Recurrent human papillomavirus infection detected with the hybrid capture II assay selects women with normal cervical smears at risk for developing high grade cervical lesions: A longitudinal study of 3,091 women

Abstract

To test the reliability of the Hybrid Capture II (HC‐II) assay detecting 13 high‐risk human papillomavirus (HR‐HPV) types for the screening of cervical lesions, we monitored by cytology, HR‐HPV testing, colposcopy and biopsy, 3,091 women with normal smears at the first entry. Our primary endpoint was clinical progression defined as the presence of a high‐grade lesion (HGSIL) at the biopsy. In our population of 659 HR‐HPV‐infected women, 241 (36.6%) had a positive HR‐HPV test at 2 to 4 examinations with a final histological diagnosis of HGSIL in 51 cases (21.2%) within 4 to 36 months, while women with regressive HPV infection did not develop any lesion during the same period. In the cohort of 2,432 women testing negative for HR‐HPV infection, only 2 women (0.08%) developed a HGSIL. Both were HR‐HPV positive 18 and 24 months after the first entry, at the time of diagnosis of disease. The RR of incident HGSIL when a HR‐HPV was detected at enrollment in women with normal smears was 96.7 (95% CI, 95.8–97.7). The RR increased to 237.3 (95% CI, 222.8–251.8) when the HR‐HPV test remained positive at 2 controls, and to 314.3 (95% CI, 260.7–367.9) when the HR‐HPV test was positive at 3 controls. The evaluation of the viral load of HR‐HPV by the HC‐II did not represent a sensitive approach to predict the recurrence of HR‐HPV infection and/or the apparition of HGSIL. Nevertheless, a recurrent HR‐HPV infection detected with HC‐II represents a reliable tool to select populations at risk for the development of HGSIL.