Reason for request
Inclusion
Clinical Benefit
| Substantial |
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
| moderate |
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. |
| minor |
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). |
See also
HAS opinions and decisions
05/03/2014
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