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BIKTARVY (bictegravir, emtricitabine, tenofovir alafenamide), antiretroviral combination

INFECTIOUS DISEASE - New medicinal product
Opinions on drugs - Posted on Oct 02 2018

Reason for request

Inclusion

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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