Generic Name and Formulations:
Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate (DF) 300mg; tabs.

Company:
Gilead Sciences, Inc.
Indications for STRIBILD:
As a complete regimen for the treatment of HIV-1 infection in adults 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 at least 6 months with no history of treatment failure or no known substitutions associated with resistance to any component of Stribild.

Adult:
1 tab once daily with food. Renal impairment (CrCl <70mL/min): not recommended; if CrCl declines to <50mL/min during therapy, discontinue. Severe hepatic impairment: not recommended.

Children:
<18yrs: not established.

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

Contraindications:
Concomitant alfuzosin, 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 during and for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection). Monitor CrCl, urine glucose, urine protein, serum phosphorus (for patients at risk for renal impairment). History of pathologic fracture or risk factors of osteoporosis or bone loss: consider monitoring bone mineral density (BMD). Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interactions:
See Contraindications. Avoid with concurrent or recent use of nephrotoxic agents. Do not administer with other antiretroviral agents (eg, cobicistat, elvitegravir, adefovir dipivoxil, or products containing emtricitabine, tenofovir, lamivudine, or ritonavir) or antimycobacterials (eg, rifabutin, rifapentine). May be potentiated by CYP3A inhibitors, antagonized by CYP3A inducers. 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 2hrs. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), carbamazepine, clonazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, calcium channel blockers, fluticasone (use alternative corticosteroid), atorvastatin, immunosuppressants, (monitor), neuroleptics, sedatives/hypnotics, PDE5 inhibitors (see full labeling for dose adjustments). Antagonized by carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, systemic dexamethasone. Concomitant colchicine (see full labeling); do not coadminister to patients with renal or hepatic impairment. Discontinue use of bosentan at least 36hrs prior to initiation of Stribild; after at least 10 days following initiation, resume bosentan. Concomitant salmeterol: not recommended; increased risk of cardiovascular events. Use alternative non-hormonal methods of contraception. Monitor INR.

Adverse Reactions:
Nausea, diarrhea; decreased BMD, fat redistribution, immune reconstitution syndrome.

Metabolism:
Hepatic (CYP3A, 2D6).

Elimination:
Fecal (major); renal.

Generic Availability:
NO

How Supplied:
Tabs—30