Risk of High-Grade Cervical Intraepithelial Neoplasia Using human Papillomavirus Extended Genotyping in Chinese Women...

To evaluate the risk of cervical intraepithelial neoplasia, grade 2 or worse (≥ CIN2) in women with normal cervical cytology using extended high-risk human papillomavirus (HR-HPV) genotyping. This study is a population-based, nationwide, multi-center prospective cohort study. A subset of 6853 women with normal cytology and HPV testing results using an extended genotyping assay were included in the analysis. The odds ratio (OR) and adjusted OR (aOR) was calculated using univariate analyses and multivariate logistic regression, with HPV negative and other 9 HR-HPV-positive genotypes (HPV 31, 35, 39, 45, 51, 56, 59, 66, and 68) as reference, respectively. The 3-year cumulative absolute risk was calculated. Over the study period, 87 ≥ CIN 2 cases were identified. Most ≥ CIN 2 cases were positive for HPV 16 (50.6%) or HPV 33/52/58 (46.0%) at baseline. Compared to other 9 h-HPV, HPV 16 (aOR = 20.5, 95% CI: 8.5-49.5), HPV18 (aOR = 10.1, 95% CI: 3.2-31.8), and HPV 33/52/58 (aOR = 4.8, 95% CI: 2.0-11.8) were significantly associated with higher risk of ≥ CIN 2. HPV 16 and 33 had the highest cumulative absolute risk of ≥ CIN2 (25.9% and 22.2%), followed by HPV 18 (15.4%), HPV 58 (11.3%), and HPV 52 (8.1%). Other 9 h-HPV had a lower risk of ≥ CIN 2 (4.7%). Extended HPV genotyping beyond HPV 16/18 (e.g., HPV 33, 52, and 58) might be effective for risk stratification in women with normal cervical cytology. The management of HPV-positive women based on refined genotype-based risk estimations may be a promising strategy for cervical cancer screening. The study was registered at the Chinese Clinical Trial Registry Center of the World Health Organization International Clinical Trials Registry Platform (Registration number ChiCRT2200055287).