Select therapeutic use:
Indications for STRIBILD:
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.
Adults and Children:
<12yrs or <35kg: not established. ≥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.
Concomitant alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, ergots, cisapride, St. John’s wort, lovastatin, simvastatin, lurasidone, pimozide, sildenafil (when dosed for PAH), triazolam, oral midazolam.
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. Assess SCr (monitor closely if >0.4mg/dL), serum phosphorus, CrCl, urine glucose, urine protein before initiating and during therapy. 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.
See Contraindications. Not recommended with other antiretroviral agents, rifabutin, rifapentine, or ledipasvir/sofosbuvir. 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 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, fluticasone (use alternatives), sofosbuvir/velpatasvir (monitor), atorvastatin, immunosuppressants (monitor), PDE5 inhibitors (see full labeling for dose adjustments), antipsychotics, quetiapine (reduce dose by ⅙ or consider alternative antiretrovirals). Concomitant buprenorphine/naloxone; monitor. Concomitant colchicine (see full labeling); not recommended in renal or hepatic impairment. Antagonized by oxcarbazepine, corticosteroids (eg, oral dexamethasone, betamethasone, budesonide); consider alternatives. Discontinue use of bosentan ≥36hrs prior to initiation of Stribild; 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.
HIV-1 integrase strand transfer inhibitor (INSTI) + pharmacokinetic enhancer + nucleos(t)ide analogue reverse transcriptase inhibitors.
Nausea, diarrhea; new onset or worsening renal impairment, decreased BMD, mineralization defects, immune reconstitution syndrome.
Hepatic (CYP3A, 2D6).
Fecal (major); renal.