Johnson & Johnson group Janssen has expanded an existing deal with Gilead to develop a once daily, darunavir-based, single-tablet regimen for the treatment of people living with HIV.
The new regimen contains a combination of darunavir (Prezista), cobicistat (Tybost), emtricitabine and tenofovir alafenamide (TAF), and “a number of Phase I and II studies” have already been completed.
Under the amended deal, Janssen will conduct all further clinical development of the regimen and, subject to regulatory approval, is responsible for all manufacturing, registration, distribution and commercialisation of the product worldwide.
The treatment could be the first protease inhibitor-based STR on the market. “If approved, this STR has the potential to provide additional choice in the form of another one pill, once a day, as a new and simplified regimen,” noted Paul Stoffels, J&J’s chief scientific officer.
Janssen and Gilead have also expanded a separate 2009 agreement regarding the approved single-tablet regimen, Complera/Eviplera (rilpivirine, tenofovir disoproxil fumarate (TDF) and emtricitabine). This allows for the replacement of TDF with Gilead's TAF, a novel nucleotide reverse transcriptase inhibitor shown in clinical trials to have a better renal and bone safety profile than its predecessor.