Goals. In the News. Primary HPV Screening 3/9/2015. Your PAP and HPV Update Primary HPV Testing- Screening Intervals- HPV Vaccine Updates-

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Your PAP and HPV Update 2015 Connie Mao, MD University of Washington Goals Primary HPV Testing- Is it time to stop doing pap smears? Screening Intervals- Should patients have a choice?

e 2 doses enough? Can vaccination prevent dysplasia? In the News HEAL

1 Your PAP and HPV Update 2015 Connie Mao, MD University of Washington Goals Primary HPV Testing- Is it time to stop doing pap smears? Screening Intervals- Should patients have a choice? HPV Vaccine Updates- 9 Valent vaccines Are 2 doses enough? Can vaccination prevent dysplasia? In the News HEALTH New York Times F.D.A. Panel Recommends Replacement for the Pap Test (Roche Cobas) By Andres Pollack MARCH 12, 2014 Primary HPV Screening Four randomized trials 176,464 women yrs. HPV or cytology in Sweden, Netherlands, England and Italy followed 6.5 years median 60-70% greater protection with HPV against invasive cancer compared to pap test. Largest gain was in protection against AdenoCa and women ages Lancet ;

2 Cumulative detection of invasive cervical carcinoma. The Lancet, Volume 383, Issue 9916, 2014, Athena Trial Over 47,000 women, 21 and older screened with Pap and HPV test Colposcopy for any abnormal Pap or positive HPV x3 years HPV more sensitive, less specific Co-test only increases sensitivity <5% compared to HPV only with 1/3 more positives Triage using 16/18 is better than cytology to detect CIN2+ Stoler, Am J Clin Path 2011; 135(3):468 Interim Guidelines Primary HPV screening with Cobas HPV Begin at age 25 Screen every 3 years Women ages % had positive HPV test 7% abnormal if cytology alone Huh, Obstet Gynecol 2015; 125: Question #1 26 yo with Positive HPV test, HPV 16/18 negative 1. Colposcopy 2. Pap smear 3. HPV test one year 4. Repeat co-test one year 2

Performance of Screening Strategies in Women Aged 25 Years No. of CIN3 Detected Strategy Total At Baseline Years 1-3 Total Missed CIN3 No. of Screening Tests No.

3 Performance of Screening Strategies in Women Aged 25 Years No. of CIN3 Detected Strategy Total At Baseline Years 1-3 Total Missed CIN3 No. of Screening Tests No. of Colpos Colpos per CIN3 Cytology , Cotesting , HPV with genotyping and reflex cytology , Total Number CIN3 Cases 347 Wright and Stoler Gyn Oncol 2015 (136): Is it time to start HPV primary screening? Need Cobas test Reduces number of tests overall Increases colpo numbers especially younger women age Vaginal screening is an option for women who have difficulty with exams however consider what you will do with results. How Often to Screen? 74% of Women surveyed thought women their age should have yearly cytology 68% willing to extend interval to every 3 years if recommended by health professional Silver, Obstet Gynecol :

4 Question #2 Which screening method provides the best protection from cervical cancer death? 1) Pap Smear every year 2) Pap Smear every 3 years 3) Co-test every 5 years Is Five Years Too Long? Cancer Risk age Pap % After 12 mo Co-test 0.007% After 3 yr 0.02% After 36 mo 0.014% After 5 yr Gage, J Natl Cancer Inst 2014: 106 What Would You Choose? 5 yr Co-test 575 colpo/1000 women 3 Year Co-test 824 colpo/1000 women Additional 249 Colposcopy Procedures Every additional cancer would require 92 Colposcopy and 3.2 Treatments Every cancer death prevented would be 409 additional Colposcopy and 14.3 additional treatments Risks and Benefits of More Screening Benefits Decrease cancer rates Increase detection precursor lesions Reduce anxiety of false negative tests Harms Cost Too many procedures Overtreatment pregnancy risks Increased anxiety, pain Kinney, Obstet Gynecol 2015 (125)

Changing risk in vaccine era Question #3 16 year old has received 2 doses of Gardasil 1) Continue with 3 rd

5 Questions Remaining Modeling has limitations, especially over time, unable to do randomized trial given rare cancers. Should cost be a factor? Morbidity of procedures? Over treatment? Changing risk in vaccine era Question #3 16 year old has received 2 doses of Gardasil 1) Continue with 3 rd dose and lifetime screening 2) Change to Gardasil 9 and 1 more dose 3) Change to Gardasil 9 and 2 more doses 4) Change to Gardasil 9 and 3 more doses 5

6 9 Valent following 4 Valent Immunogenicity and Safety of 9valent vaccine post Gardasil. Randomized study. 613 received 9Valent post Gardasil 306 received placebo 98% immunogenicity, no difference in adverse events except more localized symptoms in 9Valent group Question #4 What patients may be candidates for 2 dose vaccine schedule 1)Age 9-26 years 2)Age <15 years 3)HIV positive patients 4)None of the above Presented IPV Aug 2014 Is 2 Does Enough? Canadian study 9-13yo 0,6 mo vs 0,2,6 mo GMT non inferior Girls 2 >Women 3 doses WHO document SAGE review 3/2014 approved 2 dose schedule if <15. Using 2 Doses HPV vaccine 2 doses 0 and 6 months Must be < age 15 Immune compromised should get 3 doses Need 6 mo to activate B cells 2 dose regiments approved in Europe, Africa, Latin America, Asia No information yet regarding longevity of protection and prevention of disease Dobsen Jama

7 Question #5 38 year old women s/p LEEP for CIN3 and s/p Laser x2 for VIN3. Will she benefit from HPV vaccination? 1) Yes 2) No 3) I don t know HPV Vaccine to Prevent Recurrent Cervical Dysplasia Retrospective review of vaccination post LEEP. 2.5% (197) vaccine group and 8.5%(211) non vaccine group developed recurrence 16/18 types. Retrospective analysis of the 4valent vaccine studies underwent cervical treatment. 6.6 in vaccine group 12.2 in non vaccine group had recurrent lesion. Woo Dae Kang, Gynec Oncology 2013 (130): Time to Detection of any HPV related disease HPV vaccine for Preventing Recurrent Vulvar Dysplasia 2617 women HPV seropositive, DNA negative, randomized to vaccine or none 15 in placebo developed lesions related to vaccine types, 0 in vaccine group, 100% VE Joura, BMJ 2012; 344. Olsson, Human Vaccines 2009 (5):

8 HPV Vaccines to Prevent Dysplasia Small retrospective studies with 4Valent, awaiting randomized trials for evaluate potential to prevent disease In theory may increase antibody response Insurance usually does not cover off label use 4Valent versus 9Valent, non inferior but most vulvar, anal lesions are HPV 16 Take Home HPV primary testing detects more CIN3 and prevents more cancers but higher rates of Colposcopy and Treatment especially in women age Interval of screening based on balance of benefits and risks likely to change over time. Gardasil 9 will provide increase coverage for cancers to close to 90%. 2 doses may be enough. 8

SESSION J4. What's Next? Managing Abnormal PAPs in 2014

SESSION J4. What's Next? Managing Abnormal PAPs in 2014 37th Annual Advanced Practice in Primary and Acute Care Conference: October 9-11, 2014 2:45 SESSION J4 What's Next? Managing Abnormal PAPs in 2014 Session Description: Linda Eckert, MD Review current guidelines