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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Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Emtricitabine

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

Emtricitabine (FTC, Emtriva)
Emtricitabine (FTC, Emtriva)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Pediatric Oral Solution: 10 mg/mL
Capsule: 200 mg

Fixed-Dose Combination Tablets:
  • [Atripla and Generic] Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg
  • [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 25 mg
  • [Complera] Emtricitabine 200 mg/rilpivirine 25 mg/TDF 300 mg
  • [Descovy] Emtricitabine 200 mg/TAF 25 mg
  • [Genvoya] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg
  • [Odefsey] Emtricitabine 200 mg/rilpivirine 25 mg/TAF 25 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TDF 300 mg
  • [Symtuza] Darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg
  • [Truvada low-strength tablets]
    • Emtricitabine 100 mg/TDF 150 mg
    • Emtricitabine 133 mg/TDF 200 mg
    • Emtricitabine 167 mg/TDF 250 mg
  • [Truvada] Emtricitabine 200 mg/TDF 300 mg
Dosing Recommendations Selected Adverse Events
Neonatal and Infant (Aged 0 to <3 Months) Dose
Oral Solution:
  • Emtricitabine 3 mg/kg once daily
Child (Aged ≥3 Months) and Adolescent Dose
Oral Solution:
  • Emtricitabine 6 mg/kg once daily (maximum 240 mg per dose). The maximum dose of oral solution is higher than the capsule dose because the oral solution showed 20% lower plasma exposure during pediatric pharmacokinetic analysis.
Capsules (For Patients Weighing >33 kg):
  • Emtricitabine 200 mg once daily
Adult Dose
Oral Solution for Those Unable to Swallow Capsules:
  • Emtricitabine 240 mg (24 mL) once daily
Capsules:
  • Emtricitabine 200 mg once daily
[Atripla and Generic] Efavirenz/Emtricitabine/TDF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily
  • Take on an empty stomach.
[Biktarvy] Bictegravir/Emtricitabine/TAF
Child and Adolescent (Aged <18 Years) Dose:
  • Biktarvy has not been approved by the Food and Drug Administration (FDA) for use in patients aged <18 years.
Child (Aged <6 Years and Weighing <25 kg) Dose:
  • There are currently no data available on the appropriate dose of Biktarvy in children aged <6 years and weighing <25 kg.
Child (Aged 6 Years to <12 Years and Weighing ≥25 kg) Dose:
  • One tablet once daily. This is an investigational dose that has only been studied in patients who have been virologically suppressed (HIV RNA <50 copies/mL) on a stable antiretroviral (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 Biktarvy.
Child and Adolescent (Aged 12 Years to <18 Years and Weighing ≥35 kg) Dose:
  • One tablet once daily. This is an investigational dose that has only been studied 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 Biktarvy.
Adult (Aged ≥18 Years) Dose:
  • One tablet once daily in antiretroviral therapy (ART)-naive patients. This dose of Biktarvy 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 ARV regimen for at least 3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
  • See the bictegravir section for additional information.
[Complera] Emtricitabine/Rilpivirine/TDF
Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily in antiretroviral (ARV)-treatment naive patients who have baseline plasma HIV RNA ≤100,000 copies/mL. This dose of Complera can also be used to replace a stable ARV regimen in patients who are currently on their first or second regimen and who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no history of virologic failure or resistance to the individual components of Complera.
  • Administer with a meal of at least 500 calories.
[Descovy] Emtricitabine/TAF 
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • Body Weight 25 to <35 kg: One tablet once daily in combination with other ARV agents, except for protease inhibitors (PIs) that require a cytochrome P450 3A inhibitor (i.e., Descovy can be used in combination with an integrase strand transfer inhibitor [INSTI] or a non-nucleoside reverse transcriptase inhibitor [NNRTI], but not a boosted PI).
  • Body Weight ≥35 kg: One tablet once daily in combination with an INSTI, NNRTI, or boosted PI.
[Genvoya] Elvitegravir/Cobicistat/Emtricitabine/TAF
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with food in ART-naive patients. This dose of Genvoya 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 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.
[Odefsey] Emtricitabine/Rilpivirine/TAF
Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily in ART-naive patients with HIV RNA ≤100,000 copies per mL. This dose of Odefsey can also be used to replace a stable ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
  • Administer with a meal of at least 500 calories.
[Stribild] Elvitegravir/Cobicistat/Emtricitabine/TDF
Child and Adolescent (Weighing ≥35 kg with a Sexual Maturity Rating of 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 a stable ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Stribild.
[Symtuza] Darunavir/Cobicistat/Emtricitabine/TAF
Child and Adolescent (Aged <18 Years) Dose:
  • Symtuza has not been approved by the FDA for use in patients aged <18 years.
Adult (Aged ≥18 Years) Dose:
  • One tablet taken once daily with food in ARV-naive patients or in patients who have been virologically suppressed for at least 6 months with no known substitutions associated with resistance to darunavir or tenofovir.
[Truvada] Emtricitabine/TDF (FTC/TDF):
Child, Adolescent, and Adult Dose:
Truvada Dosing Table
Body Weight Truvada Tablet
Once Daily
17 kg to <22 kg One FTC/TDF 100 mg/150 mg tablet
22 kg to <28 kg One FTC/TDF 133 mg/200 mg tablet
28 kg to <35 kg One FTC/TDF 167 mg/250 mg tablet
≥35 kg and Adults One FTC/TDF 200 mg/300 mg tablet
  • Severe acute exacerbation of hepatitis can occur in patients with hepatitis B virus (HBV) and HIV coinfection who discontinue emtricitabine.
  • Hyperpigmentation/skin discoloration on palms and/or soles
Special Instructions
  • Although emtricitabine can be administered without regard to food, there are food requirements for some fixed-dose combination (FDC) tablet formulations that contain emtricitabine.
  • When using FDC tablets, see other sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC.
  • Emtricitabine oral solution can be kept at room temperature, up to 77oF (25oC), if used within 3 months; refrigerate for long-term storage.
  • Before using emtricitabine, screen patients for HBV.
Metabolism/Elimination
  • No cytochrome P450 interactions
  • Eighty-six percent of emtricitabine is excreted in urine. Emtricitabine may compete with other compounds that undergo renal elimination.
Emtricitabine Dosing in Patients with Renal Impairment:
  • Decrease the dose of emtricitabine in patients with impaired renal function. Consult the manufacturer’s prescribing information for recommended dose adjustments.
  • Do not use the FDC Atripla in patients with creatinine clearance (CrCl) <50 mL/min or in patients who require dialysis.
  • Do not use the FDCs Truvada or Biktarvy in patients with CrCl <30 mL/min. Do not use Truvada in patients who require dialysis.
  • Use Complera with caution in patients with severe renal impairment or end-stage renal disease. Monitor frequently for adverse events, because rilpivirine concentrations may increase in patients with severe renal impairment or end-stage renal disease.
  • 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.
  • TAF-containing formulations are not recommended for use in patients with estimated CrCl <30 mL/min.

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