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)

Tenofovir AF

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

Tenofovir Alafenamide (TAF, Vemlidy)
Tenofovir Alafenamide (TAF, Vemlidy)
Formulations
Tablets: 25 mga

Fixed-Dose Combination Tablets:
  • [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 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
  • [Symtuza] Darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 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
[Biktarvy] Bictegravir/Emtricitabine/Tenofovir Alafenamide (TAF)
Child (Weighing <25 kg) Dose:
  • There are no data on the appropriate dose of Biktarvy in children 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.
[Descovy] Emtricitabine/TAF
Child and Adolescent (Weighing ≥25 kg) and Adult Dose
Body Weight 25 kg 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 with a meal in ART-naive patients with HIV RNA ≤100,000 copies/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/per 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 Odefsey.
[Symtuza] Darunavir/Cobicistat/Emtricitabine/TAF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily with food in ART-naive patients. This dose of Symtuza can also be used to replace the current ARV regimen in patients who have been virologically suppressed (HIV RNA <50/per 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 Symtuza.
  • Asthenia, headache, diarrhea, nausea
  • Increased serum lipids
Special Instructions
  • Measure serum creatinine before starting a TAF-containing regimen.
  • Screen patients for hepatitis B virus (HBV) infection before initiating TAF. Severe acute exacerbation of HBV infection can occur when TAF is discontinued; therefore, hepatic function should be monitored for several months after patients with HBV infection stop taking TAF.
  • The Food and Drug Administration (FDA) does not recommend using Genvoya with other ARV drugs, but this FDC tablet has safely been used with darunavir (DRV).1 Descovy can be safely used with DRV or atazanavir in patients weighing ≥35 kg.2
  • Do not use Genvoya with elvitegravir, COBI, tenofovir disoproxil fumarate, emtricitabine, lamivudine, or PIs that are coformulated with COBI.
  • When using Odefsey, patients must be able to take it with a meal of at least 500 calories on a regular schedule (a protein drink alone does not constitute a meal) because it contains rilpivirine.
Metabolism/Elimination
TAF Dosing in Patients with Hepatic Impairment:
  • TAF-containing formulations do not require dose adjustment in patients with mild or moderate hepatic impairment, but they should not be used in patients with severe hepatic impairment because they have not been studied in that group.
TAF Dosing in Patients with Renal Impairment:
  • TAF is renally excreted.
  • No dose adjustment of the TAF 25-mg tablet (Vemlidy)a is required in patients with estimated creatinine clearance (CrCl) ≥15 mL/min, or in patients with estimated CrCl <15 mL/min (i.e., end stage renal disease) who are receiving chronic hemodialysis. See the Vemlidy product label for information on the use of the TAF 25 mg tablet in patients with estimated CrCl ≤15 mL/min.3
  • TAF-containing coformulations are not recommended for use in patients with estimated CrCl <30 mL/min.
a TAF 25-mg tablets (Vemlidy) are approved by the FDA for treatment of HBV. In certain circumstances, TAF 25 mg tablets (Vemlidy) might be used as one component of a combination ARV regimen, with dosing recommendations similar to those for Descovy.

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