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As part of the licensing agreement, pending USFDA approval of the Gilead product, Strides will receive a technology transfer from Gilead, enabling Strides to manufacture low-cost versions of TAF for developing countries.
TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead's Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.
The license being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV.
TAF and TAF-based regimens are investigational products in the United States and have not yet been determined safe or efficacious in humans.