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Stribild Generic Name & Formulations
Legal Class
Rx
General Description
Elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, tenofovir disoproxil fumarate (DF) 300mg; tabs.
Pharmacological Class
HIV-1 integrase strand transfer inhibitor (INSTI) + pharmacokinetic enhancer + nucleos(t)ide analogue reverse transcriptase inhibitors.
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Stribild Indications
Indications
As a complete regimen for the treatment of 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 and no known substitutions associated with resistance to any component of Stribild.
Stribild Dosage and Administration
Adults and Children
<12yrs or <35kg: not established. Test for HBV infection prior to initiation. ≥12yrs (≥35kg): 1 tab once daily with food. Renal impairment (CrCl <70mL/min): not recommended; if CrCl declines to <50mL/min during therapy, discontinue; also in children: no data available. Severe hepatic impairment: not recommended.
Stribild Contraindications
Contraindications
Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, ergots, cisapride, St. John’s wort, lomitapide, lovastatin, simvastatin, sildenafil (as Revatio for PAH), triazolam, oral midazolam.
Stribild Boxed Warnings
Boxed Warning
Post-treatment acute exacerbation of hepatitis B.
Stribild Warnings/Precautions
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. History of pathologic fracture or risk factors of osteoporosis or bone loss: consider bone mineral density (BMD) assessment; supplementation with calcium/Vit. D may be beneficial. Elderly. Pregnancy, nursing mothers: not recommended.
Stribild Pharmacokinetics
See Literature
Stribild Interactions
Interactions
See Contraindications. Not recommended with other antiretroviral agents, rifabutin, rifapentine, ledipasvir/sofosbuvir, rivaroxaban, salmeterol. Avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs). Concomitant drugs that reduce renal function or compete for active tubular secretion may potentiate emtricitabine, tenofovir (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, gentamicin). Separate dosing of antacids by at least 2hrs. May potentiate antiarrhythmics, digoxin, clarithromycin (reduce dose by 50% if CrCl 50–60mL/min), clonazepam, ethosuximide, SSRIs, TCAs, trazodone, ketoconazole (max 200mg/day), itraconazole (max 200mg/day), voriconazole, beta-blockers, calcium channel blockers, sofosbuvir/velpatasvir/voxilaprevir (monitor), atorvastatin (max 20mg/day), immunosuppressants (monitor), PDE5 inhibitors (see full labeling for dose adjustments), other sedatives/hypnotics or antipsychotics, quetiapine (reduce dose by ⅙ or consider alternative antiretrovirals), direct oral anticoagulants (see full labeling), tramadol (reduce dose). Monitor INR with warfarin. Concomitant buprenorphine/naloxone, fentanyl; monitor. Concomitant colchicine (see full labeling); not recommended in renal or hepatic impairment. Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide, fluticasone); consider alternatives. Discontinue use of bosentan ≥36hrs prior to initiation of Stribild; resume bosentan after ≥10 days following initiation. Use alternative non-hormonal methods of contraception (see full labeling).
Stribild Adverse Reactions
Adverse Reactions
Nausea, diarrhea; decreased BMD, mineralization defects, immune reconstitution syndrome.
Stribild Clinical Trials
See Literature
Stribild Note
Not Applicable
Stribild Patient Counseling
See Literature
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