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: September 12, 2019; Last Reviewed: September 12, 2019

Tenofovir Alafenamide (TAF, Vemlidy)
Tenofovir Alafenamide (TAF, Vemlidy)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablets: 25 mga

Fixed-Dose Combination Tablets:
  • [Biktarvy] Bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide (TAF) 25 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
  • [Symtuza] Darunavir 800 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 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
[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 (ARV) therapy-naive patients. This dose of Biktarvy 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 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.
[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 ARV-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 Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily with a meal in ARV-naive patients with HIV RNA ≤100,000 copies/mL. This dose of Odefsey can also be used to replace a current, stable ARV regimen in patients who have been virologically suppressed (HIV RNA <50 copies per 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.
[Symtuza] Darunavir/Cobicistat/Emtricitabine/TAF
Adult (Aged ≥18 Years) Dose:
  • One tablet 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.
  • 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 using TAF. Severe acute exacerbation of HBV infection can occur when TAF is discontinued; therefore, in patients with HBV infection, monitor hepatic function for several months after therapy with TAF is stopped.
  • The Food and Drug Administration does not recommend using Genvoya with other ARV drugs, but this FDC has safely been used with darunavir.1 Descovy can be safely used with cobicistat-boosted or ritonavir-boosted darunavir or atazanavir in patients weighing ≥35 kg.2
  • Do not use Genvoya with elvitegravir, cobicistat, tenofovir disoproxil fumarate, emtricitabine, lamivudine, or PIs that are coformulated with cobicistat.
  • 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 undergoes renal excretion.
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:
  • The TAF 25-mg tableta is not recommended for use in patients with estimated creatinine clearance (CrCl) <15 mL/min. 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 select circumstances, TAF might be used as one component of a combination ARV regimen, with dosing recommendations similar to those for Descovy.

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