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Opinions on drugs - Posted on Sep 15 2009

Reason for request

Inclusion on the list of medicines reimbursed by National Insurance and approved for use by hospitals


Actual benefit


The actual medical benefit of these medicinal products is substantial.

Improvement in actual benefit

IV (mineur)

The Committee considers that CELSENTRI, in combination with OBT, provides a minor improvement in actual benefit (IAB level IV) in terms of virological efficacy in management of a limited population of adult patients in treatment failure with a viral load of ≥ 1000 copies/mL,

- who had antiretroviral-class experience greater than or equal to 6 months with at least three of the four classes of antiretrovirals: [ ≥ 1 nucleoside reverse transcriptase inhibitor, ≥ 1 non-nucleoside reverse transcriptase inhibitor, ≥ 2 protease inhibitors] and/or enfuvirtide

- or documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes (nucleoside reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor, protease inhibitors or fusion inhibitors).

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