– Gilead’s First TAF-based Single Tablet Regimen Demonstrates High Efficacy with
Improved Renal and Bone Parameters Compared to TDF-based Regimens –
MISSISSAUGA, ON , May 4, 2017 /CNW/ – Gilead Sciences Canada, Inc. today recognizes Québec for including GENVOYA® tablets as a general benefit on the list of the Régie de l’assurance maladie du Québec (RAMQ), for the treatment of HIV-1 infection.
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 are increasingly likely to be receiving treatment for other conditions, such as heart, kidney and liver disease, because they are living longer than ever before, exposing them for longer periods of time to the virus and to the antiviral medications used to treat it,” said Dr. Réjean Thomas, President, Chef Executive Office and Founder/ président-directeur général et fondateur, Clinique médical L’Actuel, Montréal. “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. Thomas. “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 Québec 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 to work with all public drug plans to ensure equal access to GENVOYA and other TAF-based regimens that are becoming the cornerstone of HIV therapy.”