1. You are the Key to HPV Cancer Prevention Understanding the Burden of HPV Disease, the Importance of the HPV Vaccine Recommendation, and Communicating about HPV Vaccination Dana H. Greenwood Chief Nurse Consultant Immunization Division IN State Dept Health November 7, 2014

2. Disclosure  I have not financial disclosures or conflicts of interest

3. Objectives 1. Describe the burden of HPV infection in the United States 2. Share best practices for talking with parents about the HPV vaccine

4. HPV Rate Girls: 54.1% (series initiation) 34.6% (series completion) HPV Rate Boys: 18.2% (series initiation) 8.1% (series completion)

5. HPV INFECTION & DISEASE Understanding the Burden

6. HPV Types Differ in their Disease Associations Mucosal sites of infection Mucosal sites of infection Cutaneous sites of infection Cutaneous sites of infection ~ 80 Types “Common” Hand and Foot Warts “Common” Hand and Foot Warts ~40 Types Genital Warts Laryngeal Papillomas Low Grade Cervical Disease Genital Warts Laryngeal Papillomas Low Grade Cervical Disease Low risk (non-oncogenic) HPV 6, 11 High risk (oncogenic) HPV 16, 18 Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease

7. HPV Infection  Most females and males will be infected with at least one type of HPV at some point in their lives  Estimated 79 million Americans currently infected  14 million new infections/year in the US  HPV infection is most common in people in their teens and early 20s  Most people will never know that they have been infected Jemal A et al. J Natl Cancer Inst 2013;105:175-201

8. Cancers Attributed to HPV, U.S. CDC, United States Cancer Statistics (USCS), 2006-2010 Cancer site Average number of cancers per year in sites where HPV is often found Percentage of cancers per year probably caused by HPV Average number of cancers per year probably caused by HPV† MaleFemale Both SexesMaleFemale Both Sexes Anus1,5492,8214,37091%1,4002,6004,000 Cervix011,422 91%010,400 Oropharynx9,9742,44312,41772%7,2001,8009,000 Penis1,0480 63%7000 Vagina0735 75%0600 Vulva03,168 69%02,200 TOTAL12,57120,58933,160 9,30017,60026,900

9. Average Number of New Cancers Probably Caused by HPV, by Sex, United States 2006-2010 CDC, United States Cancer Statistics (USCS), 2006-2010 Women (n = 17,600) Oropharynx n=1,800 10% Anus n=2,600 15% Cervix n=10,400 59% Vagina n=600 3% Vulva n=2,200 13% Men (n = 9,300) Anus n=1,400 15% Oropharynx n=7,200 77% Penis n=700 8%

10. HPV VACCINE Evidence-Based HPV Prevention

11. HPV Prophylactic Vaccines HPV Virus-Like Particle  Recombinant L1 capsid proteins that form “virus-like” particles (VLP)  Non-infectious and non-oncogenic  Produce higher levels of neutralizing antibody than natural infection

12. HPV Vaccine Quadrivalent/HPV4 (Gardasil) Name Bivalent/HPV2 (Cervarix) Merck Manufacturer GlaxoSmithKline 6, 11, 16, 18 Types 16, 18 Females: Anal, cervical, vaginal and vulvar precancer and cancer; Genital warts Males: Anal precancer and cancer; Genital warts Indications Females: Cervical precancer and cancer Males: Not approved for use in males Hypersensitivity to yeast Contraindications Hypersensitivity to latex (latex only contained in pre-filled syringes, not single-dose vials) 3 dose series: 0, 2, 6 months Schedule (IM) 3 dose series: 0, 1, 6 months

13. ACIP Recommendation and AAP Guidelines for HPV Vaccine  Routine HPV vaccination recommended for both males and females ages 11-12 years  Also ages 13-21 years for males; 13-26 for females  Vaccine can be given starting at age 9 years of age for both males and females; vaccine can be given ages 22-26 years for males CDC. Quadrivalent Human Papillomavirus Vaccine: Recommendations of ACIP. MMWR 2007;56(RR02):1-24.

14. HPV Vaccination Schedule  ACIP Recommended schedule is 0, 1-2*, 6 months  Following the recommended schedule is preferred  Minimum intervals  4 weeks between doses 1 and 2  12 weeks between doses 2 and 3  24 weeks between doses 1 and 3  Administer IM CDC. Quadrivalent Human Papillomavirus Vaccine: Recommendations of ACIP. MMWR 2014;63(RR05):1-30.

15. HPV Vaccine Is Safe, Effective, and Provides Lasting Protection  HPV Vaccine is SAFE  Safety studies findings for HPV vaccine similar to safety reviews of MCV4 and Tdap vaccines  HPV Vaccine WORKS  Vast reductions in high grade cervical lesions decline in Australia  80% of school aged girls vaccinated  Prevalence of vaccine types declines by more than half in US  With only 33% of teens fully vaccinated  HPV Vaccine LASTS  Studies suggest that vaccine protection is long-lasting; no evidence of waning immunity Garland et al, Prev Med 2011; Ali et al, BMJ 2013; Markowitz JID 2013; Nsouli-Maktabi MSMR 2013

16. HPV VACCINE COVERAGE

17. Adolescent Vaccination Coverage United States, 2006-2013 MMWR 2014; 63(29);625-633.

18. Missed Opportunities: Indiana Females Only

19. HPV Vaccine Series Initiation Girls 13-17 Years, by State, 2013

20. Top 5 reasons for not vaccinating daughter, among parents with no intention to vaccinate in the next 12 months, NIS-Teen 2013 CDC. National and State Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2012 MMWR 2014; 63(29);625-633. 13%

21. FRAMING THE CONVERSATION Talking about HPV vaccine

22. The Conversations with Parents 1.Give a STRONG recommendation 2.Start conversation early and focus on cancer prevention 3.Offer a personal story 4.Welcome questions from parents, especially about safety

23. Framing the HPV Vaccine Conversation

24. Bundle Them Up!  Successful recommendations group all of the adolescent vaccines  Recommend HPV vaccine the same way and on the same day you recommend Tdap and meningococcal vaccines.  A strong recommendation from you is the main reason parents decide to vaccinate  Many parents responded that they trusted their child’s doctor and would get the vaccine for their child as long as they received a recommendation from the doctor Unpublished CDC data, 2013.

26. Surely, this kid isn’t going to be having sex anytime soon, right? Guess again.  47% of high school students have already engaged in sexual intercourse (vaginal-penile)  6% of these students had sexual intercourse before age 13 years  1/3 of 9th graders and 2/3 of 12th graders have engaged in sexual intercourse  1 in 7 high school students (all grades) have had sexual intercourse with 4 or more partners Jemal A et al. J Natl Cancer Inst 2013;105:175-201 Kahn. MMWR. 2014; 63(4)

27. Rationale for vaccinating early: Protection prior to exposure to HPV

28. HPV Vaccine Duration of Immunity  Studies suggest that vaccine protection is long-lasting; no evidence of waning immunity  Available evidence indicates protection for at least 8-10 years  Multiple cohort studies are in progress to monitor the duration of immunity Romanowski B. Long term protection against cervical infection with the human papillomavirus: review of currently available vaccines. Hum Vaccin. 2011 Feb;7(2):161-9.

29. COMMUNICATION TOOLS Resources for HPV vaccine conversations

30. “You Are the Key” HPV portal for Providers cdc.gov/vaccines/YouAreTheKey

31. Factsheets Resources for Patients cdc.gov/vaccines/who/teens/products/print-materials.html

32. Adolescent Immunization Schedule cdc.gov/vaccines/schedules/easy-to-read/preteen-teen.html Resources for Patients

33. Vaccines for Preteens and Teens Website cdc.gov/vaccines/teens Resources for Patients

34. Acknowledgments  A BIG thank you to the CDC’s adolescent vaccination team for contributing the slides for today’s presentation!

35. HPV VACCINE IS CANCER PREVENTION And YOU are the key! #WeCanStopHPV