elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide fumarate (Genvoya)

following a full submission

elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide film-coated tablet (Genvoya®) is accepted for use within NHS Scotland.

Indication under review: the treatment of adults and adolescents (aged 12 years and older with body weight at least 35kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.

In two phase III, randomised, double-blind studies (in treatment-naïve adults with HIV-1), and one phase III, randomised, open-label study (in treatment-experienced adults with HIV-1), Genvoya® was non-inferior to alternative antiretroviral regimens at achieving/maintaining a high rate of viral suppression (plasma HIV-1 RNA <50 copies/mL) at week 48. 
This advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of Genvoya®. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.