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Reason for request
Inclusion on the list of medicines reimbursed by National Health Insurance and approved for hospital use in the extension of indication: "PREZISTA®, -co-administered with 100 mg ritonavir is indicated in association with other anti-retroviral medicinal products for the treatment of human immunodeficiency virus (HIV-1) infection in pre-treated adult patients (amendment to Marketing Authorisation dated 24 November 2008), including highly pre-treated adult patients".
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Clinical Benefit
| Substantial |
The actual benefit of this medicinal product is substantial. |
Clinical Added Value
| minor |
PREZISTA 300 mg, in the extension of indication to moderately pre-treated patients : on the basis of data available (TITAN study), the characteristics of PREZISTA (darunavir) co-administered with a low dose of ritonavir, as compared to KALETRA (lopinavir/ritonavir) are as follows : - superior virological efficacy, although the quantity of effect was modest, - similar immunological efficacy, - a comparable lipid and digestive safety profile. As a result, PREZISTA (darunavir), co-administered with a low dose of ritonavir, provides a minor improvement in actual benefit (level IV) in terms of virological efficacy compared to KALETRA in the moderately pre-treated patient population. |
| Comments without ASMR value |
PREZISTA 300 mg, In highly pre-treated patients : |
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