Actualizado
Oct. 11, 2022
Reviewed
Oct. 11, 2022

Fixed-Dose Combinations

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

General Considerations When Using Fixed-Dose Combination Tablets

Please see the individual drug sections for information on dosing of individual fixed-dose combination (FDC) products.

Integrase Strand Transfer Inhibitors (INSTIs)
  • Bictegravir (BIC) and dolutegravir (DTG), second-generation INSTIs, have a higher barrier to resistance than the first-generation INSTIs, elvitegravir (EVG) and raltegravir (RAL).
  • For children weighing ≥10 kg, DTG is available in once-daily FDC formulations of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). If ABC/DTG/3TC is not an option, then single-entity DTG can be used in combination with other FDC tablets.
    • ABC/DTG/3TC is available in two different formulations, with the appropriate formulation depending on weight. For children weighing ≥10 kg to <25 kg, ABC/DTG/3TC is available in a dispersible tablet, once-daily regimen (Triumeq PD); the number of tablets per dose depends on the child’s weight. For children and adolescents weighing ≥25 kg, ABC/DTG/3TC is available as a once-daily single-tablet to be swallowed (Triumeq).
    • Whether considering DTG in FDC or single-entity form, the film-coated tablets and dispersible tablets are not bioequivalent and, thus, are not interchangeable on a milligram-per-milligram basis. Refer to Dolutegravir for dosing information.
  • For children weighing ≥14 kg, BIC is available as the single-tablet, once-daily regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF; Biktarvy). There are two dosage strengths for pediatric use: one for use in children weighing ≥14 to <25 kg and another for children and adolescents weighing ≥25 kg and adults.
  • For children weighing ≥25 kg, EVG is available as the single-tablet, once-daily regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/c/FTC/TAF; Genvoya). EVG/c/FTC/TAF (Genvoya) has more drug–drug interactions than ABC/DTG/3TC (Triumeq or Triumeq PD) or BIC/FTC/TAF (Biktarvy).
  • The two-drug, co-packaged regimen of long-acting cabotegravir and rilpivirine (CAB and RPV; Cabenuva) is approved by the U.S. Food and Drug Administration (FDA) for use in children and adolescents aged ≥12 years and weighing ≥35 kg. CAB and RPV are administered by intramuscular injection on a monthly or every two-month schedule after an optional oral dose lead-in. See Cabotegravir for instructions about dosing and administration.
Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTIs and NRTIs)
  • ABC or TAF in combination with 3TC or FTC are favored over zidovudine/ lamivudine (ZDV/3TC) because of the lower risk of nucleoside reverse transcriptase inhibitor (NRTI)–associated mitochondrial toxicity.
  • Tenofovir disoproxil fumarate (TDF) is more potent than ABC at high viral loads (>100,000 copies/mL) 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 not recommended for children with sexual maturity ratings (SMRs) of 1 to 3 because of TDF-associated bone toxicity.
  • For children weighing ≥14 kg who can swallow pills, FTC/TAF (Descovy) offers a once-daily alternative to twice-daily ZDV plus 3TC or ABC plus 3TC.
  • For children weighing ≥14 kg and ≤35 kg, FTC/TAF (Descovy) can be used in combination with an INSTI or NNRTI, but not with a protease inhibitor; this restriction does not apply to regimens containing ZDV or ABC.
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs)
  • The FDC tablet doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF) is approved by the FDA for children and adolescents weighing ≥35 kg who are antiretroviral (ARV) naive or virologically suppressed on a stable ARV regimen (see the Doravirine section).
  • RPV has low potency at high viral loads (>100,000 copies/mL) and requires a high-fat meal for optimal absorption, so efavirenz (EFV) or an INSTI are favored over RPV.

Fixed-Dose Combinations Available for Children and Adolescents

  • For images of most of the FDC tablets listed in this table, see the Antiretroviral Medications section of the National HIV Curriculum.
Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets and Co-packaged Formulations: Minimum Body Weights and Considerations for Use in Children

FDC tablets and individual ARV drugs also can be looked up by drug name (brand name and generic) at DailyMed. Size is listed under the Ingredients and Appearance section.

FDC by Class
Brand name and generica products, when available

FDC Components Minimum Body Weight or Weight Range (kg) or Ageb Pill Size (mm × mm) or Largest Dimension (mm)c 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 × 7

Take with or without food.

Descovy

FTC 120 mg/TAF 15 mg

With an INSTI or NNRTI

  • 14 to < 25 kg

N/A

Take with or without food.

FTC 200 mg/TAF 25 mg

With an INSTI or NNRTI

  • 25 kg

With a Boosted PI

  • 35 kg

12.5 × 6.4

Take with or without food.

Epzicom and Generic ABC/3TC

ABC 600 mg/3TC 300 mg

25 kg

21 × 9

Take with or without food.

Temixys

3TC 300 mg/TDF 300 mg

35 kg

N/A

Take with or without food.

Truvada

FTC 100 mg/TDF 150 mg

17 to <22 kg

14

Take with or without food.

FTC 133 mg/TDF 200 mg

22 to <28 kg

16

Take with or without food.

FTC 167 mg/TDF 250 mg

28 to <35 kg

18

Take with or without food.

FTC 200 mg/TDF 300 mg

35 kg

19 × 8.5

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 with a meald

Delstrigo

DOR 100 mg/3TC 300 mg/TDF 300 mg

35 kg

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 meald

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 kge

21

Take on an empty stomach.

NRTI/INSTI
Biktarvy

BIC 30 mg/FTC 120 mg/TAF 15 mg

14 to <25 kg

N/A

Take with or without food.

BIC 50 mg/FTC 200 mg/TAF 25 mg

25 kg

15 × 8

Take with or without food.

Dovato

DTG 50 mg/3TC 300 mg

Adultsf

19

Take with or without food.

Triumeq

ABC 600 mg/DTG 50 mg/3TC 300 mg

25 kg

22 × 11

Take with or without food.

Triumeq PD

ABC 60 mg/DTG 5 mg/3TC 30 mg

10 to < 25 kgg

N/A (dispersible)

Take with or without food.

NNRTI/INSTI
Cabenuvah Cabenuva 400 mg/600 mg kit contains CAB 400 mg/2 mL vial and RPV 600 mg/2 mL vial 35 kg and aged ≥12 years N/A See Cabotegravir for instructions about dosing and administration.

Cabenuva 600 mg/900 mg kit contains CAB 600 mg/3 mL vial and RPV 900 mg/3 mL vial

35 kg and aged ≥12 years

N/A

See Cabotegravir for instructions about dosing and administration.

Juluca

DTG 50 mg/RPV 25 mg

Adultsf

14

Take with a meal.d

NRTI/INSTI/COBI
Genvoya

EVG 150 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg

25 kg

19 × 8.5

Take with food.

Stribild

EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg

35 kg and SMR 4 or 5i

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 The possibility of planned and unplanned pregnancy should be considered when selecting an antiretroviral therapy (ART) regimen for an adolescent. When discussing ART options with adolescents of childbearing potential and their caregivers, it is important to consider the benefits and risks of all ARV drugs and to provide the information and counseling needed to support informed decision-making (see Table 5. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive and Appendix C: Antiretroviral Counseling Guide for Health Care Providers).

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

c Sizes or largest dimensions 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.

d Patients must be able to take oral RPV with a meal of at least 500 calories on a regular schedule (a protein drink alone does not constitute a meal).

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

f The Panel does not currently recommend using dolutegravir/lamivudine (DTG/3TC; Dovato) or dolutegravir/rilpivirine (DTG/RPV; Juluca) as a two-drug complete regimen in adolescents and children. These FDC tablets could be used as part of a three-drug regimen in children who meet the minimum body weight requirements for each component drug.

g ABC/DTG/3TC is available in dispersible tablets (Triumeq PD) for children weighing ≥10 mg to <25 mg with the dosage and number of tablets based on weight. Refer to the Dolutegravir section for exact dosage and instructions for administration. Dispersible tablets (Triumeq PD) are not recommended for children and adolescents weighing ≥25 kg.

h Long-acting CAB and RPV for intramuscular injection are available as a co-packaged product (Cabenuva); oral formulations of CAB and RPV for the optional initial lead-in dosing or bridging between injections >7 days from the target injection window must be prescribed separately (see the Cabotegravir and Rilpivirine sections).

i Although Stribild is approved by the FDA for use in children and adolescents weighing ≥35 kg and age ≥12 years, the Panel does not recommend its use in children with SMRs 1 to 3 given the availability of other INSTI-containing FDCs.

Key: 3TC = lamivudine; ABC = abacavir; ATV = atazanavir; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; DOR = doravirine; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; FDA = U.S. Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; INSTI = integrase strand transfer inhibitor; kg = kilogram; LPV = lopinavir; LPV/r = lopinavir/ritonavir; mg = milligram; mL = milliliter; mm = millimeter; N/A = information not available or not applicable; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; the Panel = Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV; PI = protease inhibitor; RPV = rilpivirine; RTV = ritonavir; SMR = sexual maturity rating; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; ZDV = zidovudine

Fixed-Dose Combinations

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

FDC tablets and individual ARV drugs also can be looked up by drug name (brand name and generic) at DailyMed. Size is listed under the Ingredients and Appearance section.

FDC by Class
Brand name and generica products, when available

FDC Components Minimum Body Weight or Weight Range (kg) or Ageb Pill Size (mm × mm) or Largest Dimension (mm)c 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 × 7

Take with or without food.

Descovy

FTC 120 mg/TAF 15 mg

With an INSTI or NNRTI

  • 14 to < 25 kg

N/A

Take with or without food.

FTC 200 mg/TAF 25 mg

With an INSTI or NNRTI

  • 25 kg

With a Boosted PI

  • 35 kg

12.5 × 6.4

Take with or without food.

Epzicom and Generic ABC/3TC

ABC 600 mg/3TC 300 mg

25 kg

21 × 9

Take with or without food.

Temixys

3TC 300 mg/TDF 300 mg

35 kg

N/A

Take with or without food.

Truvada

FTC 100 mg/TDF 150 mg

17 to <22 kg

14

Take with or without food.

FTC 133 mg/TDF 200 mg

22 to <28 kg

16

Take with or without food.

FTC 167 mg/TDF 250 mg

28 to <35 kg

18

Take with or without food.

FTC 200 mg/TDF 300 mg

35 kg

19 × 8.5

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 with a meald

Delstrigo

DOR 100 mg/3TC 300 mg/TDF 300 mg

35 kg

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 meald

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 kge

21

Take on an empty stomach.

NRTI/INSTI
Biktarvy

BIC 30 mg/FTC 120 mg/TAF 15 mg

14 to <25 kg

N/A

Take with or without food.

BIC 50 mg/FTC 200 mg/TAF 25 mg

25 kg

15 × 8

Take with or without food.

Dovato

DTG 50 mg/3TC 300 mg

Adultsf

19

Take with or without food.

Triumeq

ABC 600 mg/DTG 50 mg/3TC 300 mg

25 kg

22 × 11

Take with or without food.

Triumeq PD

ABC 60 mg/DTG 5 mg/3TC 30 mg

10 to < 25 kgg

N/A (dispersible)

Take with or without food.

NNRTI/INSTI
Cabenuvah Cabenuva 400 mg/600 mg kit contains CAB 400 mg/2 mL vial and RPV 600 mg/2 mL vial 35 kg and aged ≥12 years N/A See Cabotegravir for instructions about dosing and administration.

Cabenuva 600 mg/900 mg kit contains CAB 600 mg/3 mL vial and RPV 900 mg/3 mL vial

35 kg and aged ≥12 years

N/A

See Cabotegravir for instructions about dosing and administration.

Juluca

DTG 50 mg/RPV 25 mg

Adultsf

14

Take with a meal.d

NRTI/INSTI/COBI
Genvoya

EVG 150 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg

25 kg

19 × 8.5

Take with food.

Stribild

EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg

35 kg and SMR 4 or 5i

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 The possibility of planned and unplanned pregnancy should be considered when selecting an antiretroviral therapy (ART) regimen for an adolescent. When discussing ART options with adolescents of childbearing potential and their caregivers, it is important to consider the benefits and risks of all ARV drugs and to provide the information and counseling needed to support informed decision-making (see Table 5. Situation-Specific Recommendations for Use of Antiretroviral Drugs in Pregnant People and Nonpregnant People Who Are Trying to Conceive and Appendix C: Antiretroviral Counseling Guide for Health Care Providers).

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

c Sizes or largest dimensions 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.

d Patients must be able to take oral RPV with a meal of at least 500 calories on a regular schedule (a protein drink alone does not constitute a meal).

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

f The Panel does not currently recommend using dolutegravir/lamivudine (DTG/3TC; Dovato) or dolutegravir/rilpivirine (DTG/RPV; Juluca) as a two-drug complete regimen in adolescents and children. These FDC tablets could be used as part of a three-drug regimen in children who meet the minimum body weight requirements for each component drug.

g ABC/DTG/3TC is available in dispersible tablets (Triumeq PD) for children weighing ≥10 mg to <25 mg with the dosage and number of tablets based on weight. Refer to the Dolutegravir section for exact dosage and instructions for administration. Dispersible tablets (Triumeq PD) are not recommended for children and adolescents weighing ≥25 kg.

h Long-acting CAB and RPV for intramuscular injection are available as a co-packaged product (Cabenuva); oral formulations of CAB and RPV for the optional initial lead-in dosing or bridging between injections >7 days from the target injection window must be prescribed separately (see the Cabotegravir and Rilpivirine sections).

i Although Stribild is approved by the FDA for use in children and adolescents weighing ≥35 kg and age ≥12 years, the Panel does not recommend its use in children with SMRs 1 to 3 given the availability of other INSTI-containing FDCs.

Key: 3TC = lamivudine; ABC = abacavir; ATV = atazanavir; BIC = bictegravir; CAB = cabotegravir; COBI = cobicistat; DOR = doravirine; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; FDA = U.S. Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; INSTI = integrase strand transfer inhibitor; kg = kilogram; LPV = lopinavir; LPV/r = lopinavir/ritonavir; mg = milligram; mL = milliliter; mm = millimeter; N/A = information not available or not applicable; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; the Panel = Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV; PI = protease inhibitor; RPV = rilpivirine; RTV = ritonavir; SMR = sexual maturity rating; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; ZDV = zidovudine

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