Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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Pharmacokinetic Enhancers

Cobicistat

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Cobicistat (COBI, Tybost)
Cobicistat (COBI, Tybost)
Formulations
Tablet: 150 mg

Fixed-Dose Combination Tablets:
  • [Evotaz] Atazanavir 300 mg/cobicistat 150 mg
  • [Genvoya] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg
  • [Prezcobix] Darunavir 800 mg/cobicistat 150 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
  • [Symtuza] Darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir alafenamide 10 mg
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for information about the individual components of the FDC. See also Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

For additional information, see Drugs@FDA or DailyMed.
Dosing Recommendations Selected Adverse Events
Cobicistat is a Pharmacokinetic Enhancer:
  • The only use of cobicistat (COBI) is as a pharmacokinetic (PK) enhancer (boosting agent) for certain protease inhibitors (PIs) and integrase strand transfer inhibitors. COBI is not interchangeable with ritonavir (RTV).
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • COBI 150 mg with atazanavir (ATV) 300 mg administered at the same time and with food
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • COBI 150 mg with darunavir (DRV) 800 mg administered at the same time and with food
[Evotaz] Atazanavir/Cobicistat
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily with food
  • Use in combination with other ARV drugs.
[Genvoya] Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (TAF)
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with food
[Prezcobix] Darunavir/Cobicistat
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily with food
  • Use in combination with other ARV drugs.
[Stribild] Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate (TDF)
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily with food
  • The Panel recommends using Stribild only in patients with sexual maturity ratings of 4 or 5.
[Symtuza] Darunavir/Cobicistat/Emtricitabine/TAF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily with food
  • COBI is an inhibitor of renal tubular transporters of creatinine. This increases serum creatinine and reduces estimated glomerular filtration rate, with no change in glomerular function.
Special Instructions
  • COBI 150 mg is not interchangeable with RTV, but it has a PK boosting effect that is comparable to RTV 100 mg.
  • Drug interactions may differ between RTV and COBI, because COBI is a stronger P-glycoprotein inhibitor and lacks some of the induction effects of RTV.
  • Do not administer COBI with RTV or with FDC tablets that contain COBI.
  • COBI is not recommended for use with more than one ARV drug that requires PK enhancement (e.g., elvitegravir used in combination with a PI).
  • Using COBI with PIs other than once-daily ATV 300 mg or DRV 800 mg is not recommended.
  • Patients with a confirmed increase in serum creatinine >0.4 mg/dL from baseline should be closely monitored for renal safety.
  • When using COBI in combination with TDF, monitor serum creatinine, urine protein, and urine glucose at baseline and every 3 to 6 months while the patient is receiving therapy (see Table 15i). In patients who are at risk of renal impairment, serum phosphate should also be monitored.
  • For information on crushing and cutting tablets, please see this table from Toronto General Hospital.
Metabolism/Elimination
  • COBI is a strong inhibitor of cytochrome P450 (CYP) 3A4 and a weak inhibitor of CYP2D6.
Cobicistat Dosing in Patients with Hepatic Impairment:
  • COBI does not require dose adjustment in patients with mild to moderate hepatic impairment. No data are available in patients with severe hepatic impairment. Dosing recommendations for medications that are coadministered with COBI should be followed.1
  • Stribild, Genvoya, and Symtuza should not be used in patients with severe hepatic impairment.1
Cobicistat Dosing in Patients with Renal Impairment:
  • COBI does not require a dose adjustment in patients with renal impairment, including those with severe renal impairment. Dosing recommendations for medications that are coadministered with COBI should be followed.1
  • The use of COBI plus TDF is not recommended in patients with creatinine clearance (CrCl) <70 mL/min. Dose adjustments for TDF are required for patients with CrCl <50 mL/min, and the necessary dose adjustments for TDF when this drug is used with COBI have not been established in this group of patients.1
  • Stribild should not be initiated in patients with estimated CrCl <70 mL/min and should be discontinued in patients with estimated CrCl <50 mL/min. The dose adjustments required for emtricitabine and TDF in these patients cannot be achieved with an FDC tablet.
  • Neither Genvoya nor Symtuza should be initiated in patients with estimated CrCl <30 mL/min.

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