Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

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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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Fixed-Dose Combinations

Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

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

Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents

This table may include recently approved FDC tablets that have not yet been added to the individual drug sections in Appendix A: Pediatric Antiretroviral Drug Information.

General Considerations When Using FDC Tablets:

  • For children weighing ≥25 kg, the Panel recommends using one of the following single-tablet, once-daily regimens: Triumeq (ABC/DTG/3TC), Genvoya (EVG/c/FTC/TAF), or Biktarvy (BIC/FTC/TAF).
  • ABC and TAF are favored over ZDV because of the lower risk of NRTI-associated mitochondrial toxicity.
  • TDF is more potent than ABC at high viral loads when used in regimens that do not contain an INSTI.
  • TAF is favored over TDF because of the lower risk of TDF-associated bone and renal toxicity.
  • TDF is generally not recommended for children with SMRs of 1–3 because of TDF-associated bone toxicity; however, for a child weighing <25 kg who can swallow pills, Truvada (FTC/TDF) low-strength tablets offer a reasonable, once-daily alternative to twice-daily ZDV plus 3TC or ABC.
  • RPV has low potency at high viral loads, a low barrier to resistance, and requires a high-fat meal for optimal absorption, so EFV or an INSTI are favored over RPV.
  • BIC and DTG, the second-generation INSTIs, have a higher barrier to resistance than the first-generation INSTIs EVG and RAL.
  • For images of most of the FDC tablets listed in this table, see the Antiretroviral Medications section of the National HIV Curriculum. In addition, a resource from the United Kingdom illustrates the relative sizes of FDC tablets and individual ARV drugs (see the ARV Chart). Although most of the drugs listed in that chart are the same as those in the United States, a few of the brand names are not the same as those listed in Appendix A, Table 2.
  • FDC tablets and individual ARV drugs can also be looked up by drug name (brand name and generic) at DailyMed; size is listed under the Ingredients and Appearance section.

INSTI FDC Dosing for Children and Adolescents

Elvitegravir:

  • Genvoya (EVG/c/FTC/TAF) is approved by the FDA for children and adolescents weighing ≥25 kg.

Dolutegravir:

  • The Panel recommends DTG 50 mg for children and adolescents weighing ≥20 kg (see the Dolutegravir section). The FDA-approved dose is DTG 35 mg for patients weighing ≥30 kg to 40 kg, and DTG 50 mg for patients weighing ≥40 kg.
  • For children weighing ≥25 kg, DTG 50 mg can be given as Triumeq (ABC/DTG/3TC) in one large pill or as Descovy (FTC/TAF) plus DTG, which requires two small pills.
  • Exposure to DTG around the time of conception has been associated with a small, but significant, increase in the risk of infant NTDs. Additional information and specific recommendations about the initiation and use of DTG in adolescents and women of childbearing potential and in those who are pregnant or who are trying to conceive are available in the Adult and Adolescent Antiretroviral Guidelines (see Table 6b and Adolescents and Young Adults with HIV) and in the Perinatal Guidelines (see Teratogenicity, Recommendations for Use of Antiretroviral Drugs During Pregnancy, and Appendix D: Dolutegravir Counseling Guide for Health Care Providers).

Bictegravir:

  • Biktarvy (BIC/FTC/TAF) is now approved by the FDA for use in children and adolescents weighing ≥25 kg.

 

Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents
FDC by Class
Brand name and generica products, when available
FDC Components Minimum Body Weight (kg) or Ageb Pill Size (mm x mm) or Largest Dimension (mm) Food Requirements
NRTI
Cimduo 3TC 300 mg/TDF 300 mg 35 kg 19 Take with or without food
Combivir and Generic 3TC/ZDV 3TC 150 mg/ZDV 300 mg (scored tablet) 30 kg 18 x 7 Take with or without food
Descovy FTC 200 mg/TAF 25 mg With an INSTI or NNRTI:
  • 25 kg
With a Boosted PI:
  • 35 kg
12.5 x 6.4 Take with or without food
Epzicom and Generic ABC/3TC ABC 600 mg/3TC 300 mg 25 kg 21 x 9 Take with or without food
Temixys 3TC 300 mg/TDF 300 mg 35 kg N/A Take with or without food
Trizivir and Generic ABC/3TC/ZDV ABC 300 mg/3TC 150 mg/ZDV 300 mg 40 kg (FDA)

30 kg (Panel)c
21 x 10 Take with or without food
Truvada FTC 200 mg/TDF 300 mg 35 kg 19 x 8.5 Take with or without food
Truvada Low Strength
FTC 167 mg/TDF 250 mg 28 kg 18 Take with or without food
FTC 133 mg/TDF 200 mg 22 kg 16 Take with or without food
FTC 100 mg/TDF 150 mg 17 kg 14 Take with or without food
NRTI/NNRTI
Atripla EFV 600 mg/FTC 200 mg/TDF 300 mg 40 kg 20 Take on an empty stomach
Complera FTC 200 mg/RPV 25 mg/TDF 300 mg 35 kg and aged ≥12 years 19 Take on an empty stomach
Delstrigo DOR 100 mg/3TC 300 mg/TDF 300 mg Adults 19 Take with or without food
Odefsey FTC 200 mg/RPV 25 mg/TAF 25 mg 35 kg and aged ≥12 years 15 Take with a meal
Symfi EFV 600 mg/3TC 300 mg/TDF 300 mg (scored tablet) 40 kg 23 Take on an empty stomach
Symfi Lo EFV 400 mg/3TC 300 mg/TDF 300 mg 35 kgd 21 Take on an empty stomach
NRTI/INSTI
Biktarvy BIC 50 mg/FTC 200 mg/TAF 25 mg 25 kg 15 x 8 Take with or without food
Dovato DTG 50 mg/3TC 300 mg Adultse 19 Take with or without food
Triumeq ABC 600 mg/DTG 50 mg/3TC 300 mg 40 kg (FDA)

25 kg (Panel)f
22 x 11 Take with or without food
NNRTI/INSTI
Juluca DTG 50 mg/RPV 25 mg Adults Adults 14 Take with a meal
NRTI/INSTI/COBI
Genvoya EVG 150 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg 25 kg 19 x 8.5 Take with food
Stribild EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg 35 kg and ≥12 yearsg 20 Take with food
NRTI/PI/COBI
Symtuza DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg 40 kg 22 Take with food
PI/COBI
Evotaz ATV 300 mg/COBI 150 mg 35 kg 19 Take with food
Prezcobix DRV 800 mg/COBI 150 mg 40 kg 23 Take with food
PI/RTV
Kaletra LPV/r Oral Solution:
  • LPV 80 mg/mL and RTV 20 mg/mL
Tablets:
  • LPV 200 mg/RTV 50 mg
  • LPV 100 mg/RTV 25 mg
Post-Menstrual Age of 42 Weeks and a Postnatal Age of ≥14 Days:
  • No minimum weight
19 Take with or without food
a Size or largest dimension of generic drugs are not listed because they may vary by manufacturer; this information is available by looking up one of the drug components using DailyMed.

b Minimum body weight and age are those recommended by the FDA, unless otherwise noted.

c Based on the current FDA-approved minimum body weights for the component drugs of Trizivir, the Panel suggests that Trizivir be used at a minimum body weight of ≥30 kg, although it is approved by the FDA for use in children and adolescents weighing ≥40 kg. However, the Panel does not recommend using regimens that only contain NRTIs, or using three-NRTI regimens, in children.

d Due to PK concerns, the Panel recommends caution when using Symfi Lo in children and adolescents who have SMRs of 1–3 and weigh ≥40 kg (see the Efavirenz section).

e The Panel does not currently recommend using Dovato as a 2 drug complete regimen in adolescents and children. This FDC tablet could be used as part of a three-drug regimen in children who meet the minimum body weight requirements for each component drug.

f The Panel recommends using DTG 50 mg for children and adolescents weighing ≥20 kg based on available data. However, the doses of ABC and 3TC in Triumeq are too high for children weighing <25 kg (see the Dolutegravir section).

g Although Stribild is approved by the FDA for use in children and adolescents weighing ≥35 kg and aged ≥12 years, the Panel does not recommend using it in children or adolescents who have SMRs of 1–3.

Key: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; BIC = bictegravir; COBI = cobicistat; DOR = doravirine; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; EVG/c = elvitegravir/cobicistat; FDA = Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; INSTI = integrase strand transfer inhibitor; LPV = lopinavir; LPV/r = lopinavir/ritonavir; N/A = information not available; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NTD = neural tube defect; the Panel = Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV; PI = protease inhibitor; PK = pharmacokinetic; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SMR = sexual maturity rating; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; ZDV = zidovudine

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