Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Biktarvy® (Bictegravir, Emtricitabine and Tenofovir Alafenamide) for Treatment of HIV-1 Infection
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Biktarvy® (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg, BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. Biktarvy combines the novel, unboosted integrase strand transfer inhibitor (INSTI) bictegravir, with the demonstrated safety and efficacy profile of the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg; FTC/TAF) dual nucleoside reverse transcriptase inhibitor (NRTI) backbone, and is the smallest INSTI-based triple-therapy STR available. Biktarvy is the first HIV product that Gilead will launch and commercialize in Japan directly through its local subsidiary, Gilead Sciences K.K.
In the United States, Biktarvy has a Boxed Warning in its product label regarding the risk of post-treatment acute exacerbation of hepatitis B. See below for U.S. Important Safety Information as well as the Biktarvy Indication.
The approval of Biktarvy is supported by data from four Phase 3 studies: Studies 1489 and 1490 in treatment-naïve HIV-1 infected adults, and Studies 1844 and 1878 in virologically suppressed adults. The trials are comprised of a diverse population of 2,415 participants on Biktarvy or an active comparator, including a wide range of adult age groups and races/ethnicities. Biktarvy met its primary objective of non-inferiority at 48 weeks across all four studies. Through 48 weeks, no participants in any of the four studies developed treatment-emergent virologic resistance while taking Biktarvy, no patients discontinued Biktarvy due to renal adverse events and there were no cases of proximal renal tubulopathy or Fanconi syndrome. The most common adverse reactions in patients taking Biktarvy were diarrhea, nausea and headache.
“Gilead is pleased that Biktarvy, our latest HIV treatment innovation, will be made available to people living with HIV in Japan,” said John McHutchison, AO, MD, Chief Scientific Officer, and Head of Research and Development, Gilead Sciences. “In multiple clinical trials, Biktarvy has demonstrated high efficacy and a high barrier to resistance. With convenient dosing and few pre-screening or ongoing monitoring requirements, it has the potential to simplify treatment initiation, and follow-up over time.”
“Gilead’s operations in Japan have expanded significantly over the years and we are pleased to now be able to bring our longstanding experience and commitment as a global leader in HIV treatment to the Japanese HIV community,” said Luc Hermans, M.D., President and Representative Director, Gilead Sciences, K.K. “Biktarvy adds an important new treatment option to our portfolio of medicines for people living with HIV in Japan.”
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.
- 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.
- Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 96 were diarrhea (6%), nausea (6%), and headache (5%).
- 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.
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 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 35 countries worldwide, with headquarters in Foster City, California.
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 Annual Report on Form 10-K for the year ended December 31, 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.
Sung Lee, Investors
+1 (650) 524-7792
Seiko Noma, Media Japan
Ryan McKeel, Media US
+1 (650) 377-3548
Om Business Wire
(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
Avioq Announces CE Mark and European Launch of VioOne HIV Profile Supplemental Assay24.6.2019 15:11:00 CEST | Pressemelding
Avioq, Inc. has received CE Marking (Conformité Européenne) and has begun marketing their VioOne™ HIV Profile™ Supplemental Assay in the European Union and other CE Mark countries. The product has also been submitted for FDA approval. “We are pleased to provide the CE Mark HIV Profile™ assay to countries outside the U.S.,” said Chamroen Chetty, CEO of Avioq. Dr. Chetty continues, “We are also looking for distribution partners to expand the global availability.” The HIV Profile™ is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma that were repeatedly reactive in diagnostic screening procedures. Results can also be used to distinguish recent from longstanding HIV-1 infection for HIV-1 incidence estimation. About Confirmatory Testing In 2014, the CDC released a new algorithm for HIV testing. The second step of the algorithm includes a
Global Launch of S BLOCK, Kicked Off in Singapore on June 22nd24.6.2019 12:29:00 CEST | Pressemelding
The globally renowned 2019 WBF Singapore Technology Conference was held in Marina Bay Sands Hotel on June 22nd, 2019. S BLOCK, the conference co-host, unveiled itself and announce its mission to “Unleash your digital assets” for the first time. The conference brought together numerous industry elites and blockchain enthusiasts from all around the world, including more than 500 industry veterans from over 30 countries, such as Switzerland, Germany, France, Russia, Japan, Korea, Brazil, Australia, Argentina and Canada. Insiders shared profound global industry insights. This conference draws great attention from across the global blockchain industry. S BLOCK Kicked Off in Singapore In the morning of June 22nd, Ivan - President of S BLOCK Global Foundation, was invited to deliver a keynote speech, “Next Generation Digital Currency Wallet”. At this conference, S BLOCK was officially launched in more than 30 countries around the world, and opened up the way to a global future without borders
SpeeDx announce a collaborative agreement with GSK to supply tests and technology24.6.2019 12:00:00 CEST | Pressemelding
SpeeDx Pty. Ltd., a developer of innovative molecular diagnostic solutions, has signed a collaborative agreement with GSK, to provide a combination of existing tests and custom test development to support certain GSK antibiotic clinical trials and new product development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005302/en/ “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impacting cure rates and helping to minimise the spread of antimicrobial resistant infections.” Colin Denver, SpeeDx CEO. (Photo: Business Wire) “We welcome this extension of the utility and application of our tests and technology,” said Colin Denver, SpeeDx CEO. “SpeeDx has a demonstrated commitment to improve patient care, and our tests currently used in clinical practice are supporting Resistance Guided Therapy, positively impac
Nexon Computer Museum to Hold the Fourth VR Content Contest24.6.2019 10:13:00 CEST | Pressemelding
Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest, ‘2019 NCM OPEN CALL X REALITY’. NXC is a holding company of Nexon (TOKYO: 3659). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190624005284/en/ Nexon Computer Museum (NCM) of NXC is holding the fourth virtual reality content contest 2019 NCM OPEN CALL X REALITY with total prize money of KRW 13 million. Application received from July 1st to August 31st, winners announced on October 25th. (Graphic: Business Wire) NCM OPEN CALL is an exhibit to discover and support virtual reality content creators. This year’s keyword ‘X REALITY’ encompasses all kinds of virtualization including VR, AR, MR, and more. It also implies eXtended Reality, which broadens the perspectives of reality, and Cross Reality, which overlaps the real and virtual world. The unpredictable X signifies NCM OPEN CALL’s pursuit towards embracing various kinds of innovative an
REPLY: New Tool “China Beats” Provides Deep Insights Into the Chinese Market24.6.2019 09:15:00 CEST | Pressemelding
TD Reply, the company specializing in marketing and innovation consulting within the Reply Group, developed China Beats, a business intelligence solution that enables companies to gain an in-depth understanding of the Chinese market and its players. This is ensured by AI-supported social listening with connection to all major Chinese e-commerce, social media and search platforms such as Alibaba, Baidu, WeChat and Weibo. The prosperity of the Chinese population is growing at a rapid pace. According to analysts estimates, around 550 million Chinese will belong to the middle class by 2022. As a result, the Chinese market is also becoming increasingly important for international companies. Entering the market, however, is challenging, especially in terms of reliable identification of target groups, analysis of their consumer behavior and preferences. Digital data can provide a remedy, because the majority of Chinese consumers are netizens who shop on digital platforms, exchange their opini
MYbank Works With Financial Institution Partners to Serve Over 15 Million SMEs24.6.2019 05:42:00 CEST | Pressemelding
MYbank, a leading online private commercial bank in China with a focus on SME financing, today announced that the bank’s Star Plan has enabled MYbank, with its financial institution partners, to serve over 15 million small and micro enterprises (SMEs). SMEs are key drivers of economic growth and this partnership is now serving more SMEs than any other in the world. The announcement comes on the day that MYbank celebrates its 4th Anniversary. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190623005055/en/ MYbank’s 310 lending model enables inclusive finance for SMEs in China (Photo: Business Wire) MYbank’s Star Plan was announced on June 21, 2018 with the aim of using technology to enable 1,000 financial institution partners to provide more cost-effective financing services to 30 million SMEs in China within a three-year period. A little over a year later and the Star Plan is showing significant progress. As of June 2019, lev