EC approves darunavir single-tablet regimen for treatment of HIV-1
The European Commission has now approved the use of the single-tablet regimen (STR) darunavir/cobicistat/emtricitabine/tenofovir alafenamide (Symtuza) for the treatment of HIV-1 infection in adults and adolescents aged 12 years and over within the EU, following a positive opinion from the European Medicines Agency (EMA) in July.
Symtuza is a fixed-dose combination treatment containing 800mg darunavir, 150mg cobicistat, 200mg emtricitabine and 10mg tenofovir alafenamide. It is taken orally once-daily and the single-tablet regimen aims to address the issue of poor adherence. Darunavir inhibits HIV-1 protease and prevents the formation of mature infectious virus particles; emtricitabine and tenofovir alafenamide are both competitive inhibitors of reverse transcriptase and inhibit HIV replication; and cobicistat enhances systemic exposure of darunavir by inhibiting the CYP3A group of metabolic enzymes. Use of Symtuza should be guided by genotypic testing.
The approval follows the preliminary results of the phase 3 EMERALD study, which showed that Symtuza had a low cumulative virological rebound rate and a high virological suppression rate at 24 weeks in HIV-1 positive, virologically suppressed adults who switched from a boosted protease inhibitor regimen. A separate study demonstrated that Symtuza is bioequivalent to the combined administration of the separate components and is well tolerated. The most common adverse effects are diarrhoea, nausea, fatigue, headache and rash.