Overview of HPV; Making it Real

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1 Overview of HPV; Making it Real Deanna Kepka, PhD, MPH Cancer Control and Population Sciences, Huntsman Cancer Institute College of Nursing, University of Utah November 19, 2016

2 Objectives: Provide an overview of HPV and HPV-related cancers Discuss burden of HPV-related disease on the patient experience Introduce the HPV vaccine & its positive impact Outline state-level HPV vaccination rates Describe how the Intermountain West HPV Vaccination can help you

3 HPV Infection & Disease Understanding the Burden

4 Every year in the United States 27,000 people are diagnosed with a cancer caused by HPV That s 1 case every 20 minutes

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

6 HPV Infection Most females and males will be infected with at least one type of mucosal 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:

7 CDC, United States Cancer Statistics (USCS), Cancers Caused by HPV, U.S. Cancer site Average number of cancers per year probably caused by HPV Male Female Both Sexes Percentage per year Anus 1,400 2,600 4,000 91% Cervix 0 10,400 10,400 91% Oropharynx 7,200 1,800 9,000 72% Penis % Vagina % Vulva 0 2,200 2,200 69% TOTAL 9,300 17,600 26,900

8 New Cancers Caused by HPV per Year United States Vagina n=600 3% Oropharynx n=1,800 10% Vulva n=2,200 13% Anus n=2,600 15% Cervix n=10,400 59% Penis n=700 8% Anus n=1,400 15% Oropharynx n=7,200 77% Women (n = 17,600) Men (n = 9,300) CDC, United States Cancer Statistics (USCS),

9 Annual Report to the Nation on the Status of Cancer: HPV-Associated Cancers From 2000 to 2009, oral cancer rates increased 4.9% for Native American men 3.9% for white men 1.7% for white women 1% for Asian men Anal cancer rates doubled from 1975 to 2009 Vulvar cancer rates rose for white and African- American women Penile cancer rates increased among Asian men Jemal A et al. J Natl Cancer Inst 2013;105:

10 Cervical Cancer Cervical cancer is the most common HPVassociated cancer among women 500,000+ new cases and 275,000 attributable deaths world-wide in ,000+ new cases and 4,000 attributable deaths in 2011 in the U.S. 37% cervical cancers occur in women who are between the ages of 20 and 44 13% (or nearly 1 in 8) between 20 and 34 24% ( or nearly 1 in 4) between 35 and 44 CDC. HPV associated cancers US, MMWR 2012;61(15): Cervical Cancer Counts by Age. US Cancer Statistics data from 2010, CDC.gov.

11 HPV-Associated Cervical Cancer Incidence Rates by State, United States,

12 Without vaccination, annual burden of genital HPV-related disease in U.S. females: 4,000 cervical cancer deaths 10,846 new cases of cervical cancer 330,000 new cases of HSIL: CIN2/3 (high grade cervical dysplasia) 1 million new cases of genital warts 1.4 million new cases of LSIL: CIN1 (low grade cervical dysplasia) Nearly 3 million cases and $7 billion American Cancer Society. 2008; Schiffman Arch Pathol Lab Med. 2003; Koshiol Sex Transm Dis. 2004; Insinga, Pharmacoeconomics, 2005

Watson et al. MMWR 2012;61:258-261. U.S.

13 Watson et al. MMWR 2012;61: U.S. Cervical Cancer Rates by Race and Ethnicity,

14 Age-adjusted incidence rates for HPV-associated oropharyngeal cancers in the United States,

15 The Patient & Physician Experience

16 Survivor Videos 12 survivor videos available on YouTube at:

17 Cervical Cancer Screening Guidelines

18 Abnormal Pap Smears Proportion of U.S. women with at least one abnormal Pap smear. Includes only women without a hysterectomy. Sirovich BE, Welch HG. The Frequency of Pap Smear Screening in the United States. Journal of General Internal Medicine. 2004;19(3): doi: /j x.

Pap Screening Intervals with one abnormal Pap Pap smear screening intervals among women with a history of abnormal Pap smears. Includes only women who have not had a hysterectomy.

19 Pap Screening Intervals with one abnormal Pap Pap smear screening intervals among women with a history of abnormal Pap smears. Includes only women who have not had a hysterectomy. Sirovich BE, Welch HG. The Frequency of Pap Smear Screening in the United States. Journal of General Internal Medicine. 2004;19(3): doi: /j x.

20 Direct and Indirect Costs of Cervical Dysplasia Direct Prevention and early detection are easily accessible and cost-effective Cervical dysplasia is extremely curable Costs: testing, treatment, treatment visits Indirect Lost productivity Lost future earnings Emotional burden

21 Biopsies/Other Treatments, Resulting in Worry Abnormal tests may lead to more testing and invasive diagnostic procedures (colposcopy, cervical biopsies) Biopsies - punch, cone, endocervical curettage (ECC) Side effects: vaginal bleeding, pain, infection Risks: Failure to diagnose, miscarriage, cervical incompetence, preterm birth Increased short-term anxiety, distress, health concerns Treatments Low grade further screening Moderate - high grade cold-knife conization loop electrosurgical excision procedure (LEEP) cryotherapy laser ablation Risks: Cervical incompetence Cervical stenosis Pre-term delivery LBW, perinatal death

22 Incidence of Cervical Incompetence/ Miscarriage Post Biopsy Conization associated with higher rates of miscarriage and preterm deliveries This may be related to volume of conization and length of healing time prior to delivery Cerclage not shown to reduce preterm births LEEP most popular procedure for cervical dysplasia Some research suggests inceases preterm births as well Women who become pregnant within a year of LEEP are 5 times more likely to miscarry Suggests that length of healing time - biggest factor in pregnancy outcomes

23 Incidence of Cervical Cancer and Hysterectomies Cervical Cancer Cervical cancer is most common HPV caused cancer 4 th most common cancer in women worldwide HPV accounts for virtually all cases of cervical cancer ~ 12,000 new cases in U.S. annually ~ 4,000 die from cervical cancer in the U.S. annually Hysterectomy After C-section, hysterectomy is 2nd most common surgery among women of child-bearing age ~ 600,000 hysterectomies are performed annual per year ~ 20 million women have had a hysterectomy, most commonly in women years Radical hysterectomy is the most common treatment for early stage cervical neoplasms Survival rate for early stage cervical cancer at 5 years is 95%

Emotional Costs Disruption to daily life routine to illness and treatment (work, finances, leisure activity) Different perceptions of illness between patients and

24 Emotional Costs Disruption to daily life routine to illness and treatment (work, finances, leisure activity) Different perceptions of illness between patients and partners may result in relationship strain Sexual dysfunction, intimacy issues Anxiety about prognosis, cause of disease, sexuality, and treatments Disturbed body image

25 HPV Vaccines Evidence-Based HPV Disease Prevention

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

27 HPV Vaccines Currently Licensed in U.S. Bivalent 2vHPV (Cervarix) Quadrivalent 4vHPV (Gardasil) 9-Valent 9vHPV (Gardasil 9) Manufacturer GlaxoSmithKline Merck Merck HPV Types Included Contraindications Dose Schedule 16, 18 6, 11, 16, 18 Hypersensitivity to latex* 3 dose series: 0, 1, 6 months Hypersensitivity to yeast 3 dose series: 0, 2, 6 months 6, 11, 16, 18, 31, 33, 45, 52, 58 Hypersensitivity to yeast 3 dose series: 0, 2, 6 months * May be present in tip of pre-filled syringes

28 HPV Vaccine Comparison These Genital warts ~66% of ~15% of HPV Types Cervical Cervical Cause: Cancers Cancers

29 HPV Vaccine Recommendation Girls & Boys can start HPV vaccination at age 9 Preteens should finish HPV vaccine series by 13 th birthday Plus girls years old who haven t started or finished HPV vaccine series Plus boys years old who haven t started or finished HPV vaccine series

30 HPV Vaccination is Routinely Recommended HPV vaccination is recommended for both females and males ages years HPV vaccine series should be completed before the 13 th birthday Routine immunization for 11- and 12-year-olds includes HPV vaccination. Clinicians should recommend HPV vaccine on the same day and in the same way as the other vaccines for preteens. MMWR, August 29, 2014, Vo1 63, #RR05

31 Updated ACIP Recommendations Age Routine vaccination at age 11 or 12 years* Vaccination recommended through age 26 for females and through age 21 for males not previously vaccinated Vaccination recommended for men through age 26 who have sex with men (MSM) or are immunocompromised (including persons HIV-infected) Formulation by gender (assuming availability) 9vHPV 4vHPV 2vHPV Females Males *vaccination series can be started at 9 years of age MMWR 2015;64:300-4

New HPV Vaccination Recommendations 2-DOSE schedule for HPV vaccine NOW recommended: For those 11-12 years old at

32 New HPV Vaccination Recommendations 2-DOSE schedule for HPV vaccine NOW recommended: For those years old at least 6 months apart Teens and young adults who start the series later (ages 15-26), will continue to need the 3 doses

33 Updated ACIP Recommendations: Formulations 2vHPV, 4vHPV and 9vHPV all protect against HPV 16 and 18, types that cause about 66% of cervical cancers and the majority of other HPV-attributable cancers in the United States. 9vHPV targets five additional cancer causing types, which account for about 15% of cervical cancers. 4vHPV and 9vHPV also protect against HPV 6 and 11, types that cause genital warts. MMWR 2015;64:300-4

34 Updated ACIP Recommendations: Interchangeability If vaccination providers do not know, or do not have available the HPV vaccine product previously administered, or are in settings transitioning to 9vHPV: For protection against HPV 16 and 18, Females: Any HPV vaccine product may be used to continue or complete the series Males: 4vHPV or 9vHPV may be used to continue or complete the series MMWR 2015;64:300-4

35 HPV Vaccination Is Safe, Effective, and Provides Lasting Protection HPV Vaccine is SAFE Benefits of HPV vaccination far outweigh any potential risks Safety studies findings for HPV vaccination similar to safety reviews of MCV4 and Tdap vaccination HPV Vaccine WORKS Population impact against early and mid outcomes have been reported in multiple countries HPV Vaccine LASTS Studies suggest that vaccine protection is long-lasting No evidence of waning protection Garland et al, Prev Med 2011; Ali et al, BMJ 2013; Markowitz JID 2013; Nsouli-Maktabi MSMR 2013

36 State-Specific Statistics & Vaccination Rates

39 > 1 Dose HPV Vaccination Females years old,

40 > 1 Dose HPV Vaccination Males years old,

> 3 Dose HPV Vaccination Females 13-17 years old, 2015 http://www.cdc.

41 > 3 Dose HPV Vaccination Females years old,

> 3 Dose HPV Vaccination Males 13-17 years old, 2015 http://www.cdc.

42 > 3 Dose HPV Vaccination Males years old,

43 HPV Vaccination Impacts

44 HPV Vaccine Impact Monitoring 44 Post licensure evaluations are important to evaluate real world effectiveness of vaccines Population impact against early and mid outcomes have been reported: Genital warts Australia, New Zealand, Denmark, Sweden, Germany, Quebec, US HPV prevalence Australia, Norway, Denmark, Sweden, UK, US Cervical lesions Australia, British Columbia, Denmark, Sweden, US

45 NHANES HPV Prevalence Studies National Health and Nutrition Examination Survey (NHANES) data used to compare HPV prevalence Before the start of the HPV vaccination program ( ) & From the first 4 years after vaccine introduction ( ) Results In year olds, vaccine-type HPV prevalence decreased 56% (11.5% in to 5.1% in ) Other age groups did not show a statistically significant difference over time Vaccine effectiveness for prevention of infection was an estimated 82% Markowitz, et al. J Infect Dis 2013

46 Prevalence per 1000 Person-years Anogenital wart prevalence, female private insurance enrollees, U.S., Flagg, et al. AJPH 2013

47 Impact of HPV vaccination in Australia Proportion of Australian born females and males diagnosed as having genital warts at first visit, by age group, Females Males Ali, et al. BMJ

48 Systematic Review and Meta-Analysis: Population-Level Impact of HPV Vaccination Review of 20 studies in 9 high income countries In countries with >50% coverage, among yr olds HPV 16/18 prevalence decreased at least 68% Anogenital warts decreased by ~61% Evidence of herd effects Some evidence of cross protection against other types Drolet et al. Lancet Infect Dis

49 Challenges in Monitoring HPV Vaccine Impact on Cervical Lesions Detected through cervical cancer screening Changing screening recommendations Lack of cervical cancer screening registries in some countries Incomplete linkages with vaccination registries 49

50 HPV Vaccine: Duration of Immunity Studies suggest that vaccine protection is longlasting; 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

51 Framing the Conversation Talking about the HPV Vaccine

Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended

52 Percent Vaccinated Impact of Eliminating Missed Opportunities by Age 13 Years in Girls Born in Actual Achievable 0 HPV-1 (girls) Vaccine Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given. HPV-1: Receipt of at least one dose of HPV. MMWR. 63(29);

53 MMWR 2014; 63(29); ; Unpublished CDC data, Give a Strong Recommendation to Receive HPV Vaccine at Ages 11 or 12 A strong recommendation from you is the main reason parents decide to vaccinate Not sexually active Not recommended Safety concern/side effects Not needed or necessary Lack of knowledge Percent Many moms in focus groups stated that they trust their child s doctor and would get the vaccine for their child as long as they received a recommendation from the doctor

55 Make an Effective Recommendation Same way: Effective recommendations group all of the adolescent vaccines. Recommend HPV vaccination the same way you recommend Tdap & meningococcal vaccines. Same day: Recommend HPV vaccine today. Recommend HPV vaccination the same day you recommend Tdap & meningococcal vaccines. Unpublished CDC data, 2013.

56 If a parent were hesitant Ask Acknowledge Advise Remember Clarify & restate their concerns to make sure you understand Emphasize it is the parents decision. Acknowledge risks and conflicting information sources. Applaud them for wanting what is best for their child. Be clear that you are concerned for the health of their child, not just public health safety. Clarify their concerns to make sure you understand and are answering the question they actually care about. Allow time to discuss the pros and cons of vaccines. Be willing to discuss parents ideas. Offer written resources for parents. Tailor your advice using this sheet or CDC s Tips & Time Savers. Declination is not final. The conversation can be revisited. End the conversation with at least 1 action you both agree on. Because waiting to vaccinate is the risky choice, many pediatricians ask the parent to sign a Declination Form

57 Clinicians can give a strong and effective HPV vaccine recommendation by announcing: Sophia is due for three vaccines today. These will help protect her from meningitis, HPV cancers, and pertussis. We ll give those shots at the end of the visit.

58 If main concern is Why does my child need this vaccine try saying: HPV vaccine is very important because it prevents cancer. I know we d like to protect Maureen from cancer and I d feel better if she got her first dose of the HPV vaccine series today.

Currently have about 230 members Representation from: Public Health Departments Hospitals and primary care offices Pharmacy Dentistry Cancer survivors

60 Currently have about 230 members Representation from: Public Health Departments Hospitals and primary care offices Pharmacy Dentistry Cancer survivors Non-Profit Organizations Religious Organizations University faculty, staff, & students National Area Health Education Center Organization (AHEC) Merck Vaccines

SELECTED HIGHLIGHTS HPV COALITION WORK Coalition Activities Monthly Meetings via Tele-conference & In-person Meetings Rural Working Group Ongoing Networking Current Research Projects Multi-level HPV

61 SELECTED HIGHLIGHTS HPV COALITION WORK Coalition Activities Monthly Meetings via Tele-conference & In-person Meetings Rural Working Group Ongoing Networking Current Research Projects Multi-level HPV vaccination intervention for rural primary care practices HPV Oropharyngeal Cancer and HPV Vaccination Dental Student Survey HPV Vaccination and Education in Dental Practices Pilot Study Utah Statewide Immunization Information Systems Registry (Missed Opportunities & Vulnerable Populations) Analyses/Writing Coalition Survey and Focus Groups Manuscript Dental and Dental Hygienist Survey Manuscripts HPV Vaccination Provider Survey Utah Community Faces of Utah Focus Groups & Surveys

62 Hub and Spoke Resources We can help find local HPV advocates in your region. We can provide support through monthly conference calls and in-person meetings. We can connect you with the most up to date HPV vaccination resources for primary care providers. We are an outlet for HPV vaccination news and tools. We can facilitate sharing of HPV vaccination success stories and effective HPV intervention strategies among coalition members. We can provide you with additional one-on-one support.

63 QUESTIONS? THANK YOU! WE ARE HERE TO HELP YOU REACH YOUR GOALS.

You are the Key to HPV Cancer Prevention Understanding the Burden of HPV Disease, the Importance of the HPV Vaccine Recommendation, and Successfully

You are the Key to HPV Cancer Prevention Understanding the Burden of HPV Disease, the Importance of the HPV Vaccine Recommendation, and Successfully Communicating about HPV Vaccination Disclosure This