Gilead’s Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for the Treatment of HIV-1 Meets Primary Endpoint in Four Phase 3 Studies
Gilead Sciences, Inc. (Nasdaq:GILD) today announced that four Phase 3 studies evaluating a fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF) for the treatment of HIV-1 infection met their primary objectives of non-inferiority. Three of the ongoing studies are designed to explore the efficacy and safety of BIC/FTC/TAF compared to regimens containing dolutegravir (50mg) (DTG) among treatment-naïve patients (Studies 1489 and 1490), and among virologically suppressed patients switching from an existing antiretroviral regimen (Study 1844). A fourth ongoing study in virologically suppressed patients compares switching to BIC/FTC/TAF versus remaining on a suppressive regimen of two nucleoside/nucleotide reverse transcriptase inhibitors and a boosted protease inhibitor (Study 1878).
"Since the approval of Viread 16 years ago, Gilead has continually worked to develop and improve treatments for people living with HIV. This investigational single tablet regimen brings together the potency of an integrase inhibitor, bictegravir, with the demonstrated efficacy and safety profile of the FTC/TAF backbone,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “Based on the results from these Phase 3 studies, the combination of bictegravir and FTC/TAF could represent an important advance in triple-therapy treatment for a broad range of HIV patients, and we look forward to submitting regulatory applications in the U.S. and EU this year.”
Studies 1489 and 1490 are double-blind studies in which treatment-naïve patients (n=600 in each study) were randomized 1:1 to receive BIC/FTC/TAF and abacavir/dolutegravir/lamivudine (600/50/300mg) (ABC/DTG/3TC) (Study 1489) or DTG+FTC/TAF (Study 1490). The primary endpoint is proportion of patients with HIV-1 RNA levels <50 copies/mL at Week 48, and the lower bound of the 95 percent CI for non-inferiority is 12 percent. The studies remain blinded through 144 weeks.
In study 1844, patients (n=520) who were virologically suppressed (HIV-1 RNA levels <50 copies/mL) on a regimen of ABC/DTG/3TC or DTG+ABC/3TC were randomized 1:1 to stay on their existing regimen or switch to BIC/FTC/TAF in a blinded manner. Study 1878 is an open-label study in which patients (n=520) who were virologically suppressed on a boosted protease inhibitor of darunavir (800mg) or atazanavir (300mg) plus a nucleoside/nucleotide backbone of ABC/3TC or emtricitabine/tenofovir disoproxil fumarate (200/300mg) were randomized 1:1 to either maintain their current regimen or switch to BIC/FTC/TAF. The primary endpoint in these studies is the proportion of patients with HIV RNA ≥50 copies/mL at Week 48, and the lower bound of the 95 percent CI for non-inferiority is 4 percent. Both studies were randomized through 48 weeks, after which point patients continuing in the studies enter an open-label extension receiving BIC/FTC/TAF.
BIC/FTC/TAF met the definition of non-inferiority in all four studies, with comparable proportions of patients having HIV-1 RNA <50 copies/mL (Studies 1489 and 1490) and HIV-1 RNA ≥50 copies/mL (Studies 1844 and 1878). In all studies BIC/FTC/TAF was well tolerated and no patients discontinued study medication due to renal events. No patients randomized to the bictegravir or dolutegravir arms developed treatment-emergent resistance. One patient randomized to the protease inhibitor arm in Study 1878 developed an abacavir resistance mutation (L74V).
Gilead plans to submit data from these Phase 3 studies for presentations at scientific conferences in 2017.
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.
Further information about the clinical studies 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 risks related to its ability to submit regulatory applications for BIC/FTC/TAF in the United States and European Union in the currently anticipated timelines. In addition, there is the possibility that any regulatory applications submitted may not get approved or may have significant limitations on the product's 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 ended March 31, 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 (Investors)
Ryan McKeel, 650-377-3548 (Media)
Om Business Wire
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00 | Pressemelding
Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are
More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08 | Pressemelding
The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable
Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15 | Pressemelding
Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside
Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03 | Pressemelding
Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f
Schlumberger Announces Third-Quarter 2017 Results20.10.2017 11:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) today reported results for the third quarter of 2017. (Stated in millions, except per share amounts) Three Months Ended Change Sept. 30, 2017 Jun. 30, 2017 Sept. 30, 2016 Sequential Year-on-year
SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47 | Pressemelding
SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom