Gilead Presents Results From Phase 3 Study Evaluating Patients Who Switched to Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide From Boosted Protease Inhibitor-Based Regimens
Gilead Sciences, Inc. (NASDAQ: GILD) today announced detailed 48-week results from a Phase 3 study (Study 1878) evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone. In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. The data are being presented at IDWeek 2017 in San Diego (Session 228).
“These data demonstrate the potential of BIC/FTC/TAF to match the efficacy of a boosted protease inhibitor regimen while also offering a high barrier to resistance and fewer interactions with other drugs,” said Eric Daar, MD, Chief of the Division of HIV Medicine at Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and lead author of Study 1878. “The findings, along with data from three other Phase 3 studies in both treatment-experienced and treatment-naïve patients, suggest that the investigational regimen of BIC/FTC/TAF may be appropriate for a broad range of people living with HIV.”
In Study 1878, a total of 577 virologically suppressed adults with HIV taking regimens of boosted atazanavir (ATV) or darunavir (DRV) + abacavir/lamivudine (ABC/3TC) or FTC/tenofovir disoproxil fumarate (TDF) were randomized 1:1 to continue their bPI regimen or to switch to open-label coformulated BIC/FTC/TAF once daily. At the primary endpoint of Week 48, switching to BIC/FTC/TAF was non-inferior to continuing on a bPI regimen with 1.7 percent of patients in each group having HIV-1 RNA ≥50 c/mL (difference: 0.0 percent, 95 percent CI: -2.5 percent to 2.5 percent, p=1.00); the proportion of patients with HIV-1 RNA <50 c/mL was 92.1 percent in the BIC/FTC/TAF arm and 88.9 percent in the bPI arm, according to FDA snapshot algorithm.
No patients in the BIC/FTC/TAF arm developed treatment-emergent resistance, and one participant on DRV/ritonavir + ABC/3TC developed a treatment-emergent NRTI mutation associated with abacavir. No renal adverse events leading to discontinuations or cases of proximal renal tubulopathy occurred with BIC/FTC/TAF. The incidence of grade 3 or 4 adverse events was 4 percent (n=13) for the BIC/FTC/TAF arm versus 6 percent (n=18) for the bPI arm; the incidence of grade 3 or 4 laboratory abnormalities was 16 percent (n=45) for the BIC/FTC/TAF arm versus 29 percent (n=83) for the bPI arm. The most commonly reported adverse events (all grades) in both arms included headache, diarrhea, nasopharyngitis and upper respiratory tract infection.
“The combination of the unboosted integrase inhibitor bictegravir with the FTC/TAF backbone has the potential to further evolve HIV triple therapy with convenient dosing in a single-tablet regimen,” said Norbert W. Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. “We look forward to the opportunity to offer patients this next-generation therapy as part of our TAF-based portfolio of treatments for HIV.”
Gilead filed a New Drug Application for BIC/FTC/TAF with a Priority Review voucher on June 12, 2017, and the U.S. Food and Drug Administration (FDA) set a target action date of February 12, 2018, under the Prescription Drug User Fee Act. A marketing application for BIC/FTC/TAF is also under review in the European Union and was validated by the European Medicines Agency (EMA) on July 13.
Bictegravir in combination with FTC/TAF as a single-tablet regimen is an investigational treatment that has not been determined to be safe or efficacious and is not approved anywhere globally.
Further information about the clinical trials can be found at www.clinicaltrials.gov.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 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 10 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.
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 that regulatory authorities, including the FDA and EMA, may not approve BIC/FTC/TAF in the currently anticipated timelines or at all, and any marketing approvals, if granted, may have significant limitations on their use. As a result, BIC/FTC/TAF may never be successfully commercialized. 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, 2017, 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.
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.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Ryan McKeel, 650-377-3548
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
RagingWire Opens New VA3 Data Center and Ashburn Data Center Campus in the Heart of Famed "Data Center Alley"20.3.2018 05:09 | Tiedote
RagingWire Data Centers, Inc., the premier data center provider in North America and its parent company NTT Communications (NTT Com), the information and communications technology (ICT) solutions and international communications business within the NTT Group (TOKYO: 9432), today announced the opening of its new Ashburn VA3 Data Center, a state-of-the-art facility with 245,000 square feet of space and 16 megawatts of critical power, located on RagingWire’s new Ashburn Data Center Campus. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319006380/en/ RagingWire new Ashburn VA3 Data Center (Graphic: Business Wire) “With 16 megawatts available today at the new VA3 Data Center and massive scalability in our new Ashburn Data Center Campus, RagingWire has become the destination of choice for hyperscale, high-growth customers in the top data center market in the world,” said RagingWire President and CEO Doug Adams. “Plus our global
FAA Approves AerTrakTM to Comply with Automatic Dependent Surveillance-Broadcast (ADS-B) Operations Mandate19.3.2018 21:19 | Tiedote
The Federal Aviation Administration (FAA) has issued a Supplemental Type Certificate (STC) for installation of AerSale®’s AerTrak™ system on Boeing 737 NG series aircraft (ST04009NY), to comply with the Automatic Dependent Surveillance-Broadcast (ADS-B) Operations rule, a critical part of the agency’s Next Generation Air Transportation System (NextGen). Beginning January 1, 2020, the FAA has mandated that aircraft operating in airspace defined by 14 CFR § 91.225 must be equipped with an ADS-B Out system that meets the minimum performance requirements of 14 CFR § 91.227. ADS-B provides enhanced navigational accuracy using precise tracking via global positioning satellite (GPS) signals. Reducing risk and improving safety, the technology increases navigational coverage, especially in remote areas beyond radar range. Additionally, ADS-B enables more direct flight plans, thereby saving time, costs, and reducing emissions. “AerTrak is a cost-effective ADS-B Out solution for operators of Boei
Ghostbusters World with Google Maps API Featured During Google Keynote at GDC 201819.3.2018 21:14 | Tiedote
The recently announced Ghostbusters World, developed in collaboration between Sony Pictures Entertainment Consumer Products, Ghost Corps and publisher FourThirtyThree Inc. (4:33), was featured today on stage during the Google Keynote at the Game Developers Conference 2018. The new gameplay video will also be on display at the Google booth on the expo floor March 21-23. Created with Maps API technology, Ghostbusters World features state-of-the-art augmented reality in the map-based game where players can suit up to patrol their neighborhoods and bust their favorite Ghostbusters ghosts! Drop by the Google booth or click here (LINK) to check out the new gameplay video. Battle and capture hundreds of new and familiar ghosts in Ghostbusters World, launching everywhere on iOS and Android devices later this year. If you ain’t afraid of no ghosts and want to keep track of news and updates, follow us on Twitter (LINK), Facebook (LINK), and YouTube (LINK). More information and assets can be foun
Bajaj Electricals Showcases ‘Smart Indoors and Connected Outdoors’ at Light + Building 201819.3.2018 19:00 | Tiedote
Bajaj Electricals Limited, India’s leading player in consumer durables, fans, lighting and engineering projects, participates in world’s leading trade fair Light + Building 2018 at Frankfurt, Germany from March 18th-23rd, 2018. Bajaj Electricals is featuring its smart solutions at Stall D10 in outdoor arena-Agora. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180319005049/en/ Mr. Anant Bajaj, Joint Managing Director, Bajaj Electricals Ltd. (Photo: Business Wire) Based on the key theme of ‘Smart Indoors and Connected Outdoors’, the stall demonstrates the connection between indoors and outdoors through cloud computing. With almost eight decades of experience and expertise in lighting solutions and luminaires, Bajaj Electricals has a host of products exhibited at the trade fair ranging from smart indoor lights for home, commercial and industrial spaces to smart outdoor lights, sensor-based light, smart poles and various integra
Louis Chevrolet Watch Company launches the Chrono-Tour Bitcoin Special Edition19.3.2018 18:00 | Tiedote
Code name: Chrono-Tour Bitcoin Special Edition – Launch: 20/03/2018 – 14.00 GMT This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005494/en/ (Photo: Louis Chevrolet Swiss Watches) Event! Louis Chevrolet Swiss Watches launches a Swiss Made automatic chronograph dedicated only to Bitcoin owners. An exclusive and limited-edition series to symbolise and affirm the unique sales channel chosen by the brand: its e-commerce store. Each Louis Chevrolet Chrono Tour Bitcoin Special Edition will be Unique Chrono-Tour Bitcoin Special Edition, a well-thought-out stylish design, elegantly bringing the Bitcoin to the forefront. In addition to a specific dial, a Bitcoin logo textured around a printed circuit board will be inserted into the back glass. This gives a technological holographic effect while highlighting the mechanics of the watch. The background will be personalised with a laser and will indicate the purchase price in Bitcoins
New Global Survey Points to Key Issues, Needs and Gaps in Fight to End Smoking19.3.2018 17:00 | Tiedote
The Foundation for a Smoke-Free World released findings today from a global survey to better understand smokers, their experiences, and challenges they face when they try to quit smoking. The survey also highlights their awareness regarding the harm caused by smoking and how their perceptions of cigarettes, alternative products, and nicotine influence their motivation to move away from smoking. The data will shape the development of research to determine the best solutions to accelerate the end of smoking across diverse cultures and economic conditions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180319005647/en/ Figure 1: Which of the following situations, if any, apply to you? (% - Top Three Answers per Country) (Graphic: Business Wire) The 2018 State of Smoking Survey included 17,421 current smokers, ex-smokers, and non-smokers from 13 countries: Brazil, France, Greece, India, Israel, Japan, Lebanon, Malawi, New Zealan
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme