following a full submission:
bictegravir / emtricitabine / tenofovir alafenamide (Biktarvy®) is accepted for use within NHSScotland.
Indication under review: Treatment of adults infected with human immunodeficiency virus 1 (HIV-1) without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir.
Bictegravir / emtricitabine / tenofovir alafenamide was non-inferior for control of HIV-1 infection compared with anti-retroviral regimens comprising an integrase inhibitor plus backbone of dual nucleos(t)ide reverse transcriptase inhibitors (NRTIs) in treatment-naïve adults. Bictegravir / emtricitabine / tenofovir alafenamide was non-inferior to anti-retroviral regimens containing a dual NRTI backbone plus an integrase inhibitor or a protease inhibitor in maintaining virological suppression in virologically suppressed adults.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bictegravir / emtricitabine / tenofovir alafenamide. This advice is contingent upon the continuing availability of the PAS in NHSScotland or a list price that is equivalent or lower.
- Medicine name:
- bictegravir-emtricitabine-tenofovir alafenamide (Biktarvy)
- SMC ID:
- For the treatment of adults infected with HIV-1 without any known mutations associated with resistance to the individual components.
- Pharmaceutical company
- Gilead Sciences Ltd
- BNF chapter
- Submission type
- Full submission
- Date advice published:
- 10 September 2018