The HPV Vaccine Our Best Shot to Prevent Cervical Cancer Harold C. Wiesenfeld, MD,CM Department of Obstetrics, Gynecology and Reproductive Sciences-University of Pittsburgh Magee-Womens Hospital of UPMC Allegheny County Health Department, Pittsburgh, PA

Impact of Cervical Cancer United States: – Annual number of cases: 12,000 – 4,000 women die from cervical cancer each year (>10 per day) Worldwide: – Annual incidence: ~500,000 – Second most common cause of cancer death in women – ~270,000 deaths each year

HPV-Attributable Cancer Cases per Year

PAP Smears have Cut Cervical Cancer by 70% but ….. % of US Women > 25 Years old who have had a PAP Smear in the Last 3 Years National Center for Health Statistics, 2013

Winer, R. L. et al. Am. J. Epidemiol : ; doi: /aje/kwf180 Cumulative Incidence of HPV Infection from time of first sexual intercourse

Incident HPV Infection in Men Partridge et al J Infect Dis % 240 heterosexual male university students years old Univ of Washington, Seattle

Cumulative Incidence CIN 3/CA single HPV test at entry (HC II) Kaiser study women Khan et al JNC 2005;97:1072Pap NL/ASC/LSIL

HPV is Associated with ORAL CANCERS ORAL HPV- UNITED STATES (NHANES) Prevalence of HPV by genotype

HPV Vaccine Gardisil – Quadrivalent vaccine- 4 strains of HPV Cervarix – Bivalent vaccine- 2 strains of HPV Gardisil FDA approved in 2006 Both provide immunity against HPV 16 and 18 HPV 16 and 18 cause 70% of cervical cancers

Prophylactic Efficacy: GARDASIL Was 100% Efficacious Against HPV 16- and 18-related CIN 2/3 or AIS Populationn GARDASIL Cases n Placebo Cases Efficacy95% CI Protocol 005* %65.1–100 Protocol % – 100 FUTURE I2,20002, %78.5–100 FUTURE II5,30105, % † 80.9–100 Combined protocols 8,48708, % † 92.9–100 *Evaluated only the HPV 16 L1 VLP component of GARDASIL. † P-values were computed for the prespecified primary hypothesis tests. All p-values were 0% (FUTURE II); and efficacy against HPV 16/18-related CIN 2/3 is >25% (combined protocols).

General Population Impact: GARDASIL Reduced HPV 16- and 18-related CIN 2/3 or AIS HPV 16- or 18- Related CIN 2/3 or AISN GARDASIL or HPV 16 L1 VLP Cases N Placebo Cases % Reduction95% CI Prophylactic Efficacy* 9,34219, %93–100 HPV 16 and/or HPV 18 Positive at Day General Population Impact † 9, , %23–52

Fig 1 Proportion of Australian born women diagnosed as having genital warts at first visit, by age group, Hammad Ali et al. BMJ 2013;346:bmj.f2032 Works best in younger women, i.e. before sexual onset

HPV Vaccine- Current Recommendations March 2015 FEMALES: – Routine vaccination ages – Recommended ages MALES: – Routine vaccination ages – Recommended ages Vaccination through age 26: – Men who have sex with men – Immunocompromised

Overcoming Barriers to HPV Vaccination Fears/Concerns and Facts/Reality – No access to vaccine 85% of potential recipients had another vaccine – Vaccine is not safe Pre- and post-licensure data support safety – Not sold on vaccines Vaccines one of the greatest successes of modern medicine (e.g. polio) – Will encourage risky sexual behavior Studies confirm NO increase in risky sexual behavior after vaccination – My child is not/will not be at risk for STDs 47% of teens have had sexual intercourse 1 out of 3 teens have had sex in the previous 3 months 1 out of 6 teens have had 4 or more partners in their life Almost 1 in 2 did not use condom Nearly half of the 19 million STDs each year are in young people (15-24 years) Background check of future son-in-law? Chlamydia- Allegheny County 2013

Cervical Cancer Overview of the Problem

HPV Vaccine FDA approved for: Prevention of cervical cancer and cervical “pre-cancer” Prevention of vulvar and vaginal cancers Prevention of anal cancer Boys and Men