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
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
Thales and Gemalto Are Granted Regulatory Clearance from the Competition Commission in South Africa16.10.2018 19:00 | Tiedote
Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received Regulatory Clearance from the Competition Commission in South Africa. Together with the antitrust clearances obtained in China, Israel and Turkey, and clearances relating to foreign investments in Australia, Canada and the USA (CFIUS), Thales and Gemalto have now obtained 7 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with
Event Software Company Aventri Acquires ITN International16.10.2018 19:00 | Tiedote
Leading event management software company Aventri announced the acquisition of ITN International, the industry leader in NFC, mobile and cloud-based technology. With the acquisition of ITN, Aventri will broaden its technology and service offerings, expanding its global reach and the events that they support. Servicing annually 125 events, 10,000 exhibitors and 1.5 million attendees, ITN serves event producers by combining technology with personalized professional services to optimize events. A look at their product set includes: Online registration system with speaker management, agenda builder, session scheduling, and more. Onsite services include NFC badges, check-in stations, lead retrieval, apps, RFID scanning and more. Data visualization tools with advanced reporting and analytics around registration, badge activity and scans. “The acquisition of ITN as a global provider of cloud-based event management solutions is a major growth opportunity for Aventri,” says Oni Chukwu, CEO of A
Piraeus Bank Finances the Development of Thriassio Transit Center16.10.2018 18:39 | Tiedote
Piraeus Bank will finance the development of the Thriassio Transit Center, which will help increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. The Center will significantly increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. It will contribute to the provision of upgraded services while also reducing transport costs, which are key factors in lowering the final price of products, having a direct positive impact on the competitiveness of the economy and GDP growth. The project is also expected to boost local employment, creating up to 5,000 jobs over the next 10 years. The new Thriasio Transit Center is expected to become operational in 2024. Piraeus Bank Chief Executive Officer, Mr. Christos Megalou said: “Piraeus Bank are always looking for suitable investment projects that align with our strategy to be a pillar of stability for the Greek economy and we ar
Inside Secure’s Latest Whitebox Software Security Tool Brings Mobile Developers New Levels of Protection, Performance and Control16.10.2018 18:36 | Tiedote
Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, today announced general availability of its Whitebox 3.0 software crypto-security tool that protects cryptographic keys and algorithms inside mobile applications that demand top-notch security. Inherently running in an exposed environment, mobile applications are susceptible to attackers who can then see all the secrets within the app. As a proven innovator in software security, Inside Secure builds on numerous years of successful integrations for top developers to offer the best technology for hiding data and cryptography on mobile devices. Serving as an appealing alternative to an expensive, hardware-dependent Trusted Execution Environment (TEE) or Secure Element (SE) Whitebox 3.0 secures assets with uniquely powerful features that bring industry-changing gains in performance and flexibility – key traits that developers demand. Inside Secure’s pure software approach means
LTI and PTC Unveil IoT Center of Excellence16.10.2018 17:42 | Tiedote
Larsen & Toubro Infotech Ltd. (NSE: LTI, BSE: 540005), a global technology consulting and digital solutions company, in alliance with USA-based PTC Inc., today unveiled a state-of-the-art Center of Excellence (CoE) in Bengaluru, focused on Internet of Things (IoT)-based innovations. The CoE will focus specifically on Industry 4.0 solutions in Manufacturing and Oil & Gas sectors. LTI will leverage the CoE to design, build and showcase solutions for smart, connected enterprises, from proof-of-concept to industrialized deployments. The CoE will showcase the possibilities of transformative technologies to global customers, featuring Industrial IoT solutions developed on PTC’s ThingWorx® platform. LTI plans to deploy reusable IoT assets from its real-world experience in implementing enterprise-scale digital transformation solutions for global customers like L&T Construction and other global industrial manufacturing enterprises. A unique feature of the CoE will be the use of real-time data f
A Higher Intelligence: Huawei Unveils HUAWEI Mate 20 Series16.10.2018 17:08 | Tiedote
Huawei Consumer Business Group (BG) today unveiled the HUAWEI Mate 20 Series. Available in 6.53-inch, 6.39-inch and 7.2-inch sizes, the HUAWEI Mate 20 Series encompasses four devices: HUAWEI Mate 20, HUAWEI Mate 20 Pro, HUAWEI Mate 20 X and PORSCHE DESIGN HUAWEI Mate 20 RS. “Smartphones are an important entrance to the digital world. The HUAWEI Mate 20 Series is designed to be the best ‘mate’ of consumers, accompanying and empowering them to enjoy a richer, more fulfilled life with their higher intelligence, unparalleled battery lives and powerful camera performance,” said Richard Yu, CEO of Huawei Consumer BG. Ultimate Performance and Battery Life Manufactured with the cutting-edge 7nm technology process, the Kirin 980 is the world’s first commercial SoC to use the Cortex-A76-based cores and Mali-G76 GPU. The Kirin 980 is also the industry’s first SoC to be equipped with Dual-NPU. In addition, it supports the 4.5G LTE Cat. 21 standard, the world’s fastest Wi-Fi connection speeds, and
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