STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of STRIBILD.

STRIBILD is a complete regimen for the treatment of HIV-1 infection; therefore, STRIBILD should not be administered with other antiretroviral medications for treatment of HIV-1 infection.

Prior to initiation of STRIBILD, patients should be tested for hepatitis B virus infection. 

Prior to initiation and during use of STRIBILD, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus.

STRIBILD is not recommended for use in patients with severe hepatic impairment.

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (DF), a component of STRIBILD.

STRIBILD is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued EMTRIVA or VIREAD, two of the components of STRIBILD. Hepatic function should be monitored closely in these patients. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Severe acute exacerbations of hepatitis B (e.g., liver decompensated and liver failure) have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine or tenofovir DF, two of the components of STRIBILD. Patients who are coinfected with HIV-1 and HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure.

Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue STRIBILD. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), has been reported with the use of tenofovir DF, a component of STRIBILD, and with the use of STRIBILD.

Initiation of STRIBILD in patients with estimated creatinine clearance below 70 mL per minute is not recommended. Because STRIBILD is a fixed-dose combination tablet, STRIBILD should be discontinued if estimated creatinine clearance declines below 50 mL per minute during treatment with STRIBILD, as the dose interval adjustment required for emtricitabine and tenofovir disoproxil fumarate (DF) cannot be achieved.

Cases of osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported in association with the use of tenofovir DF.

Decreases in bone mineral density (BMD): Consider monitoring BMD in patients with a history of pathologic fracture or other risk factors of osteoporosis or bone loss.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including STRIBILD. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

Adverse reactions observed with STRIBILD included suicidal ideation and suicide attempt all in subjects with a preexisting history of depression or psychiatric illness.

STRIBILD should be avoided with concurrent or recent use of a nephrotoxic agent. (e.g., high-dose or multiple non-steroidal anti-inflammatory drugs (NSAIDs). 

Risk of significant adverse drug-drug interactions between the antipsychotic medication LATUDA (lurasidone hydrochloride) and strong CYP3A4 inhibitors.

Avoid co-administration with other antiretroviral products: Do not use with products containing any of the components of STRIBILD (cobicistat, elvitegravir, emtricitabine, and tenofovir disoproxil fumarate) or tenofovir alafenamide, including ATRIPLA, COMPLERA, DESCOVY, EMTRIVA, GENVOYA, ODEFSEY, TRUVADA, TYBOST, VIREAD, or VITEKTA; with drugs containing lamivudine; or with drugs or regimens containing ritonavir. Do not administer in combination with HEPSERA.

Co-administration of STRIBILD with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs.

Co-administration of rivaroxaban with STRIBILD is not recommended because it may lead to an increased bleeding risk.

STRIBILD is not recommended to be co-administered with colchicine colchicine to patients with renal or hepatic impairment.

Co-administration with oral dexamethasone or other systemic corticosteroids that induce CYP3A may result in loss of therapeutic effect and development of resistance to elvitegravir.

Co-administration of salmeterol and STRIBILD is not recommended because it may result in increased risk of cardiovascular adverse events associated with salmeterol, including QT prolongation, palpitations, and sinus tachycardia.

When co-administered with STRIBILD, the maximum daily dose of ketoconazole or itraconazole should not exceed 200 mg per day.

An assessment of benefit/risk ratio is recommended to justify use of voriconazole with STRIBILD.

Significant drug interactions have been either observed or are expected when STRIBILD is combined with the following drugs: entecavir, famciclovir, H2 receptor antagonists, methadone, proton pump inhibitors, ribavirin, and sertraline.

Co-administration of STRIBILD in patients on bosentan: Discontinue use of bosentan at least 36 hours prior to initiation of STRIBILD. After at least 10 days following the initiation of STRIBILD, resume bosentan at 62.5 mg once daily or every other day based upon individual tolerability.

Consider alternative antiretroviral therapy to avoid increases in quetiapine exposure. If co-administration is necessary, reduce the quetiapine dose to 1/6 of the current dose and monitor for quetiapine-associated adverse reactions.

Separate STRIBILD and antacid administration by at least 2 hours.

Co-administration with antibacterial (clarithromycin) in patients with CLcr between 50 mL/minute and 60 mL/minute should reduce the dose of clarithromycin by 50%.

Cobicistat, a component of STRIBILD, is an inhibitor of CYP3A and CYP2D6 and an inhibitor of the following transporters: P-glycoprotein (P-gp), BCRP, OATP1B1, and OATP1B3. Thus, coadministration of STRIBILD with drugs that are primarily metabolized by CYP3A or CYP2D6, or are substrates of P-gp, BCRP, OATP1B1, or OATP1B3, may result in increased plasma concentrations of such drugs. Elvitegravir is a modest inducer of CYP2C9 and may decrease the plasma concentrations of CYP2C9 substrates.

Co-administration of STRIBILD is contraindicated with drugs that:

• Are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious adverse events. 

• Strongly induce CYP3A which may lead to lower exposure of one or more components and loss of efficacy of STRIBILD and possible resistance.

These contraindicated drugs include: 
• Alpha 1-adrenoreceptor antagonist: alfuzosin
• Anticonvulsants: carbamazepine, phenobarbital, phenytoin
• Antimycobacterial: rifampin
• Antipsychotics: lurasidone, pimozide
• Ergot Derivatives: dihydroergotamine, ergotamine, methylergonovine
• GI Motility Agent: cisapride
• Herbal Products: St. John’s wort (Hypericum perforatum)
• Lipid-modifying Agents: lomitapide, lovastatin, simvastatin
• Phosphodiesterase-5 (PDE-5) Inhibitor: sildenafil when administered as Revatio for the treatment of pulmonary arterial hypertension
• Sedative/hypnotics: triazolam, orally administered midazolam

STRIBILD is not recommended for use during pregnancy because of substantially lower exposures of cobicistat and elvitegravir during the second and third trimesters.

STRIBILD should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with STRIBILD.

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV.

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• Use in patients under the age of 12. GoToSource 

• Chronic hepatitis B virus (HBV) infection. GoToSource

Increased serum creatinine. GoToSource 

Lactic acidosis (buildup of lactic acid in bloodstream), hepatomegaly with steatosis including fatal cases (enlarged fatty liver), acute exacerbations of hepatitis B, kidney impairment, including cases of acute kidney failure and fanconi syndrome (disorder of the kidney tubes), decreased bone mineral density, immune reconstitution syndrome, redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement and cushingoid appearance. GoToSource

Lawsuits filed for kidney injury and bone density loss.