FDA approves maraviroc for children aged two and older

Polly Clayden, HIV i-Base

On 4 November 2016, ViiV Healthcare received approval from the US Food and Drug Administration (FDA) for maraviroc to treat CCR5-tropic HIV in combination with other antiretrovirals in paediatric patients two years old and above weighing at least 10 kg. [1]

Maraviroc is not recommended in patients with dual/mixed- or CXCR4-tropic HIV.

New 25 mg and 75 mg tablets and a 20 mg/mL oral solution will be available in the US January 2017. The paediatric dose is based on body weight and the potential for drug-drug interactions with other medicines.

The FDA approval is based on results of an open-label trial in which 103 treatment-experienced paediatric patients with only CCR5-tropic HIV, aged 2 to 18 years and weighing at least 10 kg, received maraviroc twice daily in combination with optimised background therapy. [2]

At 48 weeks, 48% of patients achieved viral load less than 48 copies/mL and 65% viral load less than 400 copies/mL. The mean CD4 count increase from baseline to week 48 was 247 cells/mm3.

In the study, the dose was based on body surface area and whether or not the patient was receiving potent cytochrome P450 3A inhibitors and/or inducers.

The safety profile of maraviroc through 96 weeks was similar to that for adults.

US prescribing information for maraviroc has been updated accordingly. [3]


In contrast to most current paediatric antiretrovirals that take an age-staggered approach to approvals – this one included children and adolescents aged 2-18 years.

As with adults, widespread use of maraviroc is not expected.


  1. ViiV Healthcare press release: ViiV Healthcare announces FDA approval of Selzentry (maraviroc) for use in children and adolescents living with HIV. 4 November 2016.
  2. US National Institutes of Health. An open label pharmacokinetic, safety and efficacy study of maraviroc in combination with background therapy for the treatment of HIV-1 infected, CCR5-tropic children.
  3. Selzentry (maraviroc) US prescribing information. (PDF)

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