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Alexandra Stevens
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This document is provided as a courtesy to those interested in Emory Healthcare and does not constitute medical

Also, Emory Healthcare does not endorse or recommend any specific commercial product or service.

purpose. The Emory Healthcare Ebola Preparedness Protocols full site/materials Disclaimer is available at www.

1 This document is provided as a courtesy to those interested in Emory Healthcare and does not constitute medical or any other advice and does not create any physician-patient relationship. Also, Emory Healthcare does not endorse or recommend any specific commercial product or service. This document is provided solely for informational purposes only and no part of it may be used for any other purpose. The Emory Healthcare Ebola Preparedness Protocols full site/materials Disclaimer is available at These documents are subject to change based on developing epidemiology in the country. Updated 11/10/ :34 AM Copyright Emory Healthcare 2014 All Rights Reserved.

2 Care of the Patient with Ebola Virus Disease EBOLA VIRUS DISEASE (EVD)

Background on Ebola Virus Family Filoviridae Two genera: marburgvirus and ebolavirus Enveloped RNA virus Five subtypes of Ebola virus Zaire (EBOV) Sudan

3 Background on Ebola Virus Family Filoviridae Two genera: marburgvirus and ebolavirus Enveloped RNA virus Five subtypes of Ebola virus Zaire (EBOV) Sudan (SUDV) Tai Forest (TAFV) Bundibugyo (BDBV) Reston (RESTV) Mortality from Ebola virus disease (EVD) historically has ranged from 40-88% Cynthia Goldsmith/CDC

4 Ebola Transmission Zoonotic infection Natural reservoir is likely the fruit bat Can be transmitted to other mammals, including primates Human acquisition contact with infected animal, then human-human

5 Human to Human Transmission Ebola is present in blood and body fluids of symptomatic patients Ebola is spread through direct contact of mucous membranes or broken skin with: Blood or body fluids urine, saliva, feces, and vomit Contaminated objects (like needles and syringes) Deceased human victims High amount of viral release after death More infectious as patient becomes more ill

6 Current Outbreak Totals 13,733 cases and 4,920 deaths (as of October 31, 2014) Guinea 1,906 cases 997 deaths Sierra Leone 5,235 cases 1,500 deaths Liberia 6,535 cases 2,413 deaths Nigeria, Senegal, Spain, Mali and USA: 27 cases; 10 deaths

7 Clinical Characteristics of EVD Acute infection starts as a non-specific febrile illness Fever, severe headache, muscle pain, malaise Progression to include GI symptoms diarrhea and vomiting May appear 2-21 days after exposure 8-10 days most common Courtesy of Pierre Rollin, CDC

8 Clinical Characteristics of EVD Small vessel involvement Increased permeability due to cellular damage Multi-organ system failure Hypovolemia Electrolyte derangements Hemorrhage may develop in the second week Coagulopathies Disseminated intravascular coagulation (DIC) Poor prognosis associated with Shock, encephalopathy, extensive hemorrhage

9 Clinical Course of EVD Prodromal phase day 1-3 Fever, malaise/fatigue, headache, myalgias Leukopenia (esp lymphopenia) & thrombocytopenia Limited viral shedding Fever Myalgias Chills Headache Sore throat Abdominal pain Diarrhea Vomiting Rash Bleeding MOF/Death

Clinical Course of EVD Fever + Gastroenteritis/hepatitis day 3-4 to 8-12 Vomiting, diarrhea volume depletion, electrolyte loss Metabolic acidosis Elevated AST >

10 Clinical Course of EVD Fever + Gastroenteritis/hepatitis day 3-4 to 8-12 Vomiting, diarrhea volume depletion, electrolyte loss Metabolic acidosis Elevated AST > ALT but minimal hyperbilirubinemia Fever Myalgias Chills Headache Sore throat Abdominal pain Diarrhea Vomiting Rash Bleeding MOF/Death

11 Critical Illness in EVD Respiratory distress/failure Renal Failure Encephalopathy Severe Shock Severe Hemorrhage Fever Myalgias Chills Headache Sore throat Abdominal pain Diarrhea Vomiting Rash Bleeding MOF/Death

12 Care of the Patient with Ebola Virus Disease LESSONS LEARNED AT EMORY

13 The Patients July 30 SCDU team informed that Emory would receive an aid worker from Liberia with EVD First week of August two were transferred by air ambulance to our hospital, 3 days apart 33 yo male physician, day 11 of illness at arrival 59 yo female missionary, day 15 of illness at arrival Received two additional patients Evacuated physician from Sierra Leone in early September Nurse transferred from a Dallas hospital in mid October

14 This type of facility is NOT necessary for the care of patients with Ebola 14

15 Clinical Care = Supportive Care No proven therapeutics Unclear availability of any experimental agents Limited safety or efficacy data in humans BUT, we received SIGNIFICANT support and advice from CDC, FDA, and medical and scientific colleagues throughout the world

16 Experimental Therapies Therapy Mechanism Status Convalescent plasma Provide anti-ebov antibodies Studies have not shown a clear benefit Has been used in multiple evacuated patients in Hyperimmune globulin from immunized animals or previously infected humans Concentrated plasma to provide high titers of neutralizing antibody this outbreak Not currently available. Work in horses and cattle are underway ZMapp (Mapp Biopharmaceutical Inc.) Cocktail of three chimeric mouse human monoclonal antibodies targeting the GP envelope protein Very promising data in macaques No human trials Very limited supply TKM Lipid (TKM-Ebola; Tekmira) Nanoparticle Small interfering Ribonucleic acid (sirna) Targets two essential viral genes to stop the virus from replicating single-dose phase 1 study in healthy volunteers found side effects including headache, dizziness, chest tightness and raised heart rate at high doses. A limited number of treatment courses

17 Experimental Therapies Therapy Mechanism Status AVI 7537 (Sarepta) Phosphorodiamidate oligonucleotide Monkey studies showed 60-80% when given at the time of infection Tolerability has been demonstrated in early studies. No human grade availability until late October Favipiravir/T-705 (Toyama Chemical/ Fuji Film) BCX4430 (Biocryst) Brincidofovir (CMX001) (Chimerix) Selective inhibition of viral RNAdependent RNA polymerase Does not inhibit RNA or DNA synthesis in mammalian cells lipid conjugate of the nucleotide analog, cidofovir (CDV) uses endogenous lipid uptake pathways to achieve high intracellular concentrations Effective against EVD in mice, but in animal monkey study only 1/6 survived Approved in Japan for influenza treatment under special circumstances. ~ treatment courses may available % survival in rodents with EVD Effective in animals 48 hours after infection with the lethal Marburg virus Testing for EVD in monkeys is underway In vitro data at CDC showing good anti-ebov activity Has been used in 4 patients

18 Experimental Therapies Therapy Mechanism Status Chimpanzee adenovirus serotype 3 (ChAd3) vaccine Uses a chimpanzee adenovirus that does not grow Contains the gene for EVD surface protein 16/16 monkeys were protected from a lethal dose by a single dose of the vaccine Trials in humans ongoing Approximately doses might be available by the end of 2014 Recombinant Vesicular Stomatitis Virus (rvsv) vaccine Recombinant VSV vector expressing ebola GP protein to induce EBOV-specific immune responses 20/ 20 monkeys protected from a lethal dose of EVD Animals with weakened immunity were not harmed by rvsv-evd Unknown if rvsv-evd will grow in humans, which would affect immunogenicity and safety Phase 1 trials underway ~800 doses available

19 The Critical Role of Nursing The ability to provide high-level nursing care and supportive care made a significant impact 24/7 one-on-one nurses allowed for rapid response to changes and adjustment of care Ability to support patients in nutrition, physical therapy, and self care Emotional support Family support Patient- and Family-Centered Model of Care

20 The Impact of Electrolytes Our patients had MARKED electrolyte abnormalities and nutritional deficiencies Hypokalemia, hypocalcemia and hyponatremia Required both intravenous and oral replacement Used oral nutritional supplements including nutritional drinks high in easily absorbed proteins, minerals and vitamins Laboratory testing for chemistries was critical to provide supportive care

21 Antibody Titer (1:x) Monitoring Virologic Status With the help of the CDC, we monitored ebola in blood Progressive declines in viral loads that correlated with improvements in clinical condition Had very low level of nucleic acid detection for several days despite resolution of ZMAPP symptoms ZMAPP 7200 dose #2 Dose # EBOV qrt-pcr (Ct value) IgM IgG NP IgG PCR CT Day of Illness Temp (C) Diarrhea

22 Conclusions from our experience Patients with Ebola can be safely cared for in our healthcare system We do expect a lower mortality rate than in underdeveloped healthcare systems Much can be learned about patient management that can be fed back to facilities with lesser levels of infrastructure Communication is critical Comprehensive, multidisciplinary patient- and familycentered models of care can be delivered even in extreme circumstances

FREQUENTLY ASKED QUESTIONS ABOUT EBOLA VIRUS DISEASE

FREQUENTLY ASKED QUESTIONS ABOUT EBOLA VIRUS DISEASE What is EBOLA? Ebola, previously known as Ebola hemorrhagic fever, is a deadly disease caused by infection with one of the Ebola virus strains. One