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.

  •   Table of Contents

Download Guidelines

Nucleoside and Nucleotide Analogue Reverse Transcriptase Inhibitors (NRTIs)

Emtricitabine

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Emtricitabine (FTC, Emtriva)
Emtricitabine (FTC, Emtriva)
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 300 mg
  • [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg
  • [Complera] Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate  300 mg
  • [Descovy] Emtricitabine 200 mg/tenofovir alafenamide 25 mg
  • [Genvoya] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg
  • [Odefsey] Emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
  • [Symtuza] Darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg
  • [Truvada] Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg
  • [Truvada low-strength tablets]
    • Emtricitabine 100 mg/tenofovir disoproxil fumarate 150 mg
    • Emtricitabine 133 mg/tenofovir disoproxil fumarate 200 mg
    • Emtricitabine 167 mg/tenofovir disoproxil fumarate 250 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
Neonatal and Infant (Aged 0 to <3 Months) Dose
Oral Solution:
  • Emtricitabine (FTC) 3 mg/kg once daily

Child (Aged ≥3 Months) and Adolescent Dose
Oral Solution:
  • FTC 6 mg/kg once daily (maximum 240 mg per dose). The maximum dose of oral solution is higher than the capsule dose because a pediatric pharmacokinetic analysis reported that the plasma exposure for FTC was 20% lower in patients who received the oral solution than in patients who received the capsule formulation.
Capsules (For Patients Weighing >33 kg):
  • FTC 200 mg once daily

Adult Dose
Oral Solution for Patients Who Are Unable to Swallow Capsules:
  • FTC 240 mg (24 mL) once daily
Capsules:
  • FTC 200 mg once daily

[Atripla and Generic] Efavirenz/Emtricitabine/Tenofovir disoproxil fumarate (TDF)
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily
  • Take on an empty stomach.

[Biktarvy] Bictegravir/Emtricitabine/Tenofovir alafenamide (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 for at least 3 months with no history of treatment failure and no known mutations 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 treatment failure and no known mutations associated with 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 mutations 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 the current 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 mutations 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 the current 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 mutations associated with resistance to the individual components of Stribild.

[Symtuza] Darunavir/Cobicistat/Emtricitabine/TAF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily with food in ART-naive patients or in patients who have been virologically suppressed (HIV RNA <50 copies/mL) for at least 6 months with no known mutations associated with resistance to darunavir or tenofovir.

[Truvada] Emtricitabine/TDF (FTC/TDF)
Child, Adolescent, and Adult Dose:
Truvada Dosing Table
Body Weight FTC/TDF Tablet
Once Daily
17 kg to <22 kg One FTC 100 mg/TDF 150 mg tablet
22 kg to <28 kg One FTC 133 mg/TDF 200 mg tablet
28 kg to <35 kg One FTC 167 mg/TDF 250 mg tablet
≥35 kg and Adults One FTC 200 mg/TDF 300 mg tablet
  • Hyperpigmentation/skin discoloration on palms and/or soles
Special Instructions
  • Although FTC can be administered without regard to food, there are food requirements for some FDC tablet formulations that contain FTC.
  • FTC oral solution can be kept at room temperature, up to 77ºF (25ºC), if used within 3 months; refrigerate for long-term storage.
  • Screen patients for hepatitis B virus (HBV) infection before using FTC. Severe acute exacerbation of HBV infection can occur when FTC is discontinued; therefore, hepatic function and hepatitis B viral load should be monitored for several months after patients with HBV infection stop taking FTC.
Metabolism/Elimination
  • No cytochrome P450 interactions
  • Eighty-six percent of FTC is excreted in urine. FTC may compete with other compounds that undergo renal elimination.
Emtricitabine Dosing in Patients with Renal Impairment:
  • Decrease the dose of FTC in patients with impaired renal function. Consult the manufacturer’s prescribing information for recommended dose adjustments.
  • Do not use the FDC tablet Atripla in patients with creatinine clearance (CrCl) <50 mL/min or in patients who require dialysis.
  • Do not use the FDC tablets 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.

Download Guidelines