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 14, 2020; Last Reviewed: April 14, 2020

Elvitegravir (EVG)
Elvitegravir (EVG)
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 10 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 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
[Genvoya] Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (TAF)
Child (Weighing <25 kg) Dose:
  • There are no data on the appropriate dose of Genvoya for children weighing <25 kg.
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with food in antiretroviral therapy (ART)-naive patients. This dose of Genvoya can also be used to replace the current antiretroviral (ARV) regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ART regimen for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of Genvoya.
[Stribild] Elvitegravir/Cobicistat/Emtricitabine/Tenofovir disoproxil fumarate (TDF)
Child and Adolescent (Weighing <35 kg) Dose:
  • There are no data on the appropriate dose of 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 in ART-naive patients. This dose of Stribild can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable ART regimen for at least 6 months with no history of treatment failure and no known mutations associated with resistance to the individual components of 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.
  • EVG should be administered at least 4 hours before or after antacids and supplements or multivitamins that contain iron, calcium, aluminum, and/or magnesium.
  • 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 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 (FTC), TDF, or TAF. Severe acute exacerbation of HBV can occur when FTC, TDF, or TAF are discontinued; therefore, monitor hepatic function for several months after stopping therapy with FTC, TDF, or TAF.
  • For information on crushing and cutting tablets, please see this table from Toronto General Hospital
Metabolism/Elimination
  • EVG is metabolized by cytochrome P450 (CYP) 3A4 and is a modest inducer of CYP2C9.
  • EVG 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.

Elvitegravir Dosing in Patients with Hepatic Impairment

  • Stribild and Genvoya should be not used in patients with severe hepatic impairment.

Elvitegravir Dosing in Patients with Renal Impairment:

  • 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. FTC 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.

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