HPV genotype prevalence in low- and high-vaccine coverage, USA populations: Data from real-world cervical cancer screening using the Onclarity HPV assay

OBJECTIVE: HPV vaccination is an effective strategy for reducing both HPV infection and cervical disease. In the USA, vaccination with the 4-valent HPV vaccine (Merck) has led to a significant reduction in target genotypes HPV16 and 18. However, recent work suggests that vaccination can result in prevalence changes of HPV genotypes not targeted by vaccination (non-vaccine target types). Here we compared genotype prevalence results and HPV-associated cervical intraepithelial neoplasia grade 2 or worse (≥CIN2) results from low- and high-vaccine coverage USA populations. METHODS: Low-coverage vaccine population HPV genotype and ≥ CIN2 information was obtained from the Onclarity cervical cancer screening trial (USA; 2013-2014); high-coverage vaccine population data were collected across three clinical laboratories as part of real-world cervical cancer screening (USA; 2021-2023). Data were stratified into age groups: 21-29 (highest proportion of vaccinated individuals), 30-39, and ≥ 40 years. RESULTS: HPV16/18 genotype prevalence was significantly lower in the high-coverage population for individuals aged 21-29 years (2.3% versus 5.4%; p < 0.001) and 30-39 years (2.5% versus 3.6%; p < 0.001), whereas the prevalence of the Other 12 genotypes was significantly higher (29.8% versus 22.2%; p < 0.001) in the 21-29-year age group only. The overall prevalence of any HPV was higher in the high-coverage populations for the 21-29-year age group (31.1% versus 25.4%; p < 0.001). CONCLUSIONS: HPV vaccination is significantly impacting both vaccine and non-vaccine type prevalence, reducing the incidence of vaccine types with concomitant increase of certain non-target types. This apparent dynamic equilibrium has important implications for cervical cancer screening and future incidence of cervical disease.