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: September 12, 2019; Last Reviewed: September 12, 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
When using fixed-dose combination (FDC) tablets, refer to other sections of the Drug Appendix for special instructions, drug interaction information, and additional 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.             
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 (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. Studies are currently being conducted to identify the appropriate dose for this age and weight group.
Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • One tablet once daily with or without food 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 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 ART-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 FDC tablet formulations that contain emtricitabine.
  • 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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