Gilead announces HIV regimen trial results
pharmafile | February 25, 2016 | News story | Medical Communications, Research and Development, Sales and Marketing | Gilead Sciences
Gilead Sciences has reported 48-week Phase III trial results suggesting fixed-dose Emtriva and tenofovir alafenamide (F/TAF) combinations matched its Truvada (Emtriva and Viread) regimen in suppressing the HIV virus, while offering a superior safety profile in bone density and renal function.
The company says the F/TAF-based regimens were found to be statistically non-inferior to Truvada-based (F/TDF) regimens, based on copies of the virus in the blood after 48 weeks. The study also demonstrated statistically significant improvements in renal and bone laboratory parameters among patients receiving F/TAF-based regimens.
“This study reinforces the benefits we’ve consistently seen in other trials evaluating TAF-based regimens, including high rates of viral suppression and improvements in renal and bone lab safety parameters,” says Joel Gallant, lead author of the Phase III study, medical director of Specialty Services at Southwest CARE Center in Santa Fe, NM. “This is also the first study to demonstrate the versatility of F/TAF as an experimental, fixed-dose combination HIV treatment backbone that can be paired with a range of third agents to help meet the diverse needs of people living with HIV.”
TAF is a novel targeted prodrug of tenofovir that has demonstrated similarly high antiviral efficacy to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF). Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
Gilead will be keen for its newer TAF-based regimens to win back some of the market share lost to HIV treatments from ViiV Healthcare, which has eaten into Gilead’s former dominance of the space with products including three-tablet regimen Triumeq (abacavir, dolutegravir and lamivudine).
Joel Levy
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