Prevalence and genotype distribution of human papillomavirus infection of the cervix in Spain: The CLEOPATRE study


  • Conflicts of interest: Xavier Castellsagué received speaking honoraria, and research and travel grants from Sanofi Pasteur MSD, GSK and Merck & Co. Thomas Iftner received Institutional research grants from Gen-Probe, GSK, Hologic, Roche and Sanofi Pasteur MSD. Javier Cortes has received speaking honoraria, as well as research and travel grants from Sanofi Pasteur MSD, GlaxoSmithKline and Qiagen. Esther Roura has received travel grants from GlaxoSmithKline and Sanofi Pasteur MSD. José Antonio Vidart has received speaking honoraria, as well as research and travel grants from Sanofi Pasteur MSD. Susanne K. Kjaer received lecture fees, advisory board fees, and institutional research grants from Sanofi Pasteur MSD and Merck & Co. F. Xavier Bosch received advisory board fees from MSD, speaking honoraria from GlaxoSmithKline and Sanofi Pasteur MSD as well as educational grants from GlaxoSmithKline, MSD and Sanofi Pasteur MSD. Nubia Muñoz received advisory board and steering committee fees from Merck and Sanofi Pasteur MSD. Santiago Palacios received advisory board fees or speaker honoraria from Amgen, Arkopharma, Bayer Schering Pharma, Boehringer-Ingelheim, Daiichi-Sankyo, Lilly, Pfizer, Roche, Servier, Sanofi Pasteur MSD and Warner Chilcott. He has also received research grants and/or consulting fees from Amgen, Arkochim, Bayer Schering Pharma, Daiichi-Sankyo, Lilly, Pfizer and Servier. Maria San Martin Rodriguez, Laurence Serradell, Laurence Torcel-Pagnon are employees of Sanofi Pasteur MSD, provider of the HPV quadrivalent vaccine approved in the European Union. The study was supported by Sanofi Pasteur MSD.


Human papillomavirus (HPV) infection is a necessary cause of cervical cancer. The aim of this study was to estimate the prevalence of cervical HPV infection and HPV type-specific distribution among women attending cervical cancer screening in Spain during 2007 and 2008. Women aged 18–65 years were recruited according to an age-stratified sampling method. Liquid-based cervical samples were collected and analyzed for cytology, HPV detection, and genotyping. HPV genotyping was determined using the INNO-LiPA HPV Genotyping Extra Reverse Hybridization Line Probe Assay. Prevalence estimates were age-standardized using 2001 Spanish census data. The present study included 3,261 women. Age-standardized HC2-based HPV prevalence was 14.3% (95% CI, 13.1–15.5) among women aged 18–65 years, and 28.8% (26.6–31.1) among women aged 18–25 years. High-risk HPV types were detected in 12.2% (95% CI, 11.1–13.4) of HPV-tested women, representing 84.0% of HPV-positive samples. Multiple infections were present in 4.1% (95% CI, 3.4–4.8) of HPV-tested women (25.0% of HPV-positive samples). The most common high-risk HPV-types among HPV-tested women were 16 (2.9%), 52 (1.8%), 51 (1.6%), 31 (1.3%), and 66 (1.2%). HPV-type 16 was present in 16.9% of HPV-positive samples. One or more of the HPV vaccine types 6/11/16/18 were detected in 3.8% of HPV-tested women (22.1% of HPV-positive samples). Though not a true population-based survey, this study provides valuable baseline data for future assessment of the impact of current HPV vaccination programs in Spain. The high prevalence of HPV infection among young women may reflect recent changes in sexual behavior. J. Med. Virol. 84:947–956, 2012. © 2012 Wiley Periodicals, Inc.