Risk detection for high-grade cervical disease using Onclarity HPV extended genotyping in women, ≥21\u202fyears of age, with ASC-US or LSIL cytology.

Abstract

OBJECTIVES\nThere is growing interest in using human papillomavirus (HPV) genotyping as a risk-based triage approach for women with atypical squamous cells-undetermined significance (ASC-US) and low-grade squamous intraepithelial lesions (LSIL) cytology.\n\n\nMETHODS\nThis analysis includes 2807 subjects with ASC-US or LSIL cytology, ≥21\u202fyears, from the baseline phase of the Onclarity HPV trial. All women were referred to colposcopy/biopsy. Hierarchical-ranked prevalence and risk values, associated with high-grade cervical disease, were calculated based on extended genotyping.\n\n\nRESULTS\nHPV 16 carried the highest risk for cervical intraepithelial neoplasia grade 2 or worse (≥CIN2) in both the ASC-US and LSIL populations. Risk of ≥CIN3 and ≥CIN2 associated with the other 13 genotypes varied somewhat for women with ASC-US and LSIL, however, HPV 31, 18, 33/58, 51 and 52 appear to comprise an intermediate risk band. Risk associated with HPV 35/39/68, 45, and 56/59/66, in either cytology population, was relatively low and beneath the benchmark threshold risk for immediate colposcopy. Restricting the analysis to women 21-24\u202fyears, ≥25\u202fyears, or ≥30\u202fyears produced similar results.\n\n\nCONCLUSIONS\nHPV genotyping identified multiple risk bands for ≥CIN3 and ≥CIN2 in the ≥21\u202fyear-old ASC-US and LSIL populations. These results support a 1-year follow-up period to preclude immediate colposcopy for ASC-US or LSIL women positive for the lowest-risk HPV genotypes.