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PREZISTA

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Opinions on drugs - Posted on Sep 15 2014

Reason for request

Extensions of indication

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Clinical Benefit

Substantial

substantial in adolescents aged from 12 to 17 years and weighing at least 40 kg who are :

- ARV-naïve ;

- ARV-experienced but with no darunavir resistance-as sociated mutations and having a plasma HIV-1 RNA level < 100,000 copies/ml and a CD4+ cell count ≥ 100 cells × 106/l.


Clinical Added Value

no clinical added value
  • In the management of HIV-1 infection in ARV-naïve adolescents aged from 12 to 17 years weighing at least 40 kg

Taking account of :
- the very limited data on ARV-naïve adolescents weighing at least 40 kg (DIONE study), which suggest an efficacy and safety profile at 48 weeks similar to that observed in the ARV-naïve adults with, however, some uncertainty over the growth abnormalities and the long-term consequences of lipid disorders ;

- the lack of comparative data other than those versus lopinavir/ritonavir (KALETRA) in naïve adults (ARTEMIS non-inferiority study), PREZISTA as 400 mg and 800 mg tablets or as an oral suspension, co-administered with a low dose of ritonavir, does not provide any improvement in actual benefit (level V, non-existent) in the management of HIV-1 in ARV-naïve adolescents weighing at least 40 kg.

  • In the management of HIV-1 in treatment-experience d adolescents aged from 12 to 17 years weighing at least 40 kg, but with no darunavir resistance-associated mutations and having a plasma HIV-1 RNA level of < 100,000 copies/ml and a CD4+ cell count of ≥ 100 cells × 106/l

In the absence of efficacy and safety data in treatment-experienced adolescents weighing at least 40 kg but with no darunavir resistance-associated mutations and having a plasma HIV-1 RNA level of < 100,000 copies/ml and a CD4+ cell count of ≥ 100 cells × 106/l, and despite a simplified dosage regimen compared with other strengths of PREZISTA (600mg, 300 mg, 150 mg, and 75 mg), the Transparency Committee considers that PREZISTA, as 400 mg and 800 mg tablets or as an oral suspension, co-administered with a low dose of ritonavir, does not provide any improvement in actual benefit (level V, non-existent) in the management of this population. These proprietary medicinal products constitute an addition to the range.