SYMTUZA (darunavir /cobicistat /emtricitabine /tenofovir alafenamide), antiviral combination

INFECTIOUS DISEASES - New medicinal product
Opinions on drugs - Posted on Nov 27 2018

Reason for request

Inclusion

Clinical benefit insufficient in the treatment of chronic HIV-1 infection

 

 

 

  • SYMTUZA has marketing authorization (MA) for the treatment of HIV-1 infection in adults and adolescents (>  12 years, > 40 kg).

  • Its benefit is not confirmed with respect to the tritherapies recommended in first-line treatment, in particular as an alternative to darunavir/ritonavir + 2 nucleoside reverse transcriptase inhibitors (NRTIs).

  • No benefit in terms of efficacy, safety, or compliance has been demonstrated against clinically-relevant comparators.

  • It carries the risk of exposure to drug-drug interaction, especially due to the presence of cobicistat as darunavir booster, whereas the darunavir/ritonavir + 2 NRTIs combination has been shown to be effective and safe.

 

 


Clinical Benefit

Insufficient

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Therapeutic use

-