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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 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:

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.

Warnings/Precautions:

Not for treating chronic HBV infection; test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (severe acute exacerbations of hepatitis B may occur); if appropriate, initiate anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Suspend therapy if lactic acidosis or hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor CrCl, serum creatinine, serum phosphorus, urine glucose, urine protein prior to and during therapy in all patients; discontinue if significant renal dysfunction or Fanconi syndrome develops. Pregnancy. 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 drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). Separate antacids by at least 2 hours. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), telithromycin, IV midazolam, diazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole, itraconazole, voriconazole, beta-blockers, calcium channel blockers, fluticasone (use alternatives), atorvastatin, immunosuppressants, neuroleptics, sedatives/hypnotics, PDE5 inhibitors, antipsychotics, quetiapine (consider alternative antiretrovirals; if necessary, reduce quetiapine to ⅙ of current dose and monitor). Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide); consider 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 (INSTI) + pharmacokinetic enhancer + nucleos(t)ide analogue reverse transcriptase inhibitors.

Adverse Reactions:

Nausea, diarrhea, headache, fatigue; new onset or worsening renal impairment, immune reconstitution syndrome.

Metabolism:

Hepatic (CYP3A, 2D6).

Elimination:

Fecal (major); renal.

Generic Availability:

NO

How Supplied:

Tabs—30

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