HPV Vaccine is Cancer Prevention NCSR update May 2017 Dr Jane Morgan, Waikato DHB

Key Messages HPV vaccine + screening offer the most effective protection against cervical cancer Recent changes to immunisation schedule Funded 9-valent HPV vaccine Boys too – universal eligibility up to 27th birthday 2 doses vs 3 doses by age BPAC Nov 2016 http://www.bpac.org.nz/2016/docs/hpv.pdf

Why do we vaccinate vs HPV? To prevent HPV-associated cancer To improve equity of health outcomes Current screening is good but NOT enough to prevent all HPV-associated cancers

Infection With Mucosal HPV Is Common Lifetime risk > 80% Close (skin-to-skin) contact; being intimate vs ‘sexually active’ Persistent HPV infection linked to cancer Early vaccination prevents initial infection Vaccine immune protection lasts at least 10 years (studies ongoing)

HPV Types and Disease Associations Mucosal Sites of infection Cutaneous ~ 80 Types “Common” Hand and Foot Warts ~40 Types Genital Warts Laryngeal Papillomas Low Grade cervical changes Low risk (non-oncogenic) HPV 6, 11 High risk (oncogenic) HPV 16, 18, 31, 33, 45, 52, 58 Cervical Cancer Anogenital Cancers Oropharyngeal Cancer Cancer Precursors

HPV vaccines Bivalent Cervarix® Quadrivalent Qardasil® 9-valent 16 18 16 18 6 11 16 18 6 11 31 33 45 52 58 Numerous studies show a large reduction on genital warts and vaccine-related HPVs in females1-4 1 Chow EP et al. Lancet Inf Dis. 2015; 15: 1314-1323 2 Chow EP et al. Sex Trans Inf. 2015; 91: 214-219 3Ali H et al. BMJ. 2013: 346: f2032. 4Tabrizi SN et al. Lancet Inf Dis. 2014; 14: 958-66

Extra benefit of 9-Valent HPV vaccine Adds at least an extra 15% of cervical cancers Overall, these 5 => 14% HPV-related cancers in women, 4% men CIN 2+ lesions: 50% => HPV 16/18, 25% => 31,33,45,52,58

Efficacy of 9vHPV Vaccine Against HPV Types 31/33/45/52/58 Per-protocol Population End Point 9vHPV Cases/Total 4vHPV Risk Reduction (95% CI) High grade cervical, vulvar or vaginal disease 1/6016 30/6017 96.7 (80.9-99.8) High grade CIN, AIS* and cervical cancer 1/5948 27/5943 96.3 (79.5-99.8) Persistent infection (> 6 months) 35/5939 810/5953 96.0 (94.4-97.2) *AIS = adenocarcinoma in situ Joura EA, et al. New Engl J Med. 2015;372:711-723.

Why Do We Want to Protect Boys From HPV? HPV-related cancers in all men Anal, genital & oral Penile cancer rare Oropharyngeal cancer rates rising & more common in men Anal cancer risk for men who have sex with men Squamous cell carcinoma of the posterior oropharyngeal wall.

Genital HPV more common in men Higher genital HPV prevalence in men vs women Duration/clearance of initial HPV infection is similar Men: lower immune response to natural infection More new HPV infections? More re-activation of persistent HPV infection?

HPV-Related Oropharyngeal Cancers HPV-related oral cancers have more than doubled in the past 20 years. Most due to HPV-16 Expected to exceed Cervical Ca by 2020 Chatuverdi AK, et al. J Clin Oncol. 2011;29:4294-4301.

Monitoring Impact of HPV Vaccine HPV-associated Outcomes Early Outcomes (years) HPV Prevalence Genital warts Mid Outcomes (years - decades) CIN/Precancers Late Outcomes (decades) HPV-associated Cancers

HPV Vaccine: Early Evidence of Impact in Australia Genital warts in women < 21 years old decreased from 18.4% in 2004/2005 to 1.1% in 2013/20014 (P < .001) Chow EP, et al. Sex Transm Infect. 2015;91:214-219.

Early impact in NZ AKL study: decrease in new cases of genital warts among young women attending SHC from 2007-2013 Larger drop among young Māori & Pacific women (93.4% less in vaccine-era) cf to NZ European women (80.2%) HPV vaccine rates for Māori & Pacific girls in Auckland DHBs were notably higher than for others Much less impact for Auckland men Need 75-80% coverage for wider benefit, herd immunity HPV-related cancers in men who have sex with men

Goal: 75% HPV vaccine coverage National 3-dose coverage HPV4 at Dec 2016, 1990-2002

Vaccine Recommendations Aim is effective delivery of HPV vaccine to all Higher antibody levels in 9-14 yr olds vs 15-26 yr olds 2 dose schedule for under 15s: 0 & 6-12 months 3 dose schedule if older: 0, 2 months, 6 months Note 3 dose schedule if transplant/HIV aged 9-26 yr olds Catch-up programme up to 26 years (not 27) Start asap, rather than defer / miss opportunity Can use any HPV vaccine to complete the 3-dose series No need to restart if dosing was interrupted HPV9 not funded if already completed funded 3 doses x HPV4

HPV vaccine in primary care Non-immunised school-aged males in Year 9 and above Non-immunised people aged between 9 and 26 years who declined their school vaccination programme Those aged 14 years who are still eligible for a two-dose vaccine regimen before turning 15 years (when they then require the three-dose regimen) Those aged 26 years have limited opportunity to receive free vaccination; if 1st dose is given prior to turning 27 years, the funded 3-dose course can be completed

HPV Vaccine Recommendations For now … transplant patients, those receiving stem cell treatments & people who have received chemotherapy require 3 doses at zero, two and six months, regardless of age, unless an alternative schedule is advised If person aged under 14 years has already had two doses of HPV4 vaccine, a third dose of either HPV4 or HPV9 is required if the two doses were less than six months apart

Fake news and fear-mongering vs facts & science for centuries

Not yet vaccinated .. Refusers – focused on vaccine risk, biased towards information that supports their views, more likely to believe cover-up about serious events Skeptics – vaccine not necessary, disease not serious Delayers – not needed now, can we do it later? Eg child not sexually active Focus on ‘fence-sitters’: make it easy for them

HPV Vaccine Safety Millions of doses of HPV vaccine given worldwide Post-licensure monitoring Vaccine Adverse Event Reporting System Vaccine Safety Datalink Studies Pregnancy registries Only serious AES are syncope and anaphylaxis (3 per million doses) HPV9 slightly higher injection site reaction than HPV4

Ease Main Concern Elicit: “What’s your main concern about HPV vaccine?” “Do they really need it? Maybe we can wait until they’re a little older?” Acknowledge: “I get it, they’re young. I can see why you might think that they don’t yet need HPV vaccine.” Share your commitment: “But HPV vaccine protects against cancer. I think it’s really important.” Educate on what the research shows: “Children should get HPV vaccine at this age because younger children develop better protection. We want them to complete the 2- dose vaccine course way before there is any chance of being exposed to an infection that could lead to cancer.”

QUESTIONS?