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GENVOYA
Viral infections
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Drug Name:

GENVOYA Rx

Generic Name and Formulations:
Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir alafenamide 10mg; tabs.

Company:
Gilead Sciences, Inc.

Therapeutic Use:

Indications for GENVOYA:

As a complete regimen for HIV-1 infection in patients weighing ≥25kg who are antiretroviral treatment-naïve or to replace current antiretroviral (ARV) regimen in those who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen for ≥6 months with no history of treatment failure and no known substitutions associated with resistance to any components of Genvoya.

Adults and Children:

Test for HBV infection prior to initiation. <25kg: not established. ≥25kg (and CrCl ≥30mL/min): 1 tab once daily with food. Severe hepatic or renal impairment (CrCl <30mL/min): not recommended.

Contraindications:

Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, sildenafil (as Revatio for PAH), triazolam, oral midazolam.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B.

Warnings/Precautions:

Test for HBV before starting antiretroviral therapy. Discontinuation of emtricitabine and/or tenofovir DF may be associated with severe acute exacerbations of hepatitis B. Closely monitor patients co-infected with HBV and HIV for several months after stopping treatment; if appropriate, anti-HBV therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). New onset or worsening renal impairment. Assess SCr (monitor closely if >0.4mg/dL), estimated CrCl, urine glucose, urine protein in all patients, and serum phosphorus (in chronic kidney disease) before initiating and during therapy. Discontinue if significant renal dysfunction or evidence of Fanconi syndrome develops. Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

HIV-1 integrase strand transfer inhibitor (INSTI) + pharmacokinetic enhancer + nucleos(t)ide analogue reverse transcriptase inhibitors.

Interactions:

See Contraindications. Avoid with concurrent or recent use of nephrotoxic agents. Not recommended with other antiretroviral agents, rifabutin, rifapentine, or rivaroxaban. Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, high-dose or multiple NSAIDs). Separate dosing of antacids by at least 2hrs. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), telithromycin, IV midazolam, diazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, calcium channel blockers, atorvastatin, immunosuppressants (monitor), PDE5 inhibitors (see full labeling for dose adjustments), other sedatives/hypnotics or antipsychotics, quetiapine (consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor), direct oral anticoagulants (see full labeling). Monitor INR with warfarin. Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide, fluticasone); consider alternatives. Concomitant colchicine (see full labeling); not recommended 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 (see full labeling).

Adverse Reactions:

Nausea, diarrhea, headache, fatigue; immune reconstitution syndrome.

Metabolism:

Hepatic (CYP3A, 2D6).

Elimination:

Fecal (major); renal.

Generic Availability:

NO

How Supplied:

Tabs—30

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