Gilead also announced it will submit a study protocol amendment to local EU health authorities to extend the DISCOVER trial, a multi-year global Phase 3 registrational clinical trial evaluating the safety and efficacy of once-daily Descovy for PrEP compared with Truvada(emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tablets; F/TDF) (Truvada for PrEP), in men and transgender women who have sex with men and may benefit from PrEP medicines. The proposed DISCOVER extension will go through
Gilead remains deeply committed to scientific innovation and the development of novel PrEP options with the goal of achieving zero new HIV infections. To help ensure sustainable access to new PrEP options for all who can benefit, we will continue to pursue marketing authorizations in countries where payers recognize the public health and individual value of HIV prevention.
For information about the approved uses and important safety information for Descovy (emtricitabine and tenofovir alafenamide; 200/25 mg), and for Truvada (emtricitabine and tenofovir disoproxil fumarate; 200/300 mg), please see the full Prescribing Information including BOXED WARNINGS for each product, available at Gilead.com.
Please see below for
There is no cure for HIV or AIDS.
Descovy for PrEP is indicated in at-risk adults and adolescents (?35 kg) to reduce the risk of sexually acquired HIV-1 infection, excluding individuals at risk from receptive vaginal sex. HIV-1-negative status must be confirmed immediately prior to initiation.Limitation of Use:
Descovy for PrEP is not indicated in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
About
For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it's estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company's manufacturing partners.
Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19. For more information on Gilead's response to the coronavirus outbreak please visit the company's dedicated page: https://www.gilead.com/purpose/advancing-global-health/covid-19.
Forward-Looking Statement
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 possibility of unfavorable results from ongoing and additional clinical trials involving Descovy for PrEP, Truvada for PrEP, and the possibility that we are unable to complete one or more of such trials in the currently anticipated timelines or at all. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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 ended
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