Table 1.
HPV FOCAL S5 methylation case–control study design
| Description | Number in case–control study | Number in HPV FOCAL population (Intervention & Safety Arms combined) | ||
|---|---|---|---|---|
| Baseline HC2+ (all) | 1290 (8.2%) | |||
| Group 1 HC2+/LBC ≥ASCUS (“HPV prevalent/abnormal cytology group”; all CIN2/3 in this group were identified at the baseline screen) | 104 | 481 (466 attended colposcopy) |
||
| 54 CIN2/3 | 50 <CIN2 | 150 CIN2+ (32.2%) | 316 <CIN2 (67.8%) | |
| LBC NILMa | 809 (753 attended 12 mo. subsequent screen) | |||
| Group 2 HC2+ and/or LBC ≥ASCUS at 12 mo. subsequent screen (“HPV persistence group”; all CIN2/3 in this group were identified at the 12 mo. subsequent screen) | 103 | 422 (56%) (403 attended colposcopy) | ||
| 53 CIN2/3 | 50 <CIN2 | 92 CIN2+ (22.8%) |
311 <CIN2 (77.2%) |
|
| Group 3 HC2 negative and LBC NILM at 12 mo. subsequent screen (“HPV clearance group”) Colposcopy was not performed after subsequent screen; this group was assumed to be <CIN2b. | 50 | 331 (44.0%) | ||
| 50 <CIN2 | ||||
| Baseline HC2 negative (all) | 14,454 | |||
| Total | 257 | 15,744 | ||
HC2: hybrid capture 2 high‐risk HPV test; LBC: liquid‐based cytology; ASCUS: atypical squamous cells, undetermined significance; NILM: negative for intraepithelial lesions and malignancy; CIN: cervical intraepithelial neoplasia. CIN2+: includes CIN2, CIN3 and invasive cancer.
a
Groups 2 and 3 were selected from this trial subset.
b
Passive follow‐up through the screening registry of women in this group revealed five women who were subsequently referred to colposcopy in the seven to nine years after baseline with no CIN2+ lesions detected.