HPV Vaccination. Nate Herr MD, Stephanie Lauden MD, James MapelLentz MD, Logan Newman MD, Dawn Martin MD, MPH University of Minnesota Pediatrics

Transcription

1 HPV Vaccination Nate Herr MD, Stephanie Lauden MD, James MapelLentz MD, Logan Newman MD, Dawn Martin MD, MPH University of Minnesota Pediatrics

2 Disclosures I have no relevant financial relationships with the manufacturers(s) of any commercial products(s) and/or provider of commercial services discussed in this CME activity. I do not intend to discuss an unapproved/investigative use of a commercial product/device in my presentation.

3 HPV Vaccination - Objectives Why Providers Should Promote the HPV Vaccine Current Recommendations HPV Vaccine Options HPV Vaccine Efficacy & Safety Dueling Barriers to HPV Vaccination Current Trends in HPV Vaccination Rates Practical Help for Providers Simple tools, resources, ways to approach parental concerns

4 Why Physicians Should Promote the HPV Vaccine Oropharyngeal cancer 7,000 annual deaths HPV 16/18 Vaginal cancer 800 annual deaths Penile cancer 300 annual deaths HPV 16/18 Cervical cancer 4,000 annual deaths Vulvar cancer 1,000 annual deaths HPV 16/18 16/18 HPV 16/18 Anal cancer HPV 16/ annual deaths

5 HPV-Associated Cervical Cancer Rates by Race and Ethnicity, United States, Jemal A et al. J Natl Cancer Inst 2013;105:

6 Harm Caused by Lack of HPV Vaccine Administration Currently 26 million girls <13 yo in the US; If none of these girls are vaccinated then: 168,400 will develop cervical cancer and 54,100 will die from it Vaccinating 30% would prevent 45,500 of these cases and 14,600 deaths Vaccinating 80% would prevent 98,800 cases and 31,700 deaths For each year we stay at 30% coverage instead of 80% 4,400 future cervical cancer cases and 1,400 cervical cancer deaths will occur.

7 HPV Vaccination Rates vs. Meningococcus/Tdap Rates HPV girls Minnesota Percent Vaccinated Tdap MCV4 1 HPV girls 3 HPV girls 1HPV boys 3 HPV boys HPV boys Minnesota Survey Year CDC. National and state vaccination coverage among adeloscents aged years United States, MMWR 2013;62:

8 Who Should Receive the HPV Vaccine? All males AND females at years of age For females, it can be given between ages 9-26 yrs For males, it can be given between ages 9-21 yrs Males ages who are high risk (HIV, immunocompromised, MSM) should receive the HPV vaccine

9 Special Considerations for HPV Vaccine OK to Give HPV Vaccine to: Do not give HPV Vaccine to: Lactating women Patients with minor illness Women with equivocal, abnormal or HPV positive Pap test. Vaccine may not be beneficial Immunocompromised/HIV infected patients Patients with hypersensitivity reactions Specifically to yeast Moderate to severe acute illness Pregnancy No causal association with adverse outcomes, though limited data CDC: HPV Resource Page

10 HPV Vaccine Options Quadrivalent/HPV4 Bivalent/HPV2 NAME (Gardasil) (Cervarix) Merck MANUFACTURER GlaxoSmithKline 6, 11, 16, 18 TYPES 16, 18 Females: Anal, cervical, vaginal and vulvar precancer and cancer; oropharyngeal cancer Genital warts Males: Anal precancer and cancer; Genital warts Pregnancy Yeast Hypersensitivity INDICATIONS CONTRAINDICATIONS Females: Cervical precancer and cancer; oropharyngeal cancer Males: NOT approved for use in males Pregnancy Latex Hypersensitivity: 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

11 HPV Vaccine Efficacy FUTURE I Vaccine Placebo n Cases Rate n Cases Rate Efficacy (%) 95 % CI Per-Protocol CIN/Adenocarcinoma in situ Genital Warts, VaIN, VIN % (94-100) % (94-100) Unrestricted Protocol CIN/Adenocarcinoma in situ Genital Warts, VaIN, VIN * < % (92-100) % (87-99) Intention-to-treat CIN/Adenocarcinoma in situ Genital Warts, VaIN, VIN % (40-66) % (58-83) FUTURE I Study Group. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases. N Engl J Med 2007; 356:

12 HPV Vaccine Efficacy FUTURE II Vaccine Placebo n Cases Rate n Cases Rate Efficacy (%) 95 % CI Per-Protocol CIN grade % (86-100) CIN grade * < % (79-100) Adenocarcinoma in situ < % (<0-100) Unrestricted Protocol CIN grade < % (85-100) CIN grade < % (82-99) Adenocarcinoma in situ <0.1 95% (<0-100) Intention-to-treat CIN grade % (38-71) CIN grade % (23-61) Adenocarcinoma in situ < <0.1 28% (<0-82) FUTURE II Study Group. Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. N Engl J Med 2007; 356:

13 HPV Vaccine Safety 175 million doses given worldwide, 57 million in the US No significant safety concerns identified Similar safety profile to MCV4 and Tdap vaccines Most common adverse effect is injection site discomfort Most common safety concern is syncope; recommend 15 minutes observation following vaccination Strict post-marketing surveillance Vaccine Adverse Event Reporting System (VAERS) Vaccine Safety Datalink (VSD) monitoring CDC and WHO safety reviews have found no safety issues

14 Dueling Barriers to HPV Vaccination Provider-Focused Barriers Family-Focused Barriers Lack of clinician s personal recommendation Questions regarding safety and efficacy Lack of time Lack of consistency with vaccination timing Questions regarding safety and efficacy of new vaccine Moral or religious objections Perceived increase in sexual promiscuity Inconvenience of 3 dose vaccine Unaware of cancer prevention

15 Parental Concerns: Top 5 reasons for NOT vaccinating daughters Not sexually active Lack of knowledge Safety concerns/side effects Not recommended by provider Not needed or necessary** * Not mutually exclusive. ** Did not know much about HPV or HPV vaccine Percent Dorell C, Yankey D, Kennedy A, Stokley S. Parent-reported Reasons for Nonreceipt of Recommended Adolescent Vaccinations, National Immunization Survey-Teen, Clinical Pediatrics. Volume 50, Issue 12, p

16 Clinician Perception of Parents Views Regarding HPV Vaccination Healy CM, Montesinos DP, Middleman AB. Parent and provider perspectives on immunization: Are providers overestimating parental concerns? Vaccine, 2014 Jan 23;32(5):

17 HPV Vaccine: Clinician Recommendations Studies consistently show that a strong recommendation from the provider is the single best predictor of vaccination Need to find good photo of patient encounter here Lack of sincere recommendation becomes a barrier

18 HPV Vaccine: Clinician Recommendations by Age Allison et al.

19 Age at First Intercourse Data that Supports Early HPV Vaccination 82% 18 to 24 Markowitz MMWR 2007; Holl Henry J Kaiser Found 2003; Mosher Adv Data 2006

20 Does the HPV Vaccine Promote Early Sexual Activity? Kaiser Permanente Center for Health Research: 1,398 girls ages 11 or 12 in % were vaccinated Followed through 2010 No difference in markers of sexual activity, including Pregnancies Counseling on contraceptives Testing for, or diagnoses of, sexually transmitted infections Bednarczyk Pediatrics Oct 2012

21 Promoting the HPV Vaccine: What Can We Do? Preparing for Conversations with Families: Explore the data so you feel comfortable recommending HPV vaccination Consider the power of a personal endorsement or story for your families How can you get creative for your patients? Hand-outs, visuals, videos? Be patient and find common ground with families. We all want what is best for your child.

22 Promoting the HPV Vaccine: What Can We Do? Recognize HPV Vaccination as an opportunity to advocate for your patients: Remove stigma surrounding HPV vaccine Recommend HPV vaccine as you would other 12 year well-child vaccines Promotes adolescent vaccine platform (HPV, MCV4, Tdap) Emphasize that this is an anti-cancer intervention One of only two vaccines to prevent cancer Be willing to address parental concerns Are questions reflecting a lack of knowledge rather than a refusal to accept vaccination? Some families require on-going dialogue across several visits Helpful to have evidence-based resources to send home with families

23 Promoting the HPV Vaccine with Simple Phrases The HPV vaccine is very important because it prevents cancer. I want your child to be protected from cancer. That s why I m recommending that your daughter/son receive the first dose of the HPV vaccine series today. Here is some information for you to read through at home, and we can talk about this again at your next visit.

24 Clinician Resources on HPV Vaccination

25 Promoting the HPV Vaccine with Simple Phrases

26 HPV Videos

27 Summary Recommendations HPV vaccination prevents cancer HPV vaccination should be given at an early age Receiving the HPV vaccine does NOT result in early sexual activity Boys need the HPV vaccine Recommend it! Your endorsement is essential!

28 References on HPV Vaccine CDC. Human papillomavirus (HPV)-associated cancers. Atlanta, GA: US Department of Health and Human Services, CDC; Dorell C, Yankey D, Kennedy A, Stokley S. Parent-reported Reasons for Nonreceipt of Recommended Adolescent Vaccinations, National Immunization Survey-Teen, Clinical Pediatrics. Volume 50, Issue 12, p Future I/II Study Group. Four year efficacy of prophylactic human papillomavirus quadrivalent vaccine against low grade cervical, vulvar, and vaginal intraepithelial neoplasia and anogenital warts: randomised controlled trial. BMJ 2010;341:c3493. FUTURE I Study Group. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases. N Engl J Med 2007; 356: FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med 2007; 356: Guiliano AR, Palefsky JM, Goldstone S, Moreira ED, et al. Efficacy of quadrivalent HPV vaccine against HPV infection and disease in males. N Engl J Med 2011;364: Joura, EA, Leodolter S, Hernandez, Avila M, et al. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6,11,16, 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomized clinical trials. Lancet 2007; 369: Kjaer SK, Sigurdsson K, Iversen OE, et al. A pooled analysis of continued prophylactic efficacy of quadrivalent human papillomavirus (types 6/11/16/18) vaccine against high-grade cervical and external genital lesions. Cancer Prev Res 2009;2: Mayhew A, Mullins TL, Ding L, Rosenthal SL, Zimet GD, Morrow C, Kahn JA. Risk perceptions and subsequent sexual behaviors after HPV vaccination in adolescents. Pediatrics - Mar 2014; 133(3); Palefsky J, Giuliano AR, Goldstone S, et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. N Eng J Med 2011;365: