Business Wire

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

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.

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 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 , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Contact information

Gilead Sciences, Inc.
Sung Lee, 650-524-7792 (Investors)
Ryan McKeel, 650-377-3548 (Media)

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

(c) 2018 Business Wire, Inc., All rights reserved.

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

IDEMIA Partnering with Unisys to Provide Biometric Services for Home Affairs Department in Australia19.3.2018 05:00Pressemelding

IDEMIA will provide a state-of-the-art biometric matching engine solution for the Australian Department of Home Affairs (Home Affairs), underlying in particular the processing of visas, border crossings and citizenship applications. Working with prime contractor Unisys Corporation, who will provide the overall system integration as well as the biometric management and processing platform Unisys Stealth(identity)TM, the IDEMIA team will implement a flagship system to position Australia at the forefront of border and immigration systems globally. This press release features multimedia. View the full release here: (Photo: IDEMIA) Major growth in international traveller arrivals, and the heightened threat of terrorism have signalled the need for a world-class biometrics solution to ensure that individuals are who they say they are. EBIS’s highly enhanced performance will support the Department’s strategic direction by further facili

Global Powerhouses Coming to CES Asia 2018: Alibaba A.I. Labs, BYTON, FAW Hongqi, Guangzhou Automobile Group, iQIYI, KIA, Leapmotor, LG Electronics, Mitsubishi Electric Automotive, Singulato, Skyworth and TCL18.3.2018 20:00Pressemelding

The Consumer Technology Association (CTA) today announced the newest leading global brands added to its growing exhibitor list for CES Asia 2018. Technology powerhouses including Alibaba A.I. Labs, BYTON, FAW Hongqi, Guangzhou Automobile Group, iQIYI, KIA, Leapmotor, LG Electronics, Mitsubishi Electric Automotive, Singulato, Skyworth and TCL are set to showcase their latest tech tailored toward the Asian market at CES Asia in June. “The tech showcased at CES Asia 2018 will be ground-breaking,” said John T. Kelley, senior director, international programs and show director, CES Asia. “From artificial intelligence, vehicle technology, content development and distribution to smart cities and more, the show will be packed with innovation from global brands and cutting-edge startups alike. These first time exhibitors demonstrate the incredible caliber and scope of CES Asia and attendees will be blown away this year.” BYTON, who recently unveiled its first concept all-electric vehicle at CES

Summer Business with New Shop Feature and High-Performance Tyre Models16.3.2018 14:11Pressemelding

Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time,, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: An advice mode immediately helps trade customers use the full pot

Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 12:00Pressemelding

Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on This press release features multimedia. View the full release here: Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum

CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 09:00Pressemelding

Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential

AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 09:00Pressemelding

AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ