Gilead Sciences, Ltd. have announced that the European Commission has granted marketing authorisation for the once-daily single tablet regimen Genvoya® (150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir alafenamide) for the treatment of HIV-1 infection. It is the first TAF-based regimen to receive marketing authorisation in the European Union (EU).1
Genvoya is indicated in the EU for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus-1 (HIV-1) without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.1
"With access to appropriate treatment, HIV patients today have the potential to live nearly as long as the general population. However, research shows they are at an increased risk of age- and treatment-related comorbidities, which means helping preserve long-term health should be a priority when making treatment decisions," said Anton Pozniak, HIV Service Director, Chelsea and Westminster Hospital, London, UK. "With this product, we have an important new treatment option for a range of HIV patients as it offers both demonstrated sustained viral suppression and improvements in certain renal and bone safety markers compared to TDF-based regimens."
Today's marketing authorisation is based on one of the largest Phase 3 HIV clinical programmes conducted to date, including more than 3,500 patients with HIV across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients.2,3,4,5 It allows for the marketing of the product in all 28 countries of the EU.
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), as well as statistically significant improvements in surrogate laboratory markers of proximal renal tubule dysfunction and bone mineral density (hip and spine) as compared to TDF in clinical trials in combination with other antiretroviral agents at 48 weeks.3 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 91% less tenofovir in the bloodstream.6
"For more than 25 years, Gilead has continually worked to develop new treatments to improve the management of HIV," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "This has the potential to deliver long-term health benefits to people living with HIV."