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

Table 9. Antiretroviral Regimens or Components Not Recommended for Initial Treatment of HIV Infection in Children
Regimen or ARV Component Rationale
Unboosted ATV-containing regimens in children Reduced exposure
Once-daily DRV-based regimens in children aged ≥3 years to 12 years Insufficient data to recommend
Unboosted DRV Use without RTV has not been studied
Dual (full-dose) PI regimens Insufficient data to recommend

Potential for added toxicities
Dual-NRTI combination of ABC plus TDF Insufficient data to recommend
EFV-based regimens for children aged <3 years Appropriate dose not determined
ETR-based regimens Insufficient data to recommend
LPV/r dosed once daily Reduced drug exposure
MVC-based regimens Insufficient data to recommend
Regimens containing only NRTIs Inferior virologic efficacy
Regimens containing three drug classes Insufficient data to recommend
Full-dose RTV or use of RTV as the sole PI GI intolerance

Metabolic toxicity
Regimens containing three NRTIs and one NNRTI Added cost and complexity outweighs any benefit
TDF-containing regimens in children aged <2 years Potential bone toxicity

Appropriate dose has yet to be determined
Key to Acronyms: ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; 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 Therapy Regimens or Components Never Recommended for Treatment of HIV Infection in Children
ART Regimens Never Recommended for Children
Regimen Rationale Exceptions
One ARV Drug Alone (Monotherapy) Rapid development of resistance

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

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

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

Some clinicians may opt to continue this treatment in patients who are currently on two NRTIs alone and who achieve virologic goals.
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
TDF plus ddI 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 Never Recommended as Part of an ARV Regimen for Children
Regimen Rationale Exceptions
Dual-NNRTI Combinations Enhanced toxicity No exceptions
Dual-NRTI Combination 3TC plus FTC Similar resistance profile and no additive benefit No exceptions
Dual-NRTI Combination d4T plus ZDV Antagonistic effect on HIV 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 to Acronyms: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; CD4 = CD4 T lymphocyte; d4T = stavudine; ddI = didanosine; DRV = darunavir; 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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