September 25, 2015
European CHMP Adopts Positive Opinion for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV
– Gilead’s First TAF-based Regimen to Receive CHMP Positive Opinion –
The CHMP’s recommendation will now be reviewed by the
TAF is a novel investigational nucleotide reverse transcriptase inhibitor (NRTI) that has demonstrated high antiviral efficacy 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.
The MAA for Genvoya is supported by 48-week data from two pivotal Phase 3 studies (Studies 104 and 111) in which the regimen met its primary objective of non-inferiority compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among treatment-naïve adult patients. In the studies, Genvoya demonstrated improvement in surrogate laboratory markers of renal and bone safety as compared to Stribild. The MAA is also supported by data from additional Phase 3 studies evaluating the TAF-based regimen among adolescents, virologically suppressed adult patients who switched to Genvoya and adult patients with mild-to-moderate renal impairment.
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
TAF and all TAF-based regimens are investigational products and their safety and efficacy have not been established in the European Union.
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 the MAA for Genvoya, 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 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
Gilead Sciences, Inc.
Sung Lee, +1 650-524-7792
Ryan McKeel, +1 650-377-3548
Kristine Kelly, +44 (0)78 1086 8956