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Updated Pediatric ARV Guidelines

Updates to the Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection were released on Thursday, November 1, 2012. Please send your comments to ContactUs@aidsinfo.nih.gov by November 15, 2012.

Corrections were made to the guideline. For a description of the changes, please see the correction notice.

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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Entry and Fusion Inhibitors

Maraviroc

(Last updated:11/1/2012; last reviewed:11/1/2012)

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Maraviroc (MVC, Selzentry)
For additional information see Drugs@FDA: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Formulations
Tablets: 150 mg and 300 mg
Dosage Recommendations

Neonate/infant dose:

  • Not approved for use in neonates/infants.

Pediatric dose:

  • Not approved for use in children aged <16 years.
  • A pediatric clinical trial is under way.

Adolescent (aged >16 years)/adult dose:

When given with potent CYP3A inhibitors (with or without CYP3A inducers) including protease inhibitors (PIs) (except tipranavir/ritonavir [TPV/r]) 150 mg twice daily
When given with nucleoside reverse transcriptase inhibitors (NRTIs), enfuvirtide (ENF), TPV/r, nevirapine (NVP), raltegravir (RAL), and drugs that are not potent CYP3A inhibitors or inducers 300 mg twice daily
When given with potent CYP3A inducers including efavirenz (EFV) and etravirine (ETR) (without a potent CYP3A inhibitor) 600 mg twice daily

 

 Selected Adverse Events
  • Abdominal pain
  • Cough
  • Dizziness
  • Musculoskeletal symptoms
  • Fever
  • Rash
  • Upper respiratory tract infections
  • Hepatotoxicity (which may be preceded by severe rash and/or other signs of systemic allergic reaction)
  • Orthostatic hypotension (especially in patients with severe renal insufficiency)
Special Instructions
  • Conduct testing with HIV tropism assay (see Antiretroviral Drug-Resistance Testing in the main body of the guidelines) before using MVC to exclude the presence of CXCR4-using or mixed/dual-tropic HIV. Use MVC in patients with only CCR5-tropic virus. Do not use if CXCR4 or mixed/dual-tropic HIV is present.
  • MVC can be given without regard to food.
  • Instruct patients on how to recognize symptoms of allergic reactions or hepatitis.
  • Use caution when administering MVC to patients with underlying cardiac disease.
Metabolism 
  • Cytochrome P450 3A4 (CYP3A4) substrate
  • Dosing of MVC in patients with hepatic impairment:
    Use caution when administering MVC to patients with hepatic impairment. Because MVC is metabolized by the liver, concentrations in patients with hepatic impairment may be increased.
  • Do not use MVC in patients with creatinine clearance (CrCl) <30 mL/min who are receiving potent CYP3A4 inhibitors or inducers.
  • Dosing of MVC in patients with renal impairment:
    Refer to the manufacturer’s prescribing information.

Drug Interactions (see also the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents):

  • Absorption: Absorption of maraviroc is somewhat reduced with ingestion of a high-fat meal; however, maraviroc can be given with or without food.
  • Metabolism: Maraviroc is a CYP3A4 and p-glycoprotein (Pgp) substrate and requires dosage adjustments when administered with CYP- or Pgp-modulating medications.
  • Before administration, a patient’s medication profile should be carefully reviewed for potential drug interactions with maraviroc.

Major Toxicities:

  • More common: Cough, fever, upper respiratory tract infections, rash, musculoskeletal symptoms, abdominal pain, and dizziness.
  • Less common (more severe): Hepatotoxicity that may be preceded by evidence of a systemic allergic reaction (such as pruritic rash, eosinophilia or elevated immunoglobulin [IgE]) has been reported. Serious adverse events occurred in less than 2% of maraviroc-treated adult patients and included cardiovascular abnormalities (such as angina, heart failure, myocardial infarction), hepatic cirrhosis or failure, cholestatic jaundice, viral meningitis, pneumonia, myositis, osteonecrosis, and rhabdomyolysis.

Resistance: The International AIDS Society-USA (IAS-USA) maintains a list of updated resistance mutations (see http://www.iasusa.org/resistance_mutations/index.html). Clinical failure may also represent the outgrowth of CXCR4-using (naturally resistant) HIV variants.

Pediatric Use: The pharmacokinetics (PK), safety, and efficacy of maraviroc in patients aged <16 years have not been established. A dose-finding study is under way in children aged 2 to 17 years.1 In this trial, maraviroc dose is based upon body surface area and the presence or absence of a potent CYP3A4 inhibitor in the background regimen. Preliminary PK data are encouraging in those on a potent CYP3A4 inhibitor, but exposures are very low in those not on a potent CYP3A4 inhibitor.

Reference

  1. Vouvahis M, McFadyen, L., Duncan, B., et al. Maraviroc pharmacokinetics in CCR5-tropic HIV-1-infected children aged 2-<18 years: Preliminary results from study A4001031. 3rd International Workshop on HIV Pediatrics, Jul 15-16, 2011.