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®
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 from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients one year after switching from Viread® (tenofovir disoproxil fumarate 300mg) to Vemlidy® (tenofovir alafenamide 25mg) will be presented on October 21.
“Gilead continues to study the effectiveness of our once-daily sofosbuvir-based single tablet regimens in diverse chronic HCV-infected patient populations to provide the opportunity for cure for all patient populations, including those most difficult to cure,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are also committed to advancing the long-term care of patients with chronic HBV infection, and are pleased to share multiple new data presentations demonstrating the ongoing improvements in bone and renal safety observed when patients switch from Viread to Vemlidy.”
Harvoni, Epclusa and Vosevi have Boxed Warnings in their product labels regarding the risk of hepatitis B virus reactivation in HCV/HBV coinfected patients, and Vemlidy has a Boxed Warning regarding the risk of post-treatment severe acute exacerbation of hepatitis B. See below for important safety information for all products.
Harvoni in Renally Impaired Patients (Poster #1587)
In an open-label Phase 2 study evaluating once-daily Harvoni for 12 weeks among HCV genotype 1 patients with severe renal impairment (creatinine clearance ≤ 30 mL/min), 100 percent (18/18) of patients achieved SVR12, including patients with compensated cirrhosis (n=2) and those who had failed prior treatment (n=4).
Safety events were consistent with those expected for the patient population. The most common adverse events (AEs) (>15 percent) were fatigue (22 percent), headache (22 percent) and hyperkalemia (17 percent). Four patients (22 percent) reported serious AEs, none of which was related to study drug. There were no deaths and no patients discontinued treatment in the study.
Harvoni is approved for adults with chronic HCV genotype 1, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis, adults with genotype 1 infection with decompensated cirrhosis in combination with ribavirin (RBV), and adults with genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with RBV. The safety and efficacy of Harvoni have not been established in patients with severe renal impairment.
Epclusa in Liver Transplant Patients (Poster #1069)
In an open-label Phase 2 study evaluating once-daily Epclusa for 12 weeks among 79 liver transplant patients with genotype 1-4 chronic HCV infection, treatment with Epclusa resulted in an overall SVR12 rate of 96 percent, including patients with cirrhosis and prior treatment failure, and was well tolerated.
|Patient Population||SVR12||Patient Population||SVR12|
|Genotype 1-4 without cirrhosis||
|Genotype 1-4 with cirrhosis||
|Genotype 1-4, treatment-naïve||
|Genotype 1-4, treatment-experienced||
Baseline resistance mutations did not impact SVR rates. Two patients relapsed in this study – one treatment-naïve non-cirrhotic patient with HCV genotype 1a and one treatment-experienced non-cirrhotic patient with HCV genotype 3.
Common adverse effects (AEs) (>10 percent) were headache (24 percent), fatigue (20 percent) and cough (10 percent). Three patients (4 percent) experienced serious AEs; none was related to study drug. One patient discontinued treatment after one week due to hyperglycemia. There were no deaths, graft loss or episodes of acute liver transplant rejection.
Epclusa is approved for patients with genotype 1-6 without cirrhosis or with compensated cirrhosis, and in combination with RBV for patients with decompensated cirrhosis. The safety and efficacy of Epclusa in liver transplant recipients has not been established.
Vosevi in NS5A Treatment-Experienced Patients (Poster #1178)
A deferred treatment cohort of the POLARIS-1 Phase 3 study confirmed previously reported results demonstrating the effectiveness of 12 weeks of Vosevi as salvage therapy for treatment-experienced patients. The study evaluated once-daily Vosevi in NS5A-inhibitor experienced patients with chronic HCV who were initially randomized to receive placebo in POLARIS-1.
Vosevi treatment was associated with an overall SVR12 rate of 97 percent (143/147), with 97 percent (141/145) of genotype 1 patients achieving SVR12 and 100 percent (2/2) of genotype 6 patients achieving SVR12. Four patients experienced virologic relapse after completing treatment.
The most common adverse effects (>10 percent) were fatigue (21 percent), headache (20 percent), diarrhea (19 percent) and nausea (14 percent). Six patients (4 percent) experienced serious AEs unrelated to study drug, and there were no discontinuations due to AEs.
Vosevi is approved for patients without cirrhosis or with compensated cirrhosis who have HCV genotype 1, 2, 3, 4, 5 or 6 and have been previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor.
Vemlidy in Patients Switching from Viread (Poster #904) and Two Year Resistance Analysis (Oral #26)
A post-hoc analysis of a subgroup of the 1,298 treatment-naïve and treatment-experienced patients with chronic HBV infection from two Phase 3 studies (Studies 108 and 110, Poster #904) demonstrated that patients who were switched after 96 weeks of treatment with Viread to Vemlidy experienced improvements in renal function, bone mineral density (BMD) and serum alanine aminotransferase (ALT) normalization while maintaining viral suppression, after 48 weeks of treatment with Vemlidy.
In patients initially randomized to Viread, high rates of virologic control (HBV DNA <29 IU/mL) were maintained after switching from Viread to Vemlidy. When assessed at Week 96 (pre-switch), 88 percent of Viread patients (156/177) had achieved virologic suppression. When these patients were switched to Vemlidy, 89 percent (149/167) had achieved virologic suppression at Week 144.
Median creatinine clearance (CrCL) increased among switch patients by 3.6 (-3.6, +9.0) ml/min (p<0.001). Mean hip BMD (n=180) increased by 0.96 percent (2.41) (p<0.001) and spine BMD (n=181) increased by 1.83 percent (3.20) (p<0.001). In addition, rates of serum ALT normalization (by the AASLD criteria) increased from 47 percent of patients pre-switch at Week 96 to 65 percent after 48 weeks of Vemlidy (p<0.001).
A prespecified analysis that will be presented during an oral session (Oral #26) evaluated virologic resistance after 96 weeks of treatment with Vemlidy or Viread. Of the 1,242 patients who entered year two of treatment, similar percentages of patients treated with Vemlidy (10.5 percent; 87/828) or Viread (10.9 percent; 45/414) qualified for evaluation. Using genotypic and phenotypic analyses, no resistance to either Vemlidy or Viread was detected in any patients at 96 weeks.
Vemlidy is approved for the treatment of chronic HBV infection in adults with compensated liver disease. The safety and efficacy of switching virologically suppressed patients onto Vemlidy have not been established.
Important Safety Information About Harvoni, Epclusa and Vosevi
BOXED WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN HCV/HBV COINFECTED PATIENTS
- Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with Harvoni, Epclusa, or Vosevi. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals (DAAs) and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Cases have been reported in patients who are HBsAg positive, in patients with serologic evidence of resolved HBV, and also in patients receiving certain immunosuppressant or chemotherapeutic agents; the risk of HBV reactivation associated with treatment with HCV DAAs may be increased in patients taking these other agents. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
- Harvoni and Epclusa: When 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.
- Vosevi is contraindicated with rifampin.
Warnings and Precautions
- Serious Symptomatic Bradycardia When Coadministered with Amiodarone: Amiodarone is not recommended for use with Harvoni, Epclusa, or Vosevi 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. A fatal cardiac arrest was reported in a patient taking amiodarone who was coadministered a sofosbuvir containing regimen. 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 Due to Use with P-gp Inducers and/or Moderate to Potent Inducers of CYP: Rifampin, St. John’s wort and carbamazepine are not recommended for use with Harvoni, Epclusa, or Vosevi. P-gp inducers may significantly decrease ledipasvir, sofosbuvir, velpatasvir, and/or voxilaprevir plasma concentrations. Moderate to potent inducers of CYP2B6, CYP2C8 or CYP3A4 may significantly decrease sofosbuvir, velpatasvir, and/or voxilaprevir plasma concentrations.
- The most common adverse reactions (≥10%, all grades) with Harvoni were fatigue, headache, and asthenia.
- The most common adverse reactions (≥10%, all grades) with Epclusa were headache and fatigue; and when used with RBV in decompensated cirrhotics were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
- The most common adverse reactions (≥10%, all grades) with Vosevi were headache, fatigue, diarrhea, and nausea.
- Harvoni: Coadministration is not recommended with oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir due to decreased concentrations of ledipasvir and sofosbuvir; or with co-formulated elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate due to increased concentrations of tenofovir; or with simeprevir due to increased concentrations of ledipasvir and simeprevir; or with rosuvastatin due to increased concentrations of rosuvastatin.
- Epclusa: Coadministration is not recommended with topotecan due to increased concentrations of topotecan; or with proton-pump inhibitors, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, efavirenz, and tipranavir/ritonavir due to decreased concentrations of sofosbuvir and/or velpatasvir.
- Vosevi: Coadministration is not recommended with phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, atazanavir, lopinavir, tipranavir/ritonavir, efavirenz, rosuvastatin, pitavastatin, and cyclosporine due to changes (decreased or increased) in concentrations of sofosbuvir, velpatasvir, voxilaprevir, and/or the other agent.
Consult the full Prescribing Information for Harvoni, Epclusa, and Vosevi for more information on potentially significant drug interactions, including clinical comments.
Important Safety Information About Vemlidy
BOXED WARNING: POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B
- Discontinuation of anti-hepatitis B therapy, including Vemlidy, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including Vemlidy. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions
- Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, Vemlidy alone is not recommended for the treatment of HIV-1 infection. Safety and efficacy of Vemlidy have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with Vemlidy, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
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 Vemlidy, there have been no
cases of Fanconi syndrome or proximal renal tubulopathy (PRT).
Patients with impaired renal function and/or taking nephrotoxic agents
(including NSAIDs) are at increased risk of renal-related adverse
reactions. Discontinue Vemlidy in patients who develop clinically
significant decreases in renal function or evidence of Fanconi
Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.
- Lactic Acidosis and Severe Hepatomegaly with Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including tenofovir DF. Discontinue Vemlidy 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) through Week 48 were headache, abdominal pain, fatigue, cough, nausea and back pain.
- Coadministration of Vemlidy with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
- Coadministration of Vemlidy is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of Vemlidy. Drugs that strongly affect P-gp and BCRP activity may lead to changes in Vemlidy absorption.
Consult the full prescribing information for Vemlidy for more information on potentially significant drug interactions, including clinical comments.
Dosage and Administration
Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment: Not recommended in patients with CrCl <15 mL/min.
Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
Testing prior to initiation: HIV infection.
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.
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 Gilead may observe unfavorable results from additional clinical trials involving Harvoni, Epclusa, Vosevi and Vemlidy in certain difficult-to-treat patient populations. 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, 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.
U.S. Full Prescribing Information for Harvoni, Epclusa, Vosevi, Vemlidy and Viread including BOXED WARNING, is available at www.gilead.com .
Harvoni, Epclusa, Vosevi, Vemlidy and Viread are registered 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, 650-524-7792
Mark Snyder, 650-522-6167
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
Tan Delta: New Oil Condition Monitoring Kit for Gas Engine Operators Reduces Daily Operating Costs, Improves Equipment Efficiency and Extends Equipment Life.23.11.2017 13:38 | Pressemelding
The new Gas Engine oil condition monitoring kit from Tan Delta Systems can be quickly and easily fitted to any gas engine and enables the oil to be monitored and tracked continuously in real time enabling significantly reduced maintenance costs, increased equipment efficiency and extended equipment life. Operators can expect their investment returned in under four months followed by many years of net financial and operational benefits. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171123005177/en/ Gas Engine Oil Condition Monitoring (Photo: Business Wire) The kit includes everything needed for quick and easy installation on any gas engine operating in any environment. No more need for expensive laboratory oil testing. Reduce daily operating costs by optimising maintenance schedules. Protect a
Making Institut Curie a Reference for Technology Transfer in Oncology23.11.2017 13:00 | Pressemelding
Institut Curie has adopted an ambitious strategy for technology transfer and partnerships with innovative companies. This new dynamic, initiated within the framework of the 2015-2020 MC21 strategic plan (Marie Curie in the 21 st century), aims at positioning the Institut Curie as a reference for technology transfer in oncology. The strategy ambition to better accompany Institut Curie researchers and physicians in the protection, development and commercialization of their inventions, and reinforces support for the setting-up of collaborations with innovative companies. "The objective is to optimize the identification, promotion and transfer of all the scientific, technological and medical resources of the Institute in an open innovative approach" says Amaury Martin, Executive Director of Institut Curie Technology Transfer
Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 5023.11.2017 08:00 | Pressemelding
WDX ranks No.18 in the 17th annual Sunday Times Hiscox Tech Track 100 league table league which consisted of the top 100 private technology, media and telecoms (TMT) companies in Britain. WDX recorded a 155% average annual sales growth per year over the last 3 years with sales reaching £6.4M in September 2016 and £9m by end of September 2017. More recently, in November 2017, WDX also announces ranking No.19 in the 2017 Deloitte UK Technology Fast 50, a ranking of the 50 fastest growing technology companies in the UK. Rankings are based on percentage revenue growth over the last four years of which, WDX grew 1,563% during this period. WDX attributed this revenue growth to the team’s hard work and the positive change in attitude toward technology in the Wealth and Investment Management industry. WDX’s CEO, Gary Linieres credits the team with the company’s revenue growth. He sa
Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia23.11.2017 07:00 | Pressemelding
Mobidiag Ltd, a Finnish molecular diagnostics company, today announced a distribution agreement with Interlux OÜ, supplier of technologies for medicine, science and biotechnology industry. Under this agreement, Interlux becomes the exclusive distributor of the Amplidiag® product line in Estonia, in vitro diagnostic tests and compatible instrument for the detection of gastrointestinal infections. “Thanks to a large distribution network, our Amplidiag product line is now accessible in most Western European countries. This new distribution agreement allows us to introduce the Amplidiag product line to the Baltic region starting with Estonia. We are then very happy to start this new partnership with Interlux to support us in this new market”, said Miquel Vernet, CCO at Mobidiag. “Cooperation with Mobidiag offers the customers of Interlux high-quality diagnostic results. I believ
OCP Announces Date of 2017 Third Quarter and Nine Month Results22.11.2017 16:59 | Pressemelding
OCP S.A., a global leader in the fertilizer industry, will release its third quarter and nine month 2017 results on Thursday, November 30, 2017. The results will be available to holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers on the OCP Intralinks portal at 9 a.m. EDT and 2 p.m. Morocco/London time. OCP senior management will host a conference call to discuss 2017 third quarter/nine month results at 10 a.m. EDT and 3 p.m. Morocco/London time on Thursday, November 30, 2017 for holders of the Company’s bonds, qualified institutional buyers, securities analysts and market makers. Eligible parties that have not already registered for access to the Intralinks portal may do so by contacting the Investor Relations Department by emailing firstname.lastname@example.org. About OCP OCP is a global leader in the fert
Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets22.11.2017 14:46 | Pressemelding
As part of the company’s transformation journey undertaken in 2016, Tata Motors commenced a comprehensive project to articulate its corporate branding. Basis a thorough analysis of the existing and the desired future state of the Company, Tata Motors has defined its new brand identity as ‘Connecting Aspirations’ across 46 markets, internationally. ‘Connecting Aspirations’, as the new defining maxim, represents the personality of the brand as an interconnected system of mobility solutions, that are intelligent, perceptive, warm and expressive. It’s a symbolic tagline that represents the company’s past, present and future. It is humble yet bold, a statement as well as a challenge. It will define the way Tata Motors communicates with its internal as well as external stakeholders, and work as an all-encompassing guiding principle across business units.” Speaking on the
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom