Business Wire

U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease

Del

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin (RBV) for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5 and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.

“Hepatitis C-infected patients who have decompensated cirrhosis and those who have previously received a liver transplant have an urgent need for treatment, but historically their options have been limited,” said Norbert Bischofberger, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are pleased that health care providers now have the information needed to offer these patients an all-oral, 12-week duration therapy with high cure rates and a tolerable side effect profile.”

Decompensated Cirrhosis and Post-Liver Transplantation

The supplemental new drug application (sNDA) approval for genotype 1 or 4 HCV liver transplant recipients without cirrhosis or with compensated cirrhosis, and for genotype 1 HCV patients with decompensated cirrhosis, was supported by data from the Phase 2 SOLAR-1 and SOLAR-2 trials. These open-label studies evaluated 12 and 24 weeks of treatment with Harvoni in combination with RBV in HCV treatment-naïve and treatment-experienced patients with genotype 1 and 4 infection who had undergone liver transplantation and/or who had decompensated liver disease.

Pooled data from SOLAR-1 and SOLAR-2 among genotype 1 HCV patients are summarized in the table below:

      HARVONI + RBV 12 weeks

N=307

      SVR12 (N=300)a,b   Relapse (N=288)a,b,c
Pre-transplant    
  Child-Pugh-Turcotte (CPT) B   87% (45/52)   12% (6/51)
 

CPT C

  88% (35/40)   5% (2/37)
Post-transplant    
  Metavir score F0-F3   95% (94/99)   3% (3/97)
  CPT A   98% (55/56)   0% (0/55)
  CPT B   89% (41/46)   2% (1/42)
 

CPT C

  57% (4/7)   33% (2/6)
a. Five subjects transplanted prior to post-treatment Week 12 with HCV RNA<LLOQ at last measurement prior to transplant were excluded.
b. Two subjects were excluded due to failure to meet the inclusion criteria for any of the treatment groups (i.e., did not have decompensated cirrhosis and had also not received a liver transplant).
c. Twelve subjects were excluded from relapse analysis because they died (N=11) or withdrew consent (N=1) prior to reaching the 12 week post-treatment follow-up visit.
 

SVR12 rates among genotype 4 HCV post-transplant patients without cirrhosis or with compensated cirrhosis (n=12) were similar to the reported genotype 1 SVR12 rates; no subjects relapsed. Available data in subjects with genotype 4 HCV who had decompensated cirrhosis (pre- and post-liver transplantation) were insufficient for dosing recommendations.

A total of seven patients in the 12-week treatment arms of SOLAR-1 and SOLAR-2 had fibrosing cholestatic hepatitis (FCH), and all achieved SVR12. FCH is a rare and severe form of recurrent hepatitis that occurs following liver transplantation and is associated with high morbidity and mortality. Previously, there were no approved treatment options for FCH.

Adverse events observed in the two SOLAR studies were consistent with the expected clinical sequelae of liver transplantation and/or decompensated liver disease, or the known safety profile of Harvoni and/or RBV. Among liver transplant and decompensated liver disease patients, 1 percent and 2 percent of patients discontinued Harvoni with RBV due to an adverse event, respectively. The most common adverse reactions (≥10 percent, all grades) observed with treatment with Harvoni in combination with RBV for 12 weeks were asthenia, headache and cough.

Important Safety Information for Harvoni

Contraindications

If Harvoni is used in combination with ribavirin (RBV), all contraindications, warnings and precautions, in particular pregnancy avoidance, and adverse reactions to RBV also apply. Refer to RBV prescribing information.

Warnings and Precautions

Risk of Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni due to the risk of symptomatic bradycardia, particularly in patients also taking beta blockers or with underlying cardiac comorbidities and/or with advanced liver disease. In patients without alternative, viable treatment options, cardiac monitoring is recommended. Patients should seek immediate medical evaluation if they develop signs or symptoms of bradycardia.

Risk of Reduced Therapeutic Effect of Harvoni Due to P-gp Inducers: Rifampin and St. John’s wort are not recommended for use with Harvoni as they may significantly decrease ledipasvir and sofosbuvir plasma concentrations.

Related Products Not Recommended: Harvoni is not recommended for use with other products containing sofosbuvir.

Adverse Reactions

Most common (≥10%, all grades) adverse reactions were fatigue, headache and asthenia.

Drug Interactions

In addition to rifampin and St. John’s wort, coadministration of Harvoni is also not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of ledipasvir and sofosbuvir, reducing the therapeutic effect of Harvoni.

Coadministration of Harvoni is not recommended with simeprevir due to increased concentrations of ledipasvir and simeprevir. Coadministration is also not recommended with rosuvastatin or co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of rosuvastatin and tenofovir, respectively.

Consult the full Prescribing Information for Harvoni for more information on potentially significant drug interactions, including clinical comments.

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.

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 that physicians may not see the benefits of Harvoni for the additional indications. 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 September 30, 2015, 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 Harvoni is available at www.gilead.com .

Harvoni is a registered trademark 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.
Patrick O’Brien, 650-522-1936 (Investors)
Cara Miller, 650-522-1616 (Media)

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Universal Laser Systems® Expands Portfolio of Laser Material Processing Systems with the ULTRA Platform Series21.2.2018 18:00Pressemelding

ULTRA platform-based laser systems are designed and ideally suited for precision laser cutting, laser ablation, and laser surface modification in manufacturing, research and development, academic research and prototyping environments. Major features of the series include rapid, high-accuracy laser beam positioning, and the flexibility to be configured with 9.3 and 10.6 µm CO2 lasers and 1.06 µm fiber lasers. All lasers are air-cooled in a range of power from 10 to 150 watts for CO2 and 40 to 50 watts for fiber lasers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005364/en/ The ULTRA 9MW offers MultiWave processing of thin materials. (Photo: Business Wire) The variety of wavelengths and power ranges make the ULTRA platforms highly effective in the areas of organic material modification, including plastic films, industrial fabrics, engineering plastics, laminating adhesives, composite materials, and many others utilized

Luxoft One of Six Companies Collaborating with Amazon Web Services to Accelerate Blockchain Adoption21.2.2018 16:30Pressemelding

Luxoft Holding Inc (NYSE:LXFT), a global IT service provider, announces today that it is collaborating with Amazon Web Services (AWS) to enable corporates to adopt blockchain and Distributed Ledger Technologies (DLT). Luxoft is one of six IT and consulting services companies to make its blockchain advisory and development services available to AWS users. “We are very excited to be working with AWS to help users engage with blockchain and DLTs,” said Vasiliy Suvorov, Vice President of Technology Strategy at Luxoft. “Blockchain is about removing data silos, improving trust and operational efficiencies. By using AWS to deploy and integrate DLTs into day-to-day processes, businesses can revolutionize how they operate.” Luxoft helps accelerate the deployment and integration of blockchain and DLT-based projects on AWS and is already working on a number of DLT projects using the cloud. For example, Luxoft is building a healthcare claims processing system for a leading healthcare provider usin

Westinghouse Electric Company to Provide Engineering Support at Vandellós 1 in Partnership with EDF21.2.2018 16:30Pressemelding

Westinghouse Electric Company and Electricité de France (EDF), in partnership, announced today that they have been awarded a contract from Empresa Nacional de Residuos Radiactivos (ENRESA), the Spanish agency responsible for radioactive waste management and nuclear plant decommissioning. The agreement covers a four-year engineering support contract for the latency phase of the dismantling and decommissioning project at Vandellós I Nuclear Power Station in Spain and includes the preparation of technical and licensing documentation. “We are extremely pleased that ENRESA has selected Westinghouse and EDF to continue supporting the decommissioning activities at Vandellós I Nuclear Power Station,” said Yves Brachet, Westinghouse vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “This contract further demonstrates Westinghouse’s global capabilities and expertise in providing innovative decommissioning solutions.” Sylvain Granger, head of EDF's decommi

H.I.G. Europe Completes a Strategic Investment in Puerto de Indias Group21.2.2018 14:02Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced that one of its affiliates has acquired a majority interest in Puerto de Indias Group (“Puerto de Indias” or the “Company”), with the goal of accelerating the Company’s growth initiatives and supporting its expansion into international markets. Headquartered in Seville, Spain, Puerto de Indias was founded by Jose Antonio and Francisco Rodriguez Fernandez, and has become in a short period of time the leading player in the Rosé Gin market in Spain. Puerto de Indias has in place an ambitious international expansion plan targeting the development of a commercial network in Europe, the U.S., and Latin America, as well as strategic alliances with strong international distributors. Leopoldo Reaño, Principal at H.I.G. Europe, commented on the transaction: “We are thrilled to have the opportunity to support the management team led by Jose Antonio an

Savi Adds Supply Chain Star Johannes Giloth to Advisory Board21.2.2018 13:02Pressemelding

Savi®, an innovator in big data/machine learning analytic solutions, supply chain management software, and sensor technology, today announced that Johannes Giloth has joined its board of advisers. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180221005117/en/ Johannes Giloth (Photo: Business Wire) Giloth is a long-time leader in procurement, supply chain and manufacturing. He currently serves as Chief Procurement Officer and Senior Vice President of Operations at Nokia where he is in charge of every aspect of operations accountability worldwide — from demand planning to execution, procurement to manufacturing. “Johannes understands the impact the explosion of data will have on the supply chain. And his tremendous success as an innovative supply chain leader proves he knows what companies need to transform their supply chains,” said Rich Carlson, CEO of Savi Technology. “I’m thrilled to have him join Savi’s advisory board. As

Mavenir Unveils Its Industry First Mobile-Native UCaas Solution, Entering into a New UCC Market Category21.2.2018 13:00Pressemelding

Mavenir, a leader in mobile network transformation, today announced its industry first Mobile-Native Unified Communications and Collaboration as a Service (mUCaaS) solution, uniquely designed to address the specific mobility needs of SOHO and SMBs. Using mobile native wireless technologies while still supporting current communications desktop usage is a complete paradigm shift compared to traditional UCaaS offerings. Leveraging Mavenir’s expertise in mobile networks with Voice over LTE (VoLTE) and Rich Communication Services (RCS), the solution provides new recurring-revenue opportunities for mobile network operators (MNOs) while addressing the real business need for truly mobile communications for the workforce. MNOs are under pressure in the consumer market with flat growth, an intensive price war on voice and data plans, and fierce competition from OTT applications. The Enterprise market offers a better outlook with UCaaS telephony and messaging projecting growth of 15.2% CAGR1 2016