Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

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Management of Children Receiving Antiretroviral Therapy

Modifying Antiretroviral Regimens in Children with Sustained Virologic Suppression on Antiretroviral Therapy

Last Updated: September 12, 2019; Last Reviewed: September 12, 2019

Panel's Recommendations for Modifying Antiretroviral Regimens in Children with Sustained Virologic Suppression on Antiretroviral Therapy
Panel's Recommendations
  • Children who have sustained virologic suppression on their current antiretroviral (ARV) regimen should be regularly evaluated for opportunities to change to a new regimen that facilitates adherence, simplifies administration, increases ARV potency or barrier to resistance, and decreases the risk of drug-associated toxicity (AII).
  • Before making changes to a patient’s regimen, clinicians must carefully consider the patient’s previous regimens, past episodes of ARV therapy failure, prior drug resistance test results, and the patient’s ability to tolerate the new drug regimen (AIII). Archived drug resistance can limit the antiviral activity of a new drug regimen.
  • Children should be carefully monitored after a change in treatment. Viral load measurement is recommended 2 weeks to 4 weeks after a change in a child’s ARV regimen (BIII).
Rating of Recommendations: A = Strong; B = Moderate; C = Optional

Rating of Evidence: I = One or more randomized trials in children with clinical outcomes and/or validated endpoints; I* = One or more randomized trials in adults with clinical outcomes and/or validated laboratory endpoints with accompanying data in children from one or more well-designed, nonrandomized trials or observational cohort studies with long-term clinical outcomes; II = One or more well-designed, nonrandomized trials or observational cohort studies in children with long-term outcomes; II* = One or more well-designed, nonrandomized trials or observational studies in adults with long-term clinical outcomes with accompanying data in children from one or more similar nonrandomized trials or cohort studies with clinical outcome data; III = Expert opinion

Studies that include children or children/adolescents, but not studies limited to post-pubertal adolescents

Table 16. Examples of Changes in Antiretroviral Regimen Components for Children with Sustained Virologic Suppression

Note: This list is not exhaustive and does not necessarily contain all potential treatment options. Instead, it provides examples of changes that could be made. The table only includes information about switching between ARV drugs; it does not include all the information that clinicians should consider before prescribing these drugs. Please refer to individual drug sections, Table 1, and Table 2 in Appendix A: Pediatric Antiretroviral Drug Information for further information about the use of specific ARV drugs and FDC formulations.

Table 16. Examples of Changes in Antiretroviral Regimen Components for Children with Sustained Virologic Suppression
Current ARV Drug(s) Age, Weight, and SMR Requirements Potential ARV Drug Switch Comments
NRTIs
ABC or 3TC Twice Daily Aged ≥1 year ABC once daily See abacavira and lamivudine sections.
Aged ≥3 years 3TC once daily
ZDV, ddI, or d4Tb Aged ≥3 months ABC Less long-term mitochondrial toxicity. Children aged ≥1 year can take ABC once daily.

Aged ≥2 years

Weighing 17 kg to <25 kg

TDF TDF is a reasonable, once-daily option for HLA-B*5701–positive children for whom ABC is not recommended. TDF is available in low-strength tablets alone or in combination with FTC.

Aged ≥2 years 

Weighing ≥25 kg

TAFc Less long-term mitochondrial toxicity. Once-daily dosing. Coformulation with other ARV drugs can further reduce pill burden. TAF preferred over TDF for lower bone and renal toxicity.
NNRTIs
 NVP Any age (starting at full-term birth and weighing ≥2 kg RALd RAL has potentially greater barrier to resistance than NVP. Both are dosed twice daily in children.
EFV Aged ≥3 months

Weighing ≥5 kg
ATV/r ATV/r has a potentially greater barrier to resistance; however, taking ATV/r may be difficult for some patients, as ATV oral powder must be mixed with food or a beverage before administration, and the palatability of the RTV oral solution is poor.
Aged ≥3 years

Weighing ≥10 kg
DRV/r DRV/r has a potentially greater barrier to resistance. DRV/r is administered twice daily to patients aged <12 years, but may be administered once daily in children aged ≥12 years who do not have DRV resistance mutations.
Weighing ≥25 kg BIC as Biktarvy Once-daily dosing. BIC is available as a component of the FDC BIC/FTC/TAF (Biktarvy), which is a complete ARV regimen that can be taken with or without food.
Weighing ≥25 kg EVG as Genvoya EVG is available as a component of the FDC EVG/COBI/FTC/TAF (Genvoya), which is a complete ARV regimen that must be taken with food.
Weighing ≥20 kg DTG DTG is available as a smaller single-drug tablet or as an FDC, both of which can be dosed once daily if there are no concerns about INSTI resistance. DTG plus the weight-appropriate dose of FTC/TDF (Truvada) can be used in children weighing 20 kg to <25 kg. Higher barrier to resistance, which makes it a good choice for patients who have trouble with adherence. See the dolutegravir section for information regarding safety concerns when using DTG in adolescent females of childbearing potential and pregnant adolescents.e
Aged ≥12 years

Weighing ≥35 kg
RPV RPV may improve lipid levels.
PIs
LPV/r Twice Daily Any age (starting at full-term birth) and weighing ≥2 kg RALd Better palatability. RAL HD can only be given once daily in children weighing >50 kg. Unlike LPV/r, the use of RAL is not restricted to infants with a corrected gestational age of >42 weeks. RAL granules may be difficult to dose for some caregivers.
Aged ≥3 years

Weighing ≥10 kg
EFV Once-daily dosing. Better palatability. Lower incidence of adverse lipid effects. See the efavirenz section in Appendix A: Pediatric Antiretroviral Drug Information regarding concerns about EFV dosing for children aged <3 years.
Aged ≥3 months

Weighing ≥5 kg
ATV/r Once-daily dosing. ATV/r may improve lipid levels; however, taking ATV/r may be difficult for some patients, as ATV oral powder must be mixed with food or a beverage before administration, and the palatability of the RTV oral solution is poor.
Aged ≥3 years

Weighing ≥10 kg
DRV/r DRV/r may improve lipid levels. DRV/r is administered twice daily to patients aged <12 years, but may be administered once daily in children aged ≥12 years who do not have DRV resistance mutations.
Weighing ≥25 kg EVG as Genvoya EVG is available as a component of the FDC EVG/COBI/FTC/TAF (Genvoya), which is a complete ARV regimen that must be taken with food.
Weighing ≥20 kg DTG Once-daily dosing if not concerned about INSTI resistance. May be better tolerated, and can be given as an FDC to children weighing ≥25 kg. DTG plus the weight-appropriate dose of FTC/TDF (Truvada) can be used in children weighing 20 kg to <25 kg. See the dolutegravir section for information regarding safety concerns when using DTG in female adolescents of childbearing potential and pregnant adolescents.e

Aged ≥12  years

Weighing ≥35 kg

RPV  May be better tolerated.
Weighing ≥25 kg BIC as Biktarvy Once-daily dosing. BIC is available as a component of the FDC BIC/FTC/TAF (Biktarvy), which is a complete ARV regimen that can be taken with or without food.
Other
Any Multi-Pill and/or Twice-Daily Regimen Weighing ≥25 kg EVG/COBI/FTC/TAF (Genvoya) Once-daily dosing. Single pill. Alignment with adult regimens. Must be taken with food.
Weighing ≥25 kg FTC/TAFc (Descovy) plus DTG Once-daily dosing. This regimen may be more desirable because of smaller pill sizes, but it has a higher pill burden (two pills instead of one). Aligns a child's regimen with an efficacious regimen that is used in adults. See the dolutegravir section for information regarding safety concerns when using DTG in female adolescents of childbearing potential and pregnant adolescents.e
Weighing ≥35 kg

SMR 4 or 5
EVG/COBI/FTC/TDF (Stribild) Once-daily dosing. Single pill. Aligns a child's regimen with an efficacious regimen that is used in adults. Must be taken with food. Renal and bone toxicity limit its use.
Aged ≥12 years

Weighing ≥35 kg
FTC/RPV/TAF (Odefsey) Once-daily dosing. Single pill. Aligns a child's regimen with an efficacious regimen that is used in adults. Must be taken with food at a consistent time daily.
Weighing ≥25 kg BIC/FTC/TAF (Biktarvy) Once-daily dosing. Single pill that can be taken with or without food.
Aged ≥12 years

Weighing ≥35 kg

SMR 4 or 5
FTC/RPV/TDF (Complera) Once-daily dosing. Single pill. Aligns a child's regimen with an efficacious regimen that is used in adults. Must be taken with food at a consistent time daily.
Weighing ≥25 kg ABC/DTG/3TC (Triumeq) Once-daily dosing. Single pill. Aligns a child's regimen with an efficacious regimen that is used in adults. Large pill size may be a deterrent. See the dolutegravir section for information regarding safety concerns when using DTG in female adolescents of childbearing potential and pregnant adolescents.e
Weighing ≥40 kg

SMR 4 or 5
EFV/FTC/TDF (Atripla) Once-daily dosing. Single pill. Aligns a child's regimen with an efficacious regimen that is used in adults.
a For infants and young children who are being treated with liquid formulations of ABC, initiation with once-daily ABC is not generally recommended. In clinically stable patients with undetectable viral loads who have had stable CD4 T lymphocyte cell counts for >6 months (24 weeks) on twice-daily ABC, the dose can be changed from twice daily to once daily.

b d4T and ddI should be replaced with a safer drug as soon as possible because of concerns about long-term adverse effects (see Archived Drugs in Appendix A: Pediatric Antiretroviral Drug Information).

c For children and adolescents weighing 25 kg to <35 kg, TAF can be used in combination with an INSTI or an NNRTI, but not a boosted PI. For children and adolescents weighing ≥35 kg, TAF can be used in combination with an INSTI, NNRTI, or a boosted PI.

d RAL is recommended for twice-daily use in children. Chewable tablets can be used in children weighing ≥11 kg. RAL HD once daily is only recommended for virologically suppressed children weighing ≥50 kg.

e Because of recent concerns about the potential for neural tube defects in infants born to women who conceived while taking regimens that contained dolutegravir, this drug should be prescribed with caution in female adolescents. Specific recommendations about the initiation and use of DTG in 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).

Key to Acronyms: 3TC = lamivudine; ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; ATV/r = atazanavir/ritonavir; BIC = bictegravir; COBI = cobicistat; d4T = stavudine; ddI = didanosine; DRV/r = darunavir/ritonavir; DTG = dolutegravir; EFV = efavirenz; EVG = elvitegravir; FDA = Food and Drug Administration; FDC = fixed-dose combination; FTC = emtricitabine; HLA = human leukocyte antigen; INSTI = integrase strand transfer inhibitor; LPV/r = lopinavir/ritonavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; PI = protease inhibitor; RAL = raltegravir; RPV = rilpivirine; RTV = ritonavir; SMR = sexual maturity rating; TAF = tenofovir alafenamide; TDF = tenofovir disoproxil fumarate; TFV = tenofovir; ZDV = zidovudine

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