Primary Cervical Cancer Screening With Human Papillomavirus

Abstract

article i nfo Objectives. ATHENA evaluated the cobas HPV Test as the primary screen for cervical cancer in women ≥25 years. This reports the 3-year end-of-study results comparing the performance of HPV primary screening to different screening and triage combinations. Methods.42,209 women ≥25 years were enrolled and had cytologyand hrHPV testing. Women with abnormal cytology (≥atypical squamous cells of undetermined significance) and those HPV positive were referred to colposcopy. Women not reaching the study endpoint of CIN2+ entered the 3-year follow-up phase. Results.3-yearCIRofCIN3+incytology-negativewomenwas0.8%(95% CI;0.5-1.1%),0.3%(95%CI0.1-0.7%) in HPV-negative women, and 0.3% (95% CI; 0.1-0.6%) in cytology and HPV negative women. The sensitivity for CIN3+ of cytologywas 47.8% (95%CI;41.6-54.1%) compared to 61.7% (95% CI;56.0-67.5%) for thehybrid strat- egy (cytology if25-29yearsandcotestingwithcytologyandHPVif ≥30 years) and76.1% (95% CI; 70.3-81.8%) for HPV primary .T he specificity for CIN3+ was 97.1% (95% CI; 96.9-97.2%), 94.6% (95% CI; 94.4-94.8%), and 93.5% (95% CI; 93.3-93.8%)forcytology,hybrid strategy,andHPV primary, respectively. Although HPV primary detects sig- nificantlymorecasesofCIN3+inwomen ≥25 years than eithercytologyorhybrid strategy,itrequiressignificantly more colposcopies. However, the number of colposcopies required to detect a single CIN3+ is the same as for the