April 25, 2016
European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV
– Descovy is the First New HIV Treatment Backbone Approved in the EU in Over a Decade –
Descovyis indicated in the
“Treatment backbones, paired with a third agent, are a cornerstone for
successful management of HIV. Descovy is the first new HIV backbone
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 enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a much lower dose and there is 90 percent less tenofovir in the bloodstream.
“TAF represents the latest development in Gilead’s more than 25-year
history of innovation in the field of HIV, and we are pleased to offer
patients and physicians another TAF-based therapy that expands their
treatment options,” said
The marketing authorization for Descovy is supported by 48-week data from a Phase 3 study (Study 1089) evaluating the safety and efficacy of switching virologically suppressed HIV-1 infected adult patients from regimens containing emtricitabine and tenofovir disoproxil fumarate (F/TDF; Truvada®) plus a third agent to regimens containing F/TAF plus the same third agent. At Week 48, the F/TAF-based regimens were found to be statistically non-inferior to the F/TDF-based regimens, based on percentages of patients with HIV-1 RNA levels less than 50 copies per mL. The study also demonstrated statistically significant improvements in renal and bone laboratory parameters among patients receiving the F/TAF-based regimens.
The marketing authorization is also supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) evaluating an F/TAF-based regimen (administered as Genvoya®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg; E/C/F/TAF) against an F/TDF-based regimen (administered as Stribild®; elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg; E/C/F/TDF) among treatment naïve adult patients. In these studies, certain renal and bone laboratory parameters favored the F/TAF-based regimen over the F/TDF-based regimen. Additionally, the marketing authorization is supported by data from studies evaluating an F/TAF-based regimen (administered as Genvoya) among adults with mild-to-moderate renal impairment and among treatment naïve adolescents. Lastly, bioequivalence studies demonstrated that the formulation of the fixed-dose combinations of Descovy achieved the same drug levels of TAF and emtricitabine in the blood as in Genvoya.
For important safety information for Descovy, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Descovy, available from the EMA website at www.ema.europa.eu.
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 benefits of prescribing Descovy. 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
The European SmPCs for Descovy®, Genvoya®, Stribild® and Viread® are available from the EMA website at www.ema.europa.eu.
Descovy, Genvoya, Stribild and Viread are registered trademarks of
For more information on
Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548
Stephen Head, +44 (0)7768 705945