Reason for request
The actual medical benefit of these medicinal products is substantial.
Improvement in actual benefit
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).