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 DF

Last Updated: April 16, 2019; Last Reviewed: April 16, 2019

Tenofovir Disoproxil Fumarate (TDF, Viread)
Tenofovir Disoproxil Fumarate (TDF, Viread)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Tablets: 150 mg, 200 mg, 250 mg, and 300 mg
Oral Powder: 40 mg per 1 g of oral powder (1 level scoop, measured with supplied dosing scoop = 1 g oral powder)

Fixed-Dose Combination Tablets:
  • [Atripla and Generic] Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg
  • [Cimduo] Lamivudine 300 mg/TDF 300 mg
  • [Complera] Emtricitabine 200 mg/rilpivirine 25 mg/TDF 300 mg
  • [Delstrigo] Doravirine 100 mg/lamivudine 300 mg/TDF 300 mg
  • [Stribild] Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TDF 300 mg
  • [Symfi] Efavirenz 600 mg/lamivudine 300 mg/TDF 300 mg
  • [Symfi Lo] Efavirenz 400 mg/lamivudine 300 mg/TDF 300 mg
  • [Temixys] Lamivudine 300 mg/TDF 300 mg
  • [Truvada low-strength tablet]
    • Emtricitabine 100 mg/TDF 150 mg
    • Emtricitabine 133 mg/TDF 200 mg
    • Emtricitabine 167 mg/TDF 250 mg
  • [Truvada tablet] Emtricitabine 200 mg/TDF 300 mg
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • TDF has not been approved by the Food and Drug Administration or recommended for use in neonates and infants aged <2 years.
Child (Aged ≥2 Years to <12 Years) Dose:a
  • TDF 8 mg/kg/dose once daily
TDF Oral Powder Dosing Table
Body Weight TDF Oral Powder
Once-Daily Scoops of Powder
10 kg to <12 kg 2 scoops (80 mg)
12 kg to <14 kg 2.5 scoops (100 mg)
14 kg to <17 kg 3 scoops (120 mg)
17 kg to <19 kg 3.5 scoops (140 mg)
19 kg to <22 kg 4 scoops (160 mg)
22 kg to <24 kg 4.5 scoops (180 mg)
24 kg to <27 kg 5 scoops (200 mg)
27 kg to <29 kg 5.5 scoops (220 mg)
29 kg to <32 kg 6 scoops (240 mg)
32 kg to <34 kg 6.5 scoops (260 mg)
34 kg to <35 kg 7 scoops (280 mg)
≥35 kg 7.5 scoops (300 mg)

TDF Tablet Dosing Table for Patients Aged ≥2 Years and Weighing ≥17 kg
Body Weight TDF Tablet
Once Daily
17 kg to <22 kg 150 mg
22 kg to <28 kg 200 mg
28 kg to <35 kg 250 mg
≥35 kg 300 mg

Child and Adolescent (Weighing ≥35 kg)a and Adult Dose:
  • TDF 300 mg once daily
[Atripla and Generic] Efavirenz/Emtricitabine/TDF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily
  • Take on an empty stomach
[Cimduo] Lamivudine/TDF
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily
[Complera] Emtricitabine/Rilpivirine/TDF
Child and Adolescent (Aged ≥12 Years and Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily in treatment-naive adults with baseline viral loads ≤100,000 copies/mL. This dose of Complera can also be used in virologically suppressed adults who are currently on their first or second regimen and who have no history of virologic failure or resistance to rilpivirine and other antiretroviral (ARV) drugs.
  • Administer with a meal of at least 500 calories.
[Delstrigo] Doravirine/Emtricitabine/TDF
Adult Dose:
  • One tablet once daily
  • Not studied in children or adolescents (see doravirine section)
[Stribild] Elvitegravir/Cobicistat/Emtricitabine/TDF
Adolescent (Weighing >35 kg with a Sexual Maturity Rating [SMR] of 4 or 5) and Adult Dose:
  • One tablet once daily in treatment-naive adults. 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) 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 Stribild.
  • Administer with food.
[Symfi] Efavirenz 600 mg/Lamivudine/TDF
Child and Adolescent (Weighing ≥40 kg) and Adult Dose:
  • One tablet once daily
  • Take on an empty stomach
[Symfi Lo] Efavirenz 400 mg/Lamivudine/TDF
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily
  • Take on an empty stomach
Note: Symfi Lo has not been studied in children (SMR 1 to 3) and major inter-individual variability in efavirenz plasma concentrations has been found in pediatric patients in a multi-ethnic setting. The 400 mg dose of efavirenz may be too low in children or adolescents SMR 1-3 who weigh ≥40 kg. Therapeutic drug monitoring is suggested by some Panel members when Symfi Lo is used in pediatric patients weighing ≥40 kg. See the efavirenz section for more information.

[Temixys] Lamivudine/TDF
Child and Adolescent (Weighing ≥35 kg) and Adult Dose:
  • One tablet once daily
[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/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 and Adults One FTC/TDF 200 mg/300 mg tablet
  • Asthenia, headache, diarrhea, nausea, vomiting, flatulence
  • Glomerular and proximal renal tubular dysfunction
  • Decreased bone mineral densitya
Special Instructions
  • Do not crush tablets. TDF oral powder formulation is available for patients who are unable to swallow tablets.
  • TDF oral powder should be measured only with the supplied dosing scoop: 1 level scoop = 1 g powder = TDF 40 mg.
  • Mix TDF oral powder with 2 to 4 oz. of soft food that does not require chewing (e.g., applesauce, yogurt). Administer immediately after mixing to avoid the bitter taste.
  • Do not try to mix the TDF oral powder with liquid. The powder may float on the top even after vigorous stirring.
  • Although TDF can be administered without regard to food, food requirements vary depending on the other ARV drugs contained in a fixed-dose combination (FDC) tablet. Food requirements are listed with dosing recommendations and in Table 2 of the Drug Appendix.
  • Measure serum creatinine and perform a urine dipstick test for protein and glucose before starting a TDF-containing regimen. Serum creatinine should be monitored and urine should be tested for protein and glucose at intervals (see Table 15i) during continued therapy. Measure serum phosphate if there is clinical suspicion of hypophosphatemia.
  • Screen patients for hepatitis B virus (HBV) infection before using TDF. Severe acute exacerbation of HBV infection can occur when TDF is discontinued; therefore, in patients with HBV infection, monitor hepatic function and hepatitis B viral load for several months after therapy with TDF is stopped.
  • When using FDC tablets, see other drug sections for special instructions and additional information about the individual drug components.
  • Tenofovir alafenamide (TAF) is associated with less bone and renal toxicity than TDF, but it has equal antiviral efficacy. Do not use TAF and TDF together. Consider switching from TDF to TAF in appropriate clinical settings.
Metabolism/Elimination
  • TDF is renally excreted.
TDF Dosing in Patients with Renal Insufficiency:
  • TDF dose should be decreased in patients with impaired renal function (creatinine clearance [CrCl] <50 mL/min). Consult manufacturer’s prescribing information for adjustment of dose in accordance with CrCl.
  • The FDCs Atripla, Complera, and Symfi Lo should not be used in patients with CrCl <50 mL/min or in patients requiring dialysis.
  • The FDC Truvada should not be used in patients with CrCl <30 mL/min or in patients who require dialysis.
  • The FDC 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.
  • Stribild should not be used in patients with severe hepatic impairment.
a See text for concerns about decreased bone mineral density, especially in prepubertal patients and those in early puberty (SMR 1 or 2).

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