HPV as Primary Screening for Cervical Cancer: Ready for

Prime Time?

ACOG Annual Clinical MeetingMay 4, 2015

Educational Objectives

• Proposed use of new FDA approved primary HPV screening test

• Advantages of primary HPV screening• Disadvantages of primary HPV screening

The Panel

• Kevin Ault, MD - University of Kansas• Lori Boardman, MD - University of Central

Florida• Francisco Garcia, MD, MPH – Director and

CMO, Pima County Health Department• Moderator – David Chelmow, MD - Virginia

Commonwealth University

Disclosures

• Ault – Site PI for clinical trials sponsored by Merck, Hologic, Roche, and Gen Probe until 2014*

• Boardman – none• Garcia – Site PI for clinical trials by Merck,

Hologic, Roche, Innovio and Photocure 1999-2013*

• Chelmow – none

*All payments directly to University

Current recommendations

• USPSTF – Cytology alone or co-testing

• ACS (ACOG) – Co-testing preferred– Cytology alone acceptable

• Primary HPV testing discussed at 2012 ACS consensus conference, but not included in recommendation

Labeling- Primary Screening

• Women 25 and older• Positive for HPV 16 or 18 - colposcopy• HPV positive but 16/18 negative - cytology• Negative tests “should be followed up in

accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines”

Obstetrics and Gynecology February 2015. Joint publication in Gynecologic Oncology and Journal of Lower Genital Tract Disease pending

Interim Guidance

• “. . . can be considered as an alternative to current US cytology based cervical cancer ‐screening methods”

• Manage positive tests as per labelling• Rescreen after negative test “no sooner than

every 3 years”• Do not use prior to age 25