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emtricitabine, tenofovir alafenamide, darunavir and cobicistat

J05AR22

Forms & Strengths

Tablets: 200mg emtricitabine, 25mg tenofovir alafenamide, 800mg darunavir, 150mg cobicistat
Tablets: 200mg emtricitabine, 10mg tenofovir alafenamide, 800mg darunavir, 150mg cobicistat

Adult Dosing

1 tablet orally once daily with food
Dose adjustment required for patients with severe renal impairment (CrCl <30ml/min) or severe hepatic impairment
Not recommended for patients with estimated creatinine clearance below 30 mL/min

Pediatric Dosing

Safety and efficacy not established in patients <18 years
Not recommended for pediatric patients due to limited data

Indications

Treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg
Used in combination with other antiretroviral agents

Mechanism of Action

Emtricitabine: nucleoside reverse transcriptase inhibitor (NRTI)
Tenofovir alafenamide: nucleotide reverse transcriptase inhibitor (NtRTI)
Darunavir: protease inhibitor (PI)
Cobicistat: cytochrome P450 3A (CYP3A) inhibitor

Contraindications

Hypersensitivity to emtricitabine, tenofovir alafenamide, darunavir, or cobicistat
Concomitant use with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events
Concomitant use with ritonavir

Adverse Reactions

Diarrhea
Rash
Nausea
Fatigue
Headache
Abdominal pain
Elevations in serum creatinine and liver enzymes

Drug Interactions

Do not coadminister with other antiretroviral therapies
Not recommended with concomitant use of nephrotoxic agents
Cobicistat inhibits CYP3A, increasing concentrations of CYP3A substrates
Concomitant use with drugs that induce CYP3A may decrease darunavir concentrations

Curated Content: Needs Vetting Before Put to Clinical Use