HIV Treatment Regimens CDC Guidelines, Pediatric 

Updated: Dec 05, 2019
  • 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 September 2019. [1]

Significant changes to guidelines

Fixed-dose combination (FDC) bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) is now the preferred initial integrase strand transfer inhibitor (INSTI) in children older than 12 years who weigh 25 kg or more and an alternative in children older than 6 years who weigh 25 kg or more.

Based on recent data, the recommendation for dosing of dolutegravir has been revised to allow use in children who weigh 20 kg or more, although the FDA approval still applies only to children who weigh 30 kg or more.

A safety concern about possible neural tube defects in infants whose mothers were receiving dolutegravir was also added to the guidelines and should be considered when prescribing in adolescent girls.

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 children older than 6 weeks but younger than 12 weeks. This rapid initiation must include a discussion concerning the importance of adherence.

Rapid treatment initiation is also recommended in children who present with any opportunistic infection, increased infection, HIV-related cancer or kidney disease, or a CD4+ T-cell count that meets stage 3 HIV level (< 750 cells/µl during the first year of life, < 500 cells/µl in children aged 1-6 years, and < 200 cells/µl in any patient aged 6 years or older). Essentially, therapy should be rapidly initiated in any child presenting with symptomatic disease or evidence of immune deficiency, including a discussion of adherence importance.

Treatment should be initiated in all children presenting with HIV infection, but more time may be taken to address adherence issues in patients who are not aged 6-12 weeks and not in stage 3 HIV level.

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).

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. However, this is no longer the case. 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.

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 younger than 6 weeks, although this is not yet a standard of care.

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) or protease inhibitor (PI) (boosted).

NRTI backbone options include the following:

  • Birth to younger than 3 months: ZDV plus 3TC or emtricitabine (FTC)
  • Children aged 3 months to younger than 6 years: ZDV plus 3TC or FTC OR abacavir (ABC) (with pre-testing to ensure HLAB*5701-negative status) plus 3TC or FTC
  • Children 6 years or older: 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.

NNRTI options include the following:

  • Children older than 14 days to age 3 years: NVP
  • Children aged 3 years or older: NVP preferred, alternatively efavirenz (EFV)

PI options include the following:

  • Children younger than 14 days to age 3 years: LPV/r
  • Children older than 3 years and less than 25 kg: Atazanavir plus ritonavir (ATV/r) or darunavir/r (DRV/r-twice daily)

INSTI options include the following:

  • Children aged 14 days to 3 years (≥2 kg): Raltegravir (RAL) (oral suspension or chewable)
  • Children aged 3 years or older (< 25 kg): RAL
  • Children aged 3 years or older (≥25 kg): Elvitegravir/cobicistat (EVG/COBI)
  • Children aged 6 years and older (≥25 kg): Alternative not yet FDA approved is bictegravir in FDC with tenofovir and FTC
  • Children aged 12 years or older (≥25 kg): Bictegravir (BIC) in fixed dose combination (FDC)