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

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

Fixed-Dose Combination Tablets:
  • [Truvada low-strength tablet]
    • Emtricitabine 100 mg plus tenofovir disoproxil fumarate (TDF) 150 mg
    • Emtricitabine 133 mg plus TDF 200 mg
    • Emtricitabine 167 mg plus TDF 250 mg
  • [Truvada tablet] Emtricitabine 200 mg plus TDF 300 mg
  • [Atripla] Efavirenz 600 mg plus emtricitabine 200 mg plus TDF 300 mg
  • [Complera] Emtricitabine 200 mg plus rilpivirine 25 mg plus TDF 300 mg
  • [Stribild] Elvitegravir 150 mg plus cobicistat 150 mg plus emtricitabine 200 mg plus TDF 300 mg
  • [Symfi Lo] Efavirenz 400 mg plus lamivudine 300 mg plus TDF 300 mg
Dosing Recommendations Selected Adverse Events
Neonate and Infant Dose:
  • Not Food and Drug Administration-approved or recommended for use in neonates and infants aged <2 years.
Child (Aged ≥2 Years to <12 Years) Dose:a
  • 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

Adolescent (Weighing ≥35 kg)a and Adult Dose:
  • TDF 300 mg once daily


[Truvada] Emtricitabine plus TDF (FTC/TDF)
Pediatric Dose:
Truvada Pediatric 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 One FTC/TDF 200 mg/300 mg tablet

Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 1 FTC/TDF 200 mg/300 mg tablet once daily
[Atripla] Efavirenz plus Emtricitabine plus TDF
Adolescent (Weighing ≥40 kg) and Adult Dose:
  • 1 tablet once daily
[Complera] Emtricitabine plus Rilpivirine plus TDF
Adolescent (Weighing ≥35 kg) and Adult Dose:
  • 1 tablet once daily in treatment-naive adults with baseline viral load <100,000 copies/mL or virologically suppressed adults who are currently on their first or second regimen and have no history of virologic failure or resistance to rilpivirine and other antiretroviral (ARV) drugs.
  • Administer with a meal of at least 500 calories.
[Stribild] Elvitegravir plus Cobicistat plus Emtricitabine plus TDF
Adolescent (Weighing >35 kg with a Sexual Maturity Rating of 4 or 5) and Adult Dose:
  • 1 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-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 Stribild.
  • Administer with food.
[Symfi Lo] Efavirenz plus Lamivudine plus TDF
Pediatric (Weighing ≥35 kg) and Adult Dose:
  • 1 tablet once daily
Note: The new fixed-dose combination (FDC) Symfi Lo, which has a lower dose of efavirenz, has not yet been discussed by the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel). The Panel will address its use in children in a later update.
  • Asthenia, headache, diarrhea, nausea, vomiting, flatulence
  • Renal insufficiency, proximal renal tubular dysfunction that may include Fanconi syndrome
  • Decreased bone mineral densitya
Special Instructions
  • Do not crush tablets; TDF oral powder formulation is available for patients unable to swallow tablets.
  • TDF oral powder should be measured only with the supplied dosing scoop: 1 level scoop = 1 g powder = 40 mg TDF.
  • Mix TDF oral powder in 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 FDC tablet. Food requirements are listed with dosing recommendations.
  • Measure serum creatinine and urine dipstick for protein and glucose before starting a TDF-containing regimen and monitor serum creatinine and urine dipstick 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) has less bone and renal toxicity than TDF, but 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 requiring 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 (Sexual Maturity Rating 1 and 2, previously called Tanner staging).

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