Darunavir/Cobicistat

Dosing

1 tab PO once daily with food in combination with other antiretrovirals

1 tab = Darunavir 800 mg/ Cobicistat 150 mg

BW ≥40 kg 1 tab PO once daily with food in combination with other antiretrovirals

1 tab = Darunavir 800 mg/ Cobicistat 150 mg

Mild to moderate hepatic impairment No dose adjustment

Severe hepatic impairment Not recommended

CrCl <70Coadministration with Tenofovir disoproxil fumarate is not recommended

General Information

HIV infection; Adjunct

Perform HIV genotypic testing prior to initiation in patients with antiretroviral treatment experience; darunavir/cobicistat may be used in protease inhibitor-naïve patients when HIV genotypic testing is not feasible.

Monitor viral load, CD4 cell counts, and hepatitis B screening at baseline and with modification of ARV treatment.

Perform hepatitis C antibody testing prior to initiation or modification of ARV treatment.

Monitor ALT, AST, total bilirubin, and urinalysis at baseline and with modification of ARV treatment.

Obtain fasting blood glucose or HbA1C, fasting lipid profile, and CBC with a differential.

Obtain basic chemistry including serum sodium, potassium, bicarbonate, chloride, BUN, creatinine, and creatinine-based estimated glomerular filtration rate.

Monitor creatinine clearance, and renal function.

Monitor for sulfonamide allergy after initiating treatment.

Common

  • Rash

  • Abdominal pain

  • Diarrhea

  • Vomiting

  • Headache

Serious

  • Skin reaction extreme

  • Stevens-Johnson syndrome

Contraindications:

  • CYP3A4 inhibitors and substrates

  • CYP3A inhibitors

  • Select protease inhibitors

  • Ergot derivatives

  • P-gp inhibitors

  • Carbamazepine

  • Dronedarone

  • Midazolam

  • Dihydroergotamine

  • Rifampin

  • Lovastatin

  • Ranolazine

  • Astemizole

  • Phenytoin

  • Colchicine

  • Sildenafil

  • Phenobarbital

  • Riociguat

  • Alfuzosin

  • St. John's wort

  • Simvastatin

  • Domperidone

  • Cisapride

  • Pimozide

  • Lurasidone

  • Terfenadine

  • Pazopanib

Multiple drug-drug interactions

Antimicrobial class: Antiretroviral, Protease inhibitor

Pregnancy category: Do not initiate

Average serum half life: 7 hours (Darunavir), 4 hours (Cobicistat)

Precautions: Discontinue if drug rash with eosinophilia and systemic symptoms or severe skin reactions are suspected.

Hepatitis and liver dysfunction; monitoring recommended and interruption or discontinuation may be necessary.

Initiation or adjustment of hypoglycemic agents may be warranted.

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