BOXED WARNING Severe acute exacerbations of hepatitis B may occur on discontinuation in patients coinfected with HIV-1 and HBV; monitor hepatic function for several months after stopping.
Renal No adjustment if CrCl ≥30 mL/min or ESRD on chronic hemodialysis (dose after dialysis); NOT recommended if CrCl 15 to <30 mL/min or ESRD not on hemodialysis
Hepatic No adjustment for mild/moderate (Child-Pugh A/B); not recommended in severe (Child-Pugh C)
Instructions
Take one tablet orally once daily with food
Test for hepatitis B before initiating; assess serum creatinine, CrCl, urine glucose and protein before and during treatment
On hemodialysis days, administer after completion of dialysis
Not recommended during pregnancy — an alternative regimen is recommended
Available strengths
tab 150/150/200/10 mg
Contraindications
Coadministration with drugs highly dependent on CYP3A for clearance where elevated levels cause serious/life-threatening events (e.g., alfuzosin, ergot derivatives, lovastatin/simvastatin, lomitapide, pimozide, lurasidone, oral midazolam, triazolam, sildenafil for PAH), or with strong CYP3A inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's wort) that reduce efficacy
Cautions
Significant drug interactions (loss of efficacy/resistance or increased concomitant drug toxicity)
Immune reconstitution syndrome
New onset or worsening renal impairment (Fanconi syndrome, PRT); cobicistat raises serum creatinine without affecting GFR
Lactic acidosis/severe hepatomegaly with steatosis
Adverse reactions
Nausea
Diarrhea
Headache
Fatigue
Pregnancy Not recommended during pregnancy (substantially lower cobicistat/elvitegravir exposures in 2nd/3rd trimesters)
Lactation Breastfeeding not recommended (potential HIV-1 transmission)