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

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:
  • [Descovy] Emtricitabine 200 mg plus tenofovir alafenamide (TAF) 25 mg
  • [Genvoya] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus TAF 10 mg
  • [Odefsey] Emtricitabine 200 mg plus rilpivirine 25 mg plus TAF 25 mg
  • [Biktarvy] Bictegravir 50 mg plus emtricitabine 200 mg plus TAF 25 mg
Dosing Recommendations Selected Adverse Events
[Descovy] Emtricitabine plus TAF
Pediatric, 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.

[Genvoya] Elvitegravir plus Cobicistat plus Emtricitabine plus TAF

Pediatric, Adolescent (Weighing ≥25 kg), and Adult Dose:
  • 1 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-1 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 plus Rilpivirine plus TAF

Pediatric, Adolescent (Weighing ≥35 kg), and Adult Dose:
  • 1 tablet once daily with a meal in ARV-naive patients with HIV-1 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-1 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.

[Biktarvy] Bictegravir plus Emtricitabine plus TAF

Pediatric/Adolescent Dose (Aged <18 Years):
  • Biktarvy has not been Food and Drug Administration (FDA) 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/Adolescents (Aged ≥12 Years 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 ARV-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.
  • 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.
  • When using fixed-dose combination (FDC) tablets, see other sections of the Drug Appendix for special instructions and additional information about the individual components of the FDC (see the Emtricitabine, Elvitegravir, Cobicistat, Rilpivirine, and Bictegravir sections).
  • Use of Genvoya is not FDA-recommended with other ARV drugs, but this FDC has safely been used with darunavir.1 Descovy can be safely used with cobicistat- 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 co-formulated 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 Renal Insufficiency:
  • The TAF 25-mg tableta is not recommended for use in patients with estimated creatinine clearance (CrCl) <15 mL/min. TAF-containing co-formulations are not recommended in patients with estimated CrCl <30 mL/min.
  • TAF-containing formulations do not require dose adjustment in patients with mild or moderate hepatic impairment, but should not be used in patients with severe hepatic impairment because they have not been studied in that group.
a TAF 25 mg tablets (Vemlidy) are FDA-approved 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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