Student Clinical Digest

Total Page:16

File Type:pdf, Size:1020Kb

Student Clinical Digest 2014-2015 STUDENT CLINICAL DIGEST Presented by the Student College of Clinical Pharmacy— the official UGA chapter of American College of Clinical Pharmacy Volume 1, Issue 4 Clinical Pharmacist Focus ences and humble advice to our tered. I wanted to be a generalist students. and didn’t want to specialize out of fear of being too narrowly Why did you decide to pursue a focused and lacking variety. I residency? liked being able to dip my feet in other fields, and this has really I decided to pursue a residency helped me in the positions I’ve because of the opportunities held. available to me as a 4th year stu- dent on rotation at Emory Uni- What made you switch from versity Medical Center. During hospital to academia? this APPE, it was the 1st time I Michael Neville, Pharm. D., saw pharmacist working with the Someone told me many years ago BCPS, FASHP surgery team, internal medicine, they thought I would be a really intensive care unit, and transplant. great teacher and other people INSIDE THIS By Khushbu Tejani, Pharm D. Candi- What really impressed me was pointed it out a few more times ISSUE: date seeing the pharmacists being during my career. Both my par- proactive and contributing to ents come from an educational In this issue, we meet Dr. Michael patient care in a way that I never background and wanted me to Neville, a clinical pharmacist as saw before. While there, they got follow. I initially did not want to Clinical 1 well as former Clinical Associate to know me and asked me to pursue academia but it runs in my Pharmacist Focus Professor at the College of Phar- consider applying for their resi- blood. I enjoy teaching because I macy. Dr. Neville completed his dency program. At that time, it struggled a lot while a student Pharmacist’s Po- 1 PGY1 residency at Emory Hospi- was a great opportunity that I myself so I can relate to students tential Role in the tal and worked there as a clinical knew I didn’t want to pass up. who struggle. I enjoy seeing those Ebola Outbreak pharmacist in the following years. people learn things, see the light Prior to leaving the College in Why did you choose not to spe- bulb come on, and for them to December to assume responsibili- cialize and do a PGY2? realize they can really learn the Denying Immuniza- 3 ties as the Assistant Dean of stuff and do well with it in the tion: An Epidemic Student Affairs at Wingate School At the end of my PGY1, I was future. of Pharmacy, he was able to share more of an internal medicine with us his many clinical experi- clinical pharmacist and like the Continues on Page 2 Dyslipidemia Man- 4 variety of disease states encoun- agement Guide- lines: A Battle Field Pharmacist’s Potential Role in the Ebola Outbreak Brincidofovir: The 5 Potential New Drug for the Treatment Ebola By Brittany Chambers and most widespread Ebola out- vided as needed and can signifi- With the emergence of the Ebola break since the virus was first cantly increase the chance of virus outbreak spreading to the discovered in 1976, according to survival (1). There are currently United States in the fall of 2014, the World Health Organization. two experimental vaccines, cAd3- Drug digest in side- widespread panic has set in There are 5 species of the Ebola ZEBOV and VSV-EBOV, which bar! among the population. The out- virus and the most recent out- are undergoing Phase I trials that By Marisa Fortunato break began in Guinea in March break in 2014 was caused by the began in September and October of 2014 and with no therapies or Zaire species. Ebola virus disease of 2014 (2). If Phase I trials are vaccines against this deadly dis- (EVD) is a severe illness that can successful, it is thought that these ease, it spread to at least seven be fatal, especially if untreated. vaccines will be put on the fast- other countries by October of Currently, there are no FDA- track to FDA approval for use in 2014, including the United States. approved antiviral treatments for the current Ebola outbreak; The current outbreak is the largest EVD but supportive care is pro- Continued on Page 2 STUDENT CLINICAL DIGEST Page 2 Clinical Pharmacist Focus Continued from front page smaller projects for each rotation. those who are willing to take con- How would you describe your typical The day-to-day activities are really structive criticism and able to be time workday as a resident and even the varied depending on the rotation. On managers. We try to figure out all of few years after residency? some services, the team rounds twice these characteristics and skills during a day, such as the ICU rotation, but the interview process. By using multi- Emory residency was very intense. I others may only do once a day. ple preceptors to ask different ques- wasn’t really a great student in phar- tions, we were able to know more macy and really only began to under- about these skills and the candidate’s stand and focus on my work at the When you were the director of the personality, motivation, and needs. end of my degree. I knew the resi- residency program, what factors did We may even give a short exam and dency was intense but still decided to you look at in your applicants? afterwards, we would get together do it. The program is laid out with an and rank each individual candidate orientation session at the beginning We looked for applicants who were and choose the ones who would do followed by month-long experiences well rounded. Because our program well and fit well into our program. indifferent specialties such as surgery had several residents (4 or 5), we or oncology, precepted by different needed them to work well together How flexible were the rotations? clinical pharmacist. The resident is and looked for these characteristics also assigned a clinical pharmacist to during the interview. We also looked There are some rotations that their be the overall mentor/advisor as a for those who weren’t too “needy” as program considered to be essential or consistent presence and guide. This well and whether our program was a required, but also reserved a few Hysingla ER (hydrocodone): clinical pharmacist is helpful when good match for what they were months where the residents were able you do your grand round presenta- looking for in a residency. Some to choose certain rotations in which Hysingla ER is a long-acting tion and research project. The re- applicants may have had multiple they showed more interested such as hydrocodone product that was approved search project is intense for those degrees whose needs were more than bone marrow transplant. by the FDA in November 2014. It has who haven’t completed a research what we could offer. Those who are Continues on Page 3 been approved for use in patients who project. In addition to that, there are self-directed and motivated really require chronic management of severe also several longitudinal projects and stood out for us. We also sought pain and who have failed previous thera- pies. It is available in strengths of 20 mg -120 mg hydrocodone and is designed to be taken once every 24 hours. Given the high potency of this product and the already widespread problem of abuse of opioid painkillers, a high potential for misuse exists. In an attempt to solve this problem, Hysingla ER has been Pharmacist’s Potential Role in the Ebola Outbreak formulated with unique physical and Continued from front page chemical properties designed to deter its abuse. The tablet itself is difficult to break and crush, which will make alter- by Brittany Chambers response against the Ebola virus (2). nate routes of ingestion more challeng- this is where a potential role for Pharmacists have gained a large and ing. Additionally, it does not dissolve pharmacists could come into play. vital role in providing immunizations easily, forming a viscous gel instead of a cAd3-ZEBOV is derived from a and with the panic and fear of the solution, making injection difficult. It is chimpanzee adenovirus and is genet- current Ebola outbreak, administer- the hope of the manufacturer, Purdue ically engineered to express glycopro- ing vaccinations against the Ebola Pharma L.P., that Hysingla will provide teins from both the Sudan and Zaire virus may become a primary duty of an effective therapeutic option for pa- species of the Ebola virus to generate pharmacists, if and when they are tients who need chronic pain manage- an immune response (2). VSV- approved. ment, while simultaneously cutting EBOV is a recombinant vesicular down on the potential for its abuse. stomatitis virus-based vaccine that References: References: encodes for the Ebola virus (EBOV) WHO: Ebola Virus Disease update, FDA News Release. “FDA approves glycoprotein in place of the of the 1 Sept. 2014. Web. 24 Nov. 2014. extended-release, single-entity hydroco- vesicular stomatitis virus (VSV) <http://www.who.int/mediacentre/ done product with abuse-deterrent glycoprotein to provoke an immune factsheets/fs103/en/>. properties”. November 20, 2014. Gao J, Yin L. "Drug Development http://www.fda.gov/newsevents/ for Controlling Ebola Epidemic - A newsroom/pressannouncements/ Race against Time." Drug Discoveries ucm423977.htm & Therapeutics 8.5 (2014): 229-31. Web. 24 Nov. 2014. <https:// www.jstage.jst.go.jp/article/ ddt/8/5/8_2014.01040/_article>. Volume 1, Issue 4 Page 3 Clinical Pharmacist Focus Continued from page 2 “Students can What educational steps did you take competitive.
Recommended publications
  • A Multicenter, Multi-Outbreak, Randomized, Controlled Safety And
    2018 Ebola MCM RCT Protocol Page 1 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 A Multicenter, Multi-Outbreak, Randomized, Controlled Safety and Efficacy Study of Investigational Therapeutics for the Treatment of Patients with Ebola Virus Disease Short Title: 2018 Ebola MCM RCT Protocol Sponsored by: Office of Clinical Research Policy and Regulatory Operations (OCRPRO) National Institute of Allergy and Infectious Diseases 5601 Fishers Lane Bethesda, MD 20892 NIH Protocol Number: 19-I-0003 Protocol IND #: 125530 ClinicalTrials.gov Number: NCT03719586 Date: 4 October 2019 Version: 7.0 CONFIDENTIAL This document is confidential. No part of it may be transmitted, reproduced, published, or used by other persons without prior written authorization from the study sponsor and principal investigator. 2018 Ebola MCM RCT Protocol Page 2 of 92 IND#: 125530 CONFIDENTIAL 4 October 2019, version 7.0 KEY ROLES DRC Principal Investigator: Jean-Jacques Muyembe-Tamfum, MD, PhD Director-General, DRC National Institute for Biomedical Research Professor of Microbiology, Kinshasa University Medical School Kinshasa Gombe Democratic Republic of the Congo Phone: +243 898949289 Email: [email protected] Other International Investigators: see Appendix E Statistical Lead: Lori Dodd, PhD Biostatistics Research Branch, DCR, NIAID 5601 Fishers Lane, Room 4C31 Rockville, MD 20852 Phone: 240-669-5247 Email: [email protected] U.S. Principal Investigator: Richard T. Davey, Jr., MD Clinical Research Section, LIR, NIAID, NIH Building 10, Room 4-1479, Bethesda,
    [Show full text]
  • Brincidofovir Is Highly Efficacious in Controlling Adenoviremia In
    Brincidofovir is highly efficacious in controlling adenoviremia in pediatric recipients of hematopoietic cell transplant Prashant Hiwarkar,1 Persis Amrolia,2 Ponni Sivaprakasam,3 Su Han Lum,4 Hemalatha Doss,5 Ciara O’Rafferty,1 Toni Petterson,6 Katharine Patrick,7 Juliana Silva,2 Mary Slatter,5 Sarah Lawson,1 Kanchan Rao,2 Colin Steward,3 Adam Gassas,3 Paul Veys,2 Robert Wynn4 On behalf of the UK Paediatric BMT Group 1Department of Haematology and Bone Marrow Transplantation, Birmingham Children’s Hospital, Birmingham, UK; 2Department of Bone Marrow Transplantation, Great Ormond Street Hospital for Children, London; 3Department of Bone Marrow Transplantation, Royal Hospital for Children, Bristol, UK; 4Department of Bone Marrow Transplantation, Royal Manchester Children's Hospital, Manchester, UK; 5Department of Bone Marrow Transplantation, Great North Children's Hospital, Newcastle upon Tyne, UK; 6Department of Bone Marrow Transplantation, Royal Marsden Hospital, Sutton, UK; 7Department of Bone Marrow Transplantation, Sheffield Children's Hospital, Sheffield, UK Address for Correspondence: [email protected] Department of Haematology and Bone Marrow transplantation Birmingham Children’s Hospital, Steelhouse Lane, Birmingham, UK B4 6NH Tel. +44 (0)121 333 9999 Key points Brincidofovir has superior anti-adenoviral activity and safety profile compared to Cidofovir. Brincidofovir is highly efficacious in controlling adenoviraemia during lymphopenic phase of HCT. Summary Cidofovir is pre-emptively used for controlling adenoviremia and preventing disseminated viral disease in hematopoietic cell transplant (HCT) recipients but does not lead to resolution of viremia without T-cell immune-reconstitution. The lipid conjugated prodrug of Cidofovir, Brincidofovir, has improved oral bioavailability and achieves higher intracellular concentrations of active drug.
    [Show full text]
  • Ebola Hemorrhagic Fever: Properties of the Pathogen and Development of Vaccines and Chemotherapeutic Agents O
    ISSN 00268933, Molecular Biology, 2015, Vol. 49, No. 4, pp. 480–493. © Pleiades Publishing, Inc., 2015. Original Russian Text © O.I. Kiselev, A.V. Vasin, M.P. Shevyryova, E.G. Deeva, K.V. Sivak, V.V. Egorov, V.B. Tsvetkov, A.Yu. Egorov, E.A. RomanovskayaRomanko, L.A. Stepanova, A.B. Komissarov, L.M. Tsybalova, G.M. Ignatjev, 2015, published in Molekulyarnaya Biologiya, 2015, Vol. 49, No. 4, pp. 541–554. REVIEWS UDC 578.2,578.76 Ebola Hemorrhagic Fever: Properties of the Pathogen and Development of Vaccines and Chemotherapeutic Agents O. I. Kiseleva, A. V. Vasina, b, M. P. Shevyryovac, E. G. Deevaa, K. V. Sivaka, V. V. Egorova, V. B. Tsvetkova, d, A. Yu. Egorova, E. A. RomanovskayaRomankoa, L. A. Stepanovaa, A. B. Komissarova, L. M. Tsybalovaa, and G. M. Ignatjeva a Institute of Influenza, Ministry of Health of the Russian Federation, St. Petersburg, 197376 Russia; email: [email protected] b St. Petersburg State Polytechnic University, St. Petersburg, 195251 Russia c Ministry of Health of the Russian Federation, Moscow, 127994 Russia d Topchiev Institute of Petrochemical Synthesis, Moscow, 119991 Russia Received December 29, 2014; in final form, January 16, 2015 Abstract—Ebola hemorrhagic fever (EHF) epidemic currently ongoing in West Africa is not the first among numerous epidemics in the continent. Yet it seems to be the worst EHF epidemic outbreak caused by Ebola virus Zaire since 1976 as regards its extremely large scale and rapid spread in the population. Experiments to study the agent have continued for more than 20 years. The EHF virus has a relatively simple genome with seven genes and additional reading frame resulting from RNA editing.
    [Show full text]
  • Kinase Inhibitors and Nucleoside Analogues As Novel Therapies to Inhibit HIV-1 Or ZEBOV Replication
    Kinase Inhibitors and Nucleoside Analogues as Novel Therapies to Inhibit HIV-1 or ZEBOV Replication by Stephen D. S. McCarthy A thesis submitted in conformity with the requirements for the degree of Doctor of Philosophy Department of Laboratory Medicine and Pathobiology University of Toronto © Copyright by Stephen D. S. McCarthy (2017) Kinase Inhibitors and Nucleoside Analogues as Novel Therapies to Inhibit HIV-1 or ZEBOV Replication Stephen D.S. McCarthy Doctor of Philosophy Graduate Department of Laboratory Medicine and Pathobiology University of Toronto 2017 Abstract Without a vaccine for Human Immunodeficiency Virus type 1 (HIV-1), or approved therapy for treating Zaire Ebolavirus (ZEBOV) infection, new means to treat either virus during acute infection are under intense investigation. Repurposing tyrosine kinase inhibitors of known specificity may not only inhibit HIV-1 replication, but also treat associated inflammation or neurocognitive disorders caused by chronic HIV-1 infection. Moreover, tyrosine kinase inhibitors may effectively treat other infections, including ZEBOV. In addition, established nucleoside/nucleotide analogues that effectively inhibit HIV-1 infection, could also be repurposed to inhibit ZEBOV replication. In this work the role of two host cell kinases, cellular protoncogene SRC (c-SRC) and Protein Tyrosine Kinase 2 Beta (PTK2B), were found to have key roles during early HIV-1 replication in primary activated CD4+ T-cells ex vivo. siRNA knockdown of either kinase increased intracellular reverse transcripts and decreased nuclear proviral integration, suggesting they act at the level of pre-integration complex (PIC) formation or PIC nuclear translocation. c-SRC siRNA knockdown consistently reduced p24 levels of IIIB(X4) and Ba-L(R5) infection, or luciferase ii activity of HXB2(X4) or JR-FL(R5) recombinant viruses, prompting further drug inhibition studies of this kinase.
    [Show full text]
  • Situación Actual Del Tratamiento Farmacológico Frente a La Enfermedad Causada Por El Virus Ébola
    Revisión Jordi Reina Situación actual del tratamiento farmacológico frente a la enfermedad causada por el virus Ébola Unidad de Virología. Servicio de Microbiología. Hospital Universitario Son Espases. Palma de Mallorca RESUMEN Current status of drug treatment against the disease caused by the Ebola virus La reciente epidemia de enfermedad causada por el virus Ébola ha puesto en evidencia la necesidad de desarrollar y dis- ABSTRACT poner de fármacos específicos para hacer frente a esta entidad. De acuerdo con los datos virológicos se han diseñado algunos The recent epidemic of disease caused by the Ebola virus fármacos nuevos y se ha comprobado que otros podrían tener has highlighted the need to develop specific drugs and have to eficacia frente a este virus. deal with this entity. According to virological analysis they have Las principales líneas terapéuticas se basan en la inmu- been designed to give you some new drugs and are proven to noterapia (suero de pacientes convalescientes y anticuerpos others might be effective against this virus. monoclonales específicos), en fármacos antivirales (favipiora- The main lines of therapy are based on immunotherapy vir, BCX4430, Brincidofovir), RNAs de interferencia (TKM-Ébola) (convalescent serum of patients and specific monoclonal an- y oligonucleótidos sin sentido (morfolino fosforodiamidato) y tibodies), antiviral drugs (favipiravir, BCX4430, brincidofovir), otros fármacos no antivirales (clomifeno, NSC62914, FGI-103, interfering RNAs (TKM-Ebola) and antisense oligonucleotides amilorida y la ouabaina). (morpholino phosphorodiamidate) and other drugs no antiviral Los estudios existentes son escasos y principalmente en (clomiphene NSC62914, FGI-103, amiloride and ouabain). modelos animales y los ensayos clínicos han quedado la ma- Existing studies are scarce and mainly in animal models yoría inconclusos por la disminución drástica del número de and clinical trials have been inconclusive most by the drastic nuevos casos.
    [Show full text]
  • The Role of Brincidofovir in Preparation for a Potential Smallpox Outbreak
    viruses Perspective The Role of Brincidofovir in Preparation for a Potential Smallpox Outbreak Scott A. Foster 1,*, Scott Parker 2 ID and Randall Lanier 1 1 Chimerix, Durham, NC 27713, USA; [email protected] 2 Department of Molecular Microbiology and Immunology, Saint Louis University School of Medicine, St. Louis, MO 63104, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-597-7741 Received: 29 September 2017; Accepted: 26 October 2017; Published: 30 October 2017 Abstract: Smallpox (variola) virus is considered a Category A bioterrorism agent due to its ability to spread rapidly and the high morbidity and mortality rates associated with infection. Current recommendations recognize the importance of oral antivirals and call for having at least two smallpox antivirals with different mechanisms of action available in the event of a smallpox outbreak. Multiple antivirals are recommended due in large part to the propensity of viruses to become resistant to antiviral therapy, especially monotherapy. Advances in synthetic biology heighten concerns that a bioterror attack with variola would utilize engineered resistance to antivirals and potentially vaccines. Brincidofovir, an oral antiviral in late stage development, has proven effective against orthopoxviruses in vitro and in vivo, has a different mechanism of action from tecovirimat (the only oral smallpox antiviral currently in the US Strategic National Stockpile), and has a resistance profile that reduces concerns in the scenario of a bioterror attack using genetically engineered smallpox. Given the devastating potential of smallpox as a bioweapon, preparation of a multi-pronged defense that accounts for the most obvious bioengineering possibilities is strategically imperative. Keywords: smallpox; variola virus; bioterrorism; bioweapon; brincidofovir; CMX001; antiviral 1.
    [Show full text]
  • Integrated Computational Approach for Virtual Hit Identification Against
    International Journal of Molecular Sciences Article Integrated Computational Approach for Virtual Hit Identification against Ebola Viral Proteins VP35 and VP40 Muhammad Usman Mirza 1,2,*,† and Nazia Ikram 2 1 Centre for Research in Molecular Medicine (CRiMM), The University of Lahore, Defense Road, Lahore 54000, Pakistan 2 Institute of Molecular Biology and Biotechnology, The University of Lahore, Lahore 54000, Pakistan; [email protected] * Correspondence: [email protected] or [email protected]; Tel.: +92-333-839-6037 † Current address: Department of Pharmaceutical and Pharmacological Sciences, Rega Institute for Medical Research, Medicinal Chemistry, University of Leuven, Leuven B-3000, Belgium. Academic Editors: Christo Z. Christov and Tatyana Karabencheva-Christova Received: 28 July 2016; Accepted: 22 September 2016; Published: 26 October 2016 Abstract: The Ebola virus (EBOV) has been recognised for nearly 40 years, with the most recent EBOV outbreak being in West Africa, where it created a humanitarian crisis. Mortalities reported up to 30 March 2016 totalled 11,307. However, up until now, EBOV drugs have been far from achieving regulatory (FDA) approval. It is therefore essential to identify parent compounds that have the potential to be developed into effective drugs. Studies on Ebola viral proteins have shown that some can elicit an immunological response in mice, and these are now considered essential components of a vaccine designed to protect against Ebola haemorrhagic fever. The current study focuses on chemoinformatic approaches to identify virtual hits against Ebola viral proteins (VP35 and VP40), including protein binding site prediction, drug-likeness, pharmacokinetic and pharmacodynamic properties, metabolic site prediction, and molecular docking. Retrospective validation was performed using a database of non-active compounds, and early enrichment of EBOV actives at different false positive rates was calculated.
    [Show full text]
  • A Library of Nucleotide Analogues Terminate RNA Synthesis Catalyzed by Polymerases of Coronaviruses Causing SARS and COVID-19
    bioRxiv preprint doi: https://doi.org/10.1101/2020.04.23.058776; this version posted April 25, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. It is made available under aCC-BY-NC-ND 4.0 International license. A Library of Nucleotide Analogues Terminate RNA Synthesis Catalyzed by Polymerases of Coronaviruses Causing SARS and COVID-19 Steffen Jockusch1,2,#, Chuanjuan Tao1,3,#, Xiaoxu Li1,3,#, Thomas K. Anderson5,6, Minchen Chien1,3, Shiv Kumar1,3, James J. Russo1,3, Robert N. Kirchdoerfer5,6,*, Jingyue Ju1,3,4,* 1Center for Genome Technology and Biomolecular Engineering, Columbia University, New York, NY 10027; Departments of 2 Chemistry, 3Chemical Engineering, and 4Pharmacology, Columbia University, New York, NY 10027; 5Departments of Biochemistry and 6Institute of Molecular Virology, University of Wisconsin-Madison, Madison, WI 53706 #SJ, CT and XL contributed equally to this work. *To whom correspondence should be addressed: [email protected] (JJ); [email protected] (RNK) Abstract SARS-CoV-2, a member of the coronavirus family, is responsible for the current COVID-19 worldwide pandemic. We previously demonstrated that five nucleotide analogues inhibit the SARS-CoV-2 RNA- dependent RNA polymerase (RdRp), including the active triphosphate forms of Sofosbuvir, Alovudine, Zidovudine, Tenofovir alafenamide and Emtricitabine. We report here the evaluation of a library of additional nucleoside triphosphate analogues with a variety of structural and chemical features as inhibitors of the RdRps of SARS-CoV and SARS-CoV-2. These features include modifications on the sugar (2’ or 3’ modifications, carbocyclic, acyclic, or dideoxynucleotides) or on the base.
    [Show full text]
  • Management of Patients with Ebola Virus Disease: Clinical and Operational Lessons Learned
    Management of Patients with Ebola Virus Disease: Clinical and Operational Lessons Learned Colleen Kraft, MD, MSc Steven J. Lisco, MD, FCCM, FCCP Serious Communicable Diseases Unit Nebraska Biocontainment Unit Emory University Hospital University of Nebraska Medical Center Atlanta, GA Omaha, NE Disclosures • Lisco – None • Kraft – None Learning Objectives • Understand the history of Ebola Virus Disease • Review and recognize the clinical concerns in patients infected with Ebola virus • Describe the design, clinical workflow, and utilization of a biocontainment unit • Recognize the logistical challenges presented by the care of patients infected with Ebola virus and other highly pathogenic contagions and implications for healthcare workers in the biocontainment unit environment Recognize this Bill? How about now? Perhaps the only good news from the tragic Ebola epidemic in Guinea, Sierra Leone, and Liberia is that it may serve as a wake-up call: we must prepare for future epidemics of diseases that may spread more effectively than Ebola. DOI: 10.1056/NEJMp1502918 http://awesome.good.is/transparency/web/1108/deadliest-pandemics/transparency.jpg (accessed 2.11.15) Ebola: Virology • Filovirus (Latin for ‘thread’): elongated structure, -ssRNA • 6 subtypes • Zaire <<<< Currently active • Sudan • Bundibugyo • Cote d’Ivoire/Tai Forest • Reston (not pathogenic to humans) • Lloviu (no human infections identified) • Viral Hemorrhagic Fever • One of four viruses EBV Disease • Ebola virus was discovered in 1976 near the Ebola River in what is now the Democratic Republic of the Congo • Outbreaks have appeared sporadically in Africa • The 2014 outbreak is the first in West Africa, and the largest outbreak ever recorded www.cdc.gov 22 PREVIOUS EBV OUTBREAKS Mylne, A.
    [Show full text]
  • Experimental Medications and Vaccines for Ebola
    Experimental Medications and Vaccines for Ebola There are currently no FDA-approved medications or vaccines for the treatment of Ebola. The primary focus for physicians at this time is to provide general medical care and support in a safe setting where further spread of the infection can be contained. The general medical care would include things such as intravenous fluids, nutrition, and treating other infections if they occur. FDA Website with general information on Ebola: http://www.fda.gov/emergencypreparedness/counterterrorism/medicalcountermeasures/ ucm410308.htm CDC site with information for healthcare workers: http://www.cdc.gov/vhf/ebola/hcp/index.html World Health Organization Website on Ebola: http://www.who.int/csr/disease/ebola/en/ Although several medications and vaccines for Ebola are currently being developed and tested, this research is for the most part in early stages. Some have been tested only in laboratory setting, some in animals, and some in healthy individuals to see if they are safe. None of these investigational treatments have been adequately assessed to be able to say they are safe and effective in the treatment of patients with Ebola. CDC site with questions and answers on experimental treatments and vaccines for Ebola: http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/qa-experimental- treatments.html While no medications or vaccines are FDA-approved for Ebola, there is an emergency process in place to allow for use of these products while they are being evaluated. The FDA has a system for experimental products to be used for patients in certain circumstances, even when there is limited available information.
    [Show full text]
  • Ebola Virus Infection
    Ebola Virus Infection: a review on the pharmacokinetic and pharmacodynamic properties of drugs considered for testing in human efficacy trials Vincent Madelain, Thi Huyen Tram Nguyen, Anaelle Olivo, Xavier de Lamballerie, Jeremie Guedj, Anne-Marie Taburet, France Mentré To cite this version: Vincent Madelain, Thi Huyen Tram Nguyen, Anaelle Olivo, Xavier de Lamballerie, Jeremie Guedj, et al.. Ebola Virus Infection: a review on the pharmacokinetic and pharmacodynamic properties of drugs considered for testing in human efficacy trials. Clinical Pharmacokinetics, Springer Verlag, 2016, 55 (8), pp.907-23. 10.1007/s40262-015-0364-1. inserm-01344917 HAL Id: inserm-01344917 https://www.hal.inserm.fr/inserm-01344917 Submitted on 12 Jul 2016 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Title Ebola Virus Infection: a review on the pharmacokinetic and pharmacodynamic properties of drugs considered for testing in human efficacy trials Authors: Vincent Madelain (1)* • Thi Huyen Tram Nguyen (1)* • AnaelleOlivo (2) • Xavier de Lamballerie (3,4) • Jérémie Guedj (1) • Anne-Marie Taburet (2) • France Mentré (1) *Vincent Madelain and Thi Huyen Tram Nguyen contributed equally to this manuscript. Affiliations: (1) INSERM, IAME, UMR 1137, F-75018 Paris, France ; Université Paris Diderot, IAME, UMR 1137, Sorbonne Paris Cité, F-75018 Paris, France (2) Hospital Bicêtre, Assistance Publique-Hôpitaux de Paris, DHU Hepatinov ; INSERM U1184, Center for Immunology of Viral Infections and AutoimmuneDiseases, Université Paris-Sud, Kremlin Bicêtre.
    [Show full text]
  • Chimerix Announces FDA Extends PDUFA Date of New Drug Application for Brincidofovir As a Medical Countermeasure for Smallpox to July 7, 2021
    February 26, 2021 SymBio Pharmaceuticals Limited Fuminori Yoshida Representative Director President and Chief Executive Officer (Securities Code: 4582) Chimerix Announces FDA Extends PDUFA Date of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox to July 7, 2021 TOKYO, Japan, February 26, 2021 -- SymBio Pharmaceuticals Limited (Headquarters: Tokyo, "SymBio") today announced that Chimerix Inc. (Headquarters: Durham, NC, "Chimerix") announced on February 25, 2021 (US EST) that they received notification from the FDA that the Prescription Drug User Fee Act (PDUFA) goal date for review of brincidofovir (BCV) as a medical countermeasure for smallpox has been extended three months to July 7, 2021. SymBio, pursuant to a license agreement with Chimerix entered into on September 30, 2019, obtained the exclusive worldwide rights to develop, manufacture, and commercialize BCV in all human indications, excluding the prevention and treatment of orthopox infections (which includes smallpox and monkeypox), and SymBio is preparing to initiate a global study of BCV targeting adenovirus (AdV) infections occurring after hematopoietic stem cell transplantation. Chimerix is developing BCV as a potential medical countermeasure for smallpox under an ongoing collaboration and funding provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. Chimerix does not expect a later FDA action date will impact the timing of the BARDA request for proposal, which is expected this quarter, nor the potential timing of first shipments of BCV to the strategic national stockpile, expected in the second half of this year, according to “Chimerix Reports Fourth Quarter and Year End 2020 Financial Results and Provides Operational Update” published on February 25, 2021 (US EST).
    [Show full text]