Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

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  • What Not to Start: Regimens Not Recommended for Initial Therapy of Antiretroviral-Naive Children (Brief)

The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.

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What to Start

What Not to Start: Regimens Not Recommended for Initial Therapy of Antiretroviral-Naive Children

Last Updated: April 14, 2020; Last Reviewed: April 14, 2020

Table 9. Antiretroviral Regimens or Components That Are Not Recommended for Initial Treatment of HIV Infection in Children
ARV Regimen or Component Rationale
Unboosted ATV-containing regimens in children Reduced exposure
Regimens containing only NRTIs Inferior virologic efficacy
Regimens containing three drug classes Potential to induce multiclass resistance

Use as an initial regimen in children has not been studied
Regimens containing three NRTIs and one NNRTI Added cost and complexity outweighs any benefit
Full-dose RTV or use of RTV as the sole PI GI intolerance

Metabolic toxicity
LPV/r dosed once daily Reduced drug exposure
DOR-based regimens Insufficient data to recommend
Once-daily DRV-based regimens in children aged ≥3 years to <12 years Insufficient data to recommend
EFV-based regimens for children aged <3 years Appropriate dose not determined
ETR-based regimens Insufficient data to recommend
MVC-based regimens Insufficient data to recommend
Unboosted DRV Use without RTV has not been studied
Full-dose, dual-PI regimens Insufficient data to recommend

Potential for added toxicities
TDF-containing regimens in children aged <2 years Potential bone toxicity

Appropriate dose has yet to be determined
Key: ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; DOR = doravirine; DRV = darunavir; EFV = efavirenz; ETR = etravirine; GI = gastrointestinal; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; RTV = ritonavir; TDF = tenofovir disoproxil fumarate

Table 10. Antiretroviral Regimens or Components That Are Never Recommended for Treating HIV in Children
ARV Regimens That Are Never Recommended for Use in Children
Regimen Rationale Exceptions
One ARV Drug Alone (Monotherapy) Rapid development of resistance

Inferior antiviral activity compared to regimens that include ≥3 ARV drugs

Monotherapy “holding” regimens are associated with more rapid CD4 count declines than nonsuppressive ART.
Infants with perinatal HIV exposure and negative virologic tests who are receiving 4–6 weeks of ZDV prophylaxis to prevent perinatal transmission of HIV
Two NRTIs Alone Rapid development of resistance

Inferior antiviral activity compared to regimens that include ≥3 ARV drugs
Not recommended for initial therapy

Some clinicians may opt to continue using two NRTIs alone in patients who achieve virologic goals with this regimen.
TDF plus ABC plus (3TC or FTC) as a Triple-NRTI Regimen High rate of early viral failure when this triple-NRTI regimen was used as initial therapy in treatment-naive adults No exceptions
ARV Components That Are Never Recommended for Use as Part of an ARV Regimen for Children
Regimen Rationale Exceptions
Dual-NNRTI Combinations Enhanced toxicity No exceptions
Dual-NRTI Combination of 3TC plus FTC Similar resistance profile and no additive benefit No exceptions
NVP as Initial Therapy in Adolescent Girls with CD4 Counts >250 cells/mm3 or Adolescent Boys with CD4 Counts >400 cells/mm3 Increased incidence of symptomatic (including serious and potentially fatal) hepatic events in these patient groups Only if benefit clearly outweighs risk
Key: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; CD4 = CD4 T lymphocyte; FTC = emtricitabine; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; TDF = tenofovir disoproxil fumarate; ZDV = zidovudine

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