Abstract
We estimated the prevalence and incidence of 14 human papillomavirus (HPV) types (6/11/16/18/31/33/35/39/45/51/52/56/58/59) in cervicovaginal swabs, and the attribution of these HPV types in cervical intraepithelial neoplasia (CIN), and adenocarcinoma in situ (AIS), using predefined algorithms that adjusted for multiple-type infected lesions. A total of 10,656 women ages 15 to 26 years and 1,858 women ages 24 to 45 years were enrolled in the placebo arms of one of three clinical trials of a quadrivalent HPV vaccine. We estimated the cumulative incidence of persistent infection and the proportion of CIN/AIS attributable to individual carcinogenic HPV genotypes, as well as the proportion of CIN/AIS lesions potentially preventable by a prophylactic 9-valent HPV6/11/16/18/31/33/45/52/58 vaccine. The cumulative incidence of persistent infection with ≥1 of the seven high-risk types included in the 9-valent vaccine was 29%, 12%, and 6% for women ages 15 to 26, 24 to 34, and 35 to 45 years, respectively. A total of 2,507 lesions were diagnosed as CIN or AIS by an expert pathology panel. After adjusting for multiple-type infected lesions, among women ages 15 to 45 years, these seven high-risk types were attributed to 43% to 55% of CIN1, 70% to 78% of CIN2, 85% to 91% of CIN3, and 95% to 100% of AIS lesions, respectively. The other tested types (HPV35/39/51/56/59) were attributed to 23% to 30% of CIN1, 7% to 14% of CIN2, 3% to 4% of CIN3, and 0% of AIS lesions, respectively. Approximately 85% or more of CIN3/AIS, >70% CIN2, and approximately 50% of CIN1 lesions worldwide are attributed to HPV6/11/16/18/31/33/45/52/58. If 9-valent HPV vaccination programs are effectively implemented, the majority of CIN2 and CIN3 lesions worldwide could be prevented, in addition to approximately one-half of CIN1.
Highlights
We evaluated the attribution of the 14 human papillomavirus (HPV) types, which were tested for in the clinical trials (HPV6/11/16/ 18/31/33/35/39/45/51/52/56/58/59), the high-risk types that are present in a quadrivalent HPV6/11/16/18 L1 virus–like particle (qHPV) vaccine (HPV16/18), as well as those which are not present in any HPV vaccine (HPV35/39/51/56/59)
Attribution of 12 High-Risk HPV Types to Cervical Disease following histologic endpoints were included in the analyses reported here: cervical intraepithelial neoplasia (CIN) grade 1 to 3, and/or adenocarcinoma in-situ (AIS)
For the HPV types contained in the 9-valent HPV (9vHPV) vaccine, the overall prevalence was 25%, 20%, and 13% in these 3 age groups
Summary
Following the completion of 3 worldwide clinical studies conducted in more than 20,500 women ages 16 to 26Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina. 18Department of Obstetrics and Gynecology, University Central Hospital, Helsinki, Finland. 19Faculty of Tropical Medicine, Mahidol University, Thailand. 20Direction des Risques Biologiques et de la Sante au travail, Institut National de Sante Publique du Quebec, Montreal, Quebec, Canada. 21Department of Pathology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico. 22Department of Obstetrics and Gynecology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico. 23Merck & Co., Inc., Whitehouse Station, New Jersey. 24Universidad del Rosario, Bogota, Colombia.Note: Supplementary data for this article are available at Cancer Epidemiology, Biomarkers & Prevention Online (http://cebp.aacrjournals.org/).Ó2014 American Association for Cancer Research.prevention of HPV6/11-related genital warts, and HPV16/18-related cervical cancers and precancers. Prevention of HPV6/11-related genital warts, and HPV16/18-related cervical cancers and precancers. It was subsequently approved in 2008 for preventing vulvar and vaginal cancers and precancers [4]. The indication was further expanded to males ages 9 to 26 years for the prevention of genital warts and to males and females ages 9 to 26 years for the prevention of anal cancers and precancers attributed to HPV6/11/16/18 [5, 6]. The qHPV vaccine has been shown to be safe and highly efficacious in preventing anogenital infection and neoplasia in women ages 24 to 45 years [7]. We estimated the prevalence and incidence of 14 human papillomavirus (HPV) types (6/11/ 16/18/31/33/35/39/45/51/52/56/58/59) in cervicovaginal swabs, and the attribution of these HPV types in cervical intraepithelial neoplasia (CIN), and adenocarcinoma in situ (AIS), using predefined algorithms that adjusted for multiple-type infected lesions
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