Please complete the pre-assessment located in your meeting handout - PowerPoint PPT Presentation

Please complete the pre-assessment located in your meeting handout before the program begins .

Sponsorship and Support This educational activity is jointly provided by the North Carolina Academy of Family Physicians (NCAFP) and Spire Learning. This activity is supported by an educational funding donation provided by Genentech, Inc. 2

Faculty and Disclosures Activity Co-Chair Michael G. Ison, MD, MS Professor of Medicine, Division of Infectious Diseases Professor of Surgery, Division of Organ Transplantation Northwestern University Feinberg School of Medicine Medical Director, Transplant & Immunocompromised Host Infectious Diseases Service Northwestern University Comprehensive Transplant Center Chicago, IL Disclosure Statement: Consultant: Celltrion, Inc; Genentech, Inc/Roche Pharmaceuticals; Janssen Pharmaceuticals, Inc; Shionogi Inc; Viracor Eurofins, Inc; Vir Biotechnology, Inc. Data and Safety Monitoring Board – Member: Janssen Pharmaceuticals, Inc; Merck Sharp & Dohme Corp; Vitaeris Inc. Northwestern University Research: AiCuris Anti-infective Cures GmbH; Emergent BioSolutions Inc; Genentech, Inc/Roche Pharmaceuticals; Gilead Sciences, Inc; Hologic, Inc; Janssen Pharmaceuticals, Inc; Shire Plc 3

Faculty and Disclosures (cont’d) Activity Co-Chair Charles P. Vega Jr, MD Health Sciences Clinical Professor of Family Medicine Assistant Dean for Culture and Community Education UC Irvine School of Medicine Executive Director UC Irvine Program in Medical Education for the Latino Community Irvine, CA Disclosure Statement: Consultant: Genentech, Inc 4

Faculty and Disclosures (cont’d) Faculty Educator Natasha B. Halasa, MD, MPH Associate Professor of Pediatrics Division of Infectious Diseases Vanderbilt University School of Medicine Nashville, TN Disclosure Statement: Consultant: Karius, Inc; Moderna, Inc Laboratory Support and Vaccines: Sanofi U.S. 5

Faculty and Disclosures (cont’d) Faculty Educator Robert H. Hopkins Jr, MD Professor of Internal Medicine and Pediatrics Associate Program Director Internal Medicine–Pediatrics Residency Director, Division of General Internal Medicine University of Arkansas for Medical Sciences Little Rock, AR Disclosure Statement: Dr Hopkins has no financial relationship with any commercial interests to disclose. 6

Faculty and Disclosures (cont’d) Faculty Educator John J. Russell, MD Clinical Professor, Family and Community Medicine Sidney Kimmel Medical College at Thomas Jefferson University Philadelphia, PA Chair, Department of Family Medicine Director, Family Medicine Residency Program Abington Memorial Hospital Abington, PA Disclosure Statement: Advisory Board: GlaxoSmithKline plc; Sanofi U.S. Speaker: Sanofi U.S. 7

Levels of Evidence Levels of evidence are provided for any patient care recommendations made during this presentation. • Level A (randomized controlled trial/meta-analysis): High-quality, randomized controlled trial (RCT) that considers all important outcomes. High-quality meta-analysis (quantitative systematic review) using comprehensive search strategies • Level B (other evidence): A well-designed, nonrandomized clinical trial. A nonquantitative systematic review with appropriate search strategies and well-substantiated conclusions. Includes lower-quality RCTs, clinical cohort studies, and case-controlled studies with nonbiased selection of study participants and consistent findings. Other evidence, such as high-quality, historical, uncontrolled studies, or well-designed epidemiologic studies with compelling findings, is also included • Level C (consensus/expert opinion): Consensus viewpoint or expert opinion Each rating is applied to a single reference in the presentation, not the entire body of evidence on the topic. 8

Off-Label Statement The faculty intends to discuss/present information related to a non–FDA-approved or investigational use of baloxavir marboxil in patients aged 1 to 12 years and as prophylaxis. Participants should appraise the information presented critically and are encouraged to consult appropriate resources for any product or device mentioned in this activity. 9

Learning Objectives Upon completion of this activity, learners should be better able to: • Recommend age-appropriate vaccines to reduce the risk of complications from influenza infection • Identify individuals at high risk of complications from influenza • Select effective antiviral treatment strategies for high-risk patients • Evaluate the risks and benefits of available antiviral therapies for prophylaxis, prevention, and treatment of influenza 10

Consequences of Influenza CDC estimates for October 1, 2018, through May 4, 2019 37.4 – 42.9 17.3 – 20.1 MILLION MILLION flu illnesses flu medical visits 36,400 – 61,200 531,000 – 647,000 flu hospitalizations flu deaths 12

Estimated Annual Economic Burden • Direct costs – increased Total medical care and $11.2 billion healthcare utilization (superinfections, exacerbations of heart failure and reactive airway Direct Costs Indirect Costs disease) $3.2 billion $8.0 billion • Indirect costs – lost (29%) (71%) productivity, employee absenteeism 13

To Treat or Not to Treat, Part 1 • Jason – 31-year-old healthy male who calls your office in late November with a chief complaint of fever, rhinorrhea, aches, and malaise for the past 2 days • He lives with: – 28-year-old wife who is 1-month postpartum and otherwise healthy – Healthy newborn daughter – 72-year-old father who has COPD • CDC reports show local influenza activity • Wife was vaccinated for influenza 2 months ago at recommendation of her Ob-Gyn • Jason and his father both refused vaccination 14

What Would You Do and Why? Would you ask Jason to: 1. Come in for an appointment 2. Prescribe empiric antibiotics 3. Prescribe empiric antivirals 4. Recommend OTC treatment and ask to call back if not better in a couple of days 5. None of the above 15

More Considerations • Who is at high risk in the household? • What strategies would you use to convince Jason and his father to receive their influenza vaccination? 16

PREVENTION

The Standard of Care While there are subpopulations that will have additional benefit from influenza vaccines… EVERYONE > 6 MONTHS OF AGE WITHOUT A CONTRAINDICATION SHOULD BE VACCINATED 18

Vaccine Coverage – How Are We Doing? 2013-2014 2014-2015 2015-2016 2016-2017 2017-2018 6 months-4 years 70.4% 70.4% 70.0% 70.4% 67.8% 5-12 years 61.0% 61.8% 61.8% 59.9% 59.5% 13-17 years 46.4% 46.4% 46.8% 48.8% 47.4% 18-49 years with high-risk condition 38.7% 39.3% 39.5% 39.3% 31.3% 18-49 years w/o high-risk condition 31.1% 32.6% 31.5% 32.6% 26.1% 50-64 years 45.3% 47.0% 43.6% 45.4% 39.7% 65+ years 65.0% 66.7% 63.4% 65.3% 59.6% w/o, without. CDC. https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates.htm. 19 CDC. https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates-children.htm.

Vaccine Efficacy Adjusted Overall Influenza Season 95% Confidence Interval Vaccine Efficacy 1 2018-19 47%* 34, 57 2017-18 38% 31, 43 2016-17 40% 32, 46 2015-16 48% 41, 55 2014-15 19% 10, 27 • While vaccine match matters, there is still reduction of symptoms from vaccine in “bad match” years 2 * Preliminary estimate 1. CDC. https://www.cdc.gov/flu/vaccines-work/past-seasons-estimates.html. 20 2. Gravenstein S, et al. Med Health R I . 2010;93:382-384.

Cardiovascular Impact of Influenza Infection • Protein C and S • Serum Amyloid A • Cytokines • Catecholamines • Hypoxia • Vasoconstriction • Platelet aggregation and coronary plaque disruption Thrombogenesis Emboli Acute myocardial infarction 21 Adapted from MacIntyre CR, et al. Heart . 2016;102:1953-1956. (B)

Cardiovascular Protection From Vaccination Estimated efficacy of vaccine in preventing acute myocardial infarction ranges from 15% to 45% • Compare to…. 32 % -43 % 19 % -30 % 17 % -25 % Smoking Cessation Statins Antihypertensive Therapy • Author suggests that influenza vaccine should be considered as an integral part of cardiovascular disease management and prevention 22 MacIntyre CR, et al. Heart . 2016;102:1953-1956. (B)

Available Vaccine Options Age Options Route Notes Indication Inactivated influenza vaccine (IIV3), standard dose IM ≥ 6 months* Contraindication: egg allergy IM Inactivated influenza vaccine (IIV3), high dose ≥ 65 years Contraindication: egg allergy Adjuvanted, inactivated influenza vaccine (aIIV3) IM ≥ 65 years Contraindication: egg allergy Recombinant influenza vaccines (RIV3, RIV4) IM ≥ 18 years No egg proteins Inactivated influenza vaccine (IIV4), standard dose IM ≥ 6 months* Contraindication: egg allergy Egg proteins may be introduced during Cell culture-based, quadrivalent (ccIIV4), standard dose IM ≥ 4 years manufacturing process Contraindications: egg allergy, aspirin Live, attenuated, quadrivalent (LAIV4) Intranasal 2-49 years therapy in children/adolescents *Different shots are indicated for different ages. IM, intramuscular. Grohskopf LA, et al. MMWR Recomm Rep . 2017;66(2):1-20. (B) 23 CDC. https://www.cdc.gov/flu/protect/vaccine/vaccines.htm.