Reason for request
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.
Improvement in actual benefit
In patients who have no therapeutic options and whose virus is susceptible to dolutegravir :
In antiretroviral-naïve or experienced patients whose virus does not have integrase inhibitor (INI) resistance mutations :