Improving Adult Immunization Across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care

Total Page:16

File Type:pdf, Size:1020Kb

Improving Adult Immunization Across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care Improving Adult Immunization across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care 2016 ICHP Spring Meeting– East Peoria, IL– April 8, 2016 2016 MPA Health-Systems Spring Seminar – Missoula, MT – April 30, 2016 2016 LSHP 2016 Annual Meeting– New Orleans, LA– May 27, 2016 This activity is sponsored by the American Society of Health-System Pharmacists (ASHP). Supported by an educational grant from Merck Improving Adult Immunization across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care Setting Activity Overview According to the National Foundation for Infectious Diseases (NFID), more than 50,000 adults in the United States die from vaccine-preventable diseases or their complications each year, and nearly 36,000 people die from complications of seasonal influenza. The current comprehensive U.S. adult immunization schedule includes vaccination for 16 infectious diseases. Despite the availability of these vaccines, many adults remain unvaccinated against preventable infectious illnesses. Health care professionals who work in the ambulatory care setting have an opportunity to screen unimmunized patients at risk for vaccine-preventable diseases and intervene. In order to be most effective, health care professionals must remain abreast of the frequently updated recommendations for adult immunization from the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices. This symposium will highlight the latest recommendations for four important adult vaccines: influenza, pneumococcal, herpes zoster, and tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccines. Vaccination strategies for specific immunocompromised patients and immunization considerations for health care personnel will also be discussed. Learning Objectives After the conclusion of this application-based educational activity, participants should be able to Outline current adult vaccination recommendations for the influenza; pneumococcal; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap); and herpes zoster vaccines. Provide recommendations for vaccinations in adult immunocompromised patients. Recommend vaccines for healthcare personnel and strategies to optimize coverage. Outline approaches to improve adult vaccination rates across all populations in the ambulatory care setting. Continuing Education Accreditation The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity provides 1.0 hour (0.1 CEU – no partial credit) of continuing pharmacy education credit (ACPE activity # 0204- 0000-16-423-L01-P). Participants will process CPE credit online at http://elearning.ashp.org/my-activities. CPE credit will be reported directly to CPE Monitor. Per ACPE, CPE credit must be claimed no later than 60 days from the date of the live activity or completion of a home study activity. Improving Adult Immunization across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care Setting Faculty Dennis M. Williams, Pharm.D., BCPS, AE-C, FASHP, FCCP, FAPhA Associate Professor and Vice Chair Division of Pharmacotherapy and Experimental Therapeutics UNC Eshelman School of Pharmacy University of North Carolina Chapel Hill, North Carolina Dennis M. Williams, Pharm.D., BCPS, AE-C, FASHP, FCCP, FAPhA, is Associate Professor and Vice Chair for Professional Education and Practice in the Division of Pharmacotherapy and Experimental Therapeutics at the University of North Carolina (UNC) Eshelman School of Pharmacy in Chapel Hill, North Carolina. He is also a clinical specialist at UNC Hospitals. Dr. Williams earned his Bachelor of Science in pharmacy and Doctor of Pharmacy degrees at the University of Kentucky in Lexington. He is a board-certified pharmacotherapy specialist, as well as a certified asthma educator. He has received fellow recognition from the American Society of Health-System Pharmacists, American College of Clinical Pharmacy, and American Pharmacists Association. Dr. Williams focuses his practice, teaching, and research on the management of patients with pulmonary and infectious diseases. He is a member of the National Asthma Education and Prevention Program Coordinating Committee of the National Heart, Lung, and Blood Institute and several other boards. Dr. Williams has published research papers and book chapters in the area of pulmonary diseases and infectious diseases, and he regularly speaks on these topics at national and international professional programs. He has trained thousands of pharmacists and students about pulmonary, infectious disease, and immunization sciences, as well as practice considerations related to these topics. Improving Adult Immunization across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care Setting David J. Weber, M.D., M.P.H., FIDSA, FSHEA Professor of Medicine and Pediatrics, UNC School of Medicine Professor of Epidemiology, UNC School of Public Health Associate Chief Medical Officer, UNC Health Care Medical Director, Hospital Epidemiology and Occupational Health University of North Carolina Chapel Hill, North Carolina David J. Weber, M.D., M.P.H., FIDSA, FSHEA, is Professor of Medicine and Pediatrics in the University of North Carolina (UNC) School of Medicine, and Professor of Epidemiology in the UNC School of Public Health. Dr. Weber serves as the Associate Chief Medical Officer for UNC Health Care. He also serves as the Medical Director of the Departments of Hospital Epidemiology (Infection Control), Occupational Health, and Environmental Health and Safety for the UNC Health Care System. He is Associate Director of the North Carolina Statewide Infection Control Program (SPICE) and serves as Director of the Regulatory Core for the UNC Clinical Translational Research Award. Dr. Weber received his Bachelor of Arts from Wesleyan University, his Medical Degree (M.D.) from the University of California, San Diego, a Master of Public Health (M.P.H.) from Harvard University, and completed his medicine residency and infectious disease fellowship at Massachusetts General Hospital. He is Board- Certified in Internal Medicine, Infectious Disease, Critical Care Medicine, and Preventive Medicine. He is a fellow of the Infectious Diseases Society of America (FIDSA) and fellow of the Society for Healthcare Epidemiology of America (FSHEA). His research interests include the epidemiology of healthcare-associated infections, new and emerging infectious diseases, control of drug resistant pathogens, immunization practices (especially of healthcare personnel), zoonotic diseases, and epidemiology of tuberculosis. He is the Society for Healthcare Epidemiology of America (SHEA) representative to the Advisory Committee of Immunization Practices (ACIP) and has also served on several working groups of the ACIP. Dr. Weber has published more than 200 scientific papers in the peer-reviewed literature. In addition he has published 4 monographs and more than 200 book chapters, editorials, and short papers. He serves as Associate Editor for Infection Control and Hospital Epidemiology (ICHE). Improving Adult Immunization across the Continuum of Care: Making the Most of Opportunities in the Ambulatory Care Setting Disclosure Statement In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual or his or her spouse/partner has a financial relationship (e.g. employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring in the last 12 months with a commercial interest whose products or services may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content. All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity. Dennis M. Williams, Pharm.D., BCPS, AE-C, FASHP, FCCP, FAPhA, declares his spouse is a stockholder of GlaxoSmithKline plc. David J. Weber, M.D., M.P.H., FIDSA, FSHEA, declares he is a speaker and consultant for Merck and Pfizer, Inc. All other planners report no financial relationships relevant to this activity. CE IN THE MIDDAY Disclosures Improving Adult Immunization across the • Dennis M. Williams, Pharm.D., BCPS, AE‐C, FASHP, Continuum of Care: Making the Most of FCCP, FAPhA, declares his spouse is employed by and Opportunities in the Ambulatory Care Setting a stockholder of GlaxoSmithKline plc. •All other planners report no financial relationships Dennis Williams, Pharm.D. BCPS, AE‐C, FASHP, FCCP, FAPhA relevant to this activity. Associate Professor and Vice Chair UNC Eshelman School of Pharmacy
Recommended publications
  • Reversal of Oral Anticoagulation in Patients with Acute Intracerebral Hemorrhage Joji B
    Kuramatsu et al. Critical Care (2019) 23:206 https://doi.org/10.1186/s13054-019-2492-8 REVIEW Open Access Reversal of oral anticoagulation in patients with acute intracerebral hemorrhage Joji B. Kuramatsu* , Jochen A. Sembill and Hagen B. Huttner Abstract In light of an aging population with increased cardiovascular comorbidity, the use of oral anticoagulation (OAC) is steadily expanding. A variety of pharmacological alternatives to vitamin K antagonists (VKA) have emerged over recent years (direct oral anticoagulants, DOAC, i.e., dabigatran, rivaroxaban, apixaban, and edoxaban) which show a reduced risk for the occurrence of intracerebral hemorrhage (ICH). Yet, in the event of ICH under OAC (OAC-ICH), hematoma characteristics are similarly severe and clinical outcomes likewise substantially limited in both patients with VKA- and DOAC-ICH, which is why optimal acute hemostatic treatment in all OAC-ICH needs to be guaranteed. Currently, International Guidelines for the hemostatic management of patients with OAC-ICH are updated as several relevant large-sized observational studies and recent trials have established treatment approaches for both VKA- and DOAC-ICH. While the management of VKA-ICH is mainly based on the immediate reversal of elevated levels of international normalized ratio using prothrombin complex concentrates, hemostatic management of DOAC-associated ICH is challenging requiring specific antidotes, notably idarucizumab and andexanet alfa. This review will provide an overview of the latest studies and trials on hemostatic reversal agents and timing and summarizes the effects on hemorrhage progression and clinical outcomes in patients with OAC-ICH. Keywords: Intracerebral hemorrhage, Anticoagulation reversal, Tranexamic acid, Ciraparantag, Desmopressin Introduction importantly have a greater frequency of hematoma ex- Of all stroke sub-types, intracerebral hemorrhage (ICH) pansion (HE), all of which are significant outcome pre- constitutes roughly 15% and is associated with the worst dictors determining an even poorer prognosis [11–13].
    [Show full text]
  • Tuesday 6 June
    Tuesday 6 June 14:00- Registration at the Conference Venue 18:00 19:00- Opening ceremony, welcome reception and dinner 22:00 Wednesday 7 June 08:00- Registration 08:45 08:45- Welcome and Introduction 09:00 09:00- Benefit-risk profile of medicinal Chair: Oscar 10:30 products Della Pasqua Overview and implementation of multi criteria 09:00- Praveen decision analysis (MCDA) for benefit-risk 09:30 Thokala assessment European regulatory views on benefit-risk 09:30- Andreas assessment methodologies - role of MCDA and 10:00 Kouroumalis other model-based approaches Current practices and gaps in benefit-risk 10:00- Kevin Marsh assessment: opportunities for combining MCDA 10:30 with model-based approaches 10:30- Coffee break, Poster and Software session I 12:00 Page | 1 Posters in Group I (with poster numbers starting with I-) are accompanied by their presenter 12:00- Benefit-risk profile of medicinal Chair: Mats 12:40 products, continued Karlsson 12:00- Neeraj Model-Informed Drug Development (MIDD) for 12:20 Gupta ixazomib, an oral proteasome inhibitor Simulation analysis of absolute lymphocytes 12:20- Nadia counts (ALC) and relapse rate (RR) following 12:40 Terranova cladribine (re-)treatment rules in subjects with relapsing-remitting multiple sclerosis (RRMS) 12:40- Announcement for ACoP8 (2017) Jin Jin 12:45 12:45- Lunch 14:10 14:10- Chair: Lutz Scaling of PD in paediatrics 15:10 Harnisch Scaling pharmacodynamics in children: Lessons 14:10- Joseph from immunology, infectious diseases and 14:50 Standing critical care Scaling renal function in
    [Show full text]
  • HCV Treatment • Characteristics of DAA Classes
    HCV UPDATE Treatment: The Next Wave Access: Myths & Facts NASTAD National Technical Assistance Meeting October 2015 Tracy Swan HCV Treatment • Characteristics of DAA Classes • Next-generation: FDCs • Trends: 3somes and Quickies • HCV Treatment in HIV/HCV DAA CLASSES NON-NUCLEOSIDE POLYMERASE INHIBITORS (Dasabuvir): G1 only, further development/need?? PROTEASE INHIBITORS (Paritaprevir/r, Olysio): Usually G1 and G4, tendency for DDIs, possibly more side effects, resistance may not always be persistent—next generation might be pan-genotypic DAA CLASSES NS5A INHIBITORS (Daclatasvir, Ledipasvir, Ombitasvir, Velpatasvir) : pan/multi-genotypic (less information in G4, G5 and G6)—some DDIs, resistance can persist for >2 years stop them from working--next generation more potent, active against resistance? NUCLEOSIDE/TIDE POLYMERASE INHIBITORS (Sofosbuvir): pan/multi-genotypic (less information in G4, G5 and G6), few DDIs, resistance does not seem to be a major problem; a few more are finally in development Fixed-Dose Combinations (FDCs) WHAT’S HERE NOW…. Sofosbuvir + Ledipasvir Paritaprevir/r + Ombitasvir, w/ Dasabuvir WHAT’S COMING in 2016…. Grazoprevir + Elbasvir Sofosbuvir+ Velpatasvir What’s Coming in 2016 once daily DAA fixed-dose combinations, 12 weeks* Grazoprevir/Elbasvir adults w/ G 1,4 and 6 (TX- naive or -experienced, HIV/HCV; in people w/ cirrhosis or ESRD, and w/OST) ---cure rates generally >90% Sofosbuvir/Velpatasvir adults with all HCV genotypes (TX-naive or -experienced, people with cirrhosis) ---cure rates generally >90% *some
    [Show full text]
  • Management of Bleeding with Non–Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents
    NEW DRUGS AND DEVICES Management of Bleeding With Non–Vitamin K Antagonist Oral Anticoagulants in the Era of Specific Reversal Agents ABSTRACT: Vitamin K antagonists are commonly used by clinicians Downloaded from to provide anticoagulation to patients who have or are at risk of having thrombotic events. In addition to familiarity with the dosing and monitoring Christian T. Ruff, MD, of vitamin K antagonists, clinicians are accustomed to using vitamin K if MPH Robert P. Giugliano, MD, there is a need to reverse the anticoagulant effect of vitamin K antagonists. SM There are now 4 new non–vitamin K antagonist oral anticoagulants (NOACs) Elliott M. Antman, MD http://circ.ahajournals.org/ that are attractive alternatives to vitamin K antagonists. Despite similar or lower rates of serious bleeding with NOACs in comparison with warfarin, there is a pressing need for strategies to manage bleeding when it does occur with NOACs and to reverse the pharmacological effect of these agents if needed. Important steps in minimizing bleeding risks with NOACs include dose adjustment of the agents in the setting of renal dysfunction and avoidance of the concomitant use of other antithrombotic agents if by MEREDITH HURT on September 28, 2016 feasible. Laboratory measurement of the anticoagulant effect of NOACs is best accomplished with specialized assays, although some of the more widely available coagulation tests can provide information that is potentially useful to clinicians. Nonspecific hemostatic agents such as prothrombin complex concentrates and recombinant factor VIIa can be used to reverse the effect of NOACs. More specific reversing agents include the approved humanized monoclonal antibody fragment idarucizumab for reversing the effects of dabigatran, the investigational factor Xa decoy andexanet alfa, and the synthetic small molecule ciraparantag.
    [Show full text]
  • Supplementary Table 1. Available Resistance Fold Change Data
    Supplementary Table 1. Available resistance fold change data through literature search for the mutations/polymorphisms identified in the present study Target Mutationa Resistance fold change (compared with wild type of specific genotype)b GT 1a GT 1b GT 2a GT 3a GT 4a GT 5a GT 6a NS3 V36I protease V36L 2ASU [1] 1ASU [1] ≤1.3SIM [2] 1.3SIM [2] ≤1.3SIM [2] 2PAR [3] 1.7SIM [4] V36M 2ASU [1] 2ASU [1] 1.4GLE [5] <2DAN [6] 1.9GRA [5] 2SIM [4] 2PAR [3] >2.5VOX [7] 1.5SIM [8] 0.9VOX [8] Q41H T54A 0.4ASU [1] 0.4ASU [1] 0.8GRA [8] 1.3DAN [4] 0.5PAR [8] 1GLE [5] 0.4SIM [8] 1PAR [3] 0.6VOX [8] 0.6SIM [4] T54G T54S 1ASU [1] 1.2SIM [4] ≤1.3SIM [2] 1GLE [5] 1.1GRA [9] 0.4PAR [3] V55A 1ASU [1] 0.4GLE [5] 1PAR [3] V55G V55I 3ASU [1] 0.2GLE [5] 0.7GRA [5] 1PAR [3] V55P Y56F Q80D Q80G 9.8DAN [4] 1.8SIM [4] Q80K 3ASU [1] 6.5ASU [1] >2.5VOX [7] 8SIM [2] 8SIM [2] 0.9GLE [5] 2.3DAN [4] 1.1GRA [9] 7.7SIM [4] 3PAR [3] 11SIM [10] 0.8VOX [8] Q80L 1ASU [1] 1ASU [1] 2PAR [3] 1.9GRA [8] 1PAR [8] 2.1SIM [4] 1.3VOX [8] Q80M Q80N Q80R 2PAR [3] 4ASU [1] 0.4ASU [8] 3.5DAN [4] 0.1GRA [8] 6.9SIM [4] 0.2PAR [8] 0.5SIM [8] 0.8VOX [8] V107I S122G 1ASU [1] 0.5SIM [10] ≤1SIM [2] S122K S122N 1ASU [1] 1ASU [1] ≤1.3SIM [2] S122R 3ASU [1] 21SIM [10] 1.8GRA [9] S122T 1ASU [1] <1SIM [2] ≤1SIM [2] I132L I132V R155K 21ASU [1] 27ASU [1] 1ASU [8] 22ASU [8] 0.5GLE [5] 410DAN [11] 0.5GLE [5] 2.2GRA [8] 3GRA [9] 0.6GLE [5] 0.1GRA [5] 9.3PAR [8] 37PAR [3] 2.2GRA [12] 5.2PAR [5] 113SIM [8] 86SIM [10] 40PAR [3] >2.8SIM [8] 0.6VOX [8] 0.7VOX [8] 30SIM [4] 0.4VOX [8] 1.5VOX [8] R155P A156V NRASU
    [Show full text]
  • Genotype 1A – Not Recommended for Decompensated Cirrhosis Paritaprevir/Ritonavir + Ombitasvir + Dasabuvir ± Ribavirin for Genotype 1 HCV 100 97 99 94 99 100 89
    HCV Therapies: State of the Art Elizabeth Verna, MD, MSc Assistant Professor of Medicine Director of Clinical Research, Transplant Initiative Center for Liver Disease and Transplantation Columbia University Learning Objectives • Evaluate the current treatment options for the management of treatment-naive patients with HCV genotype 1 infection • Assess the current treatment options for the management of treatment-experienced patients with HCV genotype 1 infection • Outline the major issues in the current treatment of HCV infection Evolving Landscape of HCV Therapy HCV Approval Approval Approval Antibody pegIFN- alfa- Ledipasvir/Sofosbuvir Approval Telaprevir Testing 2b OBV/PTV/r + DAS Grazoprevir/Elbasvir Boceprevir Genotype-Specific Sofosbuvir/Velpatasvir Discovery of Approval RGT Approval Approval HCV Ribavirin Simeprevir (Chiron) Daclatasvir Sofosbuvir OBV/PTV/r 1989 1992 1998 2001 2005 2011 2013 2014 2015 2016 Current Benchmark >95% SVR: 6% 12% 20% 40% 54% 65–75% >90% pegIFN-alfa 2b = peg-interferon alfa-2b; RGT = response-guided therapy; OBV/PTV/r + DAS = ombitasvir/paritaprevir and ritonavir + dasabuvir (or 3D). Houghton M. Liver Int. 2009;29(Suppl 1):82-88; Carithers RL, et al. Hepatology. 1997;26(3 Suppl 1):S83-S88; Zeuzem S, et al. N Engl J Med. 2000;343(23):1666-1672; Poynard T, et al. Lancet. 1998;352(9138):1426- 1432; McHutchison JG, et al. N Engl J Med. 1998;339(21):1485-1492; Lindsay KL, et al. Hepatology. 2001;34(2):395-403; Fried MW, et al. N Engl J Med. 2002;347(13):975-982; Manns MP, et al. Lancet. 2001;58(9286):958-965; Poordad F, et al. N Engl J Med.
    [Show full text]
  • Hepatitis C Virus Treatment in the Real World: Optimising Treatment and Access to Therapies
    Recent advances in clinical practice Hepatitis C virus treatment in the real world: optimising treatment and access to therapies 1 2 3 4 Editor’s choice Fabien Zoulim, T Jake Liang, Alexander L Gerbes, Alessio Aghemo, Scan to access more 5,6,7,8 9 10 11 free content Sylvie Deuffic-Burban, Geoffrey Dusheiko, Michael W Fried, Stanislas Pol, Jürgen Kurt Rockstroh,12 Norah A Terrault,13 Stefan Wiktor14 For numbered affiliations see ABSTRACT treatments—how can we improve access to diagno- end of article. Chronic HCV infections represent a major worldwide sis and treatment for those patients who need them Correspondence to public health problem and are responsible for a large most? Professor Fabien Zoulim, proportion of liver related deaths, mostly because of Gut brought together some of the leading global Université Lyon 1, Cancer HCV-associated hepatocellular carcinoma and cirrhosis. experts in HCV to discuss these questions and Research Center of Lyon The treatment of HCV has undergone a rapid and point a way forward. The round table, held during (CRCL), INSERM U1052, spectacular revolution. In the past 5 years, the launch of the European Association for the Study of the Hospices Civils de Lyon 69003, ’ France; direct acting antiviral drugs has seen sustained Liver s International Liver Congress 2015, brought [email protected] virological response rates reach 90% and above for clarity to some of these issues and looked into the many patient groups. The new treatments are effective, future pipeline of HCV treatment. This article aims Received 21 July 2015 well tolerated, allow for shorter treatment regimens and to summarise that shared knowledge.
    [Show full text]
  • Direct-Acting Antivirals with Excellent Efficacy and Favourable Safety, Represent a Unique Opportunity to Achieve HCV Elimination
    The French and European Approach Towards Hepatitis C Virus Elimination HEPDART 2017 USA December 3rd, 2017 Tarik Asselah (MD, PhD) Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France. Disclosures • Employee of Paris Public University Hospitals (AP-H P, Beaujon’s Hospital) and University of Paris • Principal investigator for research grants : Funds paid to Hospital (AP-HP) • Consultant, expert and speaker for: Abbvie, Bristol-Myers Squibb, Gilead, Janssen, Merck Sharp Dohme, Roche. • Grants from : ANR, CNRS , INSERM , University of Paris, ANRS 2 The French and European Approach Towards Hepatitis C Virus Elimination The goal of this lecture will be to present the situation of HCV in Europe and in France. Direct-acting antivirals with excellent efficacy and favourable safety, represent a unique opportunity to achieve HCV elimination. We will discuss the European & French approach towards Hepatitis Programs and to identify models to achieve Elimination. The French and European Approach Towards Hepatitis C Virus Elimination 1 Great Drugs (Direct-acting antivirals) 2 Epidemiology : Europe & France 3 HCV management : Europe & France 4 Remaining Challenges 5 Take home messages Direct-acting antivirals : a Revolution 5’NTR Structural proteins Nonstructural proteins 3’NTR Metalloprotease Envelope Serine protease RNA Capsid glycoproteins RNA helicase Cofactors polymerase C E1 E2 NS1 NS2 NS3 NS4A NS4B NS5A NS5B Protease Inhibitors NS5A Inhibitors Polymerase Inhibitors « …previr » « ….asvir » « …..buvir » Telaprevir Daclatasvir Nucs Non-Nucs Boceprevir Ledipasvir Simeprevir Velpatasvir (GS-5816) Sofosbuvir Dasabuvir Paritaprevir Ombitasvir MK 3682 GS-9669 Glecaprevir Pibrentasvir ACH-3422 MK-8876 Grazoprevir Elbasvir ALS-335 Voxilaprevir MK-8408 Sovaprevir Samatasvir ACH-2684 Odalasvir (ACH-3102) Asselah et al.
    [Show full text]
  • Role of Ciraparantag, Andexanet Alfa, and Idarucizumab
    Vascular Health and Risk Management Dovepress open access to scientific and medical research Open Access Full Text Article REVIEW Reversing anticoagulant effects of novel oral anticoagulants: role of ciraparantag, andexanet alfa, and idarucizumab Tiffany Y Hu1 Abstract: Novel oral anticoagulants (NOACs) are increasingly used in clinical practice, but lack Vaibhav R Vaidya2 of commercially available reversal agents is a major barrier for mainstream use of these therapies. Samuel J Asirvatham2,3 Specific antidotes to NOACs are under development. Idarucizumab (aDabi-Fab, BI 655075) is a novel humanized mouse monoclonal antibody that binds dabigatran and reverses its anticoagulant 1Mayo Medical School, 2Division of Cardiovascular Diseases, Department effect. In a recent Phase III study (Reversal Effects of Idarucizumab on Active Dabigatran), a 5 g of Internal Medicine, 3Department of intravenous infusion of idarucizumab resulted in the normalization of dilute thrombin time in Pediatrics and Adolescent Medicine, 98% and 93% of the two groups studied, with normalization of ecarin-clotting time in 89% and Mayo Clinic, Rochester, MN, USA 88% patients. Two other antidotes, andexanet alfa (PRT064445) and ciraparantag (PER977) are also under development for reversal of NOACs. In this review, we discuss commonly encountered For personal use only. management issues with NOACs such as periprocedural management, laboratory monitoring of anticoagulation, and management of bleeding. We review currently available data regarding specific antidotes to NOACs with respect to pharmacology and clinical trials. Keywords: novel oral anticoagulant, dabigatran, idarucizumab, reversal Video abstract Introduction For decades, vitamin K antagonists such as warfarin were the only oral agents avail- able for long-term anticoagulation. Warfarin’s variable bioavailability and drug–drug interactions complicate achievement of therapeutic anticoagulation and necessitate regular monitoring.
    [Show full text]
  • Hepatitis Central.Com 2016 Was an Amazing Year for Hepatitis C Drug Progress
    Hepatitis C – Hepatitis Central.Com 2016 was an amazing year for Hepatitis C drug progress. In 2016, Harvoni and Viekira Pak were the most likely prescribed Hepatitis C medications. In addition, Zepatier, Viekira XR, Technivie and Epclusa were approved by the FDA to treat Hepatitis C. Used for different Hepatitis C genotypes, these medications boast a very high success rate, eliminating the Hepatitis C virus in 95 to 100 percent of patients. However, there is always room for improvement. The following pharmaceutical companies are leading the way: Gilead This combination consists of sofosbuvir, velpatasvir and voxilaprevir to treat people who had failed previous therapies and to provide higher cure rates for those who had not been previously treated (genotypes 1 through 6). The cure rates in phase 3 clinical trials were 95 to 98 percent. This led to being granted Breakthrough Therapy designation by the FDA for those with genotype 1 who had failed a previous course of therapy that contained a NS5A inhibitor and being submitted in December 2016 for approval to treat all genotypes. AbbVie The combination of glecaprevir (ABT-493) plus pibrentasvir (ABT-530) was used to treat genotypes 1, 3, 4, 5 and 6 for a duration of just eight weeks. This combination was granted Breakthrough Therapy designation by the FDA for those with genotype 1 who had failed a previous course of therapy that contained a NS5A inhibitor. In December 2016 AbbVie applied to the FDA to market and treat all Hepatitis C genotypes with this drug combination. Janssen • Samatasvir – currently in phase 1 development for genotypes 1, 2, 3 and 4, and in a phase II study with Olysio (simeprevir) in treatment-naı̈ve patients with genotype 1b or 4.
    [Show full text]
  • Single-Dose Ciraparantag Safely and Completely Reverses Anticoagulant Effects of Edoxaban
    Coagulation and Fibrinolysis 238 Single-dose ciraparantag safely and completely reverses anticoagulant effects of edoxaban Jack E. Ansell1; Sasha H. Bakhru2; Bryan E. Laulicht2; Solomon S. Steiner2; Michael A. Grosso3; Karen Brown3; Victor Dishy3; Hans J. Lanz3; Michele F. Mercuri3; Robert J. Noveck4; James C. Costin2 1New York, New York, USA; 2Perosphere Inc., Danbury, Conneticut, USA; 3Daiichi Sankyo Pharma Development, Edison, New Jersey, USA; 4Duke University Medical Center, Durham, North Carolina, USA Summary change in fibrin diameter quantified by automated image analysis. Of the new direct oral anticoagulants, direct factor Xa inhibitors are Potentially related adverse events were periorbital and facial flushing limited by the absence of a proven reversal agent. We assessed the and cool sensation following IV injection of ciraparantag. Renal excre- safety, tolerability and impact on anticoagulation reversal of cira- tion of ciraparantag metabolite was the main elimination route. There parantag (PER977) alone and following a 60 mg dose of the FXa in- was no evidence of procoagulant activity following ciraparantag as hibitor edoxaban. Escalating, single IV doses of ciraparantag were ad- assessed by D-dimer, prothrombin fragments 1.2, and tissue factor ministered alone and following a 60 mg oral dose of edoxaban in a pathway inhibitor levels. In conclusion, ciraparantag in healthy sub- double-blind, placebo-controlled fashion to healthy subjects. Serial as- jects is safe and well tolerated with minor, non-dose limiting adverse sessments of the pharmacokinetics and pharmacodynamic effects of events. Baseline haemostasis was restored from the anticoagulated ciraparantag were performed. Eighty male subjects completed the state with doses of 100 to 300 mg ciraparantag within 10–30 minutes study.
    [Show full text]
  • Ciraparantag; Expectations Regarding the U.S
    AMAG Pharmaceuticals JP Morgan 37th Healthcare Conference January 2019 © 2019 AMAG Pharmaceuticals, Inc. All rights reserved 1 Forward-Looking Statements This presentation contains forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, the anticipated regulatory timeline for AMAG’s products and product candidates and expectations for AMAG’s product portfolio; AMAG’s belief that temporary supply constraints of the Makena auto-injector are now resolved; AMAG’s belief that its historical value drivers will fund future value drivers; beliefs about Intrarosa’s market share and commercial opportunity; characterizations of and beliefs about study data; AMAG’s beliefs regarding the impact of its direct to consumer campaign for Intrarosa, including trends in prescriptions and patient engagement; expectations related to the impact of changes to AMAG’s copay program on Intrarosa’s gross to net revenues; beliefs about the Vyleesi Phase 3 studies, including favorable safety profile; beliefs about the market for, and the anticipated timeline for launch of, Vyleesi (if approved); beliefs about preeclampsia, including the potential benefits of AMAG-423 and the expected market opportunity; AMAG’s beliefs regarding the target product profile for AMAG-423, including the presumed mechanism of action, indication, and safety profile; AMAG’s beliefs regarding the clinical efficacy,
    [Show full text]