– Gilead's First TAF-based Single Tablet Regimen Demonstrates High Efficacy withImproved Renal and Bone Parameters Compared to TDF-based Regimens –
GENVOYA (150 mg elvitegravir/150 mg cobicistat/200 mg emtricitabine/10 mg tenofovir alafenamide) is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 12 years of age and older (and weighing ? 35 kg) and with no known mutations associated with resistance to the individual components of GENVOYA.
"People living with HIV today want a simple and easy to tolerate medication to treat their virus," said Dr. Mona Loutfy, Infectious Disease Specialist & Clinical Researcher, Women's College Research Institute, Toronto. "Also, patients increasingly have other co-morbidities, such as heart, kidney and liver disease, because they are living longer than ever before. Therefore, patients need access to new treatments, such as GENVOYA, that are efficacious, well tolerated and simple to dose."
GENVOYA received marketing authorization in 2015, and is Gilead Canada's first tenofovir alafenamide (TAF)-based single tablet regimen. Since GENVOYA was granted marketing authorization, Gilead Canada has received approval two additional TAF-based regimens, DESCOVY® (emtricitabine/tenofovir alafenamide) tablets and ODEFSEY™ (emtricitabine/rilpivirine/tenofovir alafenamide) tablets.
"In clinical studies, TAF has shown improvements in multiple bone and renal laboratory parameters compared to TDF (tenofovir disoproxil fumarate)," added Dr. Loutfy. "GENVOYA offers a new treatment option for patients who are new to antiretroviral treatment, or who may be needing a replacement for an older antiretroviral regimen in those who are virologically suppressed. Today, the goal of treatment is beyond achieving an undetectable status, as we are now able to address longer-term side effects to help patients live an improved quality of life."
TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's VIREAD® (tenofovir disoproxil fumarate, TDF). TAF has also demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF loads cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose resulting in >90 per cent lower concentrations of tenofovir in plasma.
"Gilead Canada commends the continued leadership of many provinces and territories to provide access to new treatment options that help address the evolving needs of a range of HIV patients," said Kennet Brysting, General Manager, Gilead Canada. "We will continue to invest in HIV research, and work with other federal, provincial and territorial public drug plans to ensure equal access to GENVOYA and other TAF-based regimens that are becoming the cornerstone of HIV therapy."
GENVOYA does not cure HIV infection or AIDS.
Important Safety InformationGENVOYA has serious warnings in its Product Monograph regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment exacerbation of hepatitis. For important safety information for GENVOYA, including contraindications and additional warnings and precautions, please see the Canadian Product Monograph.
About GileadGilead Sciences, Inc. (Gilead) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc. and was established in Mississauga, Ontario, in 2005.
Forward-Looking StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that physicians and patients may not see the advantages of GENVOYA over other therapies and may therefore be reluctant to prescribe the product. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Canadian Product Monographs for GENVOYA, DESCOVY and ODEFSEY are available at www.gilead.ca.
GENVOYA®, DESCOVY®, ODEFSEY™ and VIREAD® are trademarks of Gilead Sciences, Inc., or its related companies.
For more information on Gilead Sciences, please visit the company's website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
SOURCE Gilead Sciences, Inc.
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