Janssen has announced that the European Commission (EC) has approved the use of darunavir/cobicistat/emtricitabine/tenofovir alafenamide [D/C/F/TAF] (darunavir-STR), a once-daily darunavir-based single-tablet regimen (STR), for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg.
Gilead Sciences International supplies cobicistat, emtricitabine and tenofovir alafenamide as part of a licensing agreement with Janssen.
The only darunavir-based STR indicated for the treatment of this patient group combines the proven efficacy and durability of darunavir with the potentially improved renal laboratory and bone mineral density profile of F/TAF as compared to F/TDF (emtricitabine/tenofovir disoproxil fumarate).
It is the only approved treatment to offer the advantages of an STR alongside the high genetic barrier to resistance provided by darunavir; genotypic testing should guide use.
On 20 July, the European Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for darunavir-STR. This subsequent EC approval allows Janssen to market darunavir-STR in all 28 European Union countries as well as in the three European Economic Area countries.
Dr. Frank Wiegand, Medical Director, Janssen UK, said: “Today’s decision by the European Commission to approve the use of darunavir-STR validates our efforts to treat HIV more simply, addressing the issues of adherence and resistance.”