Prospective cohort study on the value of high-risk human papillomavirus viral load and subtype tests in predicting cervical intraepithelial neoplasia / 中国肿瘤临床

ABSTRACT

Objective:To evaluate high-risk human papillomavirus (hrHPV) genotyping and viral load in predicting CIN (cervical intraepi-thelial neoplasia (CIN) grade 2 or worse in a Chinese rural area population with limited health resources. Methods:We performed a population-based prospective study and enrolled 2,257 women aged 35 to 64 years from three rural screening sites of Jiangxi prov-ince. We conducted a hybrid capture (HC-2) assay to predict viral load. A HC-2 relative light unit (RLU) threshold of 10 was set to differ-entiate samples between low (<10) and high (≥10) viral loads. We also carried out a HybriMax test to detect different hrHPV geno-types in the samples. Women exhibiting positive HC-2 or HybriMax results underwent colposcopy and colposcopically directed biopsy. Women with negative or positive hrHPV test results but with normal biopsy or CIN1 were followed-up for 24 months without interven-tion (n=2,211). We used histopathological findings as outcome. Results:Of the 2,211 women, 1,636 provided complete follow-up data. Of the 132 women with a high viral load, 4 (3.03%) developed CIN2+in the same period. The relative risk (RR) of CIN2+for HC-2 posi-tivity at baseline was 42.24 (95%CI=4.76-375.2). Of the 159 women who were positive for HPV16 or HPV18 upon screening, 4 (2.52%) progressed to CIN2+(RR=33.06, 95%CI=3.72-293.9). The 2-year cumulative incidence rates of CIN2+did not significantly differ be-tween the high viral load group and the HPV16/18 group. Conclusion:The risks of CIN2+progression were higher among women with a high viral load or HPV16/18 positivity than among women with negative hrHPV. Increasing the HC-2 cut-off value to 10 RLU or using HPV16/18 positivity may be similarly used to triage hrHPV-positive women for immediate colposcopy and comprehensive follow-up.Both approaches were equally predictive of the CIN2+risk in rural area. Increasing the HC-2 cut-off value to 10 RLU may also help allo-cate health resources effectively.