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: May 22, 2018; Last Reviewed: May 22, 2018

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
DRV-based regimens once daily in children aged ≥3 to 12 years Insufficient data to recommend
Unboosted DRV Use without ritonavir 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
T-20-containing regimens Insufficient data to recommend

Injectable preparation
ETR-based regimens Insufficient data to recommend
FPV-based regimens Reduced exposure

Medication burden
IDV-based regimens Renal toxicities
LPV/r dosed once daily Reduced drug exposure
MVC-based regimens Insufficient data to recommend
NFV-based regimens Variable PK

Appropriate dose not determined in young infants
Regimens containing only NRTIs Inferior virologic efficacy
Regimens containing 3 drug classes Insufficient data to recommend
Full-dose RTV or use of RTV as the sole PI GI intolerance

Metabolic toxicity
Regimens containing 3 NRTIs and 1 NNRTI Added cost and complexity outweighs any benefit
SQV-based regimens Limited dosing and outcome data
TDF-containing regimens in children aged <2 years Potential bone toxicity

Appropriate dose has yet to be determined
TPV-based regimens Increased dose of RTV for boosting

Reported cases of intracranial hemorrhage
Key to Acronyms: ABC = abacavir; ARV = antiretroviral; ATV = atazanavir; DRV = darunavir; EFV = efavirenz; ETR = etravirine; FPV = fosamprenavir; GI = gastrointestinal; IDV = indinavir; LPV/r = lopinavir/ritonavir; MVC = maraviroc; NFV = nelfinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; PI = protease inhibitor; PK = pharmacokinetics; RTV = ritonavir; SQV = saquinavir; T-20 = enfuvirtide; TDF = tenofovir disoproxil fumarate; TPV = tipranavir

Table 10. ART Regimens or Components Never Recommended for Treatment of HIV Infection in Children
ART Regimens Never Recommended for Children
Regimen Rationale Exceptions
1 ARV Drug Alone (Monotherapy)
  • Rapid development of resistance
  • Inferior antiviral activity compared to combinations that include ≥3 ARV drug
  • Monotherapy “holding” regimens are associated with more rapid CD4 declines than non-suppressive ART
  • Infants with perinatal HIV exposure and negative virologic tests who are receiving 4 to 6 weeks of ZDV prophylaxis to prevent perinatal transmission of HIV
2 NRTIs Alone
  • Rapid development of resistance
  • Inferior antiviral activity compared to combinations that include ≥3 ARV drugs
  • Not recommended for initial therapy.
  • For patients currently on 2 NRTIs alone who achieve virologic goals, some clinicians may opt to continue this treatment.
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
ddI and d4T, Individually or Co-Administered
  • Increased toxicities
  • ddI plus d4T is contraindicated
  • No exceptions
ATV plus IDV
  • Potential additive hyperbilirubinemia
  • No exceptions
Dual-NNRTI Combinations
  • Enhanced toxicity
  • No exceptions
Dual-NRTI Combinations:
  • 3TC plus FTC
  • Similar resistance profile and no additive benefit
  • No exceptions
  • 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
Unboosted SQV, DRV, or TPV
  • Poor oral bioavailability
  • Inferior virologic activity compared with other PIs
  • No exceptions
Key to Acronyms: 3TC = lamivudine; ABC = abacavir; ART = antiretroviral therapy; ARV = antiretroviral; ATV = atazanavir; CD4 = CD4 T lymphocyte; d4T = stavudine; ddI = didanosine; DRV = darunavir; FTC = emtricitabine; IDV = indinavir; NNRTI = non-nucleoside reverse transcriptase inhibitor; NRTI = nucleoside reverse transcriptase inhibitor; NVP = nevirapine; SQV = saquinavir; TDF = tenofovir disoproxil fumarate; TPV = tipranavir; ZDV = zidovudine

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