Objective: To assess the risk of cervical intraepithelial neoplasia grades 2, 3 or higher (CIN 2/3+) for women with normal cytology and concurrent high-risk human papillomavirus infection (HR-HPV).
Material and methods: We examined 2 200 women every 6 months for an average of 9 years. Cervical smears and samples for HPV DNA were obtained at each visit. Absolute risk of subsequent CIN2/CIN3+ was estimated using the Kaplan-Meier method.
Results: The absolute risk of CIN2/CIN3+ among HR-HPV-positive women with normal Pap smear results was 1.06% (95%CI, 0.57-2.20), 5 times higher the risk among all women with normal Pap smears (0.20%; 95%CI, 0.12-0.32) but 7 times lower than that for women with HR-HPV infection and LSIL (7.24%; 95%CI, 3.78-15.2).
Conclusion: Short-term absolute risk of CIN2/3+ after a normal Pap smear with concurrent HR-HPV infection is low (~1%), suggesting that the HR-HPV test has limited utility in short-term clinical decision-making for women with normal cytology.