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: April 16, 2019; Last Reviewed: April 16, 2019

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

Fixed-Dose Combination Tablets:
  • [Genvoya] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 10 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg
Dosing Recommendations Selected Adverse Events
[Genvoya] Elvitegravir/Cobicistat/Emtricitabine/TAF
Child (Weighing <25 kg) Dose:
  • There are no data on the appropriate dose of elvitegravir in Genvoya for children weighing <25 kg.
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with food
[Stribild] Elvitegravir/Cobicistat/Emtricitabine/TDF
Child and Adolescent (Weighing <35 kg) Dose:
  • There are no data on the appropriate dose of elvitegravir in Stribild for children or adolescents weighing <35 kg.
Adolescent (Weighing ≥35 kg and Sexual Maturity Rating [SMR] 4 or 5) and Adult Dose:
  • One tablet once daily with food
Note: Stribild and Genvoya are approved by the Food and Drug Administration for use in antiretroviral (ARV)-naive patients or to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ARV regimen for at least 6 months with no history of treatment failure and no known 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:
  • Glomerular and proximal renal tubular dysfunction
  • Decreased bone mineral density
  • Flatulence
Cobicistat-Specific Adverse Events:
  • Benign increases in serum creatinine levels (reductions in estimated glomerular filtration) due to inhibition of tubular secretion of creatinine.
Genvoya-Associated Adverse Events:
  • Nausea
  • Diarrhea
  • Fatigue
  • Headache
TAF-Specific Adverse Events:
  • Increased levels of low-density lipoprotein cholesterol and total cholesterol.
Cobicistat-Specific Adverse Events:
  • Benign increases in serum creatinine levels (reductions in estimated glomerular filtration) due to inhibition of tubular secretion of creatinine.
Special Instructions
  • Administer both Genvoya and Stribild with food.
  • Separate elvitegravir dosing from antacids and iron, calcium, aluminum, and/or magnesium-containing supplements and multivitamins by at least 4 hours.
  • When using Stribild, which contains TDF, monitor estimated creatinine clearance (CrCl), urine glucose, and urine protein at baseline and every 3 months to 6 months while on therapy. In patients who are at risk of renal impairment, also monitor serum phosphate. Patients with an increase in serum creatinine levels >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 stopping therapy with emtricitabine, TDF, or TAF.
Metabolism/Elimination
  • Elvitegravir is metabolized by cytochrome P450 (CYP) 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 for further details.
  • Stribild should not be initiated in patients with estimated CrCl <70 mL/min, and it should be discontinued in patients with estimated CrCl <50 mL/min. Emtricitabine and TDF require dose adjustments in these patients, and these adjustments cannot be achieved with an FDC tablet.
  • Genvoya should not be initiated in patients with estimated CrCl <30 mL/min.
  • Stribild and Genvoya should be not used in patients with severe hepatic impairment.

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