HPV FREE IDAHO. Fundamentals of HPV Bill Atkinson, MD MPH

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HPV FREE IDAHO Fundamentals of HPV Bill Atkinson, MD MPH

You are the Key to HPV Cancer Prevention William Atkinson, MD, MPH Associate Director for Immunization Education Immunization Action Coalition February 2, 2017

Human Papillomavirus (HPV) Understanding the Burden HPV INFECTION & DISEASE

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 Low risk (non-oncogenic) HPV 6, 11 most common Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors Low Grade Cervical Disease Genital Warts Laryngeal Papillomas Low Grade Cervical Disease Non-Genital Warts

Pagliusi SR. Vaccine 2004;23:569-78

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 Jemal A et al. J Natl Cancer Inst 2013;105:175-201

HPV Clinical Features Most HPV infections are asymptomatic and result in no clinical disease Clinical manifestations of HPV infection include: anogenital warts recurrent respiratory papillomatosis cervical cancer precursors (cervical intraepithelial neoplasia cancer (cervical, anal, vaginal, vulvar, penile, and some head and neck cancer)

Natural History of HPV Infection Pagliusi SR. Vaccine 2004;23:569-78

CDC, United States Cancer Statistics (USCS), 2006-2010 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 1,600 3,000 4,600 91% Cervix 0 10,700 10,700 91% Oropharynx 9,100 2,000 11,100 70% Penis 700 0 700 63% Rectum 200 500 700 91% Vagina 0 600 600 75% Vulva 0 2,400 2,200 69% TOTAL 11,600 19,200 30,800

New Cancers Caused by HPV per Year United States 2008-2012 Vagina n=600 3% Oropharynx n=2,000 10% Vulva n=2,400 13% Rectum n=500 3% Anus n=3,000 16% Cervix n=10,700 56% Penis n=700 6% Rectum n=200 2% Anus n=1,600 14% Oropharynx n=9,100 78% Women (n = 19,200) Men (n = 11,600) CDC, United States Cancer Statistics (USCS), 2008-2012

Cervical Cancer Cervical cancer is the most common HPV-associated cancer among women 500,000+ new cases and 275,000 attributable deaths world-wide in 2008 ~12,900 new cases and 4,100 attributable deaths in 2015 in the U.S. 25% cervical cancers occur in women who are between the ages of 20 and 39 CDC. HPV associated cancers US, 2008-2012. MMWR 2012;61(15):258 261. Cervical Cancer Counts by Age. US Cancer Statistics data from 2010, CDC.gov.

www.cdc.gov/cancer/hpv/basic_info/cancers.htm

www.cdc.gov/cancer/hpv/statistics/headneck.htm

Evidence-Based HPV Disease Prevention HPV VACCINE

HPV 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

HPV Vaccine Comparison No longer available No longer available These Genital warts ~66% of ~15% of HPV Types Cervical Cervical Cause: Cancers Cancers

Gardasil 9 package insert, October 2016

HPV Vaccine Recommendation Girls & Boys can start HPV vaccination at age 9 Preteens should finish HPV vaccine series by 13 th birthday Plus girls 13-26 years old who haven t started or finished HPV vaccine series Plus boys 13-21 years old who haven t started or finished HPV vaccine series

Age ACIP Recommendations Routine vaccination at age 11 or 12 years* Catch-up 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 with HIV infection) *vaccination series can be started at 9 years of age MMWR 2015;64:300-4 20

MMWR 2016;65(49):1405-8

Updated ACIP Recommendations: 2-Dose Series ACIP recommends routine vaccination with two doses of HPV vaccine for 11 and 12 year olds to prevent HPV cancers The first dose is routinely recommended at 11-12 years old The second dose of the vaccine should be administered 6 to 12 months after the first dose Vaccination can be started at age 9 MMWR 2016;65(49):1405-8 22

Updated ACIP Recommendations: 2-Dose Series The 2-dose schedule must be started before age 15 years but can be completed after age 15 Doses must be separated by at least 5 months If doses are separated by less than 5 months then 3 doses are recommended 2-dose schedule can be completed with any combination of HPV vaccines and is retroactive MMWR 2016;65(49):1405-8 23

Updated ACIP Recommendations: 3-Dose Series Persons beginning the series at 15 years or older will continue to need three doses Adolescents aged 9 through 14 years who received two doses of HPV vaccine less than 5 months apart will require a third dose Three doses are recommended for immuno-suppressed people age 9 through 26 years MMWR 2016;65(49):1405-8 24

ACIP Recommendations: Timing of the 3-dose Series 9vHPV should be given in a 3-dose schedule for ages 15 through 26 years Interval between doses 1 2: Interval between doses 1 3: 1-2 months 6 months The minimum interval between doses 1 and 2 is 4 weeks The minimum interval between doses 2 and 3 is 12 weeks If the vaccine schedule is interrupted, the series does not need to be restarted MMWR 2015;64:300-4 25

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 26

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 10 years Multiple cohort studies are in progress to monitor the duration of immunity MMWR 2015;64:300-4

9vHPV ACIP Recommendations ACIP has declined to make any recommendation regarding revaccination with 9vHPV for persons who already completed a series of 2vHPV or 4vHPV Clinicians are free to revaccinate with 9vHPV but VFC will not cover additional doses and insurance plans may not pay for these doses

HPV Vaccine Special Situations Females Vaccine can be administered Equivocal or abnormal Papanicolaou test Cervical dysplasia Positive HPV DNA test Genital warts Immunosuppression Breastfeeding Vaccine is not recommended Males ACIP recommends only 4vHPV or 9vHPV Routine vaccination with 4vHPV or 9vHPV for immunosuppressed males (including HIV infection) through 26 years of age a Routine vaccination with 4vHPV or 9vHPV for MSM through 26 years of age a Pregnant women: defer further HPV vaccination until pregnancy is completed a Who have not been vaccinated previously or who have not completed the 3-dose series HIV = human immunodeficiency virus MMWR 2007;56:1-24 ; MMWR 2011;60:1705-1708

HPV Vaccine Contraindications and Precautions Contraindications Severe allergic reaction to a vaccine component or following a prior dose Pregnancy Precautions Moderate or severe acute illnesses (defer until symptoms improve) Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2007;56:1-24.

Syncope Following Vaccination Syncope is not uncommon among adolescents (aged 11-18 years), regardless of vaccine 70% of syncopal episodes occurred within 15 minutes of vaccination Observe patients for at least 15 minutes after they are vaccinated, independent of vaccine A previous syncopal episode is not a contraindication to a subsequent dose MMWR 2008;57:457-460; MMWR 2013;62:591-595

HPV VACCINE SAFETY

Percent Vaccinated Adolescent Vaccination Coverage United States, 2006-2015 100 Revised APD* definition 90 80 70 60 50 40 30 20 1 Tdap 1 MenACWY 1 HPV (F) 1 HPV (M) 3 HPV (F) 2 MenACWY 3 HPV (M) 10 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Survey Year Reagan-Steiner, et al. MMWR; August 26, 2016 / 65(33);850 858 * APD = Adequate provider data 2 doses MenACWY among adolescents aged 17 years

Percent Vaccinated Impact of Eliminating Missed Opportunities by Age 13 Years in Girls Born in 2000 100 80 91 60 40 20 47 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);620-

Prevalence, % Prevalence of HPV Before and After Introduction of HPV Vaccination in the U.S. 70 60 50 2003-2006 2009-2012 40 30 20 10 0 64% decline 34% decline 14-19 years 20-24 years 25-29 years

HPV Vaccination Is Safe, Effective, and Provides Lasting Protection HPV Vaccine WORKS Very high efficacy against precancers and cancer Population-level impact already being seen HPV Vaccine LASTS Studies suggest that vaccine protection is long-lasting No evidence of waning protection HPV Vaccine is SAFE

www.cdc.gov/hpv