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 |
- |
Therapeutic use
- |