HPV16/18 prevalence in high-grade cervical lesions in an Australian population offered catch-up HPV vaccination.

Using laser capture microdissection (LCM) and sensitive human papillomavirus (HPV) genotyping, we aimed to determine the distribution of vaccine-preventable types in cervical intraepithelial neoplasia grade 3 (CIN3) lesions and adenocarcinoma in situ (AIS) in young women in Victoria, Australia, offered catch-up HPV vaccination, as a baseline for ongoing vaccine impact monitoring. We also compared findings with available pre-vaccination estimates from women with HPV detected on concurrently-collected cytology samples. Consecutive histologically-confirmed CIN3/AIS biopsies were collected between May 2011 and December 2014 from vaccine-eligible women (born after 30th June 1981). Genotypes present in whole tissue sections (WTS) were determined by a sensitive reverse hybridisation assay; RHA kit HPV SPF10-LiPA25, v1 (Labo Bio-medical Products). Where multiple genotypes were detected, lesions were isolated using LCM and genotyped. Cervical cytology samples from a pre-vaccine cohort had been previously collected and genotyped using HPV Linear Array HPV Genotyping Test (Roche Diagnostics). Mixed-genotype detections in this cohort were resolved to single-lesion-attributable genotypes using hierarchical attribution. Overall, 213 and 530 cases were included from pre- and post-vaccine time-periods, respectively. In 18-25 year-olds, the proportion of HPV16/18-positive CIN3/AIS decreased significantly over time from 69% in 2001-2005 (pre-vaccine), to 62% in 2011-2012 (post-vaccine), to 47% in 2013-2014 (p-trend = 0.004). There was no significant change in HPV16/18 in 26-32 year-olds (p-trend = 0.15). In 2013/14, nonavalent vaccine types accounted for 80% of CIN3/AIS in 18-25 year old women and 90% in 26-32 year old women. Four to 8 years following implementation of HPV vaccination in Australia, approximately 70% of CIN3/AIS in young women was due to HPV16/18. Our data, despite some limitations due to change in methods between pre- and post-vaccine periods, suggests that for vaccine-eligible women aged 18-25 at the time of biopsy, the proportion of HPV16/18-attributable CIN3/AIS lesions is significantly declining post-vaccination.

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Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Professor Suzanne Garland, has received Grants to her institution to measure vaccine impact and effectiveness in a young women’s study and as an Investigator Initiated grant from Merck. She has received speaking fees from MSD for work performed in her personal time and is a member of the Merck HPV Global Advisory Board. Alyssa Cornall is an investigator on a research study funded by Seqirus (cervical cancer typing study) and has received an educational grant from Seqirus. Julia Brotherton reports employment as the Medical Director of the National HPV Vaccination Program Register, which was owned and funded by the Australian Government Department of Health. Julia Brotherton and Sepehr Tabrizi have been investigators on investigator-initiated HPV epidemiology studies which have received unrestricted partial funding for laboratory components from Seqirus (cervical cancer typing study) and Merck (recurrent respiratory papillomatosis study) but have never received any personal financial benefits. Sepehr Tabrizi also reports grants from The Royal Women's Hospital during the conduct of the study. C. David Wrede is the Deputy Chair of VCS Foundation Pty Ltd and a Board member since 2010, he has received sponsorship and honoraria from Seqirus. All authors attest they meet the ICMJE criteria for authorship.