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Many double-test studies showed that HPV testing is more sensitive but less specific than cytology for detecting high-grade cervical intraepithelial neoplasia (CIN). Four randomized controlled trials (RCTs) showed reduced detection of high-grade CIN in a second round after HPV-based than after cytology-based screening. This proves that HPV-based screening allows earlier diagnosis of persistent high-grade CIN. A pooled follow-up of these 4 RCTs (176,464 women followed-up for a median 6.5 years) provided direct evidence of greater protection against invasive cervical cancer (ICC): the ICC incidence ratio (HPV vs. cytology arm) was 0.60 (95% 0.40-0.89) considering all the follow-up and 0.45 (0.25-0.81) considering only the period ≥ 2.5 years from recruitment. There was no heterogeneity between studies as for the effect on cancer incidence but there was (p<0.0001) as for the biopsy rate, that was double with HPV than with cytology in the in the only RCT that used direct referral of all HPV+ women to cytology but similar in the remaining 3 that applied a triage. The cumulative incidence of ICC was 8.7 x 10-5 within 5.5 years after a negative HPV test, about half than that within 3.5 years after normal cytology (15.4 x 10-5). This shows that the screening interval can be safely prolonged to 5 years when it is 3 years with cytology. Longer follow-up of high-grade CIN suggests that the interval could be safely prolonged to 10 years when the interval with cytology is 5. Data from one RCT (but not from another one) are consistent with greater over-diagnosis of spontaneously regressive CIN in younger women. However, the greatest gain in protection with HPV was at age 30-34 years.
Following these results, a pilot study of HPV-based screening routine implementation is almost concluded in the UK. A decision to move to HPV in routine activity has been taken in the Netherlands, in Sweden and in Italy. In Italy 8% of women invited in organised cervical screening programmes in 2012 were invited for HPV, increasing to 10% in 2013 and 13% in 2014.
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