Management of HIV infection, a complete regimen for treatment-naïve adults or in adults who are virologically suppressed (HIV–1 RNA <50 copies/mL) on a stable regimen for ≥6 mo with no history of treatment failure and no known substitutions associated with resistance to the individual components of this medication
Elvitegravir–An integrase strand transfer inhibitor that inhibits an enzyme necessary for viral replication.
Cobicistat–A pharmacokinetic enhancer (inhibits CYP3A and CYP2D6) enhancing systemic exposure to elvitegravir.
Emtricitabine–Phosphorylated intracellularly where it inhibits HIV reverse transcriptase, resulting in viral DNA chain termination
Tenofovir–Phosphorylated intracellularly where it inhibits HIV reverse transcriptase resulting in disruption of DNA synthesis
Slowed progression of HIV infection and decreased occurrence of sequelae
↑ levels and risk of adverse effects with SSRIs (except for sertraline), tricyclic antidepressants, and trazodone; careful titration and monitoring recommended.
↑ levels of itraconazole, ketoconazole, and voriconazole; maximum daily dose of ketoconazole or itraconazole should not exceed 300 mg, use voriconazole with extreme caution. These azole antifungals may also ↑ levels of cobicistat and elvitegravir.
↑ levels and risk of toxicity from colchicine (concurrent use is contraindicated in patients with renal or hepatic impairment)gout flares–0.6 mg followed by 0.3 mg 1 hr later, do not repeat for at least 3 daysprophylaxis of gout flares–0.3 mg once daily if original regimen was 0.6 mg twice daily, 0.3 mg every other day if original regimen was 0.6 mg dailytreatment of familial Mediterranean fever–not to exceed 0.6 mg daily, may be given as 0.3 mg twice daily.
Concurrent use with rifabutin or rifapentine may significantly ↓ levels/effectiveness of cobicistat and elvitegravir and may foster resistance, concurrent use is not recommended.
May ↑ levels and effects of beta blockers including metoprolol and timolol; careful monitoring is recommended, ↓ dose of beta blocker if necessary.
↑ levels and effects of bosentan; initiate bosentan at 62.5 mg daily or every other day if already receiving elvitegravir/cobicistat/emtricitabine/tenofovir for at least 10 days, if already receiving bosentan discontinue at least 36 hr prior to starting elvitegravir/cobicistat/emtricitabine/tenofovir; after 10 days, bosentan may be restarted at 62.5 mg daily or every other day.
↑ levels and risk of adverse effect with atorvastatin; initiate atorvastatin at lowest dose and do not exceed dose of 20 mg/day; titrate cautiously.
↑ levels of norgestimate and ↓ levels of ethinyl estradiol; consider using non-hormonal contraception.
↑ risk of hyperkalemia with drospirenone/ethinyl estradiol; closely monitor serum potassium concentrations.
May ↑ levels of quetiapine; if taking quetiapine when initiating therapy, consider alternative antiretroviral therapy or ↓ quetiapine dose to ⅙ of the original dose and monitor for adverse effects
↑ levels and risk of serious cardiovascular adverse effects from PDE5 inhibitors including sildenafil, tadalafil, and vardenafilfor pulmonary hypertension–sildenafil is contraindicated; in patients who have received elvitegravir/cobicistat/emtricitabine/tenofovir for at least 7 days, tadalafil may be started at 20 mg/day and carefully titrated if necessary to 40 mg/day; in patients already receiving tadalafil, discontinue for at least 24 hr before initiating elvitegravir/cobicistat/emtricitabine/tenofovir; after 7 days, resume at 20 mg/day and titrate as necessary to 40 mg/dayfor erectile dysfunction–sildenafil dose should not exceed 25 mg in 48 hr, vardenafil dose should not exceed 2.5 mg in 72 hr, and tadalafil dose should not exceed 10 mg in 72 hr).
↑ levels and risk of sedation with sedative/hypnotics including midazolam, clorazepate, diazepam, estazolam, flurazepam, buspirone, and zolpidem; concurrent use with oral midazolam is contraindicated, dose ↓ of parenteral midazolam should be considered, clinical monitoring and dose reduction if necessary is recommended for others.
Ledipasvir/sofosbuvir may ↑ tenofovir levels
St. John's wort may significantly ↓ levels/effectiveness of cobicistat and elvitegravir and ↑ risk of resistance; concurrent use contraindicated.
PO (Adults and Children) ≥12 yr and ≥35 kg) One tablet once daily.
Assess for change in severity of HIV symptoms and for symptoms of opportunistic infections during therapy.
Monitor bone mineral density in patients who have a history of pathologic bone fracture or are at risk for osteoporosis or bone loss. Consider calcium and vitamin D supplementation.
Lab Test Considerations: Monitor viral load and CD4 cell count regularly during therapy.
Assess for hepatitis B virus (HBV). Stribild is not approved for administration in patients with HIV and HBV.
Determine serum phosphorous before initiating and periodically during therapy.
Monitor liver function tests before and periodically during therapy, especially in patients with underlying liver disease or marked ↑ transaminase. May cause ↑ serum creatinine, AST, ALT, total bilirubin, total cholesterol, LDL, amylase, and triglycerides. Lactic acidosis may occur with hepatic toxicity causing hepatic steatosis; may be fatal, especially in women.
Calculate serum creatinine, creatinine clearance (CCr), urine glucose, and urine protein prior to and periodically during therapy. CCr should be >70 mL/min before starting therapy. Monitor CCr, urine glucose, and urine protein in all patients periodically during therapy and serum phosphorous in patients at risk for renal impairment. Assess patients with persistent or worsening bone pain, pain in extremities, fractures and/or muscular pain or weakness for proximal renal tubulopathy; evaluate renal function promptly.
Emphasize the importance of taking Stribild as directed, at the same time each day. Do not take more than prescribed amount and do not stop taking without consulting health care professional. Take missed doses with a meal if remembered unless almost time for next dose; do not double doses. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
Advise patient to take antacids 2 hr before or 4 hr after and H2 antagonists 12 hr before or 4 hr after Stribild.
Instruct patient that Stribild should not be shared with others.
Inform patient that Stribild does not cure AIDS or prevent associated or opportunistic infections. Rilpivirine does not reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the AIDS virus to others. Advise patient that the long-term effects of Stribild are unknown at this time.
Advise patient to notify health care professional immediately if symptoms of lactic acidosis (nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) occur.
Immune reconstitution syndrome may trigger opportunistic infections or autoimmune disorders. Notify health care professional if symptoms occur.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications, especially St. John's wort.
Rep: Advise patients to notify health care professional if pregnancy is planned or suspected. Advise patient to avoid breast feeding during Stribild therapy. Encourage women who become pregnant during Stribild therapy to enroll in Antiviral Pregnancy Registry by calling 1-800-258-4263.
Emphasize the importance of regular follow-up exams and blood counts to determine progress and monitor for side effects.
Delayed progression of AIDS and decreased opportunistic infections in patients with HIV.
Decrease in viral load and increase in CD4 cell counts.
elvitegravir/cobicistat/emtricitabine/tenofovir is a sample topic from the Davis's Drug Guide.
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