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INCREASING ADOLESCENT HPV UPTAKE Gale R Burstein, MD, MPH, FAAP Erie County Department of Health SUNY at Buffalo School of Medicine QUESTIONS Let’s get to know each other! Raise your hand if you work in a…. • • • • • • Community health center or physician office Health department Hospital School based health center College health Other Raise your hand if you are a…… • • • • • Physician NP or PA Nurse Health educator Other Raise your hand if your clinical site offers HPV vaccine Raise your hand if the estimated % of HPV vaccine refusers are • • • • 0~% ~25% ~50% >75% Vaccines • 2 FDA-licensed HPV vaccines • Cervarix o bivalent HPV vaccine • prevents HPV types 16/18 o licensed for ♀ • Gardasil o quadrivalent HPV vaccine • prevents HPV types 16/18 & 6/11 o licensed for ♂ & ♀ ACIP HPV recommendations • All 11 and 12 yo ♀ and ♂ o Can begin as young as age 9 yrs • Catch – up vaccines for all 13-21 yo ♀ and ♂ who not already vaccinated • All 22-26 yo ♀ • All MSM and immunocompromised ♂ o i.e., routine vaccination for 22-26 yo ♂ with risk factors • Permissive recommendation for 22-26 yo ♂ without risk factors ♂ HPV Cost Effectiveness • Goal: estimate the cost-effectiveness of adding HPV of 12 yo ♂ to ♀-only vaccination program for ages 12–26 yo in US • Methods: o CEA o The HPV-associated outcomes: • FDA-indicated: CIN; genital warts; cervical, vaginal, vulvar, & anal CA • nonFDA-indicated: oropharyngeal & penile CA; RRP Chesson HW, et al. Vaccine 2011;29:8443–50. CEA Findings • HPV immunization of 12 yo ♂ cost-effective, particularly if o ♀ HPV4 coverage is low o all potential HPV vaccine health benefits included in analysis • ♀ coverage more efficient strategy than ♂ vaccination to overall HPV health burden Chesson HW, et al. Vaccine 2011;29:8443–50. Cost-effectiveness of male vaccination* Cost per QALY gained by vaccinating 12 year-old boys Indicated outcomes only All outcomes $160,000 Cost per QALY gained $140,000 $120,000 $100,000 $80,000 $60,000 $40,000 $20,000 $0 Lower coverage scenario Higher coverage scenario *Includes transmission effects to females “Indicated” outcomes include cervical outcomes, vaginal, vulvar, anal cancers, and genital warts. All outcomes include indicated outcomes plus oropharyngeal cancer, penile cancer, and recurrent respiratory papillomatosis. Lower coverage scenario: 30% 3-dose coverage at age 12 and 50% 3-dose coverage by age 26. Higher coverage scenario: 50% 3-dose coverage at age 12 and 70% 3-dose coverage by age 26. *Chesson HW, et al Vaccine 2011 Number of lifetime cancer cases averted by vaccinating 1 million males in a birth cohort Excludes indirect effects (herd immunity). Outcomes are not discounted. Results obtained from Chesson et al model, Vaccine 2011. Vaccine efficacy was assumed to be 90% against HPV 6/11 genital warts and 75% against HPV 16/18 cancers in males. HPV Disease Burden It’s bad!! Genital Warts—Initial Visits to Physicians’ Offices, United States, 1966–2011 NOTE: The relative standard errors for genital warts estimates of more than 100,000 range from 18% to 30%. SOURCE: IMS Health, Integrated Promotional Services ™. IMS Health Report, 1966–2011. 2011-Fig 53. SR Human Papillomavirus—Prevalence of High-risk and Low-risk Types Among Females Aged 14–59 Years, National Health and Nutrition Examination Survey, 2003–2006 *HPV=human papillomavirus. NOTE: Error bars indicate 95% confidence intervals. Both high-risk and low-risk HPV types were detected in some females. SOURCE: Hariri S, Unger ER, Sternberg M, Dunne EF, Swan D, Patel S, et al. Prevalence of genital HPV among females in the United States, the National Health and Nutrition Examination Survey, 2003-2006. J Infect Dis. 2011;204(4):566-73 2011-Fig 52. SR Genital HPV Prevalence Rates in Males (%) years Males aged 18–44 years in Tucson, Arizona (N = 290). High-risk/oncogenic HPV types included 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66. Low-risk/non-oncogenic HPV types included 6, 11, 26, 40, 42, 53, 54, 55,62, 64, 67–73, 81–84, IS39, CP6108. Giuliano AR et al. J Infect Dis. 2008;198:827–835. Age-Specific Anal Canal HPV Prevalence Among Men Having Sex with Women Nyitray AR, et al. et al J Infect Dis. 2012;206(2):202-11 The Burden of Anal Cancer is Increasing Age standardized incidence rates of anal cancer in Denmark US anal cancer rates (~2.7%/year); Nielsen et al, Int J Cancer In Press Rates ♀ >> ♂ Anal Cancer Affects Women and Men • Estimated 5,820 ♀ and ♂ in US diagnosed with anal cancer in 2011 o 3,680 in ♀ and 2,140 in ♂ • > 60% of anal CA cases and deaths occur in ♀ • Anal CA can occur in heterosexual ♂ o 53% of male anal cancers occur in heterosexual ♂ ACS. www.cancer.org/Cancer/AnalCancer/DetailedGude/anal-cancer-what-is-key-statistics Last update: 10/25/2011 Nielsen IPV 2010 Daling et al Cancer 2004 Prevalence of Oral HPV Infection in the United States, 2009-2010 Gillison ML, et al. JAMA 2012;307(7):693-703. Prevalence of Oral HPV Infection Methods • • • • • 2009-2010 NHANES survey ♀ & ♂ aged 14 to 69 yrs Participants (N=5579) provided 30-sec oral rinse PCR and type-specific hybridization Demographic and behavioral data by standardized interview Gillison ML, et al. JAMA. 2012;307(7):693-703 Prevalence of Oral HPV Infection Results • Prevalence all HPV types = 6.9% o HPV type 16 prevalence = 1.0% • 85% of HPV-related OP cancers are positive for HPV-16 • Bimodal pattern for age o 30-34 yo = 7.3% o 60-64 yo =11.4% • ♂ (10.1%) >>♀ (3.6%); PR=2.8 Gillison ML, et al. JAMA. 2012;307(7):doi:10.1001/jama.2012.101 Gillison ML, et al. JAMA. 2012;307(7):doi:10.1001/jama.2012.101 What sexual behavior was most associated with oral HPV? • • • • Oral sex Vaginal sex Any sex No sex Oral HPV and Sex • > 8 x higher in persons report ever having had sex (7.5%) vs not (0.9%) • with # partners for any kind of sex (vaginal sex, or oral sex) • More common among sexually experienced individuals who did NOT perform oral sex vs. sexually inexperienced individuals o consistent with transmission by other sexually associated contact (eg, deep kissing) Gillison ML, et al. JAMA. 2012;307(7):693-703 Gillison ML, et al. JAMA. 2012;307(7):doi:10.1001/jama.2012.101 Incidence rates for overall oropharyngeal cancer, HPV–positive oropharyngeal cancers, and HPV-negative oropharyngeal cancers during 1988 -2004 in Hawaii, Iowa, and Los Angeles. Chaturvedi AK, et al. J Clin Oncol Oral HPV transmission??!! Unclear what types of oral contact are risk Estimated average annual % and # of cancers attributable to HPV, by anatomic site and sex — United States, 2004–8 ANATOMIC AVG ANNUAL # % attributable # attributable AREA of CASES to HPV to HPV FEMALE Cervix 11,967 96 11,500 Vagina 729 64 500 Vulva 3,136 51 1,600 Anus 3,089 93 2,900 Oropharynx 2370 63 1,500 TOTAL:FEMALE 21,227 1,754 17,880 MALE Penis 1,046 36 400 Anus 1678 93 1,600 Oropharynx 9356 63 5,900 TOTAL:MALE 11,553 7490 7080 HPV IMMUNIZATION COVERAGE AND PREVALENCE AMONG 14-19 YR OLD ♀ PRE- VS POST-HPV VACCINE ERA Markowitz L E et al. J Infect Dis. 2013;208:385-393 ↓ ♀ HPV Among Following U.S. HPV4 Introduction, NHANES, 2003–2010 • National Health and Nutrition Examination Surveys (NHANES) • HPV prevalence data o vaccine era (2007–2010) vs prevaccine era (2003–2006) • Analyzed vaccine types (HPV-6, -11, -16, or 18) for 14–19 yr old ♀ Markowitz L E et al. J Infect Dis. 2013;208:385-393 HPV4 Coverage and Sexual Behavior among 14-19 yr old ♀ • 34% reported >1 HPV4 o 63% of vaccinated had 3 doses • % 14–19 yr old ♀ reported had sex similar in pre- vs post-vaccine eras o 2003–2006: 53.9% (95% CI, 50.8–56.9) o 2007–2010: 50.3% (95% CI, 45.0–55.5), (P = .24) o small, nonsignificant differences in lifetime # partners and race/ethnicity Markowitz L E et al. J Infect Dis. 2013;208:385-393 HPV4 Prevalence among 14-19 yr old ♀ pre- vs post-HPV vaccine era ???????? HPV4 Prevalence among 14-19 yr old ♀ pre- vs post-HPV vaccine • Pre-vaccine era 2003–2006 : 11.5% • Post-vaccine era 2007–2010 : 5.1% o 56% decline!!!!!! • No significant decrease in non-vaccine type HPV prevalence Prevalence of individual HPV types among ♀ aged 14–19 yrs, 2003–2006 and 2007–2010 Markowitz L E et al. J Infect Dis. 2013;208:385-393 HPV PREVALENCE AMONG SEXUALLY ACTIVE 14–19 YR OLD ♀ BY VACCINATION HISTORY HPV prevalence in pre- vs post-vaccine era among sexually active 14-19 yr old ♀ • Overall demographic and sexual risk behavior did not differ between 2 periods • Overall HPV vaccine type prevalence 53% lower in post- vs pre-vaccine era • 88% vaccine type prevalence ↓ among vaccinated ♀ • Estimated >1 dose vaccine effectiveness = 82% HOW ARE WE DOING WITH HPV IMMUNIZATION RATES? Estimated Vaccination Coverage among 13-17 yr old, NIS-Teen, US, 2006-20012 2011-12: No change 2007-2011: ↑rates 6%/yr www.cdc.gov/mmwr/preview/mmwrhtml/mm6234a1.htm?s_cid=mm6234a1_w HPV Vaccine Coverage • ≥1 dose of any HPV vaccine ↑ from 25% in 2007 to 53% in 2011, o No change in 2012 (54%) • If HPV vaccine given at visits when another vaccine given, vaccine coverage for ≥1 dose would be 93% • Safety monitoring data continue to indicate that HPV4 is safe Human papillomavirus (HPV) vaccination among females 19–26 yrs (≥1 dose), ever — National Health Interview Survey, U.S., 2010 25 20 15 %♀ ≥1 dose % change from 2009 10 5 0 Total White Black Hispanic Asian Other www.cdc.gov/mmwr/preview/mmwrhtml/mm6104a2.htm#tab1 HPV vaccination among ♂ (≥1 dose), ever— National Health Interview Survey, U.S., 2010 Age 19–26 yrs 19–21 yrs % 0.6 0.3 www.cdc.gov/mmwr/preview/mmwrhtml/mm6104a2.htm#tab1 WHAT WE CAN DO!!! #1: Education of parents • 3 of 5 of parents’ main reasons for not vaccinating daughters indicate gaps in understanding o including why vaccination is recommended by age 13 years • Parents reported vaccine safety concerns • Updated CDC educational materials addressing these issues at www.cdc.gov/vaccines/who/teens/index.html www.cdc.gov/vaccines/who/teens/products/print-materials.html #2: Providers must ↑ consistency & strength of HPV vaccine recommendations • Studies show that providers give weaker recommendations for HPV vaccine vs other adolescent vaccines o Especially young adolescents • Provider counseling and recommendations greatly influence parental vaccine acceptance • CDC developed a tip sheet available at www.cdc.gov/vaccines/who/teens/for-hcptipsheet-hpv.html #3: missed vaccination opportunities must ↓ • Health-care access is NOT main impediment • ↑ missed opportunities during 2007–2012 due to ↑ coverage for other adolescents vaccines • 2012 NIS-Teen shows 84% of unvaccinated ♀ had health-care visit where another vaccine given • If the 3-dose HPV series was started at these visits, coverage for ≥1 dose would be 93% Lessons Learned • High HPV vaccination coverage with existing infrastructure and health-care utilization is possible! • Using every health-care visit, including acute-care visits, to assess every adolescent's vaccine status can ↓ missed opportunities Office systems changes strategies • Use vaccination prompts in EMRs • Check NYSIIS • Nurse counsels for HPV4 before pt seen by provider • Schedule appointments for 2nd & 3rd doses at 1st HPV dose visit • Use automated reminder-recall systems • Assessment of practice-level vaccination rates with feedback to staff members LHD Vaccination PROGRAM strategies • Provider education o HEDIS measure • Education of potential vaccine recipients • Publicity to promote vaccination • ↑ access to vaccination services in medical and complementary settings o Workplaces and pharmacies HPV Resources • www.cdc.gov/vaccines/who/teens/for-hcp/hpvresources.html • www.cdc.gov/vaccines/who/teens/downloads/hcpfactsheet.pdf • www.health.ny.gov/prevention/immunization/providers /hpv_q_and_a.htm • www.health.ny.gov/publications/2110.pdf • www.cdc.gov/vaccines/who/teens/for-hcp-tipsheethpv.pdf • www.cdc.gov/vaccines/vpd-vac/hpv/downloads/disHPV-color-office.pdf • www.cdc.gov/vaccines/vpd-vac/hpv/downloads/PL-dispreteens-hpv.pdf QUESTIONS? 56