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Opinions on drugs - Posted on Sep 16 2014

Reason for request



Clinical Benefit


The actual benefit of TIVICAY in the indication “treatment of Human Immunodeficiency Virus (HIV)-infected adults and adolescents above 12 years of age” is substantial in antiretroviral naïve patients and in experienced patients with prior treatment failure.

Clinical Added Value


In patients who have no therapeutic options and whose virus is susceptible to dolutegravir :
The Transparency Committee considers that TIVICAY (dolutegravir), in combination with an optimised background regimen, provides a moderate improvement in actual benefit (level III) in terms of immunological and virological efficacy in therapeutic management.


In antiretroviral-naïve or experienced patients whose virus does not have integrase inhibitor (INI) resistance mutations :
The Transparency Committee considers that TIVICAY (dolutegravir) incombination with other antiretrovirals provides a minor improvement in actual benefit (level IV) compared with raltegravir (ISENTRESS) due to having an immunological and virological efficacy that is not inferior to that of raltegravir with a higher genetic barrier to the development of resistance and better ease of use than raltegravir (a single dose versus two daily doses in the case of raltegravir).