Latest news with #HDV
Yahoo
23-05-2025
- Business
- Yahoo
Is iShares Core High Dividend ETF (HDV) a Strong ETF Right Now?
Making its debut on 03/29/2011, smart beta exchange traded fund iShares Core High Dividend ETF (HDV) provides investors broad exposure to the Style Box - Large Cap Value category of the market. Products that are based on market cap weighted indexes, which are strategies designed to reflect a specific market segment or the market as a whole, have traditionally dominated the ETF industry. Investors who believe in market efficiency should consider market cap indexes, as they replicate market returns in a low-cost, convenient, and transparent way. But, there are some investors who would rather invest in smart beta funds; these funds track non-cap weighted strategies, and are a strong option for those who prefer choosing great stocks in order to beat the market. By attempting to pick stocks that have a better chance of risk-return performance, non-cap weighted indexes are based on certain fundamental characteristics, or a combination of such. While this space offers a number of choices to investors, including simplest equal-weighting, fundamental weighting and volatility/momentum based weighting methodologies, not all these strategies have been able to deliver superior results. The fund is managed by Blackrock, and has been able to amass over $10.94 billion, which makes it one of the larger ETFs in the Style Box - Large Cap Value. HDV, before fees and expenses, seeks to match the performance of the Morningstar Dividend Yield Focus Index. The Morningstar Dividend Yield Focus Index offers exposure to high quality U.S. domiciled companies that have had strong financial health and an ability to sustain above average dividend payouts. For ETF investors, expense ratios are an important factor when considering a fund's return; in the long-term, cheaper funds actually have the ability to outperform their more expensive cousins if all other things remain the same. Annual operating expenses for this ETF are 0.08%, making it one of the least expensive products in the space. It's 12-month trailing dividend yield comes in at 3.55%. Even though ETFs offer diversified exposure that minimizes single stock risk, investors should also look at the actual holdings inside the fund. Luckily, most ETFs are very transparent products that disclose their holdings on a daily basis. For HDV, it has heaviest allocation in the Consumer Staples sector --about 22.30% of the portfolio --while Energy and Healthcare round out the top three. Looking at individual holdings, Exxon Mobil Corp (XOM) accounts for about 7.76% of total assets, followed by Johnson & Johnson (JNJ) and Progressive Corp (PGR). The top 10 holdings account for about 48.62% of total assets under management. So far this year, HDV has added about 2.91%, and was up about 7.44% in the last one year (as of 05/23/2025). During this past 52-week period, the fund has traded between $106.73 and $121.28. The fund has a beta of 0.65 and standard deviation of 13.61% for the trailing three-year period, which makes HDV a medium risk choice in this particular space. With about 82 holdings, it effectively diversifies company-specific risk. IShares Core High Dividend ETF is a reasonable option for investors seeking to outperform the Style Box - Large Cap Value segment of the market. However, there are other ETFs in the space which investors could consider. Schwab U.S. Dividend Equity ETF (SCHD) tracks Dow Jones U.S. Dividend 100 Index and the Vanguard Value ETF (VTV) tracks CRSP U.S. Large Cap Value Index. Schwab U.S. Dividend Equity ETF has $67.67 billion in assets, Vanguard Value ETF has $132.07 billion. SCHD has an expense ratio of 0.06% and VTV charges 0.04%. Investors looking for cheaper and lower-risk options should consider traditional market cap weighted ETFs that aim to match the returns of the Style Box - Large Cap Value. To learn more about this product and other ETFs, screen for products that match your investment objectives and read articles on latest developments in the ETF investing universe, please visit Zacks ETF Center. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report iShares Core High Dividend ETF (HDV): ETF Research Reports Johnson & Johnson (JNJ) : Free Stock Analysis Report Exxon Mobil Corporation (XOM) : Free Stock Analysis Report The Progressive Corporation (PGR) : Free Stock Analysis Report Vanguard Value ETF (VTV): ETF Research Reports Schwab U.S. Dividend Equity ETF (SCHD): ETF Research Reports This article originally published on Zacks Investment Research ( Zacks Investment Research
Business Wire
07-05-2025
- Health
- Business Wire
Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment
FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT). In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. In addition, sustained post-treatment undetectable HDV RNA was more frequent in participants with longer on-treatment HDV RNA undetectability at end of treatment: 90% (9/10) of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment. These new data, presented at the European Association for the Study of the Liver (EASL) Congress 2025, show the potential value of bulevirtide monotherapy for some adults living with chronic HDV, even after treatment has ended. 'HDV is the most severe form of viral hepatitis with more rapid progression towards liver cancer and liver-related death. Previous data have demonstrated the potential of bulevirtide as a safe and effective treatment option and, as EASL and the European Medicines Agency guidelines recommend, continued treatment is encouraged as long as people are experiencing a clinical benefit,' said Professor Heiner Wedemeyer, Head and Chair of the Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology at Hannover Medical School. 'With today's results, we're now seeing the potential of bulevirtide to maintain virologic suppression and normalize markers of liver inflammation for a subset of people living with HDV, demonstrating a durable response, even after treatment cessation.' The findings (LBO-004) build on data, presented at The Liver Meeting ® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD), from MYR301 which demonstrated a subset of participants treated with bulevirtide monotherapy had undetectable HDV RNA 48 weeks after stopping treatment. Today's presentation adds further insight by not only showing the durability of response post-treatment, but that sustained undetectability was more frequent in people with longer, on-treatment HDV RNA undetectability at the time of bulevirtide discontinuation. Furthermore, post-treatment hepatic serious adverse events (SAEs) were reported in 14% (20/142) of participants but were resolved in 85% (17/20) of these participants, most of whom restarted bulevirtide therapy. 'At Gilead, we are committed to advancing research and exploring the full potential of bulevirtide as a monotherapy, in combination, and at different doses, to help improve outcomes for people living with chronic HDV,' said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. 'Previous results from MYR301 demonstrated the potential benefits of long-term treatment with bulevirtide. With this new data, we now have valuable insight into the durability of the response even after treatment has ended.' HDV affects an estimated 4.5% of people living with chronic hepatitis B (HBV), with an estimated global prevalence of 12 million people. Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), the UK, Switzerland and Australia and is not approved in the U.S. or elsewhere. Bulevirtide 10 mg is an investigational product and is not approved anywhere. For more information on the EASL Congress 2025 and Gilead's presentations, please visit the congress website. Marketing Authorization In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex ® (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide's conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024. In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. About MYR301 MYR301 is a Phase 3 clinical trial evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51). Primary efficacy and safety data was assessed at Week 48. After Week 48, participants in the delayed treatment group of the study were switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks. The primary endpoint, combined response, is defined as an undetectable HDV RNA or ≥2log10 IU/ml decline from baseline and ALT normalization at Week 48. Secondary endpoints at Week 48 include undetectable HDV RNA (key secondary endpoint), ALT normalization, and a change from baseline in liver stiffness measured by transient elastography. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta (HDV), Gilead's focus on advancing medicines drives hope that today's research will turn into tomorrow's cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with primary biliary cholangitis. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements 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 Gilead's ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide; uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for bulevirtide; and the risk that any such approvals, if granted, may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing bulevirtide for the treatment of HDV; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex®, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).
Yahoo
17-04-2025
- Health
- Yahoo
ESCMID Global 2025: The challenges of eliminating viral hepatitis
At the 35th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Global conference in Vienna, Austria, held from April 11-15, the challenges of eliminating viral hepatitis were discussed. In 2024, the World Health Organization (WHO) reported that aside from tuberculosis, viral hepatitis was the most common cause of mortality due to infectious diseases worldwide. Furthermore, despite a slow decrease in the global incidence of viral hepatitis B (HBV) and C (HCV) in recent years, mortality due to these viruses has been increasing. In 2016, WHO launched the Global Health Sector Strategy, which aimed to end viral hepatitis by 2030, defining elimination as a 90% reduction in incidence and 65% reduction in mortality for HBV and HCV from 2015 to 2030. One challenge to achieving this goal is the proportion of undiagnosed individuals living with viral hepatitis. According to WHO, 254 million people globally were estimated to have HBV in 2022, but only approximately 10% had been diagnosed. Likewise, 50 million people globally were estimated to have HCV in 2022, but only approximately 30% had been diagnosed. One current strategy to closing this gap and providing patients with diagnoses and treatments is reflex testing, which is the automatic addition of testing based upon initial test results. With one patient-provided sample, reflex testing can provide complete data for diagnosis, staging, coinfection, and management strategies. For example, if a patient tests positive for the hepatitis B surface antigen, this sample could be reflexed and tested for hepatitis D virus (HDV) antibodies (anti-HDV). Furthermore, if the patient tests positive for anti-HDV, this sample could be reflexed and tested for HDV-RNA. Some advantages of reflex testing include the automatic addition of testing, the fact that active infections can be confirmed using one sample, the streamlining of the diagnostic process without needing additional patient visits, reduced diagnostic delays, increased linkage to care, improved patient outcomes, and enhanced efficiency in laboratory and clinical workflows. The advantages of reflex testing have also been evidenced in primary literature. In a retrospective 2023 study by Rohit Nathani and colleagues that was published in the Journal of Viral Hepatitis, over 11,000 HBV patients were studied for five years, and 12.9% of patients were subsequently screened for HDV infection. Researchers confirmed that 18% of the patients who were found to be positive for HDV would have been missed if the researchers had followed risk-based screening guidelines. Furthermore, the European Association for the Study of the Liver published Clinical Practice Guidelines on HDV in 2023 in which it recommended that all HBV patients should be screened for anti-HDV antibodies at least once, due to evidence that reflex testing of anti-HDV in HBV-positive patients resulted in a five-fold increase in HDV diagnoses. Overall, reflex testing can be useful for generating prevalence estimates and finding undiagnosed individuals. Another strategy to close the gap of undiagnosed individuals living with viral hepatitis is opt-out testing, which is a proactive screening system. This strategy was tested in London hospitals, in which any patient who entered the emergency department and had a blood draw was automatically tested for bloodborne viruses. In a two-year period (April 2022-March 2024), nearly 2,000 HBV infections, over 760 HCV infections, and almost 400 human immunodeficiency virus infections were newly diagnosed. Closing the gap of undiagnosed individuals is clinically important to link patients to the appropriate care, and also offers epidemiological importance to reduce the transmission of these infections. One particular challenge in eliminating viral hepatitis is reaching populations that may experience obstructions in accessing proper healthcare services. These 'hard-to-reach' populations include people who inject drugs, prisoners, immigrant communities, homeless individuals, individuals with mental health disorders, and racial and ethnic minorities. Particular strategies for reaching these populations can include integrating hepatitis care into existing healthcare, expanding access to screening and treatment, expanding harm reduction services, and addressing stigma and lack of awareness. Altogether, effective hepatitis management and elimination strategies require a collaborative and multidisciplinary approach involving the community and healthcare professionals. "ESCMID Global 2025: The challenges of eliminating viral hepatitis" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Korea Herald
17-04-2025
- Health
- Korea Herald
Duke-NUS and T Cells Diagnostics team up to simplify T-cell analysis
SINGAPORE, April 17, 2025 /PRNewswire/ -- T Cell Diagnostics Pte. Ltd. ("TCD") has licensed an intellectual property (IP) and its related know-how from Duke-NUS Medical School to develop point-of-care assays that could simplify the analysis of T-cell responses. Point-of-care tests can be performed quickly and easily at the site of patient care, such as in clinics or hospitals, without the need of specialised lab equipment. They provide rapid results, helping doctors and researchers make timely decisions. TCD was established in Singapore in 2021 as a spin-off from Duke-NUS by Professor Antonio Bertoletti, Assistant Professors Nina Le Bert and Anthony Tan from Duke-NUS' Emerging Infectious Diseases Programme. Developed based on the licensed IP and its related know-how, TCD's test kits precisely measure the amount of virus-specific T cells in clinical samples by stimulating biological samples—ranging from whole blood to nasal swabs and bronchoalveolar lavage fluids—with synthetic peptides. In response to the stimulation, the T cells release chemical signals called cytokines, which can be easily measured. Assistant Professor Nina Le Bert, who is currently applying this technology in her research on samples from patients chronically infected with the Hepatitis B Virus, said: "We are impressed by the simplicity and performance of the test kit, which has allowed the testing of hundreds of patient samples with ease and precision. It is heartening to see that the interest in measuring T-cell responses induced by vaccination or infection is gaining traction as such knowledge empowers healthcare providers and researchers to better understand immune responses in patients, in turn driving innovations to improve patient care." Mr Alessandro Sidoli, CEO of T Cell Diagnostics: "We are confident that the addition of this technology to our portfolio is a major step towards achieving our goal of using T cells as a diagnostic. Our team combines deep scientific expertise with a commitment to delivering reliable, high-quality results, ensuring that our partners can confidently advance their research and clinical goals. Whether you're exploring immune responses to viral infections, vaccination, or even cancer, TCD is your trusted partner in unlocking the power of T cell immunity." TCD offers end-to-end solutions, including project management, expert consultations, and advanced research testing services. The main focus is on analysing virus-specific cellular immune responses, with a particular emphasis on infections such as HBV, HDV, Influenza, SARS-CoV-2, and Dengue. By quantifying the number and function of antigen-specific T cells, TCD provides critical insights that can guide diagnosis, treatment, and vaccine development. Operating from a state-of-the-art BSL-2 laboratory in Singapore's Biopolis, TCD is strategically positioned to serve local, regional, and international clients. Associate Professor Christopher Laing, Vice-Dean for Innovation and Entrepreneurship at Duke-NUS, said: "Innovation in science is not just about discovery—it's about turning knowledge into solutions that improve lives. Duke-NUS scientists are among the most entrepreneurial in Asia, and our culture of innovation is supportive of partnering with startups. Our collaboration with TCD exemplifies Duke-NUS' commitment to bridging academia and industry, accelerating groundbreaking discoveries from universities to patients and society." About Duke-NUS Medical School Duke-NUS is Singapore's flagship graduate entry medical school, established in 2005 with a strategic, government-led partnership between two world-class institutions: Duke University School of Medicine and the National University of Singapore (NUS). Through an innovative curriculum, students at Duke-NUS are nurtured to become multi-faceted 'Clinicians Plus' poised to steer the healthcare and biomedical ecosystem in Singapore and beyond. A leader in ground-breaking research and translational innovation, Duke-NUS has gained international renown through its five signature research programmes and 10 centres. The enduring impact of its discoveries is amplified by its successful Academic Medicine partnership with Singapore Health Services (SingHealth), Singapore's largest healthcare group. This strategic alliance has spawned 15 Academic Clinical Programmes, which harness multi-disciplinary research and education to transform medicine and improve lives.
Yahoo
17-04-2025
- Health
- Yahoo
Duke-NUS and T Cells Diagnostics team up to simplify T-cell analysis
Virus-specific T-cell measurement is made easier to enable better understanding of immune responses in patients and management of human infectious diseases. SINGAPORE, April 17, 2025 /PRNewswire/ -- T Cell Diagnostics Pte. Ltd. ("TCD") has licensed an intellectual property (IP) and its related know-how from Duke-NUS Medical School to develop point-of-care assays that could simplify the analysis of T-cell responses. Point-of-care tests can be performed quickly and easily at the site of patient care, such as in clinics or hospitals, without the need of specialised lab equipment. They provide rapid results, helping doctors and researchers make timely decisions. TCD was established in Singapore in 2021 as a spin-off from Duke-NUS by Professor Antonio Bertoletti, Assistant Professors Nina Le Bert and Anthony Tan from Duke-NUS' Emerging Infectious Diseases Programme. Developed based on the licensed IP and its related know-how, TCD's test kits precisely measure the amount of virus-specific T cells in clinical samples by stimulating biological samples—ranging from whole blood to nasal swabs and bronchoalveolar lavage fluids—with synthetic peptides. In response to the stimulation, the T cells release chemical signals called cytokines, which can be easily measured. Assistant Professor Nina Le Bert, who is currently applying this technology in her research on samples from patients chronically infected with the Hepatitis B Virus, said: "We are impressed by the simplicity and performance of the test kit, which has allowed the testing of hundreds of patient samples with ease and precision. It is heartening to see that the interest in measuring T-cell responses induced by vaccination or infection is gaining traction as such knowledge empowers healthcare providers and researchers to better understand immune responses in patients, in turn driving innovations to improve patient care." Mr Alessandro Sidoli, CEO of T Cell Diagnostics: "We are confident that the addition of this technology to our portfolio is a major step towards achieving our goal of using T cells as a diagnostic. Our team combines deep scientific expertise with a commitment to delivering reliable, high-quality results, ensuring that our partners can confidently advance their research and clinical goals. Whether you're exploring immune responses to viral infections, vaccination, or even cancer, TCD is your trusted partner in unlocking the power of T cell immunity." TCD offers end-to-end solutions, including project management, expert consultations, and advanced research testing services. The main focus is on analysing virus-specific cellular immune responses, with a particular emphasis on infections such as HBV, HDV, Influenza, SARS-CoV-2, and Dengue. By quantifying the number and function of antigen-specific T cells, TCD provides critical insights that can guide diagnosis, treatment, and vaccine development. Operating from a state-of-the-art BSL-2 laboratory in Singapore's Biopolis, TCD is strategically positioned to serve local, regional, and international clients. Associate Professor Christopher Laing, Vice-Dean for Innovation and Entrepreneurship at Duke-NUS, said: "Innovation in science is not just about discovery—it's about turning knowledge into solutions that improve lives. Duke-NUS scientists are among the most entrepreneurial in Asia, and our culture of innovation is supportive of partnering with startups. Our collaboration with TCD exemplifies Duke-NUS' commitment to bridging academia and industry, accelerating groundbreaking discoveries from universities to patients and society." About Duke-NUS Medical School Duke-NUS is Singapore's flagship graduate entry medical school, established in 2005 with a strategic, government-led partnership between two world-class institutions: Duke University School of Medicine and the National University of Singapore (NUS). Through an innovative curriculum, students at Duke-NUS are nurtured to become multi-faceted 'Clinicians Plus' poised to steer the healthcare and biomedical ecosystem in Singapore and beyond. A leader in ground-breaking research and translational innovation, Duke-NUS has gained international renown through its five signature research programmes and 10 centres. The enduring impact of its discoveries is amplified by its successful Academic Medicine partnership with Singapore Health Services (SingHealth), Singapore's largest healthcare group. This strategic alliance has spawned 15 Academic Clinical Programmes, which harness multi-disciplinary research and education to transform medicine and improve lives. For more information, please visit View original content to download multimedia: SOURCE Duke-NUS Medical School
