F/TAF (emtricitabine/tenofovir alafenamide fumarate [TAF]; Gilead) is a fixed-dose combination of two of Gilead’s nucleoside reverse transcriptase inhibitors, Emtriva (emtricitabine) and GS-7340 (TAF). The combination is currently in preregistration in the US and EU, and is in preclinical development in Japan for the treatment of HIV-1 infection.
While a superior renal and bone safety profile positions F/TAF (emtricitabine/tenofovir alafenamide fumarate [TAF]; Gilead) to replace Truvada (emtricitabine/tenofovir disoproxil fumarate; Gilead/Japan Tobacco), generic incursion will pose a significant threat to the drug’s success. Truvada is expected to go off patent in 2018 in the EU and in 2021 in the US, at which time cheaper generics will become available. The threat of generic erosion will prevent significant uptake of F/TAF in spite of renal and bone safety improvements. Datamonitor Healthcare believes that the lower price of generics will ultimately outweigh the safety benefits of TAF in populations without renal and bone issues.
TABLE OF CONTENTS
4 PRODUCT PROFILES
4 F/TAF : HIV
LIST OF FIGURES
9 Figure 1: F/TAF for HIV-1 infection – SWOT analysis
9 Figure 2: Datamonitor Healthcare drug assessment summary of F/TAF in HIV-1
10 Figure 3: Datamonitor Healthcare drug assessment summary of F/TAF in HIV-1
LIST OF TABLES
4 Table 1: F/TAF drug profile
6 Table 2: F/TAF Phase III data in HIV-1 infection
8 Table 3: F/TAF Phase III trials in HIV-1 infection
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