[December 07, 2015]

Health Canada Issues Notice of Compliance for Gilead's Single Tablet Regimen Genvoya™ (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection

Gilead Sciences Canada, Inc. today announced that Health Canada has issued a Notice of Compliance for Genvoya^™ (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive marketing authorization in Canada.

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Health Canada issues Notice of Compliance for Gilead's single tablet regimen Genvoya™ for treatment of HIV-1 infection (Photo: Business Wire)

Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older with body weight at least 35 kg and with no known mutations associated with resistance to the individual components of Genvoya.

"Because of the innovations over the last 20 years, people diagnosed with HIV are treated for decades and they have the potential to live as long as the general population. Consequently, they face accumulated age- and treatment-related comorbidities, including low bone mineral density and renal impairment, which may have a significant impact on their lives," said Dr. Jonathan Angel, MD, Professor of Medicine and Head, Division of Infectious Diseases, University of Ottawa and the Ottawa Hospital. "Given its demonstrated efficacy and safety profile, Genvoya represents an important new treatment option for a range of HIV patients who are either new to therapy or who choose to switch treatments."

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 (News - Alert)), as well as 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 enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose resulting in >90 per cent lower concentrations of tenofovir in plasma.

Genvoya was studied in a Phase 3 HIV clinicl program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. The marketing authorization for Genvoya is supported by 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naïve patients in which the regimen met its primary endpoint of non-inferiority compared to Stribild^® (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92 per cent of Genvoya patients and 90 per cent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Certain renal and bone laboratory parameters favored Genvoya over Stribild.

Additionally, the marketing authorization is supported by a Phase 3 study (Study 109) among virologically-suppressed adult patients who were randomized either to stay on their TDF-based regimen or switch to Genvoya. The study enrolled 1,436 subjects and 1,196 had reached the 48-week time point at the time of filing. Among those patients, Genvoya was found to be statistically non-inferior to the TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL at Week 48. Patients receiving Genvoya also demonstrated improvements in certain bone and renal laboratory parameters compared to those who stayed on their TDF-based baseline regimen. Finally, data from two studies evaluating Genvoya among treatment-naïve adolescents and among virologically suppressed adult patients with mild-to-moderate renal impairment (eGFR between 30-69 mL/min) supported the marketing authorization.

Genvoya does not cure HIV infection or AIDS.

Important Safety Information

Genvoya 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 for Genvoya.

About Gilead

Gilead Sciences 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 Statement

This 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 may not see the benefits of prescribing Genvoya. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, 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 Monograph, including serious warnings, for Genvoya will be available at www.gilead.ca.

Canadian Product Monographs, including serious warnings, for Stribild and Viread are available at www.gilead.ca.

Genvoya, Stribild and Viread are registered 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 (News - Alert) (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000

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