Advice

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.

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Medicine details

Medicine name:
bictegravir-emtricitabine-tenofovir alafenamide (Biktarvy)
SMC ID:
SMC2093
Indication:
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
Infections
Submission type
Full submission
Status
Accepted
Date advice published:
10 September 2018