CELSENTRI (maraviroc), CCR5 receptor antagonist antiretroviral

INFECTIOUS DISEASE - New indication
Opinions on drugs - Posted on Jul 18 2018

Reason for request

Extension of indication and Inclusion

High clinical benefit and minor clinical added value for the treatment of adolescents and children from 2 years infected with exclusively CCR5-tropic HIV-1, having undergone pretreatment and virological failure.

 

  • CELSENTRI has now been granted a marketing authorisation for the treatment of adolescents and children (aged 2 years or over and weighing at least 10 kg), infected with exclusively CCR5-tropic HIV-1, pretreated with antiretrovirals.

  • In this indication, it is a therapeutic option in combination with optimised antiretroviral therapy, in the event of proven virological failure.

  • Its use must be guided by genotypic resistance and tropism testing.

  • Particular attention should be paid to dosages based on weight and to concomitant treatments in order to minimise the risk of suboptimal exposure or of overdosage. It is preferably to assay the plasma concentration of maraviroc in order to ensure that it is above the concentration deemed to be effective.

     

 

 


Clinical Benefit

Substantial

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Clinical Added Value

minor

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