Cobicistat / Elvitegravir / Emtricitabine / Tenofovir Alafenamide Dosage

Medically reviewed by Drugs.com. Last updated on Sep 11, 2023.

Applies to the following strengths: 150 mg-150 mg-200 mg-300 mg; 150 mg-150 mg-200 mg-10 mg

Usual Adult Dose for HIV Infection

1 tablet orally once a day with food

Comments:

This drug is not recommended during pregnancy due to considerably lower exposures of cobicistat and elvitegravir during the second and third trimesters.
This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Use: As a complete regimen for the treatment of HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in patients 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 this drug

Usual Pediatric Dose for HIV Infection

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide:
At least 25 kg: 1 tablet orally once a day with food

Cobicistat/elvitegravir/emtricitabine/tenofovir disoproxil fumarate (DF):
12 years or older and at least 35 kg: 1 tablet orally once a day with food

Comments:

This drug is not recommended during pregnancy due to considerably lower exposures of cobicistat and elvitegravir during the second and third trimesters.
This drug should not be started in pregnant women; patients who become pregnant during therapy with this drug should be switched to an alternative regimen.

Renal Dose Adjustments

Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Alafenamide:
Adults and pediatric patients weighing at least 25 kg:

CrCl at least 30 mL/min: No adjustment recommended.
Severe renal dysfunction (estimated CrCl 15 to less than 30 mL/min): Not recommended.
ESRD (estimated CrCl less than 15 mL/min) not receiving chronic hemodialysis: Not recommended.

Cobicistat/Elvitegravir/Emtricitabine/Tenofovir DF:
Adults:

CrCl at least 70 mL/min: No adjustment recommended.
Estimated CrCl less than 70 mL/min prior to therapy: Not recommended.
If estimated CrCl falls below 50 mL/min during therapy: This drug should be discontinued.

Pediatric patients 12 years or older weighing at least 35 kg:

CrCl at least 70 mL/min: No adjustment recommended.
CrCl less than 70 mL/min: Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

US BOXED WARNING:

POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HIV-1 and HBV after stopping products containing emtricitabine and/or tenofovir DF, and may occur when tenofovir alafenamide-containing products are stopped. Hepatic function of HIV-1/HBV-coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, antihepatitis B therapy may be necessary.

CONTRAINDICATIONS:

Coadministration with drugs highly dependent on CYP450 3A for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events
Coadministration with drugs that may lead to reduced efficacy and possible resistance
Coadministration with alfuzosin, carbamazepine, phenobarbital, phenytoin, rifampin, lurasidone, pimozide, dihydroergotamine, ergotamine, methylergonovine, cisapride, St. John's wort, lomitapide, lovastatin, simvastatin, oral midazolam, triazolam, sildenafil (for treatment of pulmonary arterial hypertension)

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: Safety and efficacy have not been established in patients weighing less than 25 kg.
Cobicistat/elvitegravir/emtricitabine/tenofovir DF: Safety and efficacy have not been established in patients younger than 12 years or weighing less than 35 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Cobicistat/Elvitegravir/Emtricitabine/Tenofovir Alafenamide:
Adults:

CrCl less than 15 mL/min receiving chronic hemodialysis: No adjustment recommended; on hemodialysis days, dose should be administered after hemodialysis complete.

Pediatric patients: Data not available

Cobicistat/Elvitegravir/Emtricitabine/Tenofovir DF: Data not available

Other Comments

Administration advice:

Test patients for HBV infection before/when starting this drug.
In all patients, assess serum creatinine, estimated CrCl, urine glucose, and urine protein before/when starting this drug, and during therapy with this drug as clinically appropriate; in patients with chronic kidney disease, also assess serum phosphorus.
Administer with food.
Consult the manufacturer product information regarding missed doses.
Administer antacids at least 2 hours before or after this drug.

Storage requirements:

Store and dispense in original container; keep bottle tightly closed.
Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: Store below 30C (86F).
Cobicistat/elvitegravir/emtricitabine/tenofovir DF: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).

General:

Cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide: Each 4-drug fixed dose combination tablet contains cobicistat 150 mg, elvitegravir 150 mg, emtricitabine 200 mg, and tenofovir alafenamide 10 mg.
Cobicistat/elvitegravir/emtricitabine/tenofovir DF: Each 4-drug fixed dose combination tablet contains cobicistat 150 mg, elvitegravir 150 mg, emtricitabine 200 mg, and tenofovir DF 300 mg.

Monitoring:

Hepatic: Hepatic function of HIV-1/HBV-coinfected patients with clinical and laboratory follow-up (for at least several months after stopping therapy)
Infections/Infestations: For chronic HBV infection in all patients (before/when starting therapy)
Metabolic: Serum phosphorus in patients with chronic kidney disease (before/when starting therapy and during therapy)
Musculoskeletal: Bone mineral density in patients using cobicistat/elvitegravir/emtricitabine/tenofovir DF with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss
Renal: Serum creatinine, estimated CrCl, urine glucose, and urine protein in all patients (before/when starting therapy and during therapy); for renal safety if serum creatinine increases more than 0.4 mg/dL from baseline

Patient advice:

Read the US FDA-approved patient labeling (Patient Information).
Avoid taking this drug with concurrent/recent use of nephrotoxic agents.
Stop this drug if clinical symptoms suggesting lactic acidosis or pronounced hepatotoxicity develop.
Notify healthcare provider at once of any symptoms of infection.
It is important to take this drug on a regular dosing schedule with food; avoid missing doses as it can lead to development of resistance.
Notify healthcare provider if you become pregnant during therapy.