Business Wire

Gilead Announces 96-Week Results From Phase 3 Study of Biktarvy® (Bictegravir, Emtricitabine, Tenofovir Alafenamide) for the Treatment of HIV-1 in Adults New to HIV Therapy

Jaa

Gilead Sciences, Inc. (Nasdaq: GILD) today announced 96-week results from a Phase 3, randomized, double-blinded study (Study 1489) evaluating the safety and efficacy of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing study, Biktarvy was found to be statistically non-inferior to a regimen of abacavir/dolutegravir/lamivudine (600/50/300mg, ABC/DTG/3TC) through 96 weeks of therapy. The data will be presented during a late-breaking abstract session at the IDWeek 2018 conference in San Francisco.

“Healthcare providers who care for people living with HIV are always seeking treatment options that offer high efficacy, a high barrier to treatment-emergent resistance and a long-term tolerability profile,” said David Wohl, MD, Professor of Medicine, Division of Infectious Diseases, the University of North Carolina at Chapel Hill and lead study author. “This study underscores the role of Biktarvy as a first-line treatment option for appropriate adults living with HIV who are new to therapy. In addition, Biktarvy was shown to have less nausea with a similar bone and renal safety profile to the comparator through 96 weeks.”

Biktarvy is indicated in the U.S. as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those adults who are virologically suppressed (HIV-1 RNA <50 c/mL) on a stable antiretroviral regimen for at least three months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. No dosage adjustment of Biktarvy is required in adult patients with estimated creatinine clearance greater than or equal to 30 mL per minute. Biktarvy carries a Boxed Warning in its U.S. product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for Important Safety Information.

In Study 1489, treatment-naïve adults (n=629) were randomized 1:1 in a blinded fashion to receive Biktarvy (BIC/FTC/TAF) or ABC/DTG/3TC. At Week 96, non-inferiority was maintained from the primary endpoint measurement at Week 48, with 87.9 percent (n=276/314) of patients taking Biktarvy and 89.8 percent (n=283/315) of patients taking ABC/DTG/3TC achieving HIV-1 RNA levels less than 50 copies/mL (difference: -1.9 percent, 95 percent CI: -6.9 percent to 3.1 percent, p=0.45). In the resistance analysis population, none of the study participants randomized to Biktarvy developed treatment-emergent resistance.

There were no renal discontinuations and no cases of proximal renal tubulopathy or Fanconi syndrome in the Biktarvy treatment group. The median change in estimated glomerular filtration rate (eGFR) from baseline to Week 96 was significantly less with Biktarvy compared with ABC/DTG/3TC (-7.8 mL/min vs. -9.6 mL/min, p=0.01). Median changes in proteinuria were similar between both treatment groups. Additionally, the mean percent changes from baseline in spine and hip bone mineral density in the Biktarvy group were similar to ABC/DTG/3TC group (spine: -0.71 vs. -0.22, p=0.14; hip: -1.13 vs. -1.26, p=0.59).

Biktarvy was well tolerated through Week 96. Discontinuations due to adverse events were low in both groups (0.0 percent (n=0) for Biktarvy vs. 2 percent (n=5) for ABC/DTG/3TC). The most commonly reported adverse events (all grades) were nausea (11 percent for Biktarvy vs. 24 percent for ABC/DTG/3TC), diarrhea (15 percent vs. 16 percent) and headache (13 percent vs. 16 percent).

“Gilead is committed to developing innovative treatments like Biktarvy that help address the unmet needs of people living with HIV,” said John McHutchison, AO, MD, Chief Scientific Officer, Gilead Sciences. “This study further supports the efficacy and resistance profiles of Biktarvy through 96 weeks. We look forward to presenting additional data that demonstrate the long-term utility of Biktarvy at upcoming scientific conferences.”

Study 1489 is ongoing and will remain randomized and blinded through 144 weeks.

Biktarvy does not cure HIV infection or AIDS.

IMPORTANT U.S. SAFETY INFORMATION AND INDICATION FOR BIKTARVY

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

  • 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 Biktarvy. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Biktarvy. If appropriate, anti-hepatitis B therapy may be warranted.

Contraindications

  • Coadministration: Do not use Biktarvy with dofetilide or rifampin.

Warnings and precautions

  • Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during Biktarvy therapy and monitor for adverse reactions.
  • 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 Biktarvy, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate Biktarvy 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 Biktarvy in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
    Renal monitoring: Prior to or when initiating Biktarvy and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess 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 Biktarvy if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

Adverse reactions

  • Most common adverse reactions (incidence ≥5%; all grades) in clinical studies were diarrhea (6%), nausea (5%), and headache (5%).

Drug interactions

  • Prescribing information: Consult the full prescribing information for Biktarvy for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
  • Enzymes/transporters: Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of Biktarvy. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of Biktarvy. Biktarvy can increase the concentration of drugs that are substrates of OCT2 or MATE1.
  • Drugs affecting renal function: Coadministration of Biktarvy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions.

Pregnancy and lactation

  • Pregnancy: There is insufficient human data on the use of Biktarvy 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 US reference population.
  • Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.

Dosage and administration

  • Dosage: 1 tablet taken once daily with or without food.
  • Renal impairment: Not recommended in patients with CrCl <30 mL/min.
  • Hepatic impairment: Not recommended in patients with severe hepatic impairment.
  • Prior to or when initiating: Test patients for HBV infection.
  • Prior to or when initiating, and during treatment: As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.

INDICATION

Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults who have no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable ARV regimen for ≥3 months with no history of treatment failure and no known resistance to any component of Biktarvy.

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 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 physicians may not see the benefits of prescribing Biktarvy for the treatment of HIV-1 infection and the possibility of unfavorable results from additional clinical trials involving Biktarvy. 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, 2018, 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.

U.S. full prescribing information for Biktarvy, including BOXED WARNING, is available at  www.gilead.com

Biktarvy, Gilead and the 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.

Contact information

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

Tietoja julkaisijasta

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

C.H. Robinson Acquires Dema Service S.p.A. to Expand Global Presence23.5.2019 14:00:00 EESTTiedote

C.H. Robinson (NASDAQ: CHRW) continues to expand its global footprint with its announcement of the acquisition of Dema Service S.p.A. (Dema Service) on May 22, 2019. Dema Service is a leading provider of European road transportation based in Italy. “The acquisition of Dema Service is an exciting milestone for C.H. Robinson and will strengthen our existing footprint in Italy, one of the largest road transportation markets in Europe,” said Jeroen Eijsink, President of Europe for C.H. Robinson. “We are eager to work with Dema Service’s customers to offer our full suite of logistics services to help improve their supply chains.” This is the second European acquisition for C.H. Robinson in 2019. The company recently acquired the freight forwarding group Space Cargo, which expanded C.H. Robinson’s presence in Spain and Columbia. Dema Service is a privately-owned logistics company providing road transportation services across Europe. Headquartered in Pescara, Italy, Dema Service has approxima

Rapid Multiplexing with Opal® Research Kits Now Available on LabSat™ Platform23.5.2019 13:30:00 EESTTiedote

Lunaphore Technologies S.A., a Swiss medtech firm developing innovative next-generation equipment for cancer research and tissue diagnostics, announces a new rapid multiplexing application for its LabSat™ Research instrument. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190523005082/en/ FFPE IF of tonsil, 6-plex + DAPI. Total staining time: 4h12 (with Opal® 7-Color Manual IHC Kit) (Photo: Business Wire) Following the signature of a co-marketing agreement between Lunaphore Technologies S.A. and Akoya Biosciences, Inc.; Lunaphore will start providing multiplexing protocols using Akoya’s Opal® immunoassay kits for its staining platform LabSat™ Research, Lunaphore’s first solution to reach the market. LabSat™ is shown to perform rapid tests on tissue samples under 2.5 hours for a 3-plex plus counterstaining with the Opal® 4-Color Manual IHC Kit; and under 4.5 hours for a 6-plex plus counterstaining with the Opal® 7-Color Manua

Network of 1,500 Stroke-Ready Clinics across Europe23.5.2019 13:00:00 EESTTiedote

The Angels Initiative announced today at the European Stroke Organisation Conference (ESOC) 2019 in Milan that their three-year goal to create a network of 1,500 stroke-ready centres and hospitals across Europe has been achieved. The Angels Initiative is a unique healthcare approach to improve care for people who have just suffered a stroke (acute stroke care) across Europe and in emerging markets. It is run by Boehringer Ingelheim in partnership with the European Stroke Organisation (ESO), the World Stroke Organisation (WSO), the Stroke Alliance for Europe (SAFE) and many other national stroke societies and companies. “Stroke is one of the leading causes of disability and death. And when a stroke strikes, every second counts to deliver optimised care as fast as possible to preserve life and minimise disability,” commented Prof. Valeria Caso, past president of the ESO. “There is a need to vastly improve the quality and speed of stroke care in Europe. I’m delighted that through the Ange

Dawex Raises €5 Million to Accelerate the Development of the Data Economy23.5.2019 09:45:00 EESTTiedote

Dawex, a leading data exchange technology company and the operator of the largest data marketplace, today announced a new round of funding of €5 million with Amadeus (AMS.MC), Itochu Corporation (ITOCY), Bouygues Construction (BOUY.PA) and a French web entrepreneur entering Dawex’s capital, also joined by the historical investor Caisse des Dépôts (via its Banque des Territoires). Total funds raised from inception tops €12 million, including the recent €2.5M grant from Horizon 2020, the biggest European Union Research & Innovation program. Dawex co-founders Fabrice Tocco and Laurent Lafaye remain majority shareholders, retaining full control over the company’s strategy and operations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190522005927/en/ With the rise of Artificial Intelligence, Internet of Things, and the emergence of Smart Cities, among other disruptive trends like the autonomous cars, huge quantities of valuable

TTS Pharma Limited Announces Closing of £10.3 Million Fundraising and New Board Appointment23.5.2019 09:00:00 EESTTiedote

COMPLETION OF SERIES B FUNDRAISE TTS Pharma Limited (“TTS Pharma” or the “Company”), a UK company which is a vertically integrated supply chain manager in the cultivation, manufacturing and development of the emerging ethical cannabis market, announces that it has successfully closed a private equity investment totalling £10.3 million, on the basis of a two-tranche investment. This investment will permit TTS Pharma to become one of the leading global suppliers in this fast-growing multibillion-dollar industry, by allowing it to expand its existing supply chain, develop its own facilities and further strengthen its academic and commercial partnerships. It also enables the Company to advance its diversified operations in the wellness, nutraceutical and pharmaceutical sectors. The ethical cannabis market is set to become a high growth, disruptive and innovative new segment in the life sciences field and TTS Pharma is ideally positioned to capture rapid value within this market. BOARD UPDA

Buy and Sell Globally: 2019 Yiwu Imported Commodities Fair Opens in “World’s Capital of Small Commodities”23.5.2019 07:46:00 EESTTiedote

On May 23-26, China Yiwu Imported Commodities Fair 2019 opened at Yiwu International Expo Center in Eastern China’s Yiwu city – the world’s capital of small commodities. The Fair of this year provides 2,012 standard booths in five halls, namely Asia I, Asia II, Europe, America-Australia-Africa & Cross-border Trade & Zhenjiang-International Sister Cities Exchange, and Imported Sweets and Wines, with an exhibition area of over 50,000m2 . Among the nearly 1,000 exhibitors from 85 countries and regions, 170 are from 40 countries and regions along the “Belt and Road” to exhibit daily necessities, home supplies, handicrafts, foods and drinks. Echoing China International Import Expo (CIIE), a special area is reserved for over 20 CIIE companies to exhibit their quality products including Bosch Group (Germany), skin care brand Rilastil (Italy), and Alligga (Canada) specializing in health products for a complete and balanced lifestyle. In addition, a special area for international sister cities

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