Primary cervical cancer screening with human papillomavirus: End of study results from the ATHENA study using HPV as the first-line screening test

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 cytology and 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-year CIR of CIN3 + in cytology-negative women was 0.8% (95% CI; 0.5-1.1%), 0.3% (95% CI 0.1-0.7%) in HPV-negative women, and 0.3% (95% CI; 0.1-0.6%) in cytology and HPV negative women. The sensitivity for CIN3 + of cytology was 47.8% (95% CI; 41.6-54.1%) compared to 61.7% (95% CI; 56.0-67.5%) for the hybrid strategy (cytology if 25-29 years and cotesting with cytology and HPV if >= 30 years) and 76.1% (95% CI; 70.3-81.8%) for HPV primary. The 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%) for cytology, hybrid strategy, and HPV primly, respectively. Although HPV primary detects significantly more cases of CIN3 + in women >= 25 years than either cytology or hybrid strategy, it requires significantly more colposcopies. However, the number of colposcopies required to detect a single CIN3 + is the same as for the hybrid strategy. Conclusions. HPV primary screening in women >= 25 years is as effective as a hybrid screening strategy that uses cytology if 25-29 years and cotesting if >= 30 years. However, HPV primary screening requires less screening tests. (C) 2014 The Authors. Published by Elsevier Inc.