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BIKTARVY (bictegravir, emtricitabine, tenofovir alafenamide), antiretroviral combination
Reason for request
High clinical benefit in HIV-1 infection, but no demonstrated clinical improvement compared to TRIUMEQ.
BIKTARVY has MA for the treatment of HIV-1 infection in treatment-naive or virologically controlled pre-treated patients, in the absence of integrase inhibitor, emtricitabine or tenofovir resistance.
Where a treatment strategy including an integrase inhibitor (INI) is envisaged, BIKTARVY is a first-line therapeutic option for treatment-naive or virologically controlled pre-treated patients.
BIKTARVY has no role in the therapeutic strategy of patients in virological failure or in whom the virus is resistant to other integrase inhibitors.
In view of the recent data on the potential risk of congenital malformation after a treatment with dolutegravir at the time of conception and during the first trimester of pregnancy, and pending supplementary data on a potential class effect, women exposed to INIs (including bictegravir) should be reminded of the precautions (information and prescription of effective contraception) for women of reproductive age.
Clinical Benefit
| Substantial |
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Clinical Added Value
| no clinical added value |
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