Absolute risk of a subsequent abnormal pap among oncogenic human papillomavirus DNA-positive, cytologically negative women.

BACKGROUND

The addition of human papillomavirus (HPV) DNA testing to cytologic screening for cervical carcinoma is now being considered. The majority of women in screening cohorts who test positive for oncogenic types of HPV DNA have concurrent negative Pap tests. The absolute risk of a subsequent abnormal Pap test for these women is uncertain. Therefore, the proper counseling and clinical management of these women is also uncertain.

METHODS

A subcohort of 2020 women with a negative Pap test who tested positive at enrollment for oncogenic HPV DNA types using the Hybrid Capture 2 Test were followed for 57 months at Kaiser Permanente (Portland, OR). Absolute risks of new abnormal cytologic interpretations were computed using Kaplan-Meier methods. Logistic regression models were used to evaluate determinants of a new abnormal Pap test.

RESULTS

The cumulative incidence for a Pap test interpreted as atypical squamous cells or more severe (>or= ASC) was 16.8% (95% confidence interval [CI] = 15.0-18.6%), 6.4% (95% CI = 5.2-7.6%) for low-grade squamous intraepithelial lesions or more severe, and 2.2% (95% CI = 1.5-2.9%) for high-grade squamous intraepithelial lesions or more severe. By comparison, the cumulative incidence of greater than or equal to ASC among HPV-negative women was 4.2% (95% CI = 3.9-4.6%). The highest viral load (100 relative light units per the positive control or greater) was associated with a greater risk of an abnormal Pap test (odds ratio= 2.7, 95% CI = 1.7-4.1) than lower viral loads.

CONCLUSIONS

These results suggest that about 15% of women in annual screening programs who concurrently have a negative Pap test and a positive oncogenic HPV test will have a subsequent abnormal Pap test within 5 years. This risk estimate will be useful to the many clinicians and patients likely to be diagnosed with an HPV infection and negative cytology if HPV DNA is added to general screening.