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

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

Fixed-Dose Combination Tablets:
  • [Truvada low-strength tablet]
    • Emtricitabine 100 mg plus tenofovir disoproxil fumarate (TDF) 150 mg
    • Emtricitabine 133 mg plus TDF 200 mg
    • Emtricitabine 167 mg plus TDF 250 mg
  • [Truvada tablet] Emtricitabine 200 mg plus TDF 300 mg
  • [Descovy] Emtricitabine 200 mg plus tenofovir alafenamide (TAF) 25 mg
  • [Atripla] Efavirenz 600 mg plus emtricitabine 200 mg plus TDF 300 mg
  • [Complera] Emtricitabine 200 mg plus rilpivirine 25 mg plus TDF 300 mg
  • [Odefsey] Emtricitabine 200 mg plus rilpivirine 25 mg plus TAF 25 mg
  • [Stribild] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus TDF 300 mg
  • [Genvoya] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus TAF 10 mg
  • [Biktarvy] Bictegravir 50 mg plus emtricitabine 200 mg plus TAF 25 mg
Dosing Recommendations Selected Adverse Events
Note: See Antiretroviral Management of Newborns with Perinatal HIV Exposure or Perinatal HIV for information about the prevention of perinatal transmission.

Neonatal and Infant (Aged 0 to <3 Months) Dose
Oral Solution:
  • 3 mg/kg once daily
Pediatric (Aged ≥3 Months to 17 Years) Dose
Oral Solution:
  • 6 mg/kg (to a maximum dose of 240 mg) once daily; the maximum dose of oral solution is higher than the capsule dose because the oral solution has 20% lower plasma exposure in pediatric pharmacokinetic analysis.
Capsules (Patients Weighing >33 kg):
  • 200 mg once daily
Adolescent (Aged ≥18 Years) and Adult Dose
Oral Solution for Those Unable to Swallow Capsules:
  • 240 mg (24 mL) once daily
Capsules:
  • 200 mg once daily

[Truvada] Emtricitabine plus TDF
(FTC/TDF)
Pediatric Dose:
Truvada Pediatric Dosing Table
Body Weight FTC/TDF 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 One FTC/TDF 200 mg/300 mg tablet

Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 1 FTC/TDF 200 mg/300 mg tablet once daily

[Descovy] Emtricitabine plus TAF

Pediatric and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • Body Weight 25 to <35 kg: 1 tablet once daily in combination with other antiretroviral (ARV) agents, except for protease inhibitors (PIs) that require a CYP3A inhibitor (i.e., emtricitabine/TAF [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: 1 tablet once daily in combination with an INSTI, NNRTI, or boosted PI

[Atripla] Efavirenz plus Emtricitabine plus TDF

Adolescent (Weighing ≥40 kg) and Adult Dose:
  • 1 tablet once daily
  • Administer without food.

[Complera] Emtricitabine plus Rilpivirine plus TDF

Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 1 tablet once daily in antiretroviral treatment (ART)-naive patients who have baseline plasma HIV-1 RNA <100,000 copies/mL. This Complera dose 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-1 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.

[Odefsey] Emtricitabine plus Rilpivirine plus TAF

Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 1 tablet once daily as initial therapy in ART-naive patients with HIV-1 RNA ≤100,000 copies per mL. This Odefsey dose can also be used to replace a stable ART regimen in patients who have been virologically suppressed (HIV-1 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 plus Cobicistat plus Emtricitabine plus TDF

Adolescent (Weighing ≥35 kg with a Sexual Maturity Rating of 4 or 5) and Adult Dose:
  • 1 tablet once daily with food in ART-naive patients. This Stribild dose can also be used to replace a stable ARV regimen in patients who have been virologically suppressed (HIV-1 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.

[Genvoya] Elvitegravir plus Cobicistat plus Emtricitabine plus TAF

Child and Adolescent (Weighing ≥25 kg) and Adult Dose:
  • 1 tablet once daily with food in ART-naive patients. This Genvoya dose can also be used to replace the current ART regimen in patients who have been virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART 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.

[Biktarvy] Bictegravir plus Emtricitabine plus TAF

Pediatric and Adolescent Dose (Aged <18 Years):
  • Biktarvy has not been Food and Drug Administration-approved for use in patients aged <18 years.
  • Children aged <12 years: No data on appropriate dose of Biktarvy in children aged <12 years
  • Children and adolescents (aged ≥12 to 18 years and weighing ≥35 kg): 1 tablet once daily. This is an investigational dose.
Adult Dose (Aged ≥18 Years):
  • 1 tablet once daily in ART-naive patients. This Biktarvy dose can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV-1 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.
  • Severe acute exacerbation of hepatitis can occur in patients with hepatitis B virus (HBV) and HIV 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 77°F (25°C), if used within 3 months; refrigerate for longer-term storage.
  • Before using emtricitabine, screen patients for HBV.
Metabolism/Elimination
  • No cytochrome P (CYP) 450 interactions
  • Renal excretion of emticitabine is 86%. Emtricitabine may compete with other compounds that undergo renal elimination.
Emtricitabine Dosing in Patients with Renal Impairment:
  • Decrease dose in patients with impaired renal function. Consult manufacturer’s prescribing information.
  • 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. Increase monitoring 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 patients with estimated CrCl <30 mL/min.

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