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5 Dezember 2016, 17:07
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Maraviroc has been approved for children in the US

Maraviroc has been approved for children in the US - Bild 1

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]

COMMENT

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.

References:

  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.
    https://www.viivhealthcare.com/media/press-releases/2016/october/viiv-healthcare-announces-fda-approval-of-selzentry-maraviroc-for-use-in-children-and-adolescents-living-with-hiv.aspx
  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.
    https://clinicaltrials.gov/ct2/show/NCT00791700
  3. Selzentry (maraviroc) US prescribing information.
    https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Selzentry/pdf/SELZENTRY-PI-MG.PDF (PDF)