November 23, 2015
European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection
– Gilead’s First TAF-based
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 HIV-1 without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir.
“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
Photos and multimedia gallery available at www.GileadHIVEU.com.
Today’s marketing authorization is based on a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naïve, virologically suppressed, renally impaired and adolescent patients. It allows for the marketing of Genvoya 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 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 91 percent less tenofovir in the bloodstream.
“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. “Genvoya, along with other
investigational products in our TAF-based portfolio, have the potential
to deliver long-term health benefits to people living with HIV across
The marketing authorization is supported by 48-week data from two ongoing Phase 3 studies (Studies 104 and 111) among 1,733 treatment-naïve adult 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, 92.4 percent of Genvoya patients and 90.4 percent 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 approval 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. At Week 48, switching to Genvoya was found to be statistically superior to remaining on TDF-based regimens based on the percentages of patients with HIV-1 RNA levels less than 50 copies/mL. 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 30-69ml/min) supported the approval.
For important safety information for Genvoya, including contraindications, special warnings, drug interactions, and adverse drug reactions, please see the European SmPC for Genvoya, available from the EMA website at www.ema.europa.eu.
In addition to Genvoya, two other TAF-based regimens are currently under
evaluation by the EMA. The first is an investigational, fixed-dose
combination of emtricitabine 200 mg and tenofovir alafenamide 25 or
10 mg (F/TAF) for use in combination with other antiretroviral agents.
The second is an investigational, once-daily single tablet regimen that
combines emtricitabine 200 mg, tenofovir alafenamide 25 mg and
rilpivirine 25 mg (R/F/TAF). Emtricitabine and tenofovir alafenamide are
from Gilead and rilpivirine is from Janssen Sciences Ireland UC, one of
the Janssen Pharmaceutical Companies of
F/TAF and R/F/TAF are investigational products and their efficacy and
safety have yet not been established in the
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 Genvoya may not be approved by other regulatory authorities and the
marketing applications for F/TAF and/or R/F/TAF may not be approved by
the EMA, and marketing approvals, if granted, may have significant
limitations on their use. 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
The European SmPCs for Genvoya, Stribild and Viread are available from the EMA website at www.ema.europa.eu.
Genvoya, Stribild and Viread are registered trademarks of
For more information on
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Gilead Sciences, Inc.
Patrick O’Brien, +1 650-522-1936
Ryan McKeel, +1 650-377-3548
Kristine Kelly, +44 (0) 7810 868 956