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. 
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. 
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. 
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.
- ViiV Healthcare press release: ViiV Healthcare announces FDA approval of Selzentry (maraviroc) for use in children and adolescents living with HIV. 4 November 2016.
- 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.
- Selzentry (maraviroc) US prescribing information.