HIV Treatment Regimens CDC Guidelines, Pediatric 

Updated: Jul 26, 2021
  • Author: Elizabeth A Secord, MD; more...
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CDC Guidelines

The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, developed by the HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children, were updated in April 2021. [1]

Significant changes to guidelines

Infants born to HIV positive mothers are now considered at high risk of infection if maternal viral load is 50 copies/ml or greater (previously 1000 copies/ml or greater)

  • Because it is available in dispersible tablet formulation dolutegravir (DTG) , an integrase inhibitor, is now recommended as a preferred  antiretroviral for infants and children who are at least 4 weeks of age and at least 3 Kg weight (previously recommended only for children at least 3 years and 25 Kg).  
  • Fixed-dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide  (Biktarvy) is now the preferred initial  integrase strand transfer inhibitor (INSTI) in children at least 6 years  who weigh at least 25 kg (previously an alternative in children older than 6 years who weigh 25 kg or more).
  • Raltegravir (RAL) plus two NRTIs  is a recommended alternative regimen rather than a preferred regimen for infants/children 4 weeks or older because of BID dosing and lower threshold to resistance compared with DTG and BIC. Although these are treatment guidelines please be aware that RAL is used in treatment as prophylaxis from birth in exposed infants at high risk. 
  • RAL crushed chewable tablets dispersed in liquid are now approved for HIV treatment in children 4 weeks of age or more and at least 3 Kg but is also used from birth for treatment as prophylaxis in high risk infants.
  • Abacavir  (ABC) has been FDA approved for use in infants 3 months and older but the CDC panel recommends use at a 1 month or older  based on safety data.  ABC plus lamivudine or emtricitabine  is now the preferred rather than alternative NRTI backbone for infants/children over 1 month of age.  
  • Zidovudine  (ZDV) is now the recommended alternative rather than the preferred NRTI in infants/children 1 month of age or older because of the availability of ABC
  • DTG is now recommended as acceptable therapy for HIV in adolescent girls who may become pregnant as well as in pregnant women because the risk of neural tube defects is considered very small and is outweighed by benefit of daily dosing and low risk of resitance.
  • Tenofovir Alafenamide (TAF): sufficient safety data has been collected to allow use in adolescent girls who may become pregnant as well as in pregnant women.
  • Maraviroc,  although FDA approved for use in children, is not recommended by the CDC panel because of twice daily dosing and multiple drug reactions and necessity for tropism assays prior to use.
  • Intelence (ETR) may be used as part of a regimen including a ritonavir-boosted protease inhibitor.
  • Nevirapine (NVP) dosing for infants less than a month of age (post exposuure prophylaxis) is now modified (treatment as prophylaxis regimen for high risk infants).

When to initiate treatment

Antiretroviral treatment (ART) consisting of three drugs from at least two classes should be initiated in all treatment-naive infants and children with HIV infection. Delayed treatment for HIV infection is no longer recommended.

Rapid treatment initiation (within 1-2 weeks of diagnosis) is recommended in all HIV-infected children older than 6 weeks but younger than 12 weeks. This rapid initiation must include a discussion concerning the importance of adherence. Some of these infants will already be on treatment as prophylaxis (initiated as soon after birth as feasible in high risk infants) and alteration of this regimen can be considered.

If ART initiation in a child is not possible for any reason, he or she should be closely monitored virologically (HIV viral load) and immunologically (CD4+ T cells) until treatment is started.

Historically, some older medications had more toxicity and were associated with easier resistance development. Because of this, withholding therapy was once commonly recommended in various age groups and early-stage HIV infection. This is no longer the case, and all children with HIV infection should undergo treatment to avoid disease progression, to avoid infections, to ensure growth and sexual maturation, to avoid neurocognitive consequences of HIV infection, to assist with achieving a normal lifespan, and to eventually avoid further HIV transmission (treatment as prevention).

Special considerations when initiating ART in children

Infants and young children require liquid medications.

Toddlers and children require liquid or chewable medication.

These restrictions greatly limit options.

Therapy in term and preterm newborns

There are sufficient data on dosing for zidovudine (ZDV), lamivudine (3TC) and nevirapine (NVP).

Therapy in term newborns

For term infants, there are also sufficient data on dosing for emtricitabine and raltegravir.

For term infants older than 2 weeks (but not preterm infants), there are sufficient dosing data for lopinavir/ritonavir (LPV/r).

Based on newer data concerning earlier treatments and earlier results of nucleic acid testing, triple therapy may be initiated in some high-risk infants.

Preferred initial therapy in treatment-naïve infants and children:

Preferred initial therapy in treatment-naïve infants and children consists of a two–nucleoside reverse transcriptase inhibitor (NRTI) backbone plus an INSTI or nonnucleoside reverse transcriptase inhibitor (NNRTI) (preferred) or PI (boosted).

NRTI backbone options include the following:

  • Less than 14 days: ZDV plus 3TC or emtricitabine (FTC)
  • Children aged 1 month or older: ABC plus 3TC or FTC OR ZDV (ABC) plus 3TC or FTC

Although ZDV is not a preferred ART agent in children older than 6 years, it may be continued rather than changed to another ART agent if it is effectively suppressing the viral load. It is also an alternative choice for initial therapy in children over 1 month of age.

NNRTI options include the following:

  • Children less than 14 days  NVP preferred
  • Rilpivarine alternative therapy for children over the age of 12 years
  • Effeviranz not recommended under the age of 3 years and not preferred therapy

INSTI options include the following:

  • Children less than 14 days but ≥2 kg: Raltegravir (RAL) (oral suspension or chewable) may be utilized for treatment as prophylaxis in high risk infants, treatment for infants over 4 weeks of age alternative for initial therapy
  • Children at least 4 weeks of age and ≥3 kg: Dolutegravir preferred inital therapy 
  • Children aged 6 years or older (≥25 kg): Bictegravir (BIC) in fixed dose combination (FDC) a preferred inital therapy
  • Fixed-dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) is now the preferred initial INSTI in children  6 years and older who weigh at least 25 kg.
  • Children aged 3 years or older (≥25 kg): Elvitegravir/cobicistat (EVG/c) is an alternative therapy.
  • Children aged 3 years or older (≥25 kg): Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/c/FTC/TAF) is a fixed-dose combination option alternative therapy.

PI options include the following:

  • Children more than 14 days: LPV/r preferred PI therapy
  • Children more than 3 months: Atazanavir plus ritonavir (ATV/r) is alternative therapy
  • Children more than 3 years: Darunavir/r (DRV/r-twice daily) is alternative therapy
  • Cobicistat (PI booster) and regimens boosted by ritonavir or cobicistat may be used as an alternative to ritonavir boosting in children. Atazanavir boosted with cobicistat (ATV/c) is an alternative for children, as is darunavir boosted with cobicistat (DRV/c).
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