– More than 30 Abstracts Across HDV, HCV, HBV, NASH and PSC Reflect Gilead’s Ongoing Commitment to Addressing Challenges Facing People Living With Liver Diseases –
Gilead Lores,Inc. (Nasdaq GILD) moment blazoned the donation of new clinical and real- world data at the American Association for the Study of Liver Conditions (AASLD) The Liver Meeting ®, taking place from November 12-15. Donations include the impact of treatment with bulevirtide, an investigational treatment for people with habitual hepatitis delta contagion (HDV) in theU.S. that’s conditionally approved in Europe, real- world data on global sweats to support the World Health Organization’s thing of hepatitis C (HCV) elimination and long- term results from ongoing studies in the treatment of habitual hepatitis B infection (HBV).
“ We’re relentlessly working to ameliorate upon innovative curatives to meet the unmet requirements of people living with grueling liver conditions, including HDV where there’s a significant unmet need,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Lores. “ We ’re agitated to partake data from our robust clinical development programs at AASLD’s The Liver Meeting ®, including the rearmost data demonstrating the positive impacts of bulevirtide for people living with HDV.”
Hepcludex ® (bulevirtide) has been granted Precedence Drugs ( Florescence) scheme eligibility by the European Medicines Agency (EMA) for the treatment of HDV infection and Advance Remedy designation by theU.S. Food and Drug Administration (FDA). Bulevirtide is an investigational agent in theU.S. and its safety and efficacity haven’t been established.
Case Impact of HDV Treatment
HDV infection (which is always associated with HBV infection) leads to a more rapid-fire progression to liver fibrosis, cirrhosis, hepatic decompensation and an increased threat of liver cancer and death compared to HBV mono-infection. Gilead will present the rearmost findings from a Phase 3 trial that estimated case reported issues following treatment with bulevirtide after 24 weeks, demonstrating that people reported advancements in general health, fleshly pain, vitality and social and emotional functioning compared to those in the delayed treatment arm of this study ( Bill of Distinction 680).
Meeting the Requirements of Crucial Populations Living With HCV
To achieve HCV elimination, people living with HCV encyclopedically need to be suitable to pierce effective and well- permitted treatment alongside their other specifics. Data will be presented on the safety and efficacity of Epclusa ® (400 mg sofosbuvir/ 100 mg velpatasvir) in a broad range of people, including those withco-morbidities (PO-0940, 0927). An fresh study evaluates the issues of acclimatized strategies and innovative approaches in sweats to engage people who fit medicines in HCV care ( Zilches-97). TheU.S. product marker for Epclusa contains a BOXED WARNING for the threat of hepatitis B reactivation in HCV/ HBVco-infected cases. See below forU.S. Important Safety Information.
Long- term Treatment With Vemlidy in HBV
In HBV, Gilead continues to expand upon the established safety and efficacity profile of Vemlidy ® (tenofovir alafenamide 25 mg, TAF) with data demonstrating a sustained virological response in heavilypre-treated cases with multidrug-resistant HBV for over to 144 weeks (PO-812). Fresh data estimate treatment with Vemlidy in a variety of special case populations, including people livingpost-liver transplant with habitual order complaint and pregnant and suckling women (PO-803, 772). In another analysis, treatment with Vemlidy compared to tenofovir disoproxil fumarate (TDF) revealed a analogous low threat for atherosclerotic cardiovascular complaint (ASCVD) using a validated threat calculator, despite differences in their fasting lipid biographies (PO-771).
Key Accepted Abstracts Being Presented at The Liver Meeting® Include:
|Abstract Disposition||Abstract Title|
|Poster of Distinction-680||Treatment with Bulevirtide Improves Patient Reported Outcomes in Patients with Chronic Hepatitis Delta (CHD): An Interim Exploratory Analysis at Week 24|
|OS-97||Rapid Hepatitis C Treatment Initiation in Young People Who Inject Drugs: Final Results from the HCV-Seek, Test & Rapid Treatment (HCV-ST&RT) Randomized Pilot Clinical Trial|
|PO-0940||Risk of Multiple Drug Interactions in Patients Receiving Pangenotypic Direct-Acting Antiviral for the Treatment of Hepatitis C: Linked to Safety Issues|
|PO-0927||Impact of Polypharmacy and Aging on the Risk of Multiple Drug-Drug Interactions (DDIs) in HCV Patients Treated with Pangenotypic Direct-Acting Antivirals|
|PO-907||Potential Cost-Effectiveness of a Machine Learning Algorithm to Identify Undiagnosed Hepatitis C Patients in the United States|
|PO-892||HCV Cascade of Care and Next Steps for HCV Elimination in the United States Following the COVID-19 Pandemic|
|PO-803||Safety and Efficacy at 4 Years in Post-Liver Transplant Patients with Chronic Kidney Disease Receiving Tenofovir Alafenamide (TAF) For HBV Prophylaxis|
|PO-771||Atherosclerotic Cardiovascular Disease (ASCVD) Risk Profile of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Chronic HBV (CHB) Patients Treated for 2 Years|
|PO-812||Tenofovir Alafenamide for Multiple Drug-Resistant Chronic Hepatitis B: A 3-Year Clinical Trial|
|PO-772||Breast milk Pharmacokinetics of Tenofovir Alafenamide (Vemlidy®) in the setting of Chronic Hepatitis B infection|
|PO-626||Exploring The Patient Voice in Hepatitis B Care, Education, And Cure Research|
|OS-2156||Impact Of Modest Weight Reduction on Serum Markers, Liver Histology, And Disease Progression In Patients With Advanced Fibrosis Due To Nonalcoholic Steatohepatitis (NASH)|
|OS-2155||Safety And Preliminary Efficacy Of The Farnesoid X Receptor (FXR) Agonist Cilofexor In A 96-Week Open-Label Extension Of A Phase 2 Study Of PSC|
About Gilead Sciences in Liver Disease
For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. The company has transformed the trajectory of many liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. More work is required, and Gilead is committed to advancing innovative therapeutics to address the most pressing unmet needs in liver disease and overcoming barriers to better care.
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 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
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