D/C/F/TAF

Drug Overview

D/C/F/TAF (darunavir/cobicistat/emtricitabine/tenofovir alafenamide fumarate [TAF]; Johnson & Johnson) is a once-daily single-tablet regimen (STR) combination of the protease inhibitor (PI) Prezista (darunavir; Johnson & Johnson), the two nucleoside reverse transcriptase inhibitors Emtriva (emtricitabine; Gilead) and GS-7340 (TAF; Gilead), and the boosting agent Tybost (cobicistat; Gilead/Bristol-Myers Squibb/Tibotec). D/C/F/TAF is the first STR containing a PI. The combination is currently in Phase III development in the US and EU for the treatment of HIV-1 infection. Following an amended licensing agreement, Johnson & Johnson is responsible for the further development and commercialization of the product worldwide. Based on the projected pivotal Phase III trial completion date of September 2016, Datamonitor Healthcare forecasts that D/C/F/TAF will be approved in Q4 2017 in the US and Q1 2018 in the EU.

Analyst Outlook

While the high resistance barrier of the darunavir component of D/C/F/TAF (darunavir /cobicistat/ emtricitabine/ tenofovir alafenamide fumarate [TAF]; Johnson & Johnson) will position the drug as a good alternative for treatment-experienced patients who have generated resistance to other regimens, it will struggle to compete in the market due to its late launch, generic threats, and fierce competition from Triumeq (dolutegravir/abacavir/lamivudine; ViiV Healthcare). Datamonitor Healthcare believes that the improved renal and bone safety profile of TAF is likely to have a minimal impact on overall drug uptake because D/C/F/TAF will not be the first TAF-based drug to market, and because the lower price of generics will ultimately outweigh the safety benefits of TAF in populations without renal and bone issues. Additionally, unless Triumeq begins to demonstrate resistance issues, which is unlikely based on existing data, D/C/F/TAF will struggle to compete with it.