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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Integrase Inhibitors

Elvitegravir

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Elvitegravir (EVG)
Elvitegravir (EVG)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablet: Discontinued by the manufacturer. Only available in fixed-dose combination tablets.

Fixed-Dose Combination Tablets:
  • [Genvoya] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus tenofovir alafenamide (TAF) 10 mg
  • [Stribild] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus tenofovir disoproxil fumarate (TDF) 300 mg
Dosing Recommendations Selected Adverse Events
[Genvoya] Elvitegravir plus Cobicistat plus Emtricitabine plus TAF
Pediatric (Weighing <25 kg) Dose:
  • No data on appropriate dose of elvitegravir in Genvoya for children weighing <25 kg
Child and Adolescent (Weighing ≥25 kg; Any Sexual Maturity Rating [SMR]) and Adult Dose:
  • One tablet once daily

[Stribild] Elvitegravir plus Cobicistat plus Emtricitabine plus TDF
Pediatric (Weighing <35 kg) Dose:
  • No data on appropriate dose of elvitegravir in Stribild for children weighing <35 kg
Adolescent (Weighing ≥35 kg andSMR 4 or 5) and Adult Dose:
  • One tablet once daily
Note: Stribild and Genvoya are Food and Drug Administration approved for use in ARV treatment-naive patients or to replace the current ARV regimen in patients who are virologically suppressed (HIV-1 RNA <50 copies/mL) on at stable ARV regimen for at least 6 months with no history of treatment failure and no know substitutions associated with resistance to the individual components of Genvoya or Stribild.
Elvitegravir-Associated Adverse Events:
  • Diarrhea

Stribild-Associated Adverse Events:
  • Nausea
  • Diarrhea
  • Fatigue
  • Headache
TDF-Specific Adverse Events:
  • Renal insufficiency
  • Decreased bone mineral density
  • Flatulence
Cobicistat-Specific Adverse Events:
  • Alteration in tubular secretion of creatinine.

Genvoya-Associated Adverse Events:
  • Nausea
  • Diarrhea
  • Fatigue
  • Headache
TAF-Associated Adverse Events:
  • Increased low-density lipoprotein-cholesterol and total cholesterol.
Cobicistat-Associated Adverse Events:
  • Alteration in tubular secretion of creatinine.
Special Instructions
  • Administer with food.
  • When using Stribild, which contains TDF, monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein at baseline and every 3 to 6 months while on therapy. In patients at risk of renal impairment, also monitor serum phosphate. Patients with an increase in serum creatinine >0.4 mg/dL should be closely monitored for renal safety.
  • Screen patients for hepatitis B virus (HBV) infection before using emtricitabine, TDF, or TAF. Severe acute exacerbation of HBV can occur when emtricitabine, TDF, or TAF are discontinued; therefore, monitor hepatic function for several months after therapy with emtricitabine, TDF, or TAF is stopped.
  • Neither Stribild nor Genvoya is recommended for use with other antiretroviral (ARV) drugs.
Metabolism/Elimination
  • Elvitegravir is metabolized by cytochrome P (CYP) 450 3A4 and is a modest inducer of CYP2C9.
  • Elvitegravir should only be used with the pharmacokinetic enhancer (boosting agent) cobicistat in Stribild or Genvoya. Refer to the TDF and TAF sections in the guidelines for further details.
  • 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 because dose adjustments required for emtricitabine and TDF cannot be achieved with a fixed-dose combination tablet.
  • Genvoya should not be initiated in patients with estimated CrCl <30 mL/min.
  • Neither Stribild nor Genvoya should be used in patients with severe hepatic impairment.

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