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 ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Samsung Bioepis Announces Results of Additional One-Year Follow-Up Study Comparing Event-Free Survival of SB3 Trastuzumab Biosimilar Candidate to Reference Trastuzumab by ADCC Activity8.12.2018 17:10 | Tiedote
Samsung Bioepis Co., Ltd. today announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN® 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity. ADCC is a key mechanism of action for trastuzumab. The study results are being presented at the 2018 San Antonio Breast Cancer Symposium® (SABCS) which is being held December 4-8, 2018 in San Antonio, Texas. For the study, patients with HER2 positive early or locally advanced breast cancer were randomly assigned to receive SB3 or TRZ concurrently with chemotherapy. Patients then underwent surgery followed by treatment with SB3 or TRZ. Following completion of such therapy, 367 patients participated in a long-term follow-up study, 186 of whom were treated with SB3 and 181 of whom were treated with TRZ. Within the group of 181 patients who received TRZ, 126 patients who were exposed to at least
Harvest Health & Recreation, Inc. to hold Conference Call to Discuss Q3 2018 Results and Performance Outlook7.12.2018 22:00 | Tiedote
Harvest Health & Recreation, Inc. (HARV: CSE) will hold its Third Quarter 2018 earnings conference call on: Tuesday, December 11, 2018 8:30 AM (Eastern Time) Participating on the call to review Harvest Health & Recreation’s Third Quarter 2018 financial and operating results will be Jason Vedadi, Executive Chairman, Steve White, Chief Executive Officer, and Steve Gutterman, President. Third quarter results are available at www.harvestinc.com/news. To participate in the conference call, please dial: US toll free +1-866-777-2509 Canada toll free +1-866-605-3852 UK toll free +44-080-823-89064 International dial in +1-412-317-5413 Registration is required; please dial in at least ten minutes prior to the scheduled start time. Webcast: https://services.choruscall.com/links/harv181211.html The conference call will be available for replay for 3 months at: https://services.choruscall.com/links/harv181211.html. About Harvest Health & Recreation, Inc. Harvest Health & Recreation, Inc. is one of t
David Hall Wows Industry with New Technology Solution for Space Exploration7.12.2018 17:01 | Tiedote
David Hall is one of history’s rare technological visionaries with the imagination and technical wherewithal to recognize a problem, conceive a solution, and then build something that works. On December 6 at the U.S. Chamber of Commerce’s event, LAUNCH: Industry Taking Off, David Hall presented his world-changing solution to a longstanding problem: how to carry materials and people into space safely, reliably, and efficiently. The audience of industry, military, and policy representatives heard from Hall as well as keynote remarks from Secretary of the Air Force, Heather Wilson; NASA Administrator, Jim Bridenstine; Under Secretary of Defense for Research and Engineering, Michael Griffin; NOAA Deputy Administrator, Dr. Neil Jacobs; and Commerce Secretary, Wilbur Ross. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181207005226/en/ Velodyne Lidar, Inc. Founder and CEO David Hall (Photo: Business Wire) Hall’s proposal involves
Raj Subramaniam Named as FedEx Express President and CEO7.12.2018 17:00 | Tiedote
FedEx Corp. (NYSE:FDX) announced today that David L. Cunningham, president and chief executive officer of FedEx Express, will retire effective December 31, 2018. Raj Subramaniam, currently executive vice president, chief marketing and communications officer of FedEx Corporation, will succeed Cunningham effective January 1, 2019. Cunningham began his FedEx career in 1982 in operations at the FedEx Express World Hub in Memphis, Tenn. Over his more than 36-year career, David held numerous leadership positions across the FedEx Express operating company in multiple regions, including chief operating officer and president - international, FedEx Express Asia Pacific chief financial officer, and regional president of the Asia Pacific region. Most recently as president and CEO of FedEx Express, David has been responsible for the leadership and direction of the FedEx Express group, which includes FedEx Express and TNT. Subramaniam has been with FedEx for more than 27 years and has held various e
CORRECTING and REPLACING The Dedica Anthology Completes Its Planned Refinancing7.12.2018 14:43 | Tiedote
The first sentence of the release should read: Milan-based hotel group The Dedica Anthology is pleased to announce that it successfully completed its planned €337 million refinancing. (instead of Milan-based hotel group The Dedica Anthology is pleased to announce that today it successfully completed its planned €337 million refinancing). The corrected release reads: THE DEDICA ANTHOLOGY COMPLETES ITS PLANNED REFINANCING Milan-based hotel group The Dedica Anthology is pleased to announce that it successfully completed its planned €337 million refinancing. The lender is Blackstone Real Estate Debt Strategies, and the facilities will refinance legacy loans and provide additional capital for The Dedica Anthology – owned by global alternative investment firm Värde Partners – to invest significantly in its estate. London-based real estate specialist JLL advised Värde Partners on the transaction. Stephen Alden, CEO of The Dedica Anthology, commented: “We are delighted to have completed this c
The Dedica Anthology Completes Its Planned Refinancing7.12.2018 13:48 | Tiedote
Milan-based hotel group The Dedica Anthology is pleased to announce that today it successfully completed its planned €337 million refinancing. The lender is Blackstone Real Estate Debt Strategies, and the facilities will refinance legacy loans and provide additional capital for The Dedica Anthology – owned by global alternative investment firm Värde Partners – to invest significantly in its estate. London-based real estate specialist JLL advised Värde Partners on the transaction. Stephen Alden, CEO of The Dedica Anthology, commented: “We are delighted to have completed this complex refinancing. Our own team, the board, our advisors and the lending group have worked hard in collaboration to achieve this excellent result. Our focus is now fully on building The Dedica Anthology brand, carrying out strategic renovation and restoration work on our distinctive properties, strengthening our team and growing our business.” Alessandro Grassivaro, CFO of The Dedica Anthology, added, “Dedica now
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