OBJECTIVE: To investigate the risk of cervical precancer and cancer associated with detection of human papillomavirus (HPV) 6, 11, and 42.
METHODS: We used data from the New Mexico Human Papillomavirus Pap Registry. A stratified sample of 59,644 residual cervical cytology specimens from a population of 379,000 underwent HPV genotyping. We measured the 3-year cumulative incidence of cervical intraepithelial neoplasia grade 2 or more severe (CIN 2+) and grade 3 or more severe (CIN 3+) after detection of single HPV 6, 11, or 42 infections or single or multiple infections of HPV 6, 11, or 42 (“HPV 6, 11, 42, or combinations”; n=581).
RESULTS: The overall prevalence of a single infection of HPV 6, 11, or 42 was 0.8% (95% confidence interval [CI] 0.7–0.9%). The 3-year risks of CIN 2+ and CIN 3+ after HPV 6, 11, 42, or combinations infections (n=581) were 0.4% (CI 0.1–0.7%) for CIN 2+ and 0.0% for CIN 3+ (nota bene, no CI was calculable because no events occurred), respectively. By comparison, the 3-year risks of CIN 2+ and CIN 3+ after a negative HPV result (n=27,522) were 0.2% (95% CI 0.1–0.2%) and 0.1% (95% CI 0.0–0.1%), respectively.
CONCLUSION: Detection of HPV 6, 11, 42, or combinations in the absence of high-risk HPV types does not identify women at increased 3-year risk for cervical precancer. Testing for HPV 6, 11, 42, or combinations of those types should be discontinued because it has no proven benefit to patients.
LEVEL OF EVIDENCE: II
Human papillomavirus 6, 11, and 42 testing does not meaningfully predict the development of cervical precancer and therefore should not be included in cervical cancer screening.
Albert Einstein College of Medicine, New York, New York; and the University of New Mexico Health Sciences Center, Departments of Pathology and Obstetrics and Gynecology, House of Prevention Epidemiology, Albuquerque, New Mexico.
Corresponding author: Cosette M. Wheeler, PhD, Department of Pathology and Department of Obstetrics and Gynecology, House of Prevention Epidemiology, MSC 02-1670, 1816 Sigma Chi Road NE, Albuquerque, NM 87131; e-mail: email@example.com.
* For a list of members of The New Mexico HPV Pap Registry Steering Committee, see Appendix 1 online at http://links.lww.com/AOG/A451.
Philip E. Castle is a Visiting Professor at the Albert Einstein College of Medicine, New York, New York.
Supported by the National Institute of Allergy And Infectious Diseases of the National Institutes of Health under Award Number U19AI084081 to Cosette M. Wheeler.
Financial Disclosure Dr. Castle has received human papillomavirus (HPV) tests and testing for research at a reduced or no cost from Qiagen and Roche. He has been personally compensated for serving as a member on a Data and Safety Monitoring Board for Merck and has been compensated as a consultant for BD, Cepheid, Roche, and Gen-Probe. Dr. Wheeler has received funds through the University of New Mexico for grants and cooperative agreements from the National Institutes of Health related to cervical screening, funds from GSK for HPV vaccine studies, and reimbursements for travel related to publication activities and equipment and reagents from Roche Molecular Systems for HPV genotyping. The other authors did not report any potential conflicts of interest.
Roche Molecular Systems, Inc provided HPV LINEAR ARRAY Genotyping Test and equipment to automate HPV genotyping assays.
The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.