Gilead Sciences Statement on U.S. Food and Drug Administration Advisory Committee’s Recommendation on Descovy for PrEP™
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that the Antimicrobial Drugs Advisory Committee (AMDAC) of the U.S. Food and Drug Administration (FDA) recommended approval of Descovy® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets; F/TAF) for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men by a vote of 16 to 2.
“We appreciate the advisory committee’s thoughtful review and discussion of the data during today’s meeting and look forward to collaborating with FDA to make this potential new prevention option available to people at risk of HIV in the United States,” said Diana Brainard, MD, Senior Vice President, HIV and Emerging Viruses, Gilead Sciences. “Descovy represents a potential new therapeutic option for people at risk of sexually acquired HIV-1 infection. If approved for a PrEP indication, Descovy could play a meaningful role in the federal initiative to address the nation’s HIV epidemic.”
Prevention methods and practices are essential tools in the fight against HIV. PrEP is a vital tool in the fight against HIV and should be an available HIV prevention strategy for all appropriate individuals at risk for HIV infection. In addition, PrEP is included in clinical guidelines as part of a comprehensive prevention strategy for individuals at risk for HIV.
The AMDAC reviewed Descovy data from the DISCOVER global Phase 3 clinical study, which evaluated the safety and efficacy of Descovy compared with Truvada® in men and transgender women who have sex with men and are at high-risk for sexually acquired HIV infection. Results from the DISCOVER trial demonstrated that Descovy achieved non-inferiority to Truvada in study participants who were at substantial and sustained risk of HIV acquisition. Additionally, statistically significant improvements in renal and bone laboratory parameters were observed for participants receiving Descovy versus those receiving Truvada.
The AMDAC also evaluated pharmacokinetic data on Truvada and Descovy for HIV treatment and PrEP in support of the potential use of Descovy for PrEP in cis-gender women, a population that was not part of the DISCOVER study. The committee voted 10 to 8 that there were not adequate data regarding the efficacy of Descovy for PrEP in cis-women.
Gilead recognizes the value that Descovy could bring to HIV prevention efforts for the broadest possible at-risk population in the United States and will continue to work with FDA as the agency completes its review of the application.
The AMDAC is convened upon the request of FDA to review and evaluate safety and efficacy data of human products, including those for use in the treatment or prevention of HIV. While FDA is not bound by the committee’s recommendation, the recommendations made by advisory committees, including the panel deliberations and voting, may be considered by the agency in making its final decision on an application.
Descovy was approved in April 2016 for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg, in combination with other antiretroviral agents.
Descovy for the prevention of HIV is an investigational use that has not been determined to be safe or efficacious and is not approved anywhere globally.
IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR THE USE OF DESCOVY FOR HIV TREATMENT
BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
- Descovy is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Descovy have not been established in patients coinfected with HIV-1 and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Descovy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Descovy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.
Warnings and precautions
- Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of FTC and tenofovir alafenamide with elvitegravir and cobicistat, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Descovy in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue Descovy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: In all patients, monitor CrCl, urine glucose, and urine protein prior to initiating and during therapy. In patients with chronic kidney disease, additionally monitor serum phosphorus.
- Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue Descovy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
- Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).
- Prescribing information: Consult the full prescribing information for Descovy for more information on potentially significant drug interactions, including clinical comments.
- Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of Descovy. Drugs that induce P-gp can decrease the concentrations of components of Descovy, which may lead to loss of efficacy and development of resistance.
- Drugs affecting renal function: Coadministration of Descovy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of emtricitabine and tenofovir and the risk of adverse reactions.
Dosage and administration
- Dosage: Patients who weigh ≥25 kg: 1 tablet taken orally once daily with or without food.
- Renal impairment: Not recommended in patients with CrCl <30 mL/min.
- Testing prior to initiation: Test patients for HBV infection and assess CrCl, urine glucose and urine protein.
- Pediatrics: The safety and effectiveness of Descovy coadminstered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in pediatric subjects weighing less than 35 kg.
Pregnancy and lactation
- Pregnancy: There is insufficient human data on the use of Descovy during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established; available data from the APR for FTC shows no difference in the rates of birth defects compared with a U.S. reference population.
- Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
Descovy is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg.
Descovy is also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg.
Limitations of Use:
Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV-1 infection.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
For nearly 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.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
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 risk that FDA and other regulatory agencies may not approve Descovy for PrEP in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on its use. As a result, Descovy for PrEP may never be successfully commercialized. There is also the possibility of unfavorable results from additional studies involving Descovy for PrEP. 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 June 30, 2019, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Gilead and Gilead logo are trademarks of Gilead Sciences, Inc. or its related companies.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Ryan McKeel, Media
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
CES Unveiled in Paris to Shine Spotlight on Artificial Intelligence26.8.2019 10:00:00 EEST | Press release
Consumer Technology Association (CTA)®: WHAT: The Consumer Technology Association (CTA)® today announced that CES Unveiled in Paris will focus on emerging technology and trends around artificial intelligence (AI). More than 1,000 expected attendees will be able to view the latest AI innovations, learn about the latest tech trends and network with industry leaders. An official CES 2020 preview, CES Unveiled returns to Paris for a seventh year on Tuesday, Oct. 22 at Palais Brongniart. Attendees will experience a full day of tech that will feature more than 80 companies of all sizes, influential media, senior level executives, and prominent industry influencers from France and across Europe. Attendees will discover how AI is shaping our world, from changing enterprises to affecting ethics and policy. Industry experts and thought leaders from all over Europe will share insights on AI, enterprise solutions, mobility, Internet of Things (IoT) infrastructure, autonomous vehicles, diversity an
Study Investigates the Utility of Masimo ORi™, Oxygen Reserve Index, to Reduce Hyperoxia in Critically Ill Patients26.8.2019 09:00:00 EEST | Press release
Masimo (NASDAQ: MASI) announced today that in a randomized controlled study involving 150 ICU patients recently published as a letter in Intensive Care Medicine, researchers investigated whether monitoring with Masimo ORi™ (Oxygen Reserve Index) could reduce the time critically ill patients spend with moderate hyperoxia, compared to monitoring with oxygen saturation (SpO2) alone.1 ORi is an index of oxygenation in the moderate hyperoxic region, defined as arterial partial pressure of oxygen, PaO2 , in the range of 100 to 200 mmHg). As an “index” with a scale between 0.0 and 1.0, ORi can be trended to notify clinicians of changes in a patient’s oxygen reserve. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190825005030/en/ Masimo Root® and Radical-7® with ORi™ (Photo: Business Wire) Dr. Sigismond Lasocki and colleagues at the Centre Hospitalier Universitaire of Angers, France (CHU Angers), sought to evaluate whether controlli
S BLOCK 1000 Pax Interstellar Quantitative Summit Convenes in Bangkok26.8.2019 08:24:00 EEST | Press release
On August 21st, "S BLOCK Interstellar Quantitative Summit" officially convened in Bangkok, Thailand! This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190825005035/en/ (PHOTO: S BLOCK) Interstellar Quantification Assists S BLOCK to be Further Technologized S BLOCK is a brand-new multi-currency, cross-chain technology wallet from Switzerland, which jointly issued by S BLOCK foundation, Cloud Capital, Top Line, DAF, Stanford Blockchain Research center, MIT Media Lab and Cambridge Financial Alternative Center. Since its launch on June 15, it has bring an generous revenue of 6-15% per month for its millions of users. Interstellar quantification is S BLOCK's biggest source of revenue. Interstellar quantification is to realize timely capital exchanges with the quantification team under the agreement of Interstellar loan contract, so as to enlarge the capital scale at the fastest speed and lock up trading opportunities addition, S Blo
Building The Data Economy Within The G726.8.2019 08:00:00 EEST | Press release
Under the French Presidency, the G7 summit in Biarritz brings together the heads of state and government of the largest economies. This summit comes three months after the digital technology ministers meeting of G7 countries in Paris where the need to strengthen international digital cooperation was a key focal point of the debates. Discussions are still ongoing to resolve the challenges of the data economy, and the free flow of data in a trusted environment. Several international initiatives in favor of data circulation took place in recent months. As part of the Digital Single Market, the European Commission announced a new regulation on the free flow of non-personal data. The United States initiated a federal plan for data strategy. At the G20, Japan proposed the Osaka Track initiative to standardize the international rules for data flow. According to Dawex, the leading data exchange technology company and operator of the largest data marketplace, the flow of data in the G7 countrie
Gilead and Galapagos Complete Closing of Their Transformative Research and Development Collaboration23.8.2019 23:01:00 EEST | Press release
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced the closing of the global research and development collaboration agreement signed on July 14, 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190823005335/en/ This agreement has received clearance from the U.S. Federal Trade Commission under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and merger control approval from the Austrian Federal Competition Authority. Under the terms of the agreement, the closing of this transaction triggers an upfront license fee payment of $3.95 billion by Gilead to Galapagos. In addition, Gilead has made an equity investment in Galapagos of approximately $1.1 billion (or approximately €960 million) by subscribing for new shares at a price of €140.59 per share, including issuance premium. As a result, Gilead now owns 13,589,686 ordinary shares of Galapagos, representing approximately 2
32 Leading Global Fashion and Textile Companies Make Commitments on Climate, Biodiversity and Oceans23.8.2019 10:47:00 EEST | Press release
Ahead of the G7 meeting at Biarritz from August 24-26, French President Emmanuel Macron, accompanied by Economy and Finance Minister Bruno Le Maire, Minister of Labour Muriel Pénicaud, and Deputy Minister of Ecological and Solidary Transition Brune Poirson, has invited to the Elysée Palace representatives of the 32 fashion and textile companies who have launched the Fashion Pact by his side. In April 2019, ahead of the G7 meeting, Emmanuel Macron had given François-Henri Pinault, Chairman and Chief Executive Officer of Kering (Paris:KER), a mission to bring together the leading players in fashion and textile, with the aim of setting practical objectives for reducing the environmental impact of their industry. In a historic move, given the scale and importance of the coalition that has been created, 32 leading companies from the fashion and textile industry have given themselves a set of shared objectives in the form of a Fashion Pact. The coalition includes groups and brands in Luxury,
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom