovastatin, lurasidone, oral midazolam, pimozide, sildenafil used for treatment of pulmonary arterial hypertension [PAH], simvastatin, triazolam).Concomitant use with drugs that are potent inducers of CYP3A; these drugs may result in decreased elvitegravir and/or cobicistat concentrations resulting in possible decreased antiretroviral efficacy and development of resistance.Test all HIV-infected patients for presence of HBV before initiating antiretroviral therapy.EVG/c/FTC/TAF not indicated for treatment of chronic HBV infection.Severe acute exacerbations of HBV reported following discontinuance of preparations containing emtricitabine and/or tenofovir DF in HIV-infected patients with HBV infection.Closely monitor hepatic function (using both clinical and laboratory follow-up) for at least several months after EVG/c/FTC/TAF is discontinued in patients coinfected with HIV and HBV.Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with hypophosphatemia), reported with tenofovir prodrugs (e.g., tenofovir DF).Cobicistat (a component of EVG/c/FTC/TAF) may cause modest increase in SPatients receiving a tenofovir prodrug who have impaired renal function or are receiving a nephrotoxic agent (e.g., high-dose or multiple NSAIAs) are at increased risk of developing adverse renal effects.Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving HIV NRTIs, including emtricitabine and tenofovir DF, in conjunction with other antiretrovirals.Interrupt EVG/c/FTC/TAF treatment if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).Tenofovir prodrugs (tenofovir alafenamide, tenofovir DF) have been associated with decreases in bone mineral density (BMD).Long-term clinical importance of BMD changes reported with tenofovir prodrugs unknown.Consider cautions, precautions, and contraindications associated with each component of EVG/c/FTC/TAF.EVG/c/FTC/TAF is used alone as a complete regimen for treatment of HIV-1 infection;Do not use EVG/c/FTC/TAF concomitantly with any preparation that contains any of its components (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide).During initial treatment, patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution;Antiretroviral Pregnancy Registry at 800-258-4263 or Prospective pregnancy data from the Antiretroviral Pregnancy Registry insufficient to date to adequately assess risk of birth defects or miscarriage if EVG/c/FTC/TAF used in pregnant women.In animal studies, no evidence of adverse developmental effects when components of EVG/c/FTC/TAF administered separately during organogenesis at elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide exposures up to 23, 3.8, 108, and 53 times higher, respectively, than human exposures at the recommended daily dosage.Experts state data insufficient to recommend routine use of EVG/c/FTC/TAF for Elvitegravir and cobicistat distributed into milk in rats.Not known whether EVG/c/FTC/TAF affects human milk production or affects the breast-fed infant.Instruct HIV-infected women not to breast-feed because of risk of HIV transmission and risk of adverse effects in the infant.Safety and efficacy of EVG/c/FTC/TAF not established in pediatric patients <12 years of age or in those weighing <35 kg.Experts state that EVG/c/FTC/TAF is a preferred antiretroviral regimen in children and adolescents ≥12 years of age weighing ≥35 kg, including those in early puberty (SMR 1–3).Clinical trial data indicate safety and efficacy of EVG/c/FTC/TAF in HIV-1-infected, treatment-naive pediatric patients 12 to <18 years of age is similar to that reported in adults.No differences in safety or efficacy of EVG/c/FTC/TAF observed between individuals ≥65 years of age and individuals 12 to <65 years of age.Mild hepatic impairment (Child-Pugh class A): No clinically important effects on pharmacokinetics of tenofovir alafenamide.Moderate hepatic impairment (Child-Pugh class B): No clinically important effects on pharmacokinetics of elvitegravir, cobicistat, or tenofovir alafenamide;Severe hepatic impairment (Child-Pugh class C): EVG/c/FTC/TAF not recommended;Cobicistat: Substrate and inhibitor of CYP3A and 2D6.Tenofovir alafenamide: Weak inhibitor of CYP3A in vitro, but does not inhibit or induce CYP3A in vivo.The following interactions are based on studies using elvitegravir, elvitegravir administered with cobicistat (Consider potential interactions associated with each drug in the fixed combination.CYP3A or 2D6 substrates: Potential increased plasma concentrations of such substrates.CYP3A inducers: Potential decreased plasma concentrations of elvitegravir, cobicistat, and/or tenofovir alafenamide;CYP3A inhibitors: Potential increased plasma concentrations of cobicistat.P-gp substrates: Potential increased concentrations of such substrates.P-gp inhibitors: Potential increased tenofovir alafenamide concentrations.P-gp inducers: Decreased absorption and decreased plasma concentrations of tenofovir alafenamide expected.BCRP substrates: Potential increased concentrations of such substrates.BCRP inhibitors: Potential increased tenofovir alafenamide concentrations.OATP1B1 or 1B3 substrates: Potential increased concentrations of such substrates.Drugs that reduce renal function or compete for active tubular secretion: Potential increased concentrations of emtricitabine, tenofovir, and/or concomitant drug.Competition for active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the aminoglycoside;Antacids, aluminum-, calcium-, and/or magnesium-containingDecreased elvitegravir concentrations and AUC when administered simultaneouslyGive EVG/c/FTC/TAF at least 2 hours before or at least 2 hours after antacidsAntiarrhythmic agents (e.g., amiodarone, disopyramide, dronedarone, flecainide, lidocaine [systemic], mexiletine, propafenone, quinidine)Amiodarone, disopyramide, dronedarone, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine: Possible increased antiarrhythmic agent concentrationsAmiodarone, disopyramide, dronedarone, flecainide, lidocaine (systemic), mexiletine, propafenone, quinidine: Use concomitantly with caution;Anticoagulants (apixaban, dabigatran, edoxaban, rivaroxaban, warfarin)Apixaban, edoxaban, rivaroxaban: Increased anticoagulant concentrations expectedDabigatran: Possible increased dabigatran concentrationsWarfarin: Effect on warfarin pharmacokinetics not known,Apixaban, edoxaban, rivaroxaban: Avoid concomitant use with EVG/c/FTC/TAFDabigatran: Some experts state dosage adjustments not needed if used with EVG/c/FTC/TAF in patients with ClAnticonvulsants (carbamazepine, ethosuximide, oxcarbazepine, phenobarbital, phenytoin)Carbamazepine, phenobarbital, phenytoin: Possible decreased elvitegravir, cobicistat, and tenofovir alafenamide concentrations with possible decreased antiretroviral efficacy and development of resistanceEthosuximide: Possible increased ethosuximide concentrations;Oxcarbazepine: Possible decreased elvitegravir, cobicistat, and tenofovir alafenamide concentrationsCarbamazepine, phenobarbital, phenytoin: Concomitant use contraindicatedAntidepressants, tricyclics (amitriptyline, desipramine, doxepin, imipramine, nortriptyline)Possible increased tricyclic antidepressant concentrations and AUCDesipramine: Increased desipramine concentrations when used concomitantly with cobicistatInitiate tricyclic antidepressant using lowest initial dosage and carefully titrate dosage according to clinical responseIsavuconazonium (prodrug of isavuconazole): Possible increased isavuconazole, elvitegravir, and cobicistat concentrationsItraconazole: Possible increased itraconazole, elvitegravir, and cobicistat concentrationsKetoconazole: Increased ketoconazole, elvitegravir, and cobicistat concentrationsPosaconazole: Possible increased posaconazole, elvitegravir, and cobicistat concentrationsVoriconazole: Possible increased voriconazole, elvitegravir, and cobicistat concentrationsItraconazole: Do not exceed itraconazole dosage of 200 mg dailyKetoconazole: Do not exceed ketoconazole dosage of 200 mg dailyVoriconazole: Avoid concomitant use unless benefits outweigh risksAntimycobacterials (rifabutin, rifampin, rifapentine)Rifabutin: Decreased elvitegravir concentrations and AUC and increased rifabutin metabolite concentrations and AUC when used with Rifampin: Possible decreased elvitegravir, cobicistat, and tenofovir alafenamide concentrations with possible decreased antiretroviral efficacy and development of resistanceRifapentine: Possible decreased elvitegravir, cobicistat, and tenofovir alafenamide concentrations with possible decreased antiretroviral efficacy and development of resistanceTicagrelor or vorapaxar: Increased antiplatelet agent concentrations expectedAntipsychotics (e.g., lurasidone, perphenazine, pimozide, quetiapine, risperidone, thioridazine)Lurasidone: Possible serious and/or life-threatening reactionsPerphenazine, risperidone, thioridazine: Possible increased antipsychotic concentrationsPimozide: Possible increased pimozide concentrations resulting in serious and/or life-threatening reactions (e.g., cardiac arrhythmias)Quetiapine: Increased quetiapine concentrations expectedPerphenazine, risperidone, thioridazine: Decreased antipsychotic dosage may be neededMetoprolol, timolol: Possible increased β-blocking agent concentrationsBenzodiazepines (e.g., clonazepam, clorazepate, diazepam, estazolam, flurazepam, lorazepam, midazolam, triazolam)Diazepam: Possible increased diazepam concentrationsLorazepam: Clinically important effects on lorazepam concentrations not expectedMidazolam or triazolam: Increased benzodiazepine concentrations;Clonazepam, clorazepate, estazolam, flurazepam: Possible increased benzodiazepine concentrationsDiazepam: Use concomitantly only in monitored setting where respiratory depression and/or prolonged sedation can be managed;Clonazepam, clorazepate, estazolam, flurazepam: Experts recommend low initial benzodiazepine dosage with close monitoringIn patient already receiving EVG/c/FTC/TAF for ≥10 days, initiate bosentan using dosage of 62.5 mg once daily or every other day based on individual tolerabilityIn patient already receiving bosentan, discontinue bosentan for at least 36 hours prior to initiating EVG/c/FTC/TAF;Increased buprenorphine and norbuprenorphine concentrations and AUCs;Monitor closely for sedation and adverse cognitive effects;If patient receiving EVG/c/FTC/TAF is switched from transmucosal buprenorphine to subdermal implant, monitor to ensure buprenorphine effect is adequate and not excessiveCarefully titrate antidepressant dosage based on clinical responseCalcium-channel blocking agents (amlodipine, diltiazem, felodipine, nicardipine, nifedipine, verapamil)Possible increased calcium-channel blocking agent concentrationsGive EVG/c/FTC/TAF at least 2 hours before or at least 6 hours after oral calcium supplements;Increased elvitegravir concentrations and AUC as the result of cobicistat inhibition of CYP3A;Increased tenofovir alafenamide concentrations and AUC as the result of cobicistat inhibition of P-gp, BCRP, and OATP1B1 and 1B3Does not antagonize antiretroviral effects of elvitegravir, tenofovir, or emtricitabinePatients with renal or hepatic impairment: Concomitant use not recommendedColchicine for treatment of familial Mediterranean fever (FMF): In those receiving EVG/c/FTC/TAF, use maximum colchicine dosage of 0.6 mg daily (may be given as 0.3 mg twice daily)Dexamethasone (systemic): Possible decreased elvitegravir and cobicistat concentrationsFluticasone (orally inhaled, intranasal): Possible increased fluticasone concentrationsMethylprednisolone, prednisolone, or triamcinolone (intra-articular or other local injections): Increased corticosteroid concentrations;Dexamethasone (systemic): Consider alternative corticosteroidFluticasone (orally inhaled, intranasal): Consider alternative corticosteroid, particularly for long-term useMethylprednisolone, prednisolone, or triamcinolone (intra-articular or other local injections): Do not use concomitantly with EVG/c/FTC/TAFIf used concomitantly with EVG/c/FTC/TAF, use daclatasvir dosage of 30 mg once dailyFixed combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir (dasabuvir/ombitasvir/paritaprevir/ritonavir): Data not available regarding concomitant use with EVG/c/FTC/TAFDasabuvir/ombitasvir/paritaprevir/ritonavir: Concomitant use with EVG/c/FTC/TAF not recommendedUse concomitantly with caution; monitor digoxin concentrationsFixed combination of elbasvir and grazoprevir (elbasvir/grazoprevir): Possible increased elbasvir and grazoprevir concentrationsElbasvir/grazoprevir: Concomitant use not recommendedErgot alkaloids (dihydroergotamine, ergotamine, methylergonovine)Potential for serious and/or life-threatening adverse effects (e.g., peripheral vasospasm, ischemia of extremities)Oral contraceptives containing ethinyl estradiol and norgestimate: Decreased ethinyl estradiol concentrations and AUC and increased norgestimate concentrations and AUC;Oral contraceptives containing progestin other than norgestimate: Not studiedOther hormonal contraceptives (e.g., transdermal systems, vaginal ring, injections): Not studiedOral contraceptives containing ethinyl estradiol and norgestimate: Consider risks/benefits of concomitant use, particularly in women at risk of norgestimate-associated adverse effectsOral contraceptives containing progestins other than norgestimate: Consider alternative nonhormonal methods of contraceptionOther hormonal contraceptives (e.g., transdermal systems, vaginal ring, injections): Consider alternative nonhormonal methods of contraceptionFamotidine: No clinically important effect on elvitegravir concentrations or AUCElvitegravir: Component of fixed-combination EVG/c/FTC/TAF; do not use concomitantlyEmtricitabine, tenofovir alafenamide: Components of EVG/c/FTC/TAF;Tenofovir DF: Do not use any preparation containing tenofovir DF concomitantly with EVG/c/FTC/TAFOther HIV NRTIs (including lamivudine): Do not use concomitantly with EVG/c/FTC/TAFRitonavir: Do not use ritonavir or any ritonavir-containing preparation concomitantly with EVG/c/FTC/TAFAtorvastatin: Possible increased atorvastatin concentrationsLovastatin, simvastatin: Possible increased statin concentrations may lead to serious adverse effects, including myopathy and rhabdomyolysisRosuvastatin: Increased rosuvastatin concentrations and AUC;Atorvastatin: Initiate using lowest atorvastatin dosage and titrate carefully; monitor for atorvastatin-associated adverse effectsLovastatin, simvastatin: Concomitant use contraindicatedImmunosuppressive agents (everolimus, cyclosporine, sirolimus, tacrolimus)Cyclosporine: Possible increased cyclosporine, elvitegravir, and cobicistat concentrationsEverolimus, sirolimus, tacrolimus: Possible increased immunosuppressive agent concentrationsEverolimus, sirolimus, tacrolimus: Monitor immunosuppressive agent concentrations;Give EVG/c/FTC/TAF at least 2 hours before or at least 6 hours after iron preparations;Give EVG/c/FTC/TAF at least 2 hours before or at least 6 hours after laxatives containing polyvalent cations;Fixed combination of ledipasvir and sofosbuvir (ledipasvir/sofosbuvir): Clinically important pharmacokinetic interactions not expectedLedipasvir/sofosbuvir: Dosage adjustments not neededClarithromycin: Possible increased macrolide and/or cobicistat concentrationsClarithromycin: Dosage modification not needed in patients with ClClinically important pharmacokinetic interactions not expectedMultivitamins or other preparations containing calcium, iron, aluminum, magnesium, or zincGive EVG/c/FTC/TAF at least 2 hours before or at least 6 hours after multivitamins;High-dose or multiple NSAIAs: Competition for active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the concomitant NSAIA;Avoid EVG/c/FTC/TAF in patients who are receiving or have recently received a nephrotoxic drug (e.g., high-dose or multiple NSAIAs)Nucleoside and nucleotide antivirals (acyclovir, adefovir, cidofovir, entecavir, famciclovir, ganciclovir, ribavirin, valacyclovir, valganciclovir)Acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir: Competition for active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the concomitant antiviral;Entecavir, famciclovir: Clinically important interaction not expectedRibavirin: Clinically important interaction not expectedAdefovir: Do not use concomitantly with EVG/c/FTC/TAFDasabuvir/ombitasvir/paritaprevir/ritonavir: Data not available regarding concomitant use with EVG/c/FTC/TAFDasabuvir/ombitasvir/paritaprevir/ritonavir: Concomitant use with EVG/c/FTC/TAF not recommendedDasabuvir/ombitasvir/paritaprevir/ritonavir: Data not available regarding concomitant use with EVG/c/FTC/TAFDasabuvir/ombitasvir/paritaprevir/ritonavir: Concomitant use with EVG/c/FTC/TAF not recommendedOmeprazole: No clinically important effect on elvitegravir concentrations or AUCProton-pump inhibitors: Clinically important interactions with EVG/c/FTC/TAF not expectedSertraline: Clinically important interactions not expectedSSRIs: Carefully titrate SSRI dosage and monitor antidepressant responseIncreased sildenafil concentrations and increased risk of sildenafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)Sildenafil for treatment of PAH: Concomitant use with EVG/c/FTC/TAF contraindicatedSildenafil for treatment of erectile dysfunction: Do not exceed sildenafil dosage of 25 mg once every 48 hours;Clinically important pharmacokinetic interactions not expectedFixed combination of sofosbuvir and velpatasvir (sofosbuvir/velpatasvir): No clinically important pharmacokinetic interactionsPossible decreased elvitegravir, cobicistat, and tenofovir alafenamide concentrations with possible decreased antiretroviral efficacy and development of resistanceGive EVG/c/FTC/TAF at least 2 hours before or at least 6 hours after sucralfate;Increased tadalafil concentrations and increased risk of tadalafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)Tadalafil for treatment of PAH in patients who have been receiving EVG/c/FTC/TAF for ≥1 week: Use initial tadalafil dosage of 20 mg once daily;EVG/c/FTC/TAF in patients receiving tadalafil for PAH: Discontinue tadalafil for at least 24 hours prior to initiating EVG/c/FTC/TAF;Tadalafil for treatment of erectile dysfunction: Do not exceed tadalafil dosage of 10 mg once every 72 hours;Carefully titrate trazodone dosage and monitor antidepressant responsePossible increased vardenafil concentrations and increased risk of vardenafil-associated adverse effects (e.g., hypotension, syncope, visual disturbances, prolonged erection)Vardenafil for treatment of erectile dysfunction: Do not exceed vardenafil dosage of 2.5 mg once every 72 hours;Following an oral dose of EVG/c/FTC/TAF with food, peak plasma concentrations of elvitegravir and cobicistat occur at 4 and 3 hours, respectively, and peak plasma concentrations of emtricitabine and tenofovir occur at 3 and 1 hours, respectively.Cobicistat component of EVG/c/FTC/TAF increases plasma concentrations of elvitegravir and tenofovir alafenamide.Relative to fasting, administration of EVG/c/FTC/TAF with high-fat meal (approximately 800 kcal, 50% fat) increases mean systemic exposures of elvitegravir by 87%;Elvitegravir, cobicistat, tenofovir: Distributed into milk in rats;Cobicistat: Metabolized principally by CYP3A and, to a lesser extent, by CYP2D6.Emtricitabine: Converted intracellularly to active 5′-triphosphate metabolite;Emtricitabine: 70% in urine (glomerular filtration and active tubular secretion), 13.7% in feces.Tenofovir alafenamide: 31.7% in feces, <1% in urine.Mild hepatic impairment (Child-Pugh class A): No clinically important effects on pharmacokinetics of tenofovir alafenamide.Moderate hepatic impairment (Child-Pugh class B): No clinically important effects on pharmacokinetics of elvitegravir, cobicistat, or tenofovir alafenamide.Severe hepatic impairment (Child-Pugh class C): Pharmacokinetics of EVG/c/FTC/TAF not studied.EVG/c/FTC/TAF is a fixed-combination antiretroviral containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide.Elvitegravir (EVG) is an HIV integrase strand transfer inhibitor antiretroviral.Cobicistat is a mechanism-based CYP3A inhibitor and is included in EVG/c/FTC/TAF as a pharmacokinetic enhancer to decrease elvitegravir metabolism and increase plasma concentrations of the drug (Tenofovir alafenamide (TAF) is a nucleotide reverse transcriptase inhibitor antiretroviral classified as an HIV NRTI.HIV-1 resistant to elvitegravir, emtricitabine, or tenofovir have been produced in vitro and have emerged during EVG/c/FTC/TAF therapy.Cross-resistance between elvitegravir and other HIV integrase inhibitors (e.g., dolutegravir, raltegravir) has been reported.Critical nature of compliance with HIV therapy and importance of remaining under the care of a clinician.Antiretroviral therapy is not a cure for HIV infection;Advise patients that sustained decreases in plasma HIV RNA have been associated with reduced risk of progression to acquired immunodeficiency syndrome (AIDS) and death.Advise patients that effective antiretroviral regimens can decrease HIV concentrations in blood and genital secretions and strict adherence to such regimens in conjunction with risk-reduction measures may decrease, but cannot absolutely eliminate, the risk of secondary transmission of HIV to others.Importance of reading patient information provided by the manufacturer.Advise patients that EVG/c/FTC/TAF is a complete regimen for treatment of HIV-1 infection and should Inform patients that testing for HBV infection recommended before antiretroviral therapy initiated.Advise patients that renal impairment, including cases of acute renal failure or Fanconi syndrome, has occurred.Advise patients that lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have occurred in patients receiving HIV NRTIs, including emtricitabine and/or tenofovir DF, in conjunction with other antiretrovirals.Advise patients that signs and symptoms of inflammation from previous infections may occur soon after initiation of antiretroviral therapy in some individuals with advanced HIV infection (AIDS).Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements (e.g., St. John's wort), as well as any concomitant illnesses.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of advising patients of other important precautionary information.Elvitegravir 150 mg, Cobicistat 150 mg, Emtricitabine 200 mg, and Tenofovir Alafenamide Fumarate 10 mg (of tenofovir alafenamide)2.