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Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection

Entry and Fusion Inhibitors


(Last updated: February 12, 2014; last reviewed: February 12, 2014)

Maraviroc (MVC, Selzentry)

Maraviroc (MVC, Selzentry)

For additional information see Drugs@FDA:


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 (except ritonavir-boosted tipranavir) 150 mg twice daily
When given with nucleoside reverse transcriptase inhibitors, enfuvirtide, ritonavir-boosted tipranavir, nevirapine, raltegravir, and drugs that are not potent CYP3A inhibitors or inducers 300 mg twice daily
When given with potent CYP3A inducers including efavirenz and etravirine (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 maraviroc in patients with only CCR5-tropic virus. Do not use if CXCR4 or mixed/dual-tropic HIV is present.
  • Maraviroc can be given without regard to food.
  • Instruct patients on how to recognize symptoms of allergic reactions or hepatitis.
  • Use caution when administering maraviroc to patients with underlying cardiac disease.


  • Cytochrome P450 3A4 (CYP3A4) substrate
  • Dosing of maraviroc in patients with hepatic impairment: Use caution when administering maraviroc to patients with hepatic impairment. Because maraviroc is metabolized by the liver, concentrations in patients with hepatic impairment may be increased.
  • Do not use maraviroc in patients with creatinine clearance <30 mL/min who are receiving potent CYP3A4 inhibitors or inducers.
  • Dosing of maraviroc 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) has been reported. Serious adverse events occurred in less than 2% of maraviroc-treated adult patients and included cardiovascular abnormalities (e.g., angina, heart failure, myocardial infarction), hepatic cirrhosis or failure, cholestatic jaundice, viral meningitis, pneumonia, myositis, osteonecrosis, and rhabdomyolysis.


The International AIDS Society-USA (IAS-USA) maintains a list of updated resistance mutations (see 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 and efficacy study is under way in children aged 2 to 17 years.1,2 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 low exposures were seen in those not on a potent CYP3A4 inhibitor. Enrollment of and follow up with participants in this trial continues.


  1. Vourvahis M. Update from Study A4001031: maraviroc pharmacokinetics in CCR5-tropic HIV-1-infected children aged 2 to < 18 years. Paper presented at: The 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention; 2013; Kuala Lumpur, Malaysia.
  2. Giaquinto C. Safety and efficacy of maraviroc in CCR5-tropic HIV-1-infected children aged 2 to < 18 years. Paper presented at: 7th IAS Conference on HIV Pathogenesis Treatment and Prevention; June 30-July 3, 2013, 2013; Kuala Lumpur, Malaysia.

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