Shingles: What s New to Know

Transcription

1 This material was prepared by the New England Quality Innovation Network-Quality Improvement Organization (NE QIN-QIO), the Medicare Quality Improvement Organization for New England, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. CMSRIF Shingles: What s New to Know Vaccine Recommendations 2018 July 24, 2018 Stefan Gravenstein, MD, MPH If you haven t already, please dial in to the audio line: Passcode: Slides may be downloaded at:

2 Conflict of Interest Statement Stefan Gravenstein, MD, MPH serves as a consultant to Merck & Co. 2

3 Learning Objectives Identify what Shingles is, who gets it and why we should care Apply ACIP Recommendations for Shingles prevention - Using data to support recommendations - Vaccine storage requirements, durability and side effects Evaluate treatment choices for Shingles 3

4 Polling Question If an administration error occurs when vaccinating an individual you should immediately report it to: Vaccine Adverse Event Reporting System (VAERS) Vaccine Error Reporting Program (VERP) Both

5 Polling Question Local or systemic side effects for Zostavax and Shingrix: Have the same or similar impact on the individual Zostavax side effects can be more impactful Shingrix side effects can be more impactful

6 What is Shingles? (aka Herpes Zoster) Shingles is caused by Varicella Zoster Virus (VZV) Primary infection with VZV causes highly contagious Chicken Pox Reactivation causes Shingles VZV can reactivate later in a person s life and cause Shingles or Herpes Zoster Shingles rash Chicken Pox rash 6

7 Symptoms First: localized pain- burning, throbbing or stabbing Before rash appears days to weeks later Then, rash: painful maculopapular vesicular Along nerve pathways Typically, unilateral: face or trunk Vesicles dry and heal in 2-4 weeks Fever Headache Photophobia Nausea Source: CDC/John Noble, Jr., M.D. 7

8 Complications Postherpetic Neuralgia (PHN) Risk factors include Age 50 Severe pain at any time It can begin before or after onset of rash Extensive rash Trigeminal or ophthalmic distribution of rash Herpes Zoster Ophthalmicus ~15% of HZ cases Involves ophthalmic division of trigeminal nerve Untreated 50-70% acute ocular complications Can chronic ocular complications, blindness CDC. Prevention of Herpes Zoster. MMWR (RR-5): p

9 Complications Neurologic complications Myelitis Encephalitis, Meningoencephalitis, Ventriculitis Cranial nerve palsies Ischemic stroke syndrome VZV viremia Cutaneous dissemination (bilateral) Pneumonia, hepatitis Disseminated intravascular coagulation Dermatologic complications Secondary rash infections Permanent scarring and changes in pigmentation CDC. Prevention of Herpes Zoster. MMWR (RR-5): p

10 Complications: PHN Pain 30 days: in 18-30% of zoster cases Mild to excruciating pain after rash cleared Constant, intermittent, or with trivial stimuli May persist weeks, months or even years Can cause Sleep, mood, work disruption Activities of daily living impairment Social withdrawal and depression CDC. Prevention of Herpes Zoster. MMWR (RR-5): p

11 Who gets Shingles? Risk factors: Past Chicken Pox or varicella vaccination USA- >99% adults >40 yo s/p Chicken pox A person s risk for herpes zoster may increase as their immunity declines r/t : Age Medical Conditions (e.g., cancer, stress, HIV) Medications (e.g., chemo/radiotherapy, steroids) 11

12 Who is most at risk? People with compromised or suppressed immune systems including those: With cancer With Human Immunodeficiency Virus (HIV) After bone marrow or solid organ transplantation Who are taking immunosuppressive medications Steroids Chemotherapy Transplant and connective tissue disease-related immunosuppressive medications 12

13 Why should we care? ~1 million cases annually 1,2 ~1 /3 of us will eventually get HZ (absent vaccine) Age increases incidence, ranging from: <1 case/1000 children to >15 cases/1000 population 80 years and older 2,3, % of adults will go on to develop PHN Risk for PHN also increases with HZ risks 1. Jumaan et al., JID, 2005, 191:2002-7, 2. Yawn, et al., Mayo Clin Proc. 2007; 82:1341-9, 3. Insinga et al., J Gen Intern Med. 2005, 20: Harpaz et al, IDWeek 2015, 5. CDC, provisional unpublished data from NHIS 13

14 Vaccine Options 14

15 Zostavax (ZVL) ZVL (Zostavax) A live attenuated virus vaccine Single sub-cutaneous (SQ) dose

16 Shingrix (RZV) RZV (Shingrix) Recombinant zoster vaccine 2-dose intramuscular (IM) series 2 nd dose 2-6 months after the first 16

17 Polling Question Storage requirements for Shingrix requires the vaccine to be kept? In a Refrigerator In a Freezer At room temperature 17

18 Route of Administration ZVL (Zostavax) Subcutaneous (SQ) 0.65ml / dose. Administer immediately after reconstitution to minimize loss of potency Unused vaccine should be discarded if not used within 30 minutes RZV (Shingrix) Intramuscular (IM) 0.5ml /dose Shingrix Administer immediately after reconstitution or store in the refrigerator for up to 6 hours 2 dose series, spaced 2 to 6 months apart Source: CDC website (accessed Feb 5, 2018); Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines ; Refer to product package inserts for further. 18

19 ZVL (Zostavax) Storage: Freezer (between -58 and +5 F) for powder containing vial Diluent stored at room temperature (between 68 and 77 F) or refrigerator (between 36 and 46 F) Do not freeze diluent Protect vials from light Vaccine: Storage and Durablility RZV (Shingrix) Storage: Refrigerator (between 36 and 46 F) Store both vials together in refrigerator before reconstitution protect vials from light DO NOT FREEZE Discard if vaccine has been frozen Source: CDC website (accessed Feb 5, 2018); Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines ; Refer to product package inserts for further. 19

20 Side Effects ZVL (Zostavax) Injection site reactions In rare instances Disseminated rash Herpes Zoster in immunocompetent recipients Life threatening and fatal complications in immune compromised recipients RZV (Shingrix) A sore arm with mild or moderate pain Redness and swelling at site of injection ~1 out of 6 experience Grade 3 side effects preventing them doing regular activities. Symptoms resolve on their own in about 2-3 days Side effects were more common in younger people Patients might have a reaction to either or both doses Source: CDC website (accessed Feb 5, 2018); Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines ; Refer to product package inserts for further. 20

21 Notes from the Field: May 25, 2018 Vaccine Administration Errors Involving Recombinant Zoster Vaccine United States, There were 155 reports to the VAERS system, of which 13 (8%) documented vaccine administration errors. In addition, CDC has received calls about Shingrix administration errors or how to avoid them. 21

22 Highlights/Lessons Learned Storage and administration requirements differ between vaccines It takes time to adjust to new vaccine techniques and procedures Counsel patients about the potential impact of vaccination on their regular routine. Report any adverse events via VAERS* and administration errors via VERP** *VAERS: Vaccine adverse event reporting system ( **VERP: Vaccine error reporting program ( 22

23 Advisory Committee on Immunization Practices (ACIP) Recommendations

24 1) RZV is recommended for the prevention of HZ and its complications for immunocompetent adults aged 50 y Benefits HZ efficacy >90%: 97% (50-69 yo) and 91% (70+ yo) High efficacy against PHN (50+ yo) Durable efficacy >85% for 4 years post-vaccination Harms ACIP: Recombinant zoster vaccine (RZV) SAEs ~ between vaccinated and comparison groups But: Grade 3 reactions in 17% vs 3% placebo 24

25 RZV Grade 3 events Grade 3 Reactions severe enough to prevent normal activities Grade 3 injection-site reactions Pain, redness, swelling 9.4% RZV vs 0.3% placebo recipients Solicited systemic events (myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms) 10.8% RZV vs 2.4% placebo Similar proportion local grade 3 between 1 st and 2 nd dose More systemic grade 3 after 2 nd dose Most common solicited adverse reactions (grade 1 3) were pain (78%), myalgia (45%), and fatigue (45%) Lal H, et al. ; ZOE-50 Study Group. N Engl J Med 2015;372: Cunningham AL, et al. ; ZOE-70 Study Group. N Engl J Med 2016;375: ACIP GRADE RZV and ZVL;

26 2) RZV is recommended for prevention of HZ and its complications for immunocompetent adults who previously got live zoster vaccine (ZVL) Efficacy RZV (Shingrix) is more efficacious than ZVL (Zostavax) in first year all ages >50 years old: >97% RZV vs 69% ZVL; Differences are larger at older ages RZV maintained > 85% during the first 4 years for all ages Studies indicate significant waning of protection from ZVL: Vaccine Effectiveness (VE) drops 15-25% in first year By 6 years post vaccination, VE is < 35% Negligible protection by 10 years ACIP: Recombinant zoster vaccine (RZV) 26

27 3) RZV is preferred over ZVL for the prevention of HZ and complications *These vaccines have not been studied head to head efficacy trial Efficacy RZV efficacy estimates are significantly higher than ZVL estimates across all ages years 97% vs 64% years 91% vs 41% >80 years 91% vs 18% HZ/su appears to wane at a slower rate than ZVL over the first 4 years Expected cases of HZ and PHN averted are far greater with HZ/su compared to ZVL Adverse effects Neither vaccine is associated with SAEs in immunocompetent persons RZV is more reactogenic than ZVL Economics ACIP: Recombinant zoster vaccine (RZV) RZV leads to less disease and reduced costs (vaccine + expected disease costs) 27

28 Data Supporting Recommendations 28

29 Data Supporting Recommendations 29

30 Polling Question If an administration error occurs when vaccinating an individual you should immediately report it to: Vaccine Adverse Event Reporting System (VAERS) Vaccine Error Reporting Program (VERP) Both

31 Polling Question Local or systemic side effects for Zostavax and Shingrix: Have the same or similar impact on the individual Zostavax side effects can be more impactful Shingrix side effects can be more impactful

32 Summary Two shingles vaccines: one killed, one live. A new option for immunocompromised patients who cannot take a live vaccine RZV received preferred recommendation from ACIP Best Practice- Integrate specific training into your practice on the new Shingrix vaccine (storage and AEs) Make a firm yet positive vaccine recommendation Advanced discussion of side effects can help prepare patients in the event they occur 32

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