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: December 14, 2018; Last Reviewed: December 14, 2018

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 FDCs that have not yet been added to individual drug sections in the Pediatric Antiretroviral Drug Information Appendix (see individual drug components for details), and it does not include FDCs for individual component drugs that were recently approved and have not been added to the Pediatric Antiretroviral Drug Appendix (e.g., Doravirine and the FDC Delstrigo).

General Considerations When Considering a Fixed-Dose Combination Tablet:

  • ABC and TAF are favored over ZDV because of 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 SMR 1–3 because of TDF-associated bone toxicity; however, for a child weighing <25 kg who can swallow pills, Truvada low-strength tablets offer a reasonable, once daily combination alternative to twice daily ZDV plus 3TC or an alternative to 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.
  • BIC and DTG, second-generation INSTIs, have a higher barrier to resistance than EVG, a first-generation INSTI.
  • INSTI FDC dosing for children and adolescents:
    • 25 kg: Genvoya
    • 30 kg: Descovy plus DTG (2 pills, but each is small); there is no agreed-upon DTG dose yet below 30 kg
    • Recent data identified a possible increased risk of NTDs among women who were receiving DTG at the time of conception. Specific recommendations about the initiation and use of DTG in adolescents and women of childbearing potential and in pregnant women 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 and Recommendations for the Use of Antiretroviral Drugs in Pregnancy).
    • Biktarvy has been studied in youth aged ≥6 years and weighing ≥25 kg but is not FDA approved for use in children or adolescents.
    • For images of most of the FDCs 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 FDCs (see the “Intro ARV chart”). Although most of the drugs listed in the 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, below.
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 generic products, when available
FDC Components Minimum Body Weight (kg) or Age Pill Size (mm x mm) Food Required for Optimal Absorption
NRTI
Cimduo 3TC 300 mg plus TDF 300 mg 35 kg N/A No
Combivir
and
Generic 3TC/ZDV
3TC 150 mg plus ZDV 300 mg (scored tablet) 30 kg 18 x 7 No
Descovy FTC 200 mg plus TAF 25 mg 25 kg: With INSTI or NNRTI

35 kg: With boosted PI
12.5 x 6.4 No
Epzicom
and
Generic ABC/3TC
ABC 600 mg plus 3TC 300 mg 25 kg 21 x 9 No
Temixys 3TC 300 mg plus TDF 300 mg 35 kg N/A No
Trizivir
and
Generic ABC/3TC/ZDV
ABC 300 mg plus 3TC 150 mg plus ZDV 300 mg 40 kg 21 x 10 No
Truvada FTC 200 mg plus TDF 300 mg 35 kg 19 x 8.5 No
Truvada Low Strength FTC 167 mg plus TDF 250 mg 28 kg N/A No
FTC 133 mg plus TDF 200 mg 22 kg N/A No
FTC 100 mg plus TDF 150 mg 17 kg N/A No
NRTI/NNRTI
Atripla EFV 600 mg plus FTC 200 mg plus TDF 300 mg 40 kg N/A Fasting
Complera FTC 200 mg plus RPV 25 mg plus TDF 300 mg 35 kg and ≥ 12 years N/A Yes
Odefsey FTC 200 mg plus RPV 25 mg plus TAF 25 mg 35 kg and ≥ 12 years N/A Yes
Symfi EFV 600 mg plus 3TC 300 mg plus TDF 300 mg 40 kg N/A Unevaluated
Symfi Lo EFV 400 mg plus 3TC 300 mg plus TDF 300 mg 35 kg N/A Unevaluated
NRTI/INSTI
Biktarvy BIC 50 mg plus FTC 200 mg plus TAF 25 mg Adults 15 x 8 No
Triumeq ABC 600 mg plus DTG 50 mg plus 3TC 300 mg 40 kg 22 x 11 No
NNRTI/INSTI
Juluca DTG 50 mg plus RPV 25 mg Adults N/A Yes
NRTI/INSTI/COBI
Genvoya EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TAF 10 mg 25 kg 19 x 8.5 Yes
Stribild EVG 150 mg plus COBI 150 mg plus FTC 200 mg plus TDF 300 mg 35 kg N/A Yes
NRTI/PI/COBI
Symtuza DRV 800 mg plus COBI 150 mg plus FTC 200 mg plus TAF 10 mg Adults N/A Yes
PI/COBI
Evotaz ATV 300 mg plus COBI 150 mg 35 kg N/A Yes
Prezcobix DRV 800 mg plus COBI 150 mg 35 kg N/A Yes
PI/RTV
Kaletra LPV/r Oral Solution:
  • 80 mg/mL LPV plus 20 mg/mL RTV
Tablets:
  • LPV 200 mg plus RTV 50 mg
  • LPV 100 mg plus RTV 25 mg
Post-menstrual age of 42 weeks and a postnatal age of ≥ 14 days:
  • No minimum weight
N/A No
Key to Abbreviations: 3TC = lamivudine; ABC = abacavir; ATV = atazanavir; BIC = bictegravir; COBI = cobicistat; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; FDC = fixed-dose combination; FTC = emtricitabine; INSTI = integrase inhibitor; LPV = lopinavir; LPV/r = lopinavir/ritonavir; mm = millimetre; N/A = information not available; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside and nucleotide reverse transcriptase inhibitor; RPV = rilpivirine; RTV = ritonavir; SMR = sexual maturity rating; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; ZDV = zidovudine

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