Janssen-Cilag has submitted a marketing application to the European Medicines Agency for a new once-daily darunavir-based single tablet regimen (STR) to treat HIV.
This new therapy combines the protease inhibitor darunavir with the pharmacokinetic enhancer cobicistat and the nucleoside reverse transcriptase inhibitors emtricitabine and tenofovir alafenamide.
If approved, the pill would be the first protease inhibitor-based STR option indicated as a complete regimen for the treatment of HIV‑1 infection in adults and adolescents aged 12 years and older with body weight of at least 40 kg.
Treatment regimens combining darunavir and cobicistat (Janssen's Rezolsta) and emtricitabine and tenofovir alafenamide (Gilead Sciences) are already on the market for maintenance treatment of HIV; combining these is "a significant evolution of this approach", offering both treatments in a single, convenient tablet, the Johnson & Johnson group noted.
"Progress in the development of effective treatments is helping people with HIV to live longer, but treatment regimens can still impact daily life. Eliminating the need for separate tablets will not only be convenient for people living with HIV but is likely to lead to improved treatment adherence," noted Lawrence Blatt, global therapeutic area head, Janssen Infectious Diseases and Vaccines, and president and chief executive officer of Alios BioPharma.