Fixed-Dose Combinations
Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents
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
- Genvoya (EVG/c/FTC/TAF) is approved by the FDA for children and adolescents weighing ≥25 kg.
- 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).
- Biktarvy (BIC/FTC/TAF) is now approved by the FDA for use in children and adolescents weighing ≥25 kg.
| 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:
|
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:
|
Post-Menstrual Age of 42 Weeks and a Postnatal Age of ≥14 Days:
|
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 |
||||
Fixed-Dose Combinations
Appendix A, Table 2. Antiretroviral Fixed-Dose Combination Tablets: Minimum Body Weights and Considerations for Use in Children and Adolescents
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
- Genvoya (EVG/c/FTC/TAF) is approved by the FDA for children and adolescents weighing ≥25 kg.
- 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).
- Biktarvy (BIC/FTC/TAF) is now approved by the FDA for use in children and adolescents weighing ≥25 kg.
| 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:
|
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:
|
Post-Menstrual Age of 42 Weeks and a Postnatal Age of ≥14 Days:
|
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 |
||||
Updated
Apr. 14, 2020
Reviewed
Apr. 14, 2020
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