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Gilead Sciences HIV Drug [TAF/Genoya] Wins FDA Approval
  CEO says Genvoya, a single-tablet regimen, has potential to advance long-term treatment of HIV
Anne Steele
Nov. 5, 2015
Gilead Sciences said Thursday the U.S. Food and Drug Administration approved the biotech company's single tablet regimen treatment for HIV-1 infection. Genvoya is the first drug with tenofovir alafenamide, or TAF, to receive FDA approval.
Chief Executive John Martin said Genvoya is the first in a portfolio of TAF-based products that has the potential to advance the long-term treatment of HIV.
"While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease," he said.
TAF has shown high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread HIV treatment, or TDF, according to the company. Data show that because TAF enters cells—including HIV-infected cells—more efficiently than TDF, it can be given at a lower dose and results in 91% less tenofovir in the bloodstream.
Dr. David Wohl, lead author of the Genvoya efficacy analysis, said that as the HIV patient population ages there is an increased risk for development of age- and treatment-related diseases, including low bone mineral density and renal impairment as a result of the combination of HIV infection, antiretroviral treatments and the natural aging process.
Genvoya is intended as a complete regimen for the treatment of HIV-1 infection in adults and children 12 years and older who have no antiretroviral treatment history or to replace a current antiretroviral regimen, according to Gilead.
"Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of patients who are either new to therapy or who choose to switch treatments," said Dr. Wohl, who is an associate professor of medicine at the University of North Carolina at Chapel Hill's Division of Infectious Diseases.
In December, Gilead allowed pharmaceutical company Mylan Inc. to have nonexclusive rights to manufacture and distribute TAF in 112 countries, which account for more than 30 million of those with HIV or 84% globally.
Two other TAF-based regimens are currently under evaluation by the FDA. The first is a combination of emtricitabine and tenofovir alafenamide for use in combination with other antiretroviral agents, from Gilead. The second is a once-daily single tablet regimen that combines emtricitabine, tenofovir alafenamide and rilpivirine, from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Mylan to Manufacture, Distribute Gilead Sciences HIV Drug Agreement to Cover Over 30 Million People in 112 Countries
Angela Chen
Updated Dec. 1, 2014
Gilead Sciences Inc. will allow a subsidiary of the pharmaceutical company Mylan Inc. to have nonexclusive rights to manufacture and distribute its HIV treatment drug in 112 countries.
If approved by the U.S. Food and Drug Administration, Mylan Laboratories Limited will be able to manufacture the HIV drug tenofovir alafenamide, or TAF, as either a single agent or in an approved combination. The license for 112 countries accounts for more than 30 million of those with HIV, or 84% globally. It is common for pharmaceutical companies such as Gilead and Mylan to collaborate to increase drug access across the developing world. For example, Gilead shares limited licenses with generic drug manufacturers in India and South Africa, and in September said it would transfer its hepatitis C technology to seven companies that make drugs in India, including Mylan. London-based ViiV Healthcare has joined with with Mylan to create a new HIV treatment formula for pediatric cases.
TAF is currently in phase III clinical development by Foster City, Calif.-based Gilead Sciences. Gilead already manufactures HIV drugs with tenofovir, under the trade names Viread and Truvada. Truvada has been approved by the FDA as a type of HIV prevention treatment, or pre-exposure prophylaxis. Mylan, meanwhile, produces generic tablets of lamivudine and zidovudine that can be used to treat HIV in combination with other drugs. It launched these drugs at the beginning of October.
Mylan has been posting strong results lately, seeing soaring profit in the most recent quarter as the company expects to close its pending acquisition of Abbott Laboratories in the first quarter of next year. Gilead, however, has been hurt as sales of its blockbuster hepatitis C treatment Sovaldi fell 20% in the third quarter from the June period

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